# https://zjbocon.com/ llms-full.txt

## Ethylene Oxide Solutions
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##### **HANGZHOU BOCON MECHANICAL AND ELECTRICAL EQUIPMENT CO., LTD.**

# Since 2006  One-stop Solution Supplier Products of Ethylene Oxide Sterilization

[Contact us](https://zjbocon.com/contact/)

**About Us**

## 20 Long Years Of [Manufacturing Ethylene Oxide Sterilization](https://zjbocon.com/eto-sterilizer-manufacturer-hzbocon/)!

Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd. is located in Hangzhou, Zhejiang Province, specializes in the research, development, manufacturing, and installation of Ethylene Oxide Sterilization eto sterilization equipment. We also provide comprehensive eto sterilization solutions and MES systems for sterilization stations. With nearly 20 years of sterilization experience and technical expertise, we are dedicated to delivering high-quality, reliable Ethylene oxide sterilizers and associated facilities to our global clients. Our ethylene oxide sterilizer and related equipment with hot water circulation and hot air circulation heating methods use advanced and fully functional control systems to achieve automatic control. Has parameter release function in accordance with ISO 11135. The product undergoes strict quality control and testing to ensure compliance with international requirements such as ISO13485 and EN 1422.

[About BOCON](https://zjbocon.com/about/)

Our Products

### Ethylene oxide Sterilization machine, and we also offer a range of ancillary equipment, including preconditioning rooms, aeration rooms, EO gas scrubbers, and pioneering EO gas recovery and energy recovery technologies.

#### [Ethylene oxide sterilizer](https://zjbocon.com/product/eto-sterilzer/)

It is a type of Ethylene Oxide Sterilization equipment used in the healthcare and pharmaceutical industries to eliminate microorganisms from medical devices, instruments, and supplies that cannot withstand high temperatures or moisture. Ethylene oxide gas is the primary sterilizing agent used in this process

#### [Preconditioning rooms, aeration rooms](https://zjbocon.com/product/precondition-room/)

In order to improve sterilization efficiency and save energy consumption, we have launched a special set of sterilization products    Precondition and Aeration Room.

#### [EO gas scrubber for eo sterilizer](https://zjbocon.com/product/eo-scrubber/)

Eo gas scrubber, hzboconcan provides a controlled soulution to handling ethylene oxide gas , as low as 1mg/m3

## The only place where you l get the perfect Ethylene Oxide Sterilization solution for all your industry needs.

[BOCON Products](https://zjbocon.com/product/)

Zjbocon Main Products    Enhanced Images

## Our Products

Ethylene oxide sterilizer

![Pneumatic Sliding Door ETO Sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/01/eto_sterilizer_hzbocon_4.webp)

### Pneumatic Sliding Door ETO Sterilizer

Uses an inflatable seal for convenience and reliability. Automatically controlled by cylinders for safe operation without manual switching.

[Read More](https://zjbocon.com/product/eto-sterilzer/)

![Pneumatic Revolving Door ETO Sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/01/eto_sterilizer_hzbocon_2.webp)

### Pneumatic Revolving Door ETO Sterilizer

Features a semi-inflatable seal. A cylinder lifts the door 100-200mm to separate it from the groove for smooth opening and closing.

[Read More](https://zjbocon.com/product/eto-sterilzer/)

![Overall Lifting Door ETO Sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/01/eto_sterilizer_hzbocon_5.webp)

### Overall Lifting Door ETO Sterilizer

An explosion-proof electric lifting door and the most space-saving option. Raising the door to the top or lowering to the bottom automatically.

[Read More](https://zjbocon.com/product/eto-sterilzer/)

Zjbocon Auxiliary Products    Enhanced

## Our Products

Auxiliary Product Of ETO Sterilizer

![Hospital Laboratory ETO Sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/01/unnamed.webp)

### Hospital Laboratory ETO Sterilizer

Sterilize instruments in the cavity with ethylene oxide gas under controlled temperature, pressure, and humidity.

[Read More](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/)

![Precondition Room](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/Precondition_Room_.webp)

### Precondition Room

Preheating and humidifying products in advance to effectively shorten the total EO sterilization process time.

[Read More](https://zjbocon.com/product/precondition-room/)

![Aeration Room](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/Aeration_Room.webp)

### Aeration Room

Accelerate the removal speed of EO residue by placing products in a temperature-controlled aeration environment.

[Read More](https://zjbocon.com/product/aeration-room/)

![EO Scrubber](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/Eo_Scrubber_.webp)

### EO Scrubber

Hzbocon EO scrubber provides a controlled solution for handling ethylene oxide gas emissions, as low as 1mg/m3.

[Read More](https://zjbocon.com/product/eo-scrubber/)

![Sterilizer Control System](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/Sterilizer_Control_System.webp)

### Sterilizer Control System

Long-term audited systems by Medline, Cardinal, Medtronic, and other global medical leaders.

[Read More](https://zjbocon.com/product/sterilizer-control-system/)

![Sterilizer Chamber Conveyor](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/Sterilizer_Chamber_Conveyor.webp)

### Sterilizer Chamber Conveyor

Ensures high precision at loading and unloading with stainless steel rollers and ATEX-type motors.

[Read More](https://zjbocon.com/product/sterilizer-chamber-conveyor/)

Corporate Clients Section

## Our Clients

Global Partners

![Allmed](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-1.webp)

![Nipro](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-2.webp)

![Zhengde Mdeical](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-6.webp)

![MPV](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-3.webp)

![Winner](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-5.webp)

![Iso Valley](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-12.webp)

![Wego](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-4-1.webp)

![ICWN](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-9.webp)

Customer Reviews    Zjbocon Style

## Customer Voice

Professional Manufacturer Of Ethylene Oxide Sterilizers

![Halil from T urkiye](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/customer-1.webp)

### Halil

Customer from T urkiye

Thank you very much for the high-quality products and services provided by Bocon. Welcome to visit my ETO sterilization workshop at any time.  

![Glen from Indonesia](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/customer-2.webp)

### Glen

Customer from Indonesia

The products and services are excellent! I am happy to recommend these good EO sterilizers to my friends. Welcome friends from Indonesia to consult me.  

![Daniel from Korea](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/customer-3.webp)

### Daniel

Customer from Korea

 Bocon is the largest manufacturer I have visited. I am very grateful to Bocon for meeting my high requirements. I will continue to purchase from Bocon.  

![TOP GLOVE Algeria](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/customer_5.webp)

### TOP GLOVE

Enterprise in Algeria

 Bocon eto sterilizer is great, we will choose them again. Professional execution and reliable technology.  

[Go back](https://zjbocon.com/)

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## ETO Sterilization Resources
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## EO Sterilization Solutions
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JiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-67-225x300.webphttps://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-59-244x300.webphttps://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-21.webphttps://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-12-300x139.webphttps://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/Industry\_ETO\_Sterilizer-1-300x300.webphttps://zjbocon.com/projects/2026-01-29T03:13:35+00:00https://zjbocon.com/wp-content/uploads/2024/10/customer-1.webphttps://zjbocon.com/wp-content/uploads/2024/10/customer-2.webphttps://zjbocon.com/wp-content/uploads/2024/10/customer-3.webphttps://zjbocon.com/wp-content/uploads/2024/10/customer\_5.webphttps://zjbocon.com/services/2026-01-30T10:06:48+00:00https://zjbocon.com/wp-content/uploads/2025/09/turn-key-solution.webphttps://zjbocon.com/wp-content/uploads/2025/09/Qualification\_Services-2.webphttps://zjbocon.com/wp-content/uploads/2025/09/sterilizer-station-design-1-1.webphttps://zjbocon.com/wp-content/uploads/2025/09/after-sale\_service.webphttps://zjbocon.com/about/2026-02-02T01:04:57+00:00https://zjbocon.com/wp-content/uploads/2025/12/russia-health-week-6-scaled.webphttps://zjbocon.com/wp-content/uploads/2025/10/CMEF-26.webphttps://zjbocon.com/wp-content/uploads/2026/01/CMEF-1.webphttps://zjbocon.com/wp-content/uploads/2026/01/RUSSIA-HEALTH-WEEK-1.webphttps://zjbocon.com/wp-content/uploads/2026/01/CMEF\_2.webphttps://zjbocon.com/wp-content/uploads/2026/01/CMEF\_3.webphttps://zjbocon.com/wp-content/uploads/2025/09/CE-2-1.webphttps://zjbocon.com/wp-content/uploads/2025/09/patent-8.webphttps://zjbocon.com/wp-content/uploads/2025/10/map-1024x576.webp

## News Sitemap XML
https://zjbocon.com/

## Company News & Products
https://zjbocon.com/category/company-news/2026-01-20T02:36:51+00:00https://zjbocon.com/category/eto-sterilizer/2026-02-25T03:28:53+00:00

## Ethylene Oxide Sterilization Guide
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bocon.com/wp-content/uploads/2026/02/35m3-High-Capacity-ETO-Sterilization-Plant-in-Turkey-5.webphttps://zjbocon.com/comparison-of-medical-sterilization-methods/2026-02-09T01:18:36Zhttps://zjbocon.com/wp-content/uploads/2026/02/eto-sterilization-vs.-other-methods.webphttps://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/2026-02-09T05:05:52Zhttps://zjbocon.com/wp-content/uploads/2026/02/20230904235420809.webphttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:20:30Zhttps://zjbocon.com/wp-content/uploads/2026/02/40m3-ETO-sterilizer-hot-air-system-lifting-door-Malaysia-2-scaled.webphttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:20:40Zhttps://zjbocon.com/wp-content/uploads/2026/02/40m3-ETO-sterilizer-hot-air-system-lifting-door-Malaysia-3.webphttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:20:42Zhttps://zjbocon.com/wp-content/uploads/2026/02/AIR-JACKETED-SYSTEM-ETO-STERILIZER-1.webphttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:20:45Zhttps://zjbocon.com/wp-content/uploads/2026/02/AIR-JACKETED-SYSTEM-ETO-STERILIZER-2.webphttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:20:48Zhttps://zjbocon.com/wp-content/uploads/2026/02/AIR-JACKETED-SYSTEM-ETO-STERILIZER-3.webphttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:52:23Zhttps://zjbocon.com/wp-content/uploads/2026/02/40m3-ETO-sterilizer-hot-air-system-lifting-door-Malaysia-2.jpghttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:52:25Zhttps://zjbocon.com/wp-content/uploads/2026/02/40m3-ETO-sterilizer-hot-air-system-lifting-door-Malaysia-3.jpghttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:52:27Zhttps://zjbocon.com/wp-content/uploads/2026/02/AIR-JACKETED-SYSTEM-ETO-STERILIZER-1.jpghttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:52:28Zhttps://zjbocon.com/wp-content/uploads/2026/02/AIR-JACKETED-SYSTEM-ETO-STERILIZER-2.jpghttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:52:30Zhttps://zjbocon.com/wp-content/uploads/2026/02/AIR-JACKETED-SYSTEM-ETO-STERILIZER-3.jpghttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:55:37Zhttps://zjbocon.com/wp-content/uploads/2026/02/40m3-ETO-sterilizer-hot-air-system-lifting-door-Malaysia-2-1-e1772071665332.jpghttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:55:39Zhttps://zjbocon.com/wp-content/uploads/2026/02/40m3-ETO-sterilizer-hot-air-system-lifting-door-Malaysia-3-1.jpghttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:55:42Zhttps://zjbocon.com/wp-content/uploads/2026/02/AIR-JACKETED-SYSTEM-ETO-STERILIZER-1-1.jpghttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:55:44Zhttps://zjbocon.com/wp-content/uploads/2026/02/AIR-JACKETED-SYSTEM-ETO-STERILIZER-2-1.jpghttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T01:55:46Zhttps://zjbocon.com/wp-content/uploads/2026/02/AIR-JACKETED-SYSTEM-ETO-STERILIZER-3-1.jpghttps://zjbocon.com/product/eto-sterilizer-hot-air-system/2026-02-26T02:11:10Zhttps://zjbocon.com/wp-content/uploads/2026/02/hot\_air.webp

## Sterilization Solutions Experts
[Skip to content](https://zjbocon.com/about/#content)

# About Us

##### High Quality Tactical Solutions

## Finding A Permanent Solution Is Our Ultimate Goal!

### Since 2006, Our Team Has Succeeded In Understanding The Needs Of The Industry And Creating Reliable Products To Serve Them All.

Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd. is located in Hangzhou, Zhejiang Province, and specializes in the research, development, manufacturing, and installation of sterilization equipment. We also provide comprehensive sterilization solutions and MES systems for sterilization stations. With nearly 20 years of sterilization experience and technical expertise, we are dedicated to delivering high-quality, reliable Ethylene oxide sterilizers and associated facilities to our global clients. Our ethylene oxide sterilizer and related equipment with hot water circulation and hot air circulation heating methods use advanced and fully functional control systems to achieve automatic control. Has parameter release function in accordance with ISO 11135. The product undergoes strict quality control and testing to ensure compliance with international requirements such as ISO13485 and EN 1422.

In addition to ethylene oxide sterilizers, we offer a range of ancillary equipment, including preconditioning rooms, aeration rooms, EO gas scrubbers, and pioneering EO gas recovery and energy recovery technologies.

#### 2006

Founded in Hangzhou from industrial control system assembling and programming

#### 2007

develop the software for ETO sterilier

#### 2008

Started to deveop new components for sterilizer:

Such as door controller, local contorl box, water heating tank, EO vaporizer, maganetic fans   

#### 2013

developed conveyors and EO scrubber

#### 2014

developed preconditon& aeration room

#### 2015

established own foreign trade department

#### 2020

Glycol burner and EO recycling is develped

#### 2022

ZHEJIANG BOCON is established

Exhibition Gallery

## Exhibition Moments

Global Presence & Showcase

![2025 Rissia Health Week](<Base64-Image-Removed>)

### 2025 Rissia Health Week

Moscow, Russia \| 2025

![2025 CMEF](<Base64-Image-Removed>)

### 2025 CMEF

Guangzhou, China \| 2025

![2025 CMEF](<Base64-Image-Removed>)

### 2025 CMEF

Shanghai, China \| 2025

![2024 Rissia Health Week](<Base64-Image-Removed>)

### 2024 Rissia Health Week

Moscow, Russia \| 2024

![2024 CMEF](<Base64-Image-Removed>)

### 2024 CMEF

Guangzhou, China \| 2024

![2024 CMEF](<Base64-Image-Removed>)

### 2024 CMEF

Shanghai, China \| 2024

## Team

### Qiping sheng

President

With 29 years of experience, he is responsible for upgrading sterilization technology solutions and new technologies and has multiple invention patents for sterilizer technology. Responsible for more than 100 sterilization turnkey projects, highly recognized and trusted by customers.

### Nancy Huang

sales

With 24 years of experience, often attends medical product exhibitions overseas and visits customers in more than 30 countries and regions, including the United States, Japan, South Korea, T urkiye, Malaysia, Indonesia, Egypt, Saudi Arabia, etc.

nancy.huang@hzbocon.com

### Hayley He

sales

Responsible for providing customers with quotations of sterilization technology and equipment comprehensive scheme, providing sterilization technology consultation, and has served customers in more than 30 countries, i, etc.

hayley@hzbocon.com

### Mr.Jin

Manager

With 24 years of experience, Responsible for the production management of EtO sterilizers, strictly requiring every step of production, with a 100% pass rate, and being an excellent production manager.

### Mr.Sun

Designer

specializes in developing and optimizing products, blending engineering principles with creative design. They focus on functionality, aesthetics, and manufacturability, ensuring that designs meet industry standards.

### Certificates And Patent

![](<Base64-Image-Removed>)![](<Base64-Image-Removed>)

##### Some Cool Facts

## Numbers Speak For Themselves

Countries

Years of Experience

Completed Projects

### Quality Comes First! We Make Sure That Every Minute Detail Is Looked Into While Manufacturing Even The Smallest Product. Our Focus Is 100% On Client Needs And Satisfaction.

#### **Quality Goal : the acceptance rate of 100% !**

Seriously treat every customer, every order is our duty, to meet customer requirements is our aim: from the procurement semi-finished production, welding, assembly, testing and experiment monitoring the whole process, step by step of control, strictly follow the ISO 13485:2016 quality management system control program to control.

#### **Quality Policy: reputation from lasting quality!**

Performance from the constant pursuit. In 2010, we developed a preheating cabinet, and put it into the market, in succession, we developed the preheating, sterilization, and aeration one-body cabinet and applied for a patent. At the same time we also developed the manufacture preheating room, aeration room, automatic transmission system of EO sterilizer, EO tail gas treatment system, and all of these had been sold and used. We got a good impression from our customers.

### We Are The Creators You Can Trust On For A Perfect Solution To All Your Needs.

![](<Base64-Image-Removed>)

### Need Help with Easier Industrial Solutions? We Are Experts!?

Click here to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

[Learn More](https://zjbocon.com/contact/)

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## Global EO Sterilization Projects
[Skip to content](https://zjbocon.com/projects/#content)

# Projects

## Global Project Footprint

Leading EO Sterilization Solutions Across 44 Countries

All ProjectsIndustrial (35m3+)Medium (10-30m3)AsiaEurope & Americas

100m3

Russia

### 100m3 Eto Sterilizer

Maximum throughput for large-scale medical device manufacturing, featuring advanced gas recycling.

Operational

70m3

Mexico

### Automated Sterilization Center

Integrated 70m3 solution for the North American market, compliant with CE and ISO standards.

Operational

53m3

Indonesia

### Large Scale Turnkey Solution

Full-process automation from pre-conditioning to aeration for medical consumables.

Operational

Custom

Flagship Project

### Winner Medical Production Line

High-standard industrial setup for a world-leading medical PPE supplier.

Operational

40m3

Multi-National

### Standard Industrial Sterilizer

The versatile 40m3 choice for mid-to-large medical manufacturers.

Operational

35m3

Turkey

### Turnkey Project

35m3 system optimized for the European market safety requirements.

Operational

35m3

Bangladesh

### Pharmaceutical Grade System

Reliable ETO sterilization technology supporting the growing South Asian medical sector.

Operational

35m3

Vietnam

### Smart Control ETO Sterilizer

Equipped with Bocon  latest system for precise cycle monitoring.

Operational

30m3

Saudi Arabia

### GCC Regional Standard Project

Robust performance in high-temperature environments for local hospitals.

Operational

30m3

India

### Contract Sterilization Hub

High-frequency usage design for commercial sterilization providers.

Operational

20m3

India

### Medium Capacity Industrial Unit

Optimized footprint for urban manufacturing facilities.

Operational

11m3+21m3

Russia

### Dual-Unit Combo Installation

Flexible production capacity with two separate ETO chambers.

Operational

10m3

Algeria

### North Africa Healthcare Project

Compact industrial ETO solution for regional medical device producers.

Operational

10m3

USA

### EPA-Ready Precision Unit

Advanced instrumentation meeting the highest North American safety standards.

Operational

2 x 10m3

India

### Synchronized Dual Systems

Professional sterilization lines for specialized medical tools.

Operational

6m3

Thailand

### Compact Lab-Grade Sterilizer

Ideal for small batch production or high-end laboratory validation.

Operational

Project

Global Service

### Complete Station Engineering

End-to-end design from infrastructure to ETO system integration.

Operational

Custom

Key Client

### Allmed Medical Group Project

Massive scale sterilization facility for leading healthcare textile exporter.

Operational

Standard

Cambodia

### Infrastructure Development

Supporting regional medical supply self-sufficiency with ETO sterilization technology.

Operational

Customer Reviews    Zjbocon Style

## Customer Voice

Professional Manufacturer Of Ethylene Oxide Sterilizers

![Halil from T urkiye](<Base64-Image-Removed>)

### Halil

Customer from T urkiye

Thank you very much for the high-quality products and services provided by Bocon. Welcome to visit my ETO sterilization workshop at any time.  

![Glen from Indonesia](<Base64-Image-Removed>)

### Glen

Customer from Indonesia

The products and services are excellent! I am happy to recommend these good EO sterilizers to my friends. Welcome friends from Indonesia to consult me.  

![Daniel from Korea](<Base64-Image-Removed>)

### Daniel

Customer from Korea

 Bocon is the largest manufacturer I have visited. I am very grateful to Bocon for meeting my high requirements. I will continue to purchase from Bocon.  

![TOP GLOVE Algeria](<Base64-Image-Removed>)

### TOP GLOVE

Enterprise in Algeria

 Bocon eto sterilizer is great, we will choose them again. Professional execution and reliable technology.  

### Need Help with Easier Industrial Solutions? We Are Experts!?

Click here to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

[Learn More](https://zjbocon.com/contact/)

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## Connect With Us
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# Contact us

We love to hear from you! Whether you have a question, feedback, or just want to say hello, feel free to reach out. Our team is here to help you with anything you need.

## Contact Us

Find us or contact us as follows

OFFICE: Room1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

hayley@hzbocon.com

+86 19975258603

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## Sterilization Safety Insights
[Skip to content](https://zjbocon.com/blog-posts/#content)

[![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/01/Bangladesh-35-1024x958.webp)](https://zjbocon.com/advanced-sterilization-solutions-for-medical-implants-a-comprehensive-guide/)

## [Advanced Sterilization Solutions for Medical Implants: A Comprehensive Guide](https://zjbocon.com/advanced-sterilization-solutions-for-medical-implants-a-comprehensive-guide/)

Advanced Sterilization Solutions for Medical Implants: A Comprehensive Guide Optimizing Patient Safety and Material Integrity through Industry-Leading Technology. In the \[ ]

[Advanced Sterilization Solutions for Medical Implants: A Comprehensive Guide Read more](https://zjbocon.com/advanced-sterilization-solutions-for-medical-implants-a-comprehensive-guide/)

[![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eo-scrubber-23-1024x576.webp)](https://zjbocon.com/global-ethylene-oxide-eto-emission-standards-occupational-exposure-limits-2024-2026/)

## [Global Ethylene Oxide (EtO) Emission Standards & Occupational Exposure Limits (2024-2026)](https://zjbocon.com/global-ethylene-oxide-eto-emission-standards-occupational-exposure-limits-2024-2026/)

A comprehensive guide to the latest Ethylene Oxide (EtO) regulatory limits across 31 countries and agencies, including OSHA, EU, and GBZ standards. This table provides detailed 8-hour TWA and 15-minute STEL values, along with critical safety remarks on skin absorption and carcinogenic risks to help your facility stay compliant with global environmental and workplace safety mandates.

[Global Ethylene Oxide (EtO) Emission Standards & Occupational Exposure Limits (2024-2026) Read more](https://zjbocon.com/global-ethylene-oxide-eto-emission-standards-occupational-exposure-limits-2024-2026/)

[![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/02/20230904235420809-1024x416.webp)](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/)

## [Ethylene Oxide Sterilization Audit Checklist (ISO 11135)](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/)

Comprehensive Ethylene Oxide (EO) Sterilization Audit Checklist based on ISO 11135 and ISO 13485. Evaluate IQ/OQ/PQ validation, equipment calibration, and routine monitoring to ensure medical device compliance.

[Ethylene Oxide Sterilization Audit Checklist (ISO 11135) Read more](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/)

[![Turnkey-EO-Sterilisation-Project](<Base64-Image-Removed>)](https://zjbocon.com/code-compliance-ethylene-oxide-eto/)

## [Code Compliance: Ethylene Oxide (ETO)](https://zjbocon.com/code-compliance-ethylene-oxide-eto/)

Expert guide to California ETO safety codes. Explore ASME-standard sterilization and BOCON  EO Scrubber systems to ensure 100% compliance for your facility.

[Code Compliance: Ethylene Oxide (ETO) Read more](https://zjbocon.com/code-compliance-ethylene-oxide-eto/)

[![](<Base64-Image-Removed>)](https://zjbocon.com/sterilization-methods-for-syringe-filters/)

## [Sterilization Methods for Syringe Filters](https://zjbocon.com/sterilization-methods-for-syringe-filters/)

Compare ETO vs. Gamma sterilization methods for syringe filters. Learn about bacterial metabolism destruction, DNA alteration, and BOCON  advanced EO Scrubber solutions for residue-free results.

[Sterilization Methods for Syringe Filters Read more](https://zjbocon.com/sterilization-methods-for-syringe-filters/)

[![](<Base64-Image-Removed>)](https://zjbocon.com/three-primary-sterilization-methods-for-spices/)

## [Three Primary Sterilization Methods for Spices](https://zjbocon.com/three-primary-sterilization-methods-for-spices/)

Three Primary Sterilization Methods for Spices Ensuring microbial safety while preserving the aroma, color, and flavor of spices is a

[Three Primary Sterilization Methods for Spices Read more](https://zjbocon.com/three-primary-sterilization-methods-for-spices/)

[![](<Base64-Image-Removed>)](https://zjbocon.com/comparison-of-medical-sterilization-methods/)

## [Comparison of Medical Sterilization Methods](https://zjbocon.com/comparison-of-medical-sterilization-methods/)

Medical Device Sterilization: Methods Comparison Choosing the right sterilization process is essential for device integrity and patient safety. Below is

[Comparison of Medical Sterilization Methods Read more](https://zjbocon.com/comparison-of-medical-sterilization-methods/)

[![](<Base64-Image-Removed>)](https://zjbocon.com/compatibility-of-sterile-barrier-systems-with-sterilization-processes/)

## [Compatibility of Sterile Barrier Systems with Sterilization Processes](https://zjbocon.com/compatibility-of-sterile-barrier-systems-with-sterilization-processes/)

Compatibility of Sterile Barrier Systems with Sterilization Processes In selecting materials for sterile barrier systems for medical devices, ensuring a

[Compatibility of Sterile Barrier Systems with Sterilization Processes Read more](https://zjbocon.com/compatibility-of-sterile-barrier-systems-with-sterilization-processes/)

[![](<Base64-Image-Removed>)](https://zjbocon.com/9276-2/)

## [Sterilization Compatibility of Sterile Barrier Systems](https://zjbocon.com/9276-2/)

Sterilization Compatibility of Sterile Barrier Systems Technical White Paper 1. Introduction The compatibility between sterile barrier systems (SBS) and sterilization

[Sterilization Compatibility of Sterile Barrier Systems Read more](https://zjbocon.com/9276-2/)

[![](<Base64-Image-Removed>)](https://zjbocon.com/project-spotlight-35m%c2%b3-high-capacity-eto-sterilization-plant-in-turkey/)

## [Project Spotlight: 35m3 High-Capacity ETO Sterilization Plant in Turkey](https://zjbocon.com/project-spotlight-35m%c2%b3-high-capacity-eto-sterilization-plant-in-turkey/)

35m3 High-Capacity ETO Sterilization Plant in Turkey Bocon recently completed the turnkey installation of a 35m3 ETO sterilization system for

[Project Spotlight: 35m3 High-Capacity ETO Sterilization Plant in Turkey Read more](https://zjbocon.com/project-spotlight-35m%c2%b3-high-capacity-eto-sterilization-plant-in-turkey/)

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## Sterilization Equipment Collection
[Skip to content](https://zjbocon.com/product/#content)

Showing all 12 results

Default sortingSort by popularitySort by average ratingSort by latestSort by price: low to highSort by price: high to low

- [![ventilated autoclave sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/03/autoclave_1-600x533.webp)](https://zjbocon.com/product/ventilated-autoclave-sterilizer/)[Read more](https://zjbocon.com/product/ventilated-autoclave-sterilizer/)

Autoclave Sterilizer [**ventilated autoclave sterilizer**](https://zjbocon.com/product/ventilated-autoclave-sterilizer/)

- [![Eto sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-64-600x600.webp)](https://zjbocon.com/product/eto-sterilzer/)[Read more](https://zjbocon.com/product/eto-sterilzer/)

Eto Sterilizer [**Eto sterilizer**](https://zjbocon.com/product/eto-sterilzer/)

- [![ETO sterilizer hot air system](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/02/hot_air.webp)](https://zjbocon.com/product/eto-sterilizer-hot-air-system/)[Read more](https://zjbocon.com/product/eto-sterilizer-hot-air-system/)

Eto Sterilizer [**ETO sterilizer hot air system**](https://zjbocon.com/product/eto-sterilizer-hot-air-system/)

- [![Overall Lifting Door ethylene oxide sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-7-600x600.webp)](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/)[Read more](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/)

Eto Sterilizer [**Overall Lifting Door ethylene oxide sterilizer**](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/)

- [![Pneumatic Revolving Door ethylene oxide sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-11-600x600.webp)](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/)[Read more](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/)

Eto Sterilizer [**Pneumatic Revolving Door ethylene oxide sterilizer**](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/)

- [![pneumatic sliding door ethylene oxide sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-3-600x600.webp)](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/)[Read more](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/)

Eto Sterilizer [**pneumatic sliding door ethylene oxide sterilizer**](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/)

- [![Hospital / Laboratory ETO Sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Hospital_laboratory_ETO_sterilizer__1-1-1-600x600.webp)](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/)[Read more](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/)

Eto Sterilizer [**Hospital / Laboratory ETO Sterilizer**](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/)

- [![Eo Scrubber](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eo-scrubber-22-1-600x600.webp)](https://zjbocon.com/product/eo-scrubber/)[Read more](https://zjbocon.com/product/eo-scrubber/)

[**Eo Scrubber**](https://zjbocon.com/product/eo-scrubber/)

- [![Precondition Room](<Base64-Image-Removed>)](https://zjbocon.com/product/precondition-room/)[Read more](https://zjbocon.com/product/precondition-room/)

[**Precondition Room**](https://zjbocon.com/product/precondition-room/)

- [![Aeration Room](<Base64-Image-Removed>)](https://zjbocon.com/product/aeration-room/)[Read more](https://zjbocon.com/product/aeration-room/)

[**Aeration Room**](https://zjbocon.com/product/aeration-room/)

- [![Sterilizer Control System](<Base64-Image-Removed>)](https://zjbocon.com/product/sterilizer-control-system/)[Read more](https://zjbocon.com/product/sterilizer-control-system/)

[**Sterilizer Control System**](https://zjbocon.com/product/sterilizer-control-system/)

- [![Sterilizer Chamber Conveyor](<Base64-Image-Removed>)](https://zjbocon.com/product/sterilizer-chamber-conveyor/)[Read more](https://zjbocon.com/product/sterilizer-chamber-conveyor/)

[**Sterilizer Chamber Conveyor**](https://zjbocon.com/product/sterilizer-chamber-conveyor/)


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## EO Sterilization Services
[Skip to content](https://zjbocon.com/services/#content)

## our services

### Turnkey EO Sterilization Project

[![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/turn-key-solution.webp)](https://zjbocon.com/turnkey-eo-sterilization-project/)

### Qualification Services

[![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Qualification_Services-2.webp)](https://zjbocon.com/qualification-services/)

### Sterilizer Station Design

[![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/sterilizer-station-design-1-1.webp)](https://zjbocon.com/sterilizer-station-design/)

### After-Sales Service

[![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/after-sale_service.webp)](https://zjbocon.com/after-sales-service/)

## FAQ

Q.What is ethylene oxide (EtO) sterilization?

A.Ethylene oxide is a gas and widdely used in sterilization, more than 50% medical device are sterilized by EtO. ETO is used either as 100% ETO or in combination with carbon dioxide.

Q.What is the advantage of ethylene oxide (EtO) sterilization?

A.   profer for large volume sterilization, becasue of the peneratration property of EO gas

\\* To sterilize after final packing, to avoid secondary pollution because of the peneration property of EO gas

\\* Low temperature,

\\* to maintain the original characteristics of the product

\\* Low sterilization cost and low maintenance cost

   Best materials compatibility

   Products can be processed in sealed, final packaging

   ~50,000 medical devices validated

   Simple to operate and monitor

   Can sterilize products with batteries and electronics

   Long history of safe and effective use

   Broad microbicidal activity

Q.What is the scope of use for an ETO Steriliser?

A.If you have any questions about this, pls contact us, and we will be glad to answer your questions.

1\. Endoscopes: Throat scopes, bronchoscopes, esophagoscopes, cystoscopes and ureteroscopes, mediastinoscopes, thoracoscopes, esophageal fiberscopes, gastric fiberscopes, duodenal fiberscopes, bronchial fiberscopes, vascular fiberscopes, etc.

2\. Plastic and rubber products: Gloves, finger cots, syringes, injection devices, blood collection devices, infusion devices, urine collection bags, test tubes, intracranial catheters, venous catheters, arterial catheters, hoses, catheters, sponges, linings, etc.

3\. Instruments and equipment: Surgical room automatic suturing machines, sutures, suturing needles, artificial esophagus, artificial bones, artificial pericardial membranes, artificial blood vessels, polytetrafluoroethylene artificial membranes, artificial lung circuits, pacemakers, pacemaker electrodes, drainage devices, postoperative suction devices, lumbar puncture devices, urinary catheterization devices, abdominal dialysis circuits, thermistors, stethoscopes, medical electric drills, medical electric saws, electric knives, batteries, bone plates, cameras, etc.

4\. Anesthetic vessels: Endotracheal tubes, nasal tubes, tracheostomy tubes, suction tubes, anesthesia masks, corrugated tubes, anesthesia bags, closed circulation loops, artificial respiration components, atomizers, oxygen tents, etc.

5\. Cotton fiber products and others: Clothes, gauze, bandages, cotton balls, cotton swabs, defatted cotton, towels, blankets, surgical gowns, surgical caps, brushes, bedding, pillowcases, mattresses, bedding, books, toys, etc.

Q.What are your Payment terms?

A.The way of payment is T/T. The lowest down payment that can be accepted is 30%.

The product lead time will count from the date of receiving the prepayment. 10 days before the shipment, the seller informs the buyer to come to the factory to do FAT, buyer decides whether to do FAT or not.

Q.How about your Warranty?

A.The mainframe of the cabinet is guaranteed for at least 5 years, the control system is 2 years, and other purchase parts are guaranteed for 1 year.

Q.Can you provide the overseas service?

A.Yes, after the machine arrives client factory, engineers will be arranged to go on-site to install the machine and train the operators.

Q.Can you tell me the production and installation time?

A.The equipment production and delivery term is 60-90 days. Clients can choose to do FAT in our factory or not after we finish the EO sterilizer. The installation and debugging period is 15-60 days (according to the chamber size),and IQ and OQ are about 7 days, which could provide the support of PQ.

Q.Can we visit the factory?

A.Of course, we highly welcome clients to come to our factory, it will be our great honor to meet you.

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## EO Sterilization Solutions
[Skip to content](https://zjbocon.com/turnkey-eo-sterilization-project/#content)

## Turnkey EO Sterilization Project

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/sterilizer-station-design-2-768x384.webp)

### What is a Turnkey EO Sterilisation Project?

EO sterilization projects are typically large-scale and complex undertakings that require careful consideration. Given the hazardous nature of EO gas, safety must be a paramount focus throughout every phase of the project. Companies that need to sterilize large quantities, such as multiple pallets, often seek comprehensive turnkey solutions to seamlessly integrate into their facilities.

### What does turnkey EO sterilisation project consist of?

It depends on the requirements and necessities of the clients, usually it including:

\\* ETO sterilizer chamber \* preheating room \* Aeration Room \* Scrubber \* Conveyor \* control system cabinet \* local control box \* Door controller \* Water tank \* EO vaporizer \* Medical steam generator \* Internal circulation fan \* workshop EO gas monitoring system \* Sterilization conveyor system

### What does Bocon do in the project

#### Bocon Comprehensive EO Sterilization Solutions

In Bocon, we manage every aspect of EO sterilization projects from inception to completion. Our company excels in the design, manufacturing, qualification, installation, and commissioning of all related equipment and modules, utilizing advanced technologies and state-of-the-art components to deliver comprehensive, safe, and reliable solutions.

#### Quality Protocols

To ensure optimal sterilization processes, we provide a comprehensive package of quality protocols, including Design Qualification (DQ), Functional Design Specification (FDS), Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and support for Performance Qualification (PQ).

#### Advanced Control Systems

Our control system has undergone long-term strict audits by Medline, Cardinal, Medtronic, WINNER, ZHENDE, and ALLMED companies, and has the most comprehensive functions and the best stability.

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## Qualification Services
[Skip to content](https://zjbocon.com/qualification-services/#content)

## With You Every Step Of The Way

In order to comply with EN 1422    EN ISO 11135, ISO 13485 Standards, and GMP guidelines, our protocols and procedures are created to help you comply with [validation requirements and meet your requirement specifications.](https://zjbocon.com/eto-sterilization-2/)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/Qualification_Services.webp)

## URS (User Requirement Specifications)

Definition of requirements to fulfill the demands of the process. Generally, URS is required for eto sterilizer machine before making the design.

In order to meet the user requirement, we pay special attention to the URS (User Requirement Specifications) (such as chamber size, product, package, EO percentage, etc.)

Issued by: User

## FDS (Functional Design Specifications)

Specification in which the demands of the buyer are transferred into a technical solution (from the manufacturer point of view)

Issued by: Manufacturer

## DESIGN SPECIFICATION (DS)

Specification of the technical basis and specification of the limiting factors that are to be considered during development, construction and assembly. DS ensures that all customer requirements and current valid standards from CGMP, EU, EN ISO and the FDA are satisfied.

## FAT / SAT (Factory Acceptance Test /Site Acceptance Test)

Documented acceptance tests at the supplier/customer with test log, test summary, list of open issues, and release certificates.

In BOCON, before the sale, the factory provides customers with the design and consultation on the overall equipment and facilities of the ETO workshop and assists in the formulation of the overall planning and layout of the ETO workshop. According to the characteristics of the customer site and product, material, packaging, transportation, and future development, we choose the material, configuration, control mode, volume, and quantity for the sterilizer. To assist in the preparation of the ethylene oxide sterilization process, verification scheme, ETO workshop management rules and regulations, equipment use and maintenance, etc. At the same time to provides relevant standards, preheating, residual analysis, processing technology consultation, and cooperation.

## DQ, IQ, OQ, PQ

DQ(Design Qualification)

[IQ (Installation Qualification)](https://zjbocon.com/iq-in-eto-sterilization-process/)

[OQ(Operational Qualification)](https://zjbocon.com/oq-in-eto-sterilization-machine/)

[PQ(Performance Qualification)](https://zjbocon.com/ethylene-oxide-sterilization-chamber/)

From product and requirements specifications, to risk analyses, to planning and execution of the individual qualification steps, we takes care of everything implementation requires.

**Validation**: BOCON would provide software validation. IQ, OQ report, and support of PQ after installation.

## IQ OQ PQ report

![iq oq pq](<Base64-Image-Removed>)

![iq oq pq](<Base64-Image-Removed>)

![iq oq pq](<Base64-Image-Removed>)

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## After-Sales Support
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## After-Sales Service

With the server system, as long as the server is connected Internet network, which can support the online remote diagnosis service, service hours are 24 hours \*365 days (means anytime), LE series of products within 1 year of free, GE series of products within 2 years of free.

During the warranty period, if technical personnel are required to serve on the spot, only the visa锛  transportation, and accommodation costs of the on-site service personnel should be paid.

Over the warranty period, if need to send technical personnel on-site service, need to pay visa, travel expenses, accommodation expenses, and 100USD/ day. The time of calculation is from the day of departure from China to the day of landing at China port.

**Our quality policy: reputation comes from constant quality and performance from constant demand.**

**Our quality objectives:100%of qualified products and 100% on-time after-sales service.**

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## Sterilizer Station Design
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## layout Design

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## Eto Sterilizer Solutions
[Skip to content](https://zjbocon.com/product/eto-sterilzer/#content)

[馃攳](https://zjbocon.com/product/eto-sterilzer/#)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-64-600x600.webp)

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[![Eto sterilizer - Image 2](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-63-scaled.webp)

[![Eto sterilizer - Image 3](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-13.webp)

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[![Eto sterilizer - Image 5](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-70.webp)

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[Eto Sterilizer](https://zjbocon.com/product-category/eto-sterilizer/)

# Eto sterilizer

Rated **5.00** out of 5 based on 4 customer ratings

[(6 customer reviews)](https://zjbocon.com/product/eto-sterilzer/#reviews)

The ethylene oxide sterilizer machine (Eto sterilizer) was developed and designed by BOCON, with sizes of 1-128m3?1-36 US pallets) (1-44 Euro pallets)    PS: European Pallet Size (1200 x 800 mm) & US Pallet Size (1200 x 1000 mm)

In order to do ETO sterilization in optimum conditions, we can offer the following services: FAT, SAT, DQ, IQ, OQ, and support for PQ.

Following customer requests, we can supply: Pre-conditioning, Sterilization, Degassing Chambers, EO Scrubber, and EO Energy Recycling.

Category: [Eto Sterilizer](https://zjbocon.com/product-category/eto-sterilizer/)

- [Description](https://zjbocon.com/product/eto-sterilzer/#tab-description)
- [Reviews (6)](https://zjbocon.com/product/eto-sterilzer/#tab-reviews)

## BOCON ETO STERILIZER

We offer: **FAT, SAT, DQ, IQ, OQ**, and support for **PQ**. Standard compliance: **EN 1422, CE, ISO 13485**.

01\. Chamber Volume

1m32m33m34.5m35m36m38m310m315m320m326m328m330m330m3-235m335m3-240m3-248m352m355m3-257m3-263m3-270m3-278m3-286m3-2101m3-2118m3-2

#### Engineering Support

Custom dimensions or automatic conveyor loading systems available.

[INQUIRE NOW 鈫抅(https://zjbocon.com/contact/)

1m3

SINGLE DOOR

Pallet Loading Capacity

/

Inner Chamber (mm)

1400 脳 700 脳 1000

Exterior Dimensions (mm)

Pneumatic Sliding Door1750 脳 1270 脳 1520

Pneumatic Revolving DoorN/A

Overall Lifting DoorN/A

[GET A PRICE & FULL SPECS 鈫抅(https://zjbocon.com/contact/)

### Industry ETO Sterilizer Turnkey EO Sterilization Project

A turnkey project is a complete project that is designed, built, and tested by a single provider. In the context of ETO sterilization, a turnkey project typically involves designing and building a complete ETO sterilization facility, including :

\\* [ETO sterilizer chamber](https://deepskyblue-eagle-499665.hostingersite.com/ethylene-oxide-gas-sterilizer/)

\\* preheating room

\\* Aeration Room

\\* Scrubber

\\* Sterilization conveyor system

\\* control system cabinet

\\* local control box

\\* etc

We are the main designated eto sterilizer supplier for Medline, Cardinal, and Medtronic. Medline, Cardinal, and Medtronic are all Fortune 100 companies, and the sterilization cabinets we provide account for over 60% of their total sterilization cabinet needs.

In addition to our partnerships with global leaders, we also serve as the mainethylene oxide sterilizersupplier for ALLMED, WINNER, and ZHENDE he three largest medical device manufacturers in China. Our sterilization cabinet solutions account for over 90% of their sterilization equipment needs, further solidifying our position as a market leader.

BOCON Company has a strong R&D team, and we invest 2~3 million RMB in R&D expenses every year. We have 28 patents, including 3 Chinese invention patents and 2 American invention patents. Many companies focus their energy on sales, but we have always been dedicated to product research and development.

You could view our**[catalog](https://zjbocon.com/wp-content/uploads/2025/11/BOCON-ETO-STERILIZER.pdf)** to know more about our Chamber.

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/STERILIZER.webp)

### ETO Sterilizer Chamber Door System

Normally there are 3 kinds of doors: siding door, lifting door and revolving door. There is no need to vacuum when opening the door, door system has the pressure test function.

#### Pneumatic Revolving Door

#### Pneumatic Sliding Door

#### Overall Lifting Door

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/01/eto_sterilizer_hzbocon_2-1024x1024.webp)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/01/eto_sterilizer_hzbocon_4-1024x1024.webp)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/01/eto_sterilizer_hzbocon_5-1024x1024.webp)

### [Functions of Eto control system](https://deepskyblue-eagle-499665.hostingersite.com/eto-sterilizer-system/)

- Automatic quality assessment report for software, which is an important function to assist operators and quality control personnel in quickly assessing production quality and identifying problems. Our sterilization cabinet software has more than 400 built-in automatic assessment functions, which can almost meet the quality automatic detection and assessment needs of all customers
- Very detailed software audit tracking function. Specifically, it is manifested by more than 120 automatic detection and prediction alarm functions, and almost all operations will be recorded in the system, making it easy to quickly identify the root cause of problems and repair them in the later stage.
- Standardized backend MES interface, with the customer consent, data can be automatically uploaded to cloud servers or the customer  own backup server
- And more

Our control system has undergone long-term strict audits by Medline, Cardinal, Medtronic, WINNER, ZHENDE, and ALLMED companies, and has the most comprehensive functions and the best stability.

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-5-1.webp)

## Why Choose BOCON EO Sterilizer?

**180 Tons / Month** Water saved for 20m3 chamber

(Equipped with Eo Vaporizer)

**RMB 230,000 / Year** Electricity saved (100m3 Unit)

Based on China Industrial Power Rates

**Eo Vaporizer** Bocon Exclusive

Water-Saving Technology

**Central Heating** Redundant Dual-pump Stability

for Large-scale Facilities

### 1\. Vacuum Pump Technology

| Item | BOCON | OTHERS |
| --- | --- | --- |
| Vacuum Pump Options | Dry Screw / Water Ring / Oil Ring (Multiple options available) | Usually only Water Ring Pump |
| Ultimate Vacuum Level | Up to -101.27 kPa (Dry Screw Pump) | Approx. -90 kPa |
| Water Consumption | With BOCON Eo Vaporizer: Water replaced once per week | Continuous water consumption |
| Maintenance | Low maintenance (Dry pump), No oil emulsification risk | Frequent oil change (Oil pump) or limited performance |

Deep vacuum capability is essential for removing moisture and oil residues, especially for biological products such as sutures. Japanese manufacturers commonly use dry pumps to shorten aeration time from two days to less than half a day through repeated deep vacuum cycles.

### 2\. Water-Saving Performance

Example: A 5.5 kW water ring pump consumes approximately 20 liters per minute. For a 20m3 sterilizer chamber with 8 vacuum cycles (22 minutes each), total water consumption per cycle reaches 3.52 tons.

With 14 cycles per week, total weekly consumption exceeds 49 tons. After installing **BOCON  exclusive Eo Vaporizer** system, water replacement is required only once per week, saving approximately **45 tons of water per week (approx. 180 tons per month)**. This is especially valuable in water-scarce regions.

### 3\. Exclusive EG Burner System

| Item | BOCON | OTHERS |
| --- | --- | --- |
| Exhaust Treatment | Gas + Liquid waste combustion with energy recovery | Combustion only (gas) or scrubber only |
| Energy Recovery | High-temperature flue gas heats water for sterilizer use | No energy recovery |
| Liquid Waste Handling | Integrated liquid waste combustion | Scrubber cannot treat liquid waste |

The **BOCON EG Burner** combines waste liquid treatment and energy recycling. For example, a 100m3 sterilizer system can save approximately **RMB 230,000 per year** in electricity costs based on China industrial power rates. It also enables catalyst recovery, reducing ongoing operating expenses.

Note: Others currently mostly use combustion-only exhaust treatment, which involves higher risk and needs to stay on at all times, or use scrubbers which cannot handle liquid waste.

### 4\. Centralized Heating System

| Item | BOCON | OTHERS |
| --- | --- | --- |
| System Design | Centralized heating with dual pump redundancy | Single water heating unit |
| System Stability | Backup pump ensures continuous operation | System stops if pump fails |
| Application | Suitable for multiple sterilizers in one workshop | Individual heating per unit |

The **BOCON centralized heating system** improves operational reliability through dual-pump redundancy, ensures stable operation even during a single pump failure, and significantly reduces heating tube failure rates through an optimized large-capacity water tank design.

## Our Partners

![Partner 1](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-1.webp)

![Partner 11](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-11.webp)

![Partner 2](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-2.webp)

![Partner 12](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-12.webp)

![Partner 7](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-7.webp)

![Partner 6](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-6.webp)

![Partner 3](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-3.webp)

![Partner 5](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-5.webp)

![Partner 9](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-9-1.webp)

![Partner 4](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-4.webp)

### Safety of our EO sterilization equipment

EO is a flammable, explosive chemical. Its fire and explosion characteristics are system dependent. Some of the

characteristics for EO/air mixtures are as follows:

   Theminimumvaluecitedforthelowerflammable limit of EO air mixtures is 2.6% EO\[20\].

   The upper flammable limit is typically stated to be 100% because under certain conditions pure EO can violently

decompose with a significant release of heat in the absence of air or oxygen.

   Accordingly, the flammable range of EO-air mixtures is 2.6  100% EO.

   The autoignition temperature of EO in air at 14.7 psia is 833Fahrenheit (445degrees celsius)

Bocon use mixed gas processes and full Nitride protection Processes to keep it safe.

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/2_Flammable_Region_of_Ethylene_Oxide_Nitrogen_Air_Mixtures.webp)

#### Mixed gas processes

#### Full Nitride protection Processes

1.Heating

2.Keep warm

3\. Pre-vacuum

4.Leak testing

5.Humiditying

6.Humidity dwelling

7.EO injection

8\. EO injection2

9.EO injection 3

10.EO dwelling

11.EO removal 2

12.Air washing

13.Aeration

1.Heating

2.Keep warm

3\. Pre-vacuum

4.Leak testing

5.Humiditying

6.Humidity dwelling

7.EO injection

8\. EO injection2

9.EO injection 3

10.EO dwelling

11.EO removal 2

12.Air washing

13.Aeration

1.Heating

2.Keep warm

3\. Pre-vacuum

4.Leak testing

5.Humiditying

6.Humidity dwelling

7.EO injection

8\. EO injection2

9.EO injection 3

10.EO dwelling

11.EO removal 2

12.Air washing

13.Aeration

## Frequently Asked Questions

Everything you need to know about BOCON ETO Sterilization technology.

### Q1. What is the typical cycle time for an ETO sterilization process?

The entire ETO sterilization cycle usually takes between **12 to 24 hours**. This includes critical stages: pre-conditioning (temperature/humidity adjustment), gas injection, exposure, and a lengthy aeration period to safely remove residual EO gas.

### Q2. Why choose EO sterilization over Steam sterilization for medical devices?

EO is a **low-temperature process** (37degrees celsius to 55degrees celsius), making it ideal for heat-sensitive materials like plastics, electronics, and delicate surgical instruments that would be damaged by the high heat and moisture of steam autoclaves.

### Q3. Are BOCON sterilizers compliant with ISO 11135 and EN 1422?

Yes. All BOCON equipment is manufactured to meet **ISO 11135 and EN 1422** international standards. We provide full validation documentation support, including **FAT, SAT, DQ, IQ, OQ**, and assist with your PQ.

### Q4. How do you ensure environmental safety regarding EO gas emissions?

BOCON ETO sterilizers can be integrated with our high-efficiency **EO Scrubber system**. This system uses chemical hydrolysis to neutralize 99.9% of ethylene oxide gas before it is exhausted, ensuring compliance with EPA and local environmental regulations.

### Q5. What safety features are integrated into the Siemens PLC control system?

Our systems include explosion-proof components, real-time pressure and temperature monitoring, gas leak detection, and automatic interlocking doors. The **Siemens PLC** ensures precise control and records all cycle data for traceability.

Have more technical questions?

[Contact our engineers for a free consultation 鈫抅(https://zjbocon.com/contact/)

### Download BOCON EtO sterilizer Catalogue

[![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/BOCON-EtO-sterilizer-Catalogue.webp)](https://zjbocon.com/wp-content/uploads/2025/11/BOCON-ETO-STERILIZER.pdf)

[Dowload BOCON EtO sterilizer Catalogue](https://zjbocon.com/wp-content/uploads/2025/11/BOCON-ETO-STERILIZER.pdf)

[Click here to send inquiry to us](https://zjbocon.com/contact/)

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##### More information about eto sterilization

[Pneumatic Revolving Door ethylene oxide sterilizer](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/ "Pneumatic Revolving Door ethylene oxide sterilizer")

[pneumatic sliding door ethylene oxide sterilizer](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/ "pneumatic sliding door ethylene oxide sterilizer")

[Overall Lifting Door ethylene oxide sterilizer](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/ "Overall Lifting Door ethylene oxide sterilizer")

## 6 reviews for Eto sterilizer

1. ![](<Base64-Image-Removed>)





Rated **5** out of 5





**rebort**  2024-11-20





great eto sterilizer,

2. ![](<Base64-Image-Removed>)





Rated **5** out of 5





**15657615935a**  2025-06-13





Thank you very much for the high-quality products and services provided by Bocon. Welcome to visit my ETO sterilization workshop at any time.  

3. ![](<Base64-Image-Removed>)





Rated **5** out of 5





**Glen**  2025-06-13





The products and services are excellent!

I am happy to recommend these good EO sterilizers to my friends.

Welcome friends from Indonesia to consult me.

4. ![](<Base64-Image-Removed>)





Rated **5** out of 5





**alex**  2026-02-11





We purchased a 30m3 ETO sterilization system from BOCON for our new facility. Their engineering team provided exceptional support during the DQ, IQ, and OQ phases. The equipment fully complies with ISO 11135 standards, and we passed our audit without any issues. Highly professional!

5. ![](<Base64-Image-Removed>)



**CEO, Medical Packaging Solutions (Thailand)**  2026-02-11





Excellent communication and after-sales service. Even with the time difference, BOCON  technical support team responds quickly to our inquiries. The training they provided to our staff was thorough and very helpful.

6. ![](<Base64-Image-Removed>)



**Technical Engineer, Sterilization Services (India)**  2026-02-11





We have been running BOCON ETO machines for over three years now. The uptime is impressive, and maintenance is straightforward. Compared to European brands, BOCON offers the best balance of advanced technology and cost-efficiency.    斺€ 


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## Related products

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## Sterilizer Chamber Conveyor
[Skip to content](https://zjbocon.com/product/sterilizer-chamber-conveyor/#content)

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![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Sterilizer_Chamber_Conveyor.webp)

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# Sterilizer Chamber Conveyor

Automatic Sterilizer Chamber Conveyor independently developed by our company is mainly used for large sterilization cabinets, aiming at reducing the time of work products entering and leaving the cabinet, reducing the risk of contact between operators and ethylene oxide, and reducing labor costs. It has the advantages of safety and reliability, ?exible positioning, simple structure, convenient maintenance, etc.

- [Description](https://zjbocon.com/product/sterilizer-chamber-conveyor/#tab-description)
- [Reviews (0)](https://zjbocon.com/product/sterilizer-chamber-conveyor/#tab-reviews)

## Sterilizer Chamber Conveyor

Sterilizer Chamber Conveyor Ensures high precision at loading and unloading when useing[eto sterilizer](https://zjbocon.com/product/eto-sterilzer/)

Stainless steel rollers, ATEX-type motors

**Option 1:**Passive EO Sterilizer transmission mode, which mainly relies on the operator to transfer the products in or out by means of tray, pushing into or outside of the chamber.

**Option 2**: Pneumatic EO Sterilizer Automatic Transmission Device.

**Option 3**: Tracked ETO Sterilizer Automatic Transmission Device.

**Option 4**: Fully automatic based on AGV solution.

Pls[contact us](https://zjbocon.com/contact/)to know more about our product

## Principle of automatic transmission device

Automatic Sterilizer Chamber Conveyoradopts the flexible and rotatable chain to drive the pallet to move back and forth, and the chain guides the outside of the cabinet through external shaft threading inside the equipment. The outside is equipped with servo motor or asynchronous motor + frequency converter for smooth acceleration start and smooth deceleration stop;

## Function of automatic transmission device

### Pallet can be automatically transported from the feed door to the cabinet or exit in the reverse direction

Operator places the pallet on the position of the first pallet at the feed inlet, and then manually initiates the feed command (also through the remote control, optional accessories), the distance between the original pallet and the previous pallet is generally 50mm. The automatic transmission device can realize the function of forward and backward, so that when the position of the pallet is inaccurate, the position can be adjusted freely;

### Position of the pallet can be automatically positioned when a servo motor is used

When the automatic transmission device adopts servo positioning device, it can realize positioning transmission. There is no limit switch or position sensor in the equipment to realize numerical positioning system, which is convenient for operation and positioning;

## Advantages of the Automatic Sterilizer Chamber Conveyor

1.When the automatic transmission device is driven by servo motor, it has few structural components, high driving precision and stable and reliable driving. Digital positioning and calculation to realize the intelligent and visual control of the system. The system can automatically determine the number of pallets and locking function

2.There are no electrical and pneumatic components in the cabinet, which effectively avoids the potential safety hazards caused by electrical components. Without any pneumatic components, the cabinet opening is avoided and the risk of leakage is avoided;

3\. spacing between the pallets can be set, and the system can automatically control the position of the pallets in the preheating cabinet, sterilization cabinet and aeration cabinet according to the set spacing, the distance between the door and the tray and other parameters. In the case of special needs, the reverse exit function can also be realized;

4.system structure is mainly composed of stainless steel chain and driving mechanism. There are few other auxiliary components, less failure rate and fewer components to be maintained;

5.Because it adopts servo or variable frequency drive, it is very convenient to realize slow acceleration. High speed is adopted in the middle, and the process of slow deceleration when it is almost in place can prevent sudden start and sudden stop, and the risk of cargo dumping, which affects the loading quality.

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[Pneumatic Revolving Door ethylene oxide sterilizer](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/ "Pneumatic Revolving Door ethylene oxide sterilizer")

[pneumatic sliding door ethylene oxide sterilizer](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/ "pneumatic sliding door ethylene oxide sterilizer")

[Eto sterilizer](https://zjbocon.com/product/eto-sterilzer/ "Eto sterilizer")

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## Hospital ETO Sterilizer
[Skip to content](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/#content)

[馃攳](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/#)

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![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Hospital_laboratory_ETO_sterilizer__1-1-1-600x600.webp)

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[![Hospital / Laboratory ETO Sterilizer - Image 3](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Hospital_laboratory_ETO_sterilizer__4.webp)

[![Hospital / Laboratory ETO Sterilizer - Image 4](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Hospital_laboratory_ETO_sterilizer__3.webp)

[![Hospital / Laboratory ETO Sterilizer - Image 5](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Hospital_laboratory_ETO_sterilizer__1.webp)

[![Hospital / Laboratory ETO Sterilizer - Image 6](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Hospital_laboratory_ETO_sterilizer__2-1.webp)

[Eto Sterilizer](https://zjbocon.com/product-category/eto-sterilizer/)

# Hospital / Laboratory ETO Sterilizer

hospital eto sterilizer and Laboratory eto sterilizer is used to sterilize the instruments in the cavity with ethylene oxide gas

Category: [Eto Sterilizer](https://zjbocon.com/product-category/eto-sterilizer/)

- [Description](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/#tab-description)
- [Reviews (0)](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/#tab-reviews)

Our hospital eto sterilizer sterilizer is a highly effective solutions by using Ethylene Oxide (ETO) sterilization, one of the most widely used methods for sterilizing medical equipment and supplies. We also suppluy[industry eto sterilizer](https://www.hzbocon.com/)

## Basic parameters of hospital eto sterilizer and Laboratory eto sterilizer

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/01/0251106095245_313_268-768x638.webp)

## Sterilizer Photo Display

![Hospital_laboratory_ETO_sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Hospital_laboratory_ETO_sterilizer.webp)Hospital / Laboratory ETO Sterilizer

## Characteristics of hospital eto sterilizer

### A銆丼atety

Our Hospital / Laboratory ETO Sterilizeruse Negative pressure sterilization, negative pressure cleaning, negative pressure residue removal, the whole process of negative pressure to ensure safety!

This hospitel eto sterilizer belongs to class B sterilizer, the sterilization temperature can be adjusted in 30鈩儈55鈩 .Sterilization, cleaning and residue removal processes, the sterilizer always maintains a relative negative pressure to ensure that ethylene oxide does not leak.

Even if leakage occurs, the control system will automatically detect the leakage, and automatically abort the sterilization process to send an alarm, and automatically discharge the ethylene oxide gas.

### B銆丷esidue removal and aeration

When thehospital eto sterilizersterilization process reaches the end of the cleaning process, it automatically enters the residue removal (to fully ensure that the EO residue of the sterilized articles is minimized).

### C銆丆ontinuous temperature monitoring

=Sterilization stage temperature is maintained within the selected temperature 卤 3 鈩 , once the temperature sensor detects a deviation from the predetermined temperature of 3 鈩 , then the over-temperature protection device is automatically activated, and the text prompts the temperature abnormality and alarm, and interrupt the heating.

### D銆丠umidity control

The humidity sensor is open and displayed throughout the sterilization process. According to the set humidity value, humidification is uniformly applied several times to ensure the right humidity level.

### F銆丄utomatically control of puncturingEO gas cartridge

Only when the dosing process is entered normally will the system automatically activate the dosing unit, puncturing theEO gas cartridgeand releasing the ethylene oxide gas.

### G銆丼terilization process status display

Located in front of the liquid crystal display real-time continuous display of the sterilization process status. (e.g. temperature, humidity, pressure, time, sterilization process, etc.)

## Implementation standard of hospital eto sterilizer

Our hospitel eto sterilizer use following standards

YY0503-2016 Ethylene Oxide Sterilizer

GB4793.1-2007 Safety requirements for measuring, controlling and

laboratory electricalequipment(Part I: General Requirements)

GB18279-2000 Confirmation and routine control of ethylene oxide sterilization of medical devices

GB/T18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use

GB 4793.8-2008Safety requirements for electrical equipment for measurement, control, and laboratory use    Part 2-042: Specific requirements for the treatment of medical materials with toxic gases and for pressure sterilizers and sterilizers intended for laboratory use

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/EO__bottle_-1024x683.png)eo gas bottle

## Download BOCON Hospitel EtO Sterilizer Catalogue

[![catalog of hospital](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/catalog-of-hospital.webp)](https://zjbocon.com/wp-content/uploads/2024/10/hospital-eto-sterilizer-pdf.pdf) catalog of hospital

[Dowload Hospital EtO sterilizer Catalogue](https://zjbocon.com/wp-content/uploads/2024/10/hospital-eto-sterilizer-pdf.pdf)

[DOWLOAD THE operation manual](https://zjbocon.com/wp-content/uploads/2024/10/operation-manual2.pdf)

## Our Partners

![Partner 1](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-1.webp)

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![Partner 4](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-4.webp)

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##### More information about eto sterilization

[Pneumatic Revolving Door ethylene oxide sterilizer](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/ "Pneumatic Revolving Door ethylene oxide sterilizer")

[pneumatic sliding door ethylene oxide sterilizer](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/ "pneumatic sliding door ethylene oxide sterilizer")

[Overall Lifting Door ethylene oxide sterilizer](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/ "Overall Lifting Door ethylene oxide sterilizer")

## Reviews

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## Related products

- [![pneumatic sliding door ethylene oxide sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-3-600x600.webp)](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/)[Read more](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/)

Eto Sterilizer [**pneumatic sliding door ethylene oxide sterilizer**](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/)

- [![ETO sterilizer hot air system](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/02/hot_air.webp)](https://zjbocon.com/product/eto-sterilizer-hot-air-system/)[Read more](https://zjbocon.com/product/eto-sterilizer-hot-air-system/)

Eto Sterilizer [**ETO sterilizer hot air system**](https://zjbocon.com/product/eto-sterilizer-hot-air-system/)

- [![Overall Lifting Door ethylene oxide sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-7-600x600.webp)](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/)[Read more](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/)

Eto Sterilizer [**Overall Lifting Door ethylene oxide sterilizer**](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/)

- [![Pneumatic Revolving Door ethylene oxide sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-11-600x600.webp)](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/)[Read more](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/)

Eto Sterilizer [**Pneumatic Revolving Door ethylene oxide sterilizer**](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/)


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## Sterilizer Control System
[Skip to content](https://zjbocon.com/product/sterilizer-control-system/#content)

[馃攳](https://zjbocon.com/product/sterilizer-control-system/#)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-4-600x600.webp)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-8-600x600.webp)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-2-600x600.webp)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-1-600x600.webp)

![](<Base64-Image-Removed>)

![](<Base64-Image-Removed>)

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[![Sterilizer Control System - Image 2](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-8-scaled.webp)

[![Sterilizer Control System - Image 3](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-2-scaled.webp)

[![Sterilizer Control System - Image 4](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-1-scaled.webp)

[![Sterilizer Control System - Image 5](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Functions-of-software-control-system.webp)

[![Sterilizer Control System - Image 6](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-3.webp)

[![Sterilizer Control System - Image 7](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-6-1.webp)

[![Sterilizer Control System - Image 8](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-4-1.webp)

[![Sterilizer Control System - Image 9](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Control-System-7-1.webp)

# Sterilizer Control System

Our control system has undergone long-term strict audits by Medline, Cardinal, Medtronic, WINNER, ZHENDE, and ALLMED companies, and has the most comprehensive functions and the best stability.

- [Description](https://zjbocon.com/product/sterilizer-control-system/#tab-description)
- [Reviews (0)](https://zjbocon.com/product/sterilizer-control-system/#tab-reviews)

### Sterilizer Control System Control cabinet(hardware)

#### IPC integrated type

#### IPC Separated type

![](https://zjbocon.com/wp-content/uploads/2024/10/IPC-integrated-type-1024x768.webp)

![](https://zjbocon.com/wp-content/uploads/2024/10/IPC-Separated-type-1024x766.webp)

### Functions of software control system

1 Main interface layout and various details of our sterilizer control system, please see the follow picture.

2 Automatic quality assessment report for software, which is an important function to assist operators and quality control personnel in quickly assessing production quality and identifying problems. Our[eto sterilization cabinet](https://zjbocon.com/product/eto-sterilzer/) software has more than 400 built-in automatic assessment functions, which can almost meet the quality automatic detection and assessment needs of all customers.

3 .Very detailed software audit tracking function. Specifically, it is manifested by more than 120 automatic detection and prediction alarm functions, and almost all operations will be recorded in the system, making it easy to quickly identify the root cause of problems and repair them in the later stage.

4 .Standardized backend MES interface, with the customer  consent, data can be automatically uploaded to cloud servers or the customer  own backup server.

5.The Sterilizer Control System device has many other built-in functions, if you need custom function, pls [contact us](https://zjbocon.com/contact/).

![](https://zjbocon.com/wp-content/uploads/2024/10/Main-interface-layout-and-various-details-1024x576.webp)

#### Mixed gas processes

#### Full Nitride protection Processes

1.Heating

2.Keep warm

3\. Pre-vacuum

4.Leak testing

5.Humiditying

6.Humidity dwelling

7.EO injection

8\. EO injection2

9.EO injection 3

10.EO dwelling

11.EO removal 2

12.Air washing

13.Aeration

1.Heating

2.Keep warm

3\. Pre-vacuum

4.Leak testing

5.Humiditying

6.Humidity dwelling

7.EO injection

8\. EO injection2

9.EO injection 3

10.EO dwelling

11.EO removal 2

12.Air washing

13.Aeration

1.Heating

2.Keep warm

3\. Pre-vacuum

4.Leak testing

5.Humiditying

6.Humidity dwelling

7.EO injection

8\. EO injection2

9.EO injection 3

10.EO dwelling

11.EO removal 2

12.Air washing

13.Aeration

### Software Report

![eo sterilizer software report](<Base64-Image-Removed>)

![eo sterilizer software report](<Base64-Image-Removed>)

![eo sterilizer software report](<Base64-Image-Removed>)

![eo sterilizer software report](<Base64-Image-Removed>)

![eo sterilizer software report](<Base64-Image-Removed>)

![eo sterilizer software report](<Base64-Image-Removed>)

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[Sterilizer Chamber Conveyor](https://zjbocon.com/product/sterilizer-chamber-conveyor/ "Sterilizer Chamber Conveyor")

[Hospital / Laboratory ETO Sterilizer](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/ "Hospital / Laboratory ETO Sterilizer")

[Pneumatic Revolving Door ethylene oxide sterilizer](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/ "Pneumatic Revolving Door ethylene oxide sterilizer")

## Reviews

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## EO Scrubber
[Skip to content](https://zjbocon.com/product/eo-scrubber/#content)

[馃攳](https://zjbocon.com/product/eo-scrubber/#)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eo-scrubber-22-1-600x600.webp)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eo-scrubber-9-600x600.webp)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/EO-scrubber-600x600.webp)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eo-scrubber-23-600x600.webp)

![](<Base64-Image-Removed>)

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[![Eo Scrubber - Image 2](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eo-scrubber-9.webp)

[![Eo Scrubber - Image 3](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/EO-scrubber-scaled.webp)

[![Eo Scrubber - Image 4](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eo-scrubber-23.webp)

[![Eo Scrubber - Image 5](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eo-scrubber-54-1.webp)

[![Eo Scrubber - Image 6](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eo-scrubber-22-1.webp)

[![Eo Scrubber - Image 7](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eo-scrubber-1-1-scaled.webp)

[![Eo Scrubber - Image 8](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Eo_Scrubber_.webp)

# Eo Scrubber

The process principle is that EO and water can react under the catalytic action of acid to generate ethylene glycol (EG), diethylene glycol (DEG), triethylene glycol (TEG), little polyethylene glycol and trace polyester polyol.

Eo scrubber means The EO and water can dissolve in any proportion, and then EO tail gas can be treated by a reaction absorption tower.

- [Description](https://zjbocon.com/product/eo-scrubber/#tab-description)
- [Reviews (0)](https://zjbocon.com/product/eo-scrubber/#tab-reviews)

Eo scrubber which is also called eo, eto gas scrubber, is used for removing ethylene oxide from industrial exhaust streams by using[eto sterilizer](https://zjbocon.com/product/eto-sterilzer/)

## Eo gas scrubber process

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/process.png)

## Process Description of eo scrubber

The process description of eo gas scrubber

(1) Water volume and flow rate: the flow rate of the spay pump and the air volume of the centrifugal fan can be determined according to the exhaust volume of the vacuum pump;

(2) Acid medium for absorption reaction: 0.5-1.5% sulfuric acid solution (solid acid catalyst can be added);

(3) Temperature and pressure: Although the reaction is exothermic, the increase in temperature and pressure is limited. The reaction temperature is between normal temperature and 50degrees celsius, and the pressure is between slight negative pressure and normal pressure;

(4) waste liquid production: ethylene oxide reacts with water in the reactor tower to form a hybrid alcohol solution mainly composed of ethylene glycol.

After the reaction, the concentration of ethylene glycol in the reactor will rise.

After the density of ethylene glycol in the tower reaches the specified value, the waste liquid will be transferred to the rich liquid tank through the rich liquid pump, and then the new liquid will be added.

(5) Supplement of fresh liquid: after the transfer, fresh reaction liquid should be added to the tower kettle;

(6) Neutralization of discharged solution: The discharged solution should be treated and recycled by a qualified hazardous chemicals & waste liquid treatment plant, and the hazardous waste transfer manifest (five-sheet) should be handled.

(7) Equipment parameters: Maximum operating power: 25kw;

## EO Scrubber Electrical safety design

On-site electrical devices such as motors, temperature sensors and pressure transmitters are of flame-proof type, and the explosion-proof grade is DIIBT4.

The isolation-type safety barrier, which is an intrinsically safe explosion-proof structure with the highest explosion-proof grade, is used for switch signal devices such as limit switch and liquid level switch.

Non-explosion proof cabinet body will be adopted if installed in the area with no explosion hazard and explosion-proof control cabinet will be adopted if installed on site.

### Automatic control scrubber

Siemens PLC control system is adopted to ensure safe and reliable operation of the equipment.

The touch screen on-line monitoring system is adopted to realize good human-machine interface, so that operators can timely know the running status of the equipment in the daily production process.

In case of equipment failure, the operators can analyze and judge the cause of the failure in time and eliminate the failure with the help of the monitoring system.

A RS485 communication interface is reserved in the control system for the connection with the user  DCS system. This interface supports Modbus protocol.

## Our Customers Who Use Scrubber

Eo scrubber

Eo scrubber

Eo scrubber

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[Pneumatic Revolving Door ethylene oxide sterilizer](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/ "Pneumatic Revolving Door ethylene oxide sterilizer")

[pneumatic sliding door ethylene oxide sterilizer](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/ "pneumatic sliding door ethylene oxide sterilizer")

[Eto sterilizer](https://zjbocon.com/product/eto-sterilzer/ "Eto sterilizer")

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## Aeration Room Overview
[Skip to content](https://zjbocon.com/product/aeration-room/#content)

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# Aeration Room

After EO sterilization, the product can be put into the aeration room, which can accelerate the removal speed of EO residue after sterilization. Meanwhile, the e?ciency of the sterilization cabinet is improved.

- [Description](https://zjbocon.com/product/aeration-room/#tab-description)
- [Reviews (0)](https://zjbocon.com/product/aeration-room/#tab-reviews)

### The function of Aeration Room

After EO sterilization, the product can be put into the aeration room, which can accelerate the removal speed of EO residue after sterilization. Meanwhile, the e铿僣iency of the sterilization cabinet is improved.

Forced hot air cleaning and negative pressure keeping accelerate the residual ethylene oxide parse out.

Stop heating, and exhaust fan running to avoid inhaling EO during loading and unloading for more safety.

Temperature uniformity of 卤5 degrees celsius, exhaust temperature control for maximum energy saving.

Low investments, low energy consumption and use cost, easy operation, and convenient maintenance.

The preheating room and ETO sterilizer volume ratio is normally 1:1, 3:1, or 4:1.

![Aeration Room](<Base64-Image-Removed>)

### On-site requirements

a) Building Requirements: The height of the factory space should not be less than 5 meters, and the dimensions of the entrance door should not be less than 3 meters in width and 3.5 meters in height. The factory area should have good ventilation measures, adequate lighting, and emergency lighting. All electrical appliances must meet explosion-proof standards. (There should be dust removal and disinfection devices at personnel entrances and exits, and disinfection and dust filtration devices at goods entrances and exits.)

b) Floor Requirements: The ground must be level, capable of bearing a load of 2t/m虏, constructed with concrete, fully coated with floor paint, and equipped with dedicated safety passages and signage.

c) Environmental Requirements: Ambient temperature: 5鈩  to 40鈩 . Relative humidity: 鈮 85% RH. Atmospheric pressure: 90 to 105 kPa.

d) Electrical Requirements: The total power for the preheating room is 120 kW, and for the analysis room, it is 100 kW, with a supply of 380V, 50Hz, three-phase five-wire system.

e) Water Requirements: Heating water: Pure water pipeline DN25, with a pressure greater than 2 kg, including valves and pressure gauges; Humidification water: Pure water pipeline DN15, with a pressure greater than 2 kg, including valves and pressure gauges.

f) Gas Requirements: Compressed air must be free of water and oil, with a pressure of 4-6 kg, and should include filtration and pressure regulation with valves and pressure gauges.

g) Lifting Requirements: Transportation to the client should be handled by our factory. The transportation company will directly contact the client by phone upon arrival at the site. After the client inspects and confirms that there is no damage, the items will be lifted or forked to the designated area, and then wait for the supplier  representative to arrive for installation. Note: The client must prepare lifting and unloading tools and personnel in advance.

h) Exhaust and Drainage Requirements: Drainage outlets should be set up near the lower part of the room, inside the preheating room, and in the control room to regularly discharge condensate from the preheating room.

i) Layout Requirements: The area awaiting sterilization must be completely isolated from the sterilized area, with clear signage. The logistics direction should ensure that unsterilized products and sterilized products are completely separated and cannot be confused. The sterilized area must have sufficiently high walls for physical separation from the factory  cold analysis area (if such an area exists). The area awaiting release must be isolated from the released area, and it should reserve at least three working days of storage space for goods (greater than or equal to the capacity of the analysis room). Products must not be placed directly on the ground and should be stored on pallets.

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[Hospital / Laboratory ETO Sterilizer](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/ "Hospital / Laboratory ETO Sterilizer")

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## Precondition Room
[Skip to content](https://zjbocon.com/product/precondition-room/#content)

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# Precondition Room

Before the EO sterilization process, preheating and humidifying the products in the precondition room in advance, can effectively shorten the heating and humidifying time of the products in the sterilizer.

- [Description](https://zjbocon.com/product/precondition-room/#tab-description)
- [Reviews (0)](https://zjbocon.com/product/precondition-room/#tab-reviews)

### The function of Preconditioning Room

Before the [EO sterilization process](https://zjbocon.com/eto-sterilization-process/), preheating and humidifying the products in the precondition room in advance, can effectively shorten the heating and humidifying time of the products in the sterilizer.

Temperature (卤3 degrees celsius) and humidity (5梅10%) uniformity

Forced air circulation and positive pressure inside the room to speed up that transfer and heat penetration.

Precise control, high level of automation, parameters records.

Relatively simple construction and fast installation.

Easy operation and convenient maintenance.

Low investments, low use cost, and energy consumption.

The preheating room and [ETO sterilizer](https://zjbocon.com/product/eto-sterilzer/) volume ratio is normally 1:1.

![The function of Preconditioning Room](https://zjbocon.com/wp-content/uploads/2024/10/The_function_of_Preconditioning_Room-768x612.webp)

### On-site requirements

a) Building Requirements: The height of the factory space should not be less than 5 meters, and the dimensions of the entrance door should not be less than 3 meters in width and 3.5 meters in height. The factory area should have good ventilation measures, adequate lighting, and emergency lighting. All electrical appliances must meet explosion-proof standards. (There should be dust removal and disinfection devices at personnel entrances and exits, and disinfection and dust filtration devices at goods entrances and exits.)

b) Floor Requirements: The ground must be level, capable of bearing a load of 2t/m虏, constructed with concrete, fully coated with floor paint, and equipped with dedicated safety passages and signage.

c) Environmental Requirements: Ambient temperature: 5鈩  to 40鈩 . Relative humidity: 鈮 85% RH. Atmospheric pressure: 90 to 105 kPa.

d) Electrical Requirements: The total power for the preheating room is 120 kW, and for the analysis room, it is 100 kW, with a supply of 380V, 50Hz, three-phase five-wire system.

e) Water Requirements: Heating water: Pure water pipeline DN25, with a pressure greater than 2 kg, including valves and pressure gauges; Humidification water: Pure water pipeline DN15, with a pressure greater than 2 kg, including valves and pressure gauges.

f) Gas Requirements: Compressed air must be free of water and oil, with a pressure of 4-6 kg, and should include filtration and pressure regulation with valves and pressure gauges.

g) Lifting Requirements: Transportation to the client should be handled by our factory. The transportation company will directly contact the client by phone upon arrival at the site. After the client inspects and confirms that there is no damage, the items will be lifted or forked to the designated area, and then wait for the supplier  representative to arrive for installation. Note: The client must prepare lifting and unloading tools and personnel in advance.

h) Exhaust and Drainage Requirements: Drainage outlets should be set up near the lower part of the room, inside the preheating room, and in the control room to regularly discharge condensate from the preheating room.

i) Layout Requirements: The area awaiting sterilization must be completely isolated from the sterilized area, with clear signage. The logistics direction should ensure that unsterilized products and sterilized products are completely separated and cannot be confused. The sterilized area must have sufficiently high walls for physical separation from the factory  cold analysis area (if such an area exists). The area awaiting release must be isolated from the released area, and it should reserve at least three working days of storage space for goods (greater than or equal to the capacity of the analysis room). Products must not be placed directly on the ground and should be stored on pallets.

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## Spice Sterilization Methods
[Skip to content](https://zjbocon.com/sterilization-for-spice/#content)

There arethreetypesofsterilizationfor spice( [ethyleneoxidesterilization](https://zjbocon.com/product/eto-sterilzer/) )(EtO, gamma, steam) :

with eogas(eto sterilization) 撀爏picestreatedwithethyleneoxide(EtO),

- withirradiation 撀爏picestreatedwithradiation(e.g.gammarays,x-rays),
- withsteam(high temperature,and water steam).

![](https://zjbocon.com/wp-content/uploads/2024/10/advantage-and-disadvantage-between-eto-sterilization-irradiation-and-steam-in-spice-sterilization-1-1024x576.webp)

1\. [Ethyleneoxidesterilization(ETO)](https://zjbocon.com/product/eto-sterilzer/) exposestheproducttoETOgasundercontrolledconditionsinasealedchamber,tokillbacteriaintheproduct.

advantage:Thisisacost-effective,widely-usedsterilizationmethodthathasbeencommonformanyyears, when you buy the machine, you can sterilize by yourself, and the cost is very cheap.large volume (1-36pallet) (around 1-35ton spice one time, depending on the density Of spice )

disadvantage:ETOisaheavily-regulated, gas.Andwilltakemoretimethanthe othertwosterilizationway(you can install a pre-heating room and aeration room to solve this problem).

2\. Irradiationexposestheproducttogammaraysorelectronbeamradiationtosterilizeit.

advantage:Mosteffectivemethodandnochemicalsareusedinthisprocess

Disadvantages: expensiveprice,willcausedamagetothepackage,andpublicpressureduetothenegativeconnotationsofradiationhasresultedinspecificlabelingrequirementstodisclosethattheproductisirradiated.Thatcanbeunappealingtoconsumers.

3\. Steamsterilizationisaprocessthatuseshotsteaminacontrolledenvironmenttoheattheproduct.

advantage:Nochemicalsorradiationareusedinthisprocess.

disadvantage: hightemperature,andifanymoistureisintroducedtotheproduct,itcanresultincakingandmolding,and changethecolorand flavorofspice.

## Know more about eto sterilization

[Microbial Killing Performance of Ethylene Oxide Sterilizers](https://zjbocon.com/microbial-killing-performance-of-ethylene-oxide-sterilizers/)

[eto sterilization Chamber Temperature Distribution Testing](https://zjbocon.com/eto-sterilization-chamber-temperature-distribution-testing/)

[Preparatory Work Before eto Sterilization](https://zjbocon.com/preparatory-work-before-eto-sterilization/)

[The Guide to ethylene oxide in sterilization](https://zjbocon.com/the-guide-to-ethylene-oxide-in-sterilization/)

[what is eto sterilization](https://zjbocon.com/eto-sterilization/)

## Contact

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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[Safety Requirements for Using Ethylene Oxide in sterilization](https://zjbocon.com/safety-requirements-for-using-ethylene-oxide-in-sterilization/ "Safety Requirements for Using Ethylene Oxide in sterilization")

[what is eto sterilization](https://zjbocon.com/eto-sterilization/ "what is eto sterilization")

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## Ethylene Oxide Sterilization
[Skip to content](https://zjbocon.com/eto-sterilization/#content)

## Ethylene Oxide (EtO) Overview

![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-19-1024x768.webp)

Ethylene Oxide (EtO or EO) sterilization is a colorless gasbroadlyutilizedindifferentbusinesses,includingthegenerationofmaterials,individualcareitems, and the eto sterilization oftherapeuticgadgets,makeup, andflavors. EtO is anessentialstrategyfor sterilizingrestorativegadgets, playing acrucialpartinavoidingcontaminationin patientsexperiencingsurgicalmethodsand otherrestorativetreatments.

Approximately 50% of allrestorativegadgetsare sterilizedutilizingEtO, and fornumerous, it is theas it wereexperimentallyrecognizedalternativeavailable.

Hundreds of thousands oftherapeutic,healing center, andresearch facilityformsdepend on EtO to sterilizegadgetsandhardware,defendingmillions of patients from thegenuinedangersofirresistibleinfectionscaused bymicroscopic organisms,infections, andparasites.

For thelion  shareof theseitems, EtO sterilization is notas it werethe mostsuccessfulandproductivestrategybutregularlytheas it werereasonablearrangement. Thedelicatehowevercarefulnature of EtOpermitsfor the sterilization ofbasictherapeuticadvancesandgadgetsthatseembeharmedor rendered unusable by other sterilization methods.

Limitations ofElectiveSterilization Methods

Manyrestorativegadgetscannot be sterilizedutilizingstrategiesother than EtO due to thefollowingreasons:

Gamma and E-beam Radiation: Thesestrategiescan make plasticsdelicateor cause certain non-woven materials to disintegrate.

Steam Sterilization: Thetalltemperaturesincludedcanliquefyplastics andharmitemstouchytowarmand moisture.

Hydrogen Peroxide and Gas Plasma: These areplannedfor small-scale, surface sterilizationas it wereand cannotentergadgetswithinsidechambers or surfaces in contact with one another (e.g., thecylinderand barrel of a syringe).

EtOextraordinarilyentersbundlingand plastic without causingharm,viablysterilizingsomething elsehard-to-reacharrangements(e.g.,interiortubing,itemswith touching surfaces, connectors, etc.).

## MedicalGadgetsRequiring EtO Sterilization

Thetaking afterrestorativegadgetsrequires [EtO sterilization](https://zjbocon.com/product/eto-sterilzer/):

Fiberoptic endoscopes

Specula

Surgical kits

Syringes

Sutures

Catheters

IV sets

Plastic tubing

Inhalationtreatmentsupplies

Surgical telescopes

Anesthesiacoversand circuits

Renal peritoneal dialysis sets

Renal hemodialysis sets

Tubing sets/bloodlines

Gowns and drapes

Heart valves

Pacemakers

Surgical drills

Pumps

Respirators

Electrical equipment

Uterine monitors

Surgical staplers

Diagnosticterminalcatheters

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[What Can Be Sterilized by Ethylene Oxide?](https://zjbocon.com/what-can-be-sterilized-by-ethylene-oxide/ "What Can Be Sterilized by Ethylene Oxide?")

[Understanding What is ETO Sterilizers: A Comprehensive Guide](https://zjbocon.com/understanding-what-is-eto-sterilizers-a-comprehensive-guide/ "Understanding What is ETO Sterilizers: A Comprehensive Guide")

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## ETO Sterilization Overview
[Skip to content](https://zjbocon.com/eto-sterilization-process/#content)

![eto sterilization process](https://zjbocon.com/wp-content/uploads/2024/10/eto-sterilization-process-e1729654271899.webp)

## Implementation of the ETO Sterilization Process

Eto Sterilization is conducted using a eto sterilizer located in a dedicated facility. Outside the sterilization room, control equipment regulates the process according to established parameters and requirements.

## Composition of Agents Used in theETOSterilization Process

The agents employed in sterilization consist of either pure ethylene oxide or mixtures of carbon dioxide and nitrogen.

## Precautionary Measures for Ethylene Oxide

Ethylene oxide (EO) gas must be handled, stored, and used with extreme caution due to its highly toxic nature, flammability, and explosion risk at concentrations as low as 2.6% in air.

## Steps Involved in the Sterilization Process

The eto sterilization process comprises two critical steps:

1. [Preconditioning](https://zjbocon.com/product/precondition-room/)
2. [Sterilization Process](https://zjbocon.com/product/eto-sterilzer/)

### Preconditioning

Preconditioning involves achieving the necessary humidity and temperature levels prior to introducing the load into the chamber, ensuring effective sterilization unaffected by internal environmental factors.

### Sterilization Cycle

The EO sterilization process includes the following elements:

1.Heating

2.Keep warm

3\. Pre-vacuum

4.Leak testing

5.Humiditying

6.Humidity dwelling

7.EO injection

8\. EO injection2

9.EO injection 3

10.EO dwelling

11.EO removal 2

12.Air washing

13.Aeration

1.Heating

2.Keep warm

3\. Pre-vacuum

4.Leak testing

5.Humiditying

6.Humidity dwelling

7.EO injection

8\. EO injection2

9.EO injection 3

10.EO dwelling

11.EO removal 2

12.Air washing

13.Aeration

1.Heating

2.Keep warm

3\. Pre-vacuum

4.Leak testing

5.Humiditying

6.Humidity dwelling

7.EO injection

8\. EO injection2

9.EO injection 3

10.EO dwelling

11.EO removal 2

12.Air washing

13.Aeration

### Influence of Load Chamber

The configuration of the load within the chamber affects:

- Heat distribution patterns
- Humidity levels
- EO gas penetration
- EO gas removal

### Design of Load Configuration

The load configuration should be designed to facilitate the sterilization process by:

- Removing air
- Aiding heat penetration
- Eliminating humidity
- Ensuring EO removal during and after the process

## Process Characterization & Safe Delivery of Sterilization Processes

Process characterization defines the range of variables required by ISO 11135 and identifies four key process variables, which must be documented at every stage of the sterilization process:

1. **Phase**

Covers variables associated with each phase of the process.

2. **Pre-conditioning**

Involves time, temperature, humidity, and transfer time.

3. **Sterilization Cycle**

Includes exposure time, temperature, humidity, EO concentration, and pressure.

4. **Aeration**

Pertains to time and temperature during the aeration or gassing phase.


## References

[ISO 11135:2014Sterilization of health-care products    Ethylene oxide    Requirements for the development, validation and routine control of a sterilization process for medical devices](https://www.iso.org/obp/ui/#iso:std:iso:11135:ed-2:v1:en)

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## EtO Sterilization Overview
[Skip to content](https://zjbocon.com/eto-sterilization-cycle/#content)

The Detail EtO Sterilization Cycle

A typical EtO sterilization cycle comprises three main stages:

## Preconditioning

This stage prepares the chamber to create optimal conditions for temperature, pressure, and humidity. First, air is evacuated to enhance gas penetration, followed by a leakage test to ensure safety for personnel and the environment. Steam is then injected to humidify the load, as EtO functions effectively only in moist conditions. The chamber is heated using hot airor hot water circulating in the jacket, which is maintained at a consistent temperature to prevent fluctuations.

[![Preconditioning](https://zjbocon.com/wp-content/uploads/2024/10/Pecondition-Room-2.webp)](https://zjbocon.com/product/precondition-room/)

## EtO sterilization cycle

During this phase, EtO is introduced into the chamber through evaporation, along with steam to maintain humidity. Once the desired concentration of EtO is reached, the sterilization process begins. Lower gas concentrations require longer sterilization times. Since EtO is absorbed by various plastics, it  crucial to monitor and maintain appropriate concentration levels throughout the process.

[![ EtO sterilization cycle](https://zjbocon.com/wp-content/uploads/2024/10/Industry_ETO_Sterilizer-4.webp)](https://zjbocon.com/product/eto-sterilzer/)

## Aeration (Degassing)

Aeration is the longest and most critical part of the cycle. Materials like plastics and rubbers can absorb EtO, posing risks if used on patients. Thus, extensive aeration is essential to remove any residual gas. This is achieved by circulating HEPA-filtered air over the load at temperatures between 30degrees celsius and 50degrees celsius, typically for 48 hours, which can slow instrument turnaround. A dedicated infrastructure with gas-tight ventilation is required, as using the hospital  ventilation system poses safety hazards. Regular gas leak tests on the ventilation piping are vital to minimize risks.

[![Aeration Room](https://zjbocon.com/wp-content/uploads/2024/10/Aeration-Room-1.webp)](https://zjbocon.com/product/aeration-room/)

## Advantages of EtO Sterilization:

Low temperature

High efficiency in destroying microorganisms, including resistant spores(1-120m3?

Large chamber capacity, accommodating significant volumes

Non-corrosive to plastics, metals, and rubber

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## Ethylene Oxide Sterilization Guide
[Skip to content](https://zjbocon.com/the-guide-to-ethylene-oxide-in-sterilization/#content)

## ethylene oxide in sterilization Introduction

ETO is a colorless gas that is flammable and explosive. The four essential parameters (operational ranges) of ethylene oxide in sterilization are: gas concentration (450 to 1200 mg/l); temperature (37 to 63degrees celsius); relative humidity (40 to 80%)(water molecules carry ETO to reactive sites); and exposure time (1 to 6 hours).

## What is Ethylene Oxide Sterilization?

![Industry_ETO_Sterilizer](https://zjbocon.com/wp-content/uploads/2024/10/Industry_ETO_Sterilizer.webp)

(EtO or EO) sterilization is a colorless gasbroadlyutilizedindifferentbusinesses,includingthegenerationofmaterials,individualcareitems, and the eto sterilization oftherapeuticgadgets,makeup, andflavors. EtO is anessentialstrategyfor sterilizingrestorativegadgets, playing acrucialpartinavoidingcontaminationin patientsexperiencingsurgicalmethodsand otherrestorativetreatments.

## [The Process of EtO Sterilization](https://zjbocon.com/eto-sterilization-process/)

Phase Covers variables associated with each phase of the process.

Pre-conditioning Involves time, temperature, humidity, and transfer time.

Sterilization Cycle includes exposure time, temperature, humidity, EO concentration, and pressure.

Aeration Pertains to time and temperature during the aeration or gassing phase.

## Why Use Ethylene Oxide for Sterilization?

Eto sterilization is preferred for several reasons:

Compatibility: EtO is compatible with a wide range of materials, including plastics, metals, and glass, making it suitable for diverse medical devices.Penetration: Ethylene oxide can penetrate complex devices and packaging, ensuring thorough sterilization.Efficacy: It effectively kills microorganisms at relatively low temperatures, preserving the integrity of heat-sensitive materials.

## Applications of EtO Sterilization

EtO sterilization is widely used across various sectors:

Medical Devices: From surgical instruments to catheters, EtO sterilization is essential for ensuring the safety and sterility of medical tools.Pharmaceuticals: Certain pharmaceutical products require sterilization to maintain their efficacy and safety.Laboratories: In research settings, sterilized equipment is crucial for accurate and reliable results.

## Understanding EO Sterilization

EO sterilization, another term for ethylene oxide sterilization, follows the same principles. It is vital for maintaining sterility in environments where precision and safety are paramount.

## The Medical Abbreviation: EtO

In medical terminology, EtO stands for ethylene oxide. This abbreviation is commonly used in medical and industrial settings to refer to the sterilization process.

## EtO Sterilized: What Does It Mean?

When an item is labeled as  淓tO sterilized,   it signifies that it has undergone the ethylene oxide sterilization process. This label assures users that the item is free from viable microorganisms and is safe for its intended use.

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## ETO Sterilization Validation
[Skip to content](https://zjbocon.com/eto-sterilization-2/#content)

## 1. **Purposefor validation** eto sterilization

1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been provided and installed in accordance with its specification and can stably operate within predetermined limits and consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification.

[![eto sterilization validation](https://zjbocon.com/wp-content/uploads/2024/10/Qualification_Services-2.webp)](https://zjbocon.com/qualification-services/)

1.2

This part specifies requirements for the development,validation and routine control of the ETO sterilization process and provide guidance for it to comply with relevant regulatory requirements like ISO 11135.

## 2\. Scope

2.1.Relevant equipment used in ETO sterilization(Precondition room?Sterilizer?Aeration room?Incubator ,etc.).

## 3\. Terms and Definitions

3.1.?IQ

Installation qualification:IQ

3.2.?OQ

Operation qualification:OQ

3.3.?PQ(MPQ/PPQ)

Performance qualification:PQ(Microbiological PQ/Physical PQ )

3.4.:Requalification

3.5.:Bioburden

3.6.:Biological indicator

3.7.:Fractional cycle

3.8.:Half cycle

3.9.:Full cycle

3.10.PCD: process challenge device

3.11.:Product and product family

3.12.?: Usable volume/Product load volume

3.13.:Sterility

3.14.SAL: Sterility assurance level

## 4\. Responsibilities

4.1 The eto sterilization validation engineer is responsible for drafting the validation protocol, and the trained personnel and the uses are responsible for performing the validation and collecting relevant data to assist in the completion of the validation.

## 5\. Procedure

5.1.IQ is undertaken to demonstrate that the sterilization equipment and any ancillary items have been supplied and installed in accordance with their specification. Before performing IQ, the equipment manufacturer will conduct FAT and SAT to ensure that the equipment has been delivered normally.

## References

[ISO 11135:2014Sterilization of health-care products    Ethylene oxide    Requirements for the development, validation and routine control of a sterilization process for medical devices](https://www.iso.org/obp/ui/#iso:std:iso:11135:ed-2:v1:en)

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## ETO Sterilizer System
[Skip to content](https://zjbocon.com/eto-sterilizer-system/#content)

## Protection mechanism and explanation OF ETO Sterilizer System

[![Ethylene Oxide Sterilizer Control System (5)](https://zjbocon.com/wp-content/uploads/2024/10/Ethylene-Oxide-Sterilizer-Control-System-5.webp)](https://zjbocon.com/product/sterilizer-control-system/)

1. ETO sterilizer system has six different levels of operation permissions. Personnel with different permissions can operate different contents to prevent operation confusion, or equipment failure or safety accident caused by operation by personnel without professional training

2\. By default, the system will perform the leak detection test before dosing of each batch. If the leak detection test fails, the system will automatically stop the cycle and no longer continue, and the alarm will prompt

![](https://zjbocon.com/wp-content/uploads/2024/10/4.-leak-testing.webp)

3.If the cabinet body leaks during the exposure stage of the equipment, the ETO chamber System will automatically jump to the cleaning stage to ensure that EO will not leak into the workshop and cause safety accidents

4\. When the equipment is in operation, if it wants to stop the cycle halfway, the system will automatically jump to a safe processing process according to different operating conditions. For example, after dosing, the system needs forced cleaning to reset the whole process.

5\. If the system is equipped with an electronic scale, as long as the equipment is powered on, you can check whether the weight of the EO cylinder changes abnormally at any time, so as to timely notify the equipment maintenance personnel of potential safety hazards

6\. The ETO chamber System has the function of ultra-high pressure detection and protection. If the system detects that the pressure in the cabinet is greater than the maximum allowable pressure, whether the equipment is in operation or not, the vacuum pump must be forced to start to reduce the pressure in the cabinet to prevent the gas in the cabinet from leaking into the workshop, or the cabinet will be damaged by the high pressure in the cabinet

7.Each time the door is opened, the ETO chamber System will check whether the pressure in the cabinet is within the safe range, and whether the operation state in the cabinet is in the safe state, otherwise the door will be locked and cannot be opened

8.In order to ensure personal safety, the equipment can be equipped with a harmless exhaust system. After the cabinet door is opened, ensure that the air in the workshop can only enter the cabinet, but cannot be discharged from the cabinet to the workshop environment

9.If the equipment has been cleaned but the door has not been opened, the system will automatically check the unloading timeout. If the unloading timeout is more than 30 minutes, the door will be locked and cannot be opened, and the cleaning process must be executed again. This function is used to ensure that EO in the product will not be slowly released into the workshop environment, causing pollution to the workshop environment and personal health damage

10.The whole control system has self-diagnosis function for all kinds of equipment and sensors, which is used to prevent the abnormal operation of the equipment in case of sensor failure, and at the same time prompt the maintenance personnel what sensor or equipment has failed, so that the maintenance personnel can quickly find and solve problems

11.The ETO sterilizer SYSTEM has more than 100 fault and alarm information, which allows operators and maintenance personnel to know the operation of the equipment in a timely and accurate manner, so that maintenance personnel can quickly find and solve problems

12.After downloading process parameters, if there are unreasonable parameters, there will be a prompt of download failure to prevent the operation of the whole batch from failing when the parameters are unreasonable

13.After downloading process parameters, if there are unreasonable parameters, there will be a prompt of download failure to prevent the operation of the whole batch from failing when the parameters are unreasonable

14\. In case of loss of external power supply, UPS will continue to supply power to the system, and the equipment will deal with the suspended state to ensure that the equipment will not leak after power failure, and ensure a safety buffer time of at least 15 minutes. After the equipment is shut down through the normal operation process, the equipment can still continue to operate when the external power is restored

15.When the IPC fails during the system operation, the IPC can be restarted directly, and the software can automatically connect the original record

16.The system has a detailed audit tracking function, which can record almost all operation actions for the convenience of accident analysis and fault prevention in the later stage

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## Ethylene Oxide Sterilization
[Skip to content](https://zjbocon.com/ethylene-oxide-gas-sterilizer/#content)

![](https://zjbocon.com/wp-content/uploads/2024/11/eto-sterilizer-hzbocon-4-1024x1024.png)

## Low-Temperature Sterilization:

Ethylene oxide sterilizer operate at low temperatures, making them ideal for sterilizing heat-sensitive medical devices and instruments. This characteristic allows for the preservation of the integrity and functionality of complex medical devices that might be damaged by heat.

## Ethylene oxide Gas Sterilization Process:

EO sterilization is a chemical process that uses ethylene oxide gas to achieve sterility. The gas is highly effective in penetrating packaging and complex device structures, ensuring thorough Ethylene oxide sterilizer sterilization of all surfaces.

## Broad Material Compatibility:

One of the significant advantages of EO sterilization is its compatibility with a wide range of materials, including plastics, polymers, and electronic components. This makes it suitable for sterilizing a diverse array of medical products, such as catheters, surgical kits, and electronic medical devices.

## Effective Against Microorganisms:

Ethylene oxide is both sporicidal and microbicidal, meaning it is effective in destroying a wide range of microorganisms, including bacteria, viruses, and fungi. This ensures a high level of sterility assurance for medical devices.

## Complex Sterilization Process:

The EO sterilization process involves several critical steps, including pre-conditioning, vacuum phase, gas introduction, exposure time, and aeration. Each step is carefully controlled to ensure effective sterilization while maintaining the safety and integrity of the devices.

## Safety and Environmental Concerns:

While effective, EO sterilization poses certain safety and environmental risks. Ethylene oxide is a known human carcinogen, and exposure can lead to various health issues. Therefore, strict regulations and safety measures are in place to protect workers and the environment from EO emissions.

## Regulatory Compliance:

EO sterilizers are highly regulated by health and safety authorities, such as the FDA and EPA, to ensure that the sterilization process is safe and effective. Manufacturers must comply with stringent guidelines to validate their sterilization processes and ensure that devices meet sterility assurance levels without compromising performance or safety.

## Aeration Requirement:

After the sterilization process, items must undergo aeration to remove residual ethylene oxide gas. This step is crucial to ensure that no toxic residues remain on the sterilized items, which could pose a risk to patients.

## Widespread Use in Healthcare:

Ethylene oxide sterilization is one of the most common methods used in healthcare for sterilizing medical devices. It is estimated that over 50% of all medical devices are sterilized using EO, highlighting its importance in maintaining public health and safety.

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[Introduction to Ethylene Oxide Sterilizers](https://zjbocon.com/introduction-to-ethylene-oxide-sterilizers/ "Introduction to Ethylene Oxide Sterilizers")

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## IQ in ETO Sterilization
[Skip to content](https://zjbocon.com/iq-in-eto-sterilization-process/#content)

Iq in eto sterilization process is undertaken to demonstrate that the sterilization equipment and any ancillary items have been supplied and installed in accordance with their specification. Before performing IQ, the equipment manufacturer will conduct FAT and SAT to ensure that the equipment has been delivered normally.

![](https://zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Installation-Guide-1-1024x473.webp)

## During IQ the following events need to be further identified and substantiated.

a.Equipment to be used in the sterilization process, including anyancillary items, shall comply with its design specifications.The corresponding documents include functional design specifications, user requirements specifications, design drawings, etc. (Equipment schematic diagram, energy supply diagram, electrical schematic diagram, system schematic diagram, etc.)

b.Verify that all components (including control software) are functioning properly; Key measuring instruments need to be calibrated; Key component information should be recorded;

c.Ensure the installation and use environment is safe and complies with local regulations. Meet safety and personnel health requirements.

d.Develop safety production and operatingprocedure documents, including maintenance and exception handling documents; conduct operator training; operators can only start work after they are qualified.

e. IQ may be a one-time exercise for the specific equipment being employed for a sterilization process.

f. Additional IQ needs to be performed in the event of significant component changes or functional changes, as well

## IF YOU WANT TO KNOW MORE ABOUT IQ IN ETO STERILIZATION PROCESS

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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## ETO Sterilization Machine OQ
[Skip to content](https://zjbocon.com/oq-in-eto-sterilization-machine/#content)

## OQ is undertaken to demonstrate the ability of the ETO STERILIZATION MACHINE to meet the performance requirements of its design specification.

![](https://zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Installation-Guide-1-1024x473.webp)

During ETO STERILIZATION MACHINE OQ the following events need to be identified and substantiated.

In OQ, the performance of the relevant auxiliary system should be determined and the software system should be tested by simulating the fault conditions.

For the preconditioning room , sterilizer and aeration room, the pattern of air circulation and ventilation capacity throughout the chamber to be occupied by the sterilization load(s) should be determined. This can be performed by smoke tests in combination with the calculation of air change rates and anemometric determinations.

Temperature and humidity should be monitored throughout thepreconditioning area over a period long enough to demonstrate that valuesare maintained within the desired ranges. The temperature and humidity ina number of locations distributed throughout the preconditioningarea should be determined;

Temperature should be monitored throughout theheated aerationarea over a period long enough to demonstrate that valuesare maintained within the desired ranges. The temperature ina number of locations distributed throughout the aeration area should be determined;

The sterilizer should do leak test before OQ to ensure safety.(under vacuum for subatmospheric cycles or under vacuum and at pressure for super atmospheric cycles)

For sterilizer,a chamber wall temperature study should be completed to verify adequatetemperature uniformity provided by the jacket heating system. The studyshould characterize the temperature profile for comparison on a periodicbasis to ensure the system continues to operate effectively.

Repetition cycles shall be performed (at least three times) to demonstrate reproducibility of control and operation effects;The temperature of the injected EO-gas should be within the volatizer specification or above the boiling point of EO (10,7degrees celsius at atmospheric pressure);

In empty chamber OQ exercises, the recorded temperature range, withinthe usable chamber volume during EO or inert gas exposure, of

卤3?ofthe average recorded chamber temperature at each time point should beobtained after an equilibration period. When the OQ exercise is carriedout using a loaded chamber, then the卤3?tolerance might not beachievable.

 ︹€︹€ 

## Annual OQ

Review of OQ should include an assessment of the equipment performance and engineering changes that were made during the year to ensure that the results from the original OQ are still valid. In order to do so, it is common practice to perform periodic requalification of equipment and should include:

1. review of IQ status of equipment;
2. assessment of trends in equipment performance;
3. temperature and humidity profiles of the preconditioning areas;
4. chamber temperature profile;

e.temperature profile of the aeration room;

## IF YOU WANT TO KNOW MORE ABOUT IQ IN ETO STERILIZATION PROCESS

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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## Sterilization Process Validation
[Skip to content](https://zjbocon.com/ethylene-oxide-sterilization-chamber/#content)

![Ethylene oxide sterilization chamber](https://zjbocon.com/wp-content/uploads/2024/10/tp2.jpg)

PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate that the Ethylene oxide sterilization equipment consistently operates in accordance with predetermined acceptance criteria and the process yields a product that is sterile and meets the specified requirements.

PQ should be carried out for each new process and/or product to be validated to demonstrate that the process complies with identified acceptance criteria and is capable of delivering the required SAL to the product.PQ consists of both microbiological and physical performance qualifications and is performed in the Ethylene oxide sterilization equipment used to sterilize the product.

During PQ process, the package of the product and loading mode of the productshould be specified;Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.

During PQ process, the package of the product and loading mode of the productshould be specified;Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.

In general, MPQ and PPQ are performed simultaneously.If PPQ is performed in parallel with at least three MPQ runs, then a minimum of one additional PPQ run shall be performed using the full cycle process specification. Physical PQ (PPQ) shall demonstrate that the specified acceptance criteria are met throughout the load for the duration of the proposed routine process specification.

PQ shall be performed on the introduction of new or modified products,packaging, load configuration, Ethylene oxide sterilization chamber or process parameters unless equivalence to a previously validated product, packaging, load configuration Ethylene oxide sterilization chambernt or process has been documented.

## PQ verification Ethylene oxide sterilization chamber process

The process of PQ verification is generally as : perform a fractional cycle first, and test the sterility status of the product after

fractional

cycle sterilization; compare the EO resistance relationship between IPCD, EPCD and representative products (the expected result is EPCD > IPCD > Product,); Refer to ISO-11737-2 for the test requirements involved in the fractional cycle.

Perform half cycle to prove the reproducibility of the sterilization process and sterilization effect; If the overkill method is used, then there should be no positive IPCD during half-cycle.Positive EPCD during the half cycle are acceptable if have demonstrated greater resistance than the IPCD providing a

  

worst-case challenge

  

for routine processing.

The routine sterilization parameters are usually determined by the full cycle parameters, so residual challenges are generally done during the full cycle to determine the appropriate aeration time. Since the effectiveness of the sterilization process has been proven in fraction cycle and half cycles, the sterilization effect can be ensured by EPCD.

If, in any of these runs, sterility or product functionality requirements are not met, an investigation should be conducted to determine if additional qualification runs are necessary. If process parameters cannot be maintained within the defined limits, an investigation should be conducted. If modifications are made, additional runs must be necessary.

## Annual PQ in Ethylene oxide sterilization chamber process

Review of PQ should assessment that the sterilization process remains valid for the designated product.Reduced MPQ/PPQ can be necessary in certain situations, e.g. to verify continued appropriateness of the resistance of the internal PCD in the product load to the resistance of the product bioburden, or, after a defined interval, to provide evidence that there has been no inadvertent change since the previous requalification study. This would typically include, minimally,one fractional or half cycle exposure including load temperature and humidity measurements. Fractional cycles in a developmental chamber can also be used to support a requalification program, but requalification of the production chamber should be performed in the production chamber.

## Assessment of equivalence

1.Process Equivalence?Ethylene oxide sterilization equipment that delivers the same process parameters, having undergone [IQ](https://zjbocon.com/iq-in-eto-sterilization-process/) and [OQ](https://zjbocon.com/oq-in-eto-sterilization-machine/), shall be qualified either.

2\. in the same manner as the original chamber, or using a reduced MPQ that demonstrates the delivery of the required level of microbiological lethality and PPQ to demonstrate temperature and humidity uniformity of the load and control by the production chamber. The rationale for this reduced qualification shall be recorded and documented.

3\. The influence of different geographical locations on the product or load properties shall be determined.

4\. Process equivalence is a method used to demonstrate that the same validated sterilization process is delivered by two or more pieces or sets of Ethylene oxide sterilization equipment. It does not require that the equipment be physically identical. Even if the parameters delivered by the equipment are not statistically identical, the processes delivered can still be equivalent if they are all capable of running the process within the defined, validated process limits

5\. Process equivalence among multiple pieces of equipment is intended to minimize the amount of testing required to qualify the process. The sterilization process should be validated in one chamber. The remaining equipment can undergo reduced PQ if the remaining equipment has undergone installation qualification (IQ) and operational qualification (OQ) (see 9.2 and 9.3). Equivalence can also be used to reduce requalification of several pieces of equipment. The equipment used to deliver a sterilization process commonly consists of a chamber or room and ancillary control systems. Sterilization process equipment might be located within a given processing facility or among several facilities.This equipment can be used independently to deliver the same process conditions and could be exactly the same design or might differ in size or in the extent of ancillary equipment.

6\. Process equivalence among multiple pieces of equipment is intended to minimize the amount of testing required to qualify the process. The sterilization process should be validated in one chamber. The remaining equipment can undergo reduced PQ if the remaining equipment has undergone installation qualification (IQ) and operational qualification (OQ) (see 9.2 and 9.3). Equivalence can also be used to reduce requalification of several pieces of equipment. The equipment used to deliver a sterilization process commonly consists of a chamber or room and ancillary control systems. Sterilization process equipment might be located within a given processing facility or among several facilities.This equipment can be used independently to deliver the same process conditions and could be exactly the same design or might differ in size or in the extent of ancillary equipment.

## IF YOU WANT TO KNOW MORE

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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[Safety Requirements for Using Ethylene Oxide in sterilization](https://zjbocon.com/safety-requirements-for-using-ethylene-oxide-in-sterilization/ "Safety Requirements for Using Ethylene Oxide in sterilization")

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## ETO Sterilizer Solutions
[Skip to content](https://zjbocon.com/eto-sterilizer-manufacturer-hzbocon/#content)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/STERILIZER.webp)

## **ETO Sterilizer Manufacturer-HZBOCON**

- ![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/11/eto-sterilizer-hzbocon-5-1024x1024.png)hzbocon eto sterilizer
- ![](<Base64-Image-Removed>)hzbocon eto sterilizer
- ![](<Base64-Image-Removed>)hzbocon eto sterilizer
- ![](<Base64-Image-Removed>)
- ![](<Base64-Image-Removed>)hzbocon eto sterilizer
- ![](<Base64-Image-Removed>)hzbocon eto sterilizer
- ![](<Base64-Image-Removed>)hzbocon eto sterilizer
- ![](<Base64-Image-Removed>)hzbocon eto sterilizer
- ![](<Base64-Image-Removed>)hzbocon eto sterilizer

**Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd., commonly referred to as HZBOCON, stands out as a dedicated Ethylene Oxide (EO/ETO) sterilizer** **manufacturer. Established in 2006, HZBOCON has committed itself to the design, development, and manufacturing of EO sterilization equipment, catering to a wide array of industries that require effective sterilization solutions for thermosensitive products.**

## **ETO Sterilizer Manufacturer** SUPPLY

**The product line includes:**

**Standard EO Sterilizers Manufacturer: These units are designed for general sterilization purposes and are suitable for a variety of applications across different industries(medical device, libraries. And more)**

**Large Capacity ETO Sterilizers Manufacturer** **:1-128cbm eto sterilizer, these sterilizers can accommodate larger batches of products, making them suitable for hospitals and manufacturing plants**

**Customized Solutions: HZBOCON also provides tailored ETO** **sterilization solutions based on specific client requirements, ensuring that unique sterilization challenges are effectively addressed**

**Preconditioning Equipment: To enhance the efficiency of the sterilization process, HZBOCON offers preconditioning equipment that prepares items for sterilization by controlling humidity and temperature.**

## **Global Reach and Customer Support**

**With an ETO Sterilizer Manufacturer facility and a dedicated workforce, HZBOCON has established a strong presence in the global market. The company exports its sterilization equipment to various countries, serving clients in the healthcare, pharmaceutical, and biotechnology sectors. HZBOCON  reputation for reliability and performance has made it a preferred choice among industry professionals.**

**HZBOCON places a strong emphasis on customer support. The company provides comprehensive training and technical assistance to ensure that clients can operate their sterilizers effectively. This support extends beyond the initial purchase, as HZBOCON is committed to maintaining long-term relationships with its customers.**

## IF YOU WANT TO KNOW MORE

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

view more about [ETO Sterilization Chamber Testing](https://zjbocon.com/eto-sterilization-chamber-testing/)

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## ETO Sterilization Equipment
[Skip to content](https://zjbocon.com/eto-sterilization-equipment/#content)

## **Process Water** For ETO Sterilization Equipment

![](https://zjbocon.com/wp-content/uploads/2025/11/eto-sterilzer-1024x452.webp)

The humidification water used in the ETO Sterilization Equipment should be free from contaminants, should not weaken the ETO sterilization process, and should not damage the sterilizer, sterilized products, or the load. Humidification should be done by injecting steam, not by directly injecting atomized water.

**Note**: It is recommended to use purified water that meets the requirements of the Chinese Pharmacopoeia for humidification. If purified water is not used, the steam supply or steam condensate should be validated to ensure that the humidification steam meets the requirements of this section. The steam quality testing methods are outlined in YY/T 1612 and the Chinese Pharmacopoeia.

**Steam Contaminant Limits**

| Contaminant | Condensate | Steam Supply |
| --- | --- | --- |
| Residue | Less than 10mg/kg | Less than 100mg/L |
| Heavy Metals | Not exceeding the limits for purified water in the Chinese Pharmacopoeia | Not exceeding the limits for purified water in the Chinese Pharmacopoeia |
| Chlorides | Less than 1mg/kg | Less than 10mg/L |
| Conductivity | Less than 15?S/cm | Less than 50?S/cm |
| pH | 5  8.5 | 5  8.5 |
| Appearance | Colorless | Colorless |

**Note 1**: If the contaminant levels in the feedwater or steam exceed the above limits, the sterilizer  service life will be significantly reduced.

## **Process Air** For Sterilization

The air used in the sterilizer should be dried and filtered to ensure the service life and filtering performance of the ETO Sterilization sterilizer  terminal filter.

## IF YOU WANT TO KNOW MORE

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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## Eto Sterilizer Verification
[Skip to content](https://zjbocon.com/industry-eto-sterilizer/#content)

![Industry Eto Sterilizer](https://zjbocon.com/wp-content/uploads/2024/10/sterilizer-station-design-2.webp)

## Industry Eto Sterilizer Installation Verification

The installation of Industry Eto Sterilizer and all associated services should comply with the requirements of the construction and engineering drawings. It is recommended to verify the components of the Industry Eto Sterilizer to ensure the installation meets applicable standards and requirements. These equipment components include:

### **3.2.3.1 Pre-treatment Area (if applicable)**

a) Structure of the cabinet and doors;

b) Air circulation system;

c) Airflow monitoring equipment and alarm system;

d) Temperature and humidity monitoring and control system.

### **3.2.3.2 Industry Eto Sterilizer**

a) Structure of the cabinet and doors;

b) Sealing and connections of the cabinet and piping system, ensuring no leakage;

c) Calibration of instruments for monitoring, controlling, indicating, or recording parameters (e.g., temperature, humidity, pressure, and EO concentration) such as sensors, recorders, pressure gauges, and testing equipment;

d) Gas and liquid supply systems (e.g., air, nitrogen, steam, EO, and water), including filters (if used);

e) Power supply system, ensuring adequate, stable, and continuous power for the operation of equipment and instruments;

f) Gas circulation system;

g) Gas injection system;

h) Vacuum system, including pumps, pump cooling system, and piping;

i) Exhaust, emission control, and reduction systems;

j) Other critical systems that may affect process conditions, such as process automation systems, safety systems, etc.

### **3.2.3.3 Decontamination Area**

a) Structure of the cabinet and doors;

b) Air recirculation equipment;

c) Airflow monitoring equipment and alarm system;

d) Temperature monitoring and control system.

If forced decontamination is applied externally to the sterilizer, it is recommended to verify the qualifications of the decontamination chamber  contractor, drawings, standard operating procedures, spare parts list, etc.

## IF YOU WANT TO KNOW MORE

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## Process Challenge Devices
[Skip to content](https://zjbocon.com/production-of-process-challenge-devices-in-eo-sterilization/#content)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Turnkey-EO-Sterilisation-Project-1-1024x724.webp)

## 3.4.1.1 Production of Process Challenge Devices (PCD)

A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters. It is typically a device or test package containing biological indicators (e.g., Bacillus atrophaeus spores with known spore count). The resistance of the PCD to the sterilization process should be greater than or equal to the resistance of the natural microbial load in the most difficult-to-sterilize area of the product. The quantity of PCDs should meet the requirements outlined in Table C.3 of Appendix C in GB18279.1-2015. PCDs are classified into Internal PCDs (IPCD) and External PCDs (EPCD).

### a)Internal PCD (IPCD) Production

Internal PCDs are typically medical devices selected by the company to represent a product family. Based on design and material composition, these products are considered some of the most difficult to sterilize. Biological indicators (BI) are placed at the most difficult-to-sterilize position of the product, ensuring that the sterilization process does not block the channels or interfere with the product design.

Place the biological indicator (BI) in the most difficult-to-sterilize area of the product, or inoculate the test microorganism (e.g., Bacillus atrophaeus) in the location with the most difficult-to-achieve sterilization conditions.If the BI or test microorganism cannot be placed at the hardest-to-sterilize location, an alternative device can be designed and placed within a sterile barrier system, ensuring that it has the same resistance as the hardest-to-sterilize location in the product.

Common IPCDs include, but are not limited to:

Placing the contaminated carrier between components such as rings, piston heads, washers, or syringe pistons.Placing the microorganism challenge in the middle of a catheter lumen, then using adhesive solvents or connectors to reseal the catheter and restore the product  integrity.Placing the microorganism challenge at the piston interface.

### b)External PCD (EPCD) Production

External PCDs are placed on the outside of the loaded product. EPCDs are typically used for routine processing and are retrieved from the load after treatment. The resistance of the EPCD to the biological load of the sterilized product should be compared with the IPCD  resistance. The EPCD should also represent the most difficult-to-sterilize product in the load.

The relationship between EPCDs and contaminated product samples should be periodically reviewed to ensure that no changes have occurred in the sterilized product and that the EPCD still represents the most difficult-to-sterilize product in the load.

When placing a BI in a PCD, the PCD should have at least the same resistance as the most difficult-to-sterilize location in the product.

Common EPCDs include, but are not limited to:

Placing a biological indicator (BI) inside product packaging or equivalent, such as plastic bags, which is then placed inside a Manila envelope.Placing a biological indicator in a thick plastic bag that has been folded a specified number of times.Placing the biological indicator in various parts of a syringe, such as in the piston washer or piston head.Sealed plastic tubes containing contaminated carriers, with or without additional packaging.

PCDs produced in the above manner are packaged using the same methods as regular production products, evenly distributed within the product load, and positioned to cover the cold spots within the sterilizer chamber.

## 3.4.1.2 Partial Cycle (Short Cycle) Testing

After selecting the PCD, its suitability is confirmed by running a partial cycle. The evaluation method is as follows:

a) Determine the placement methods for PCDs, test samples, and sensors based on the results of the operational evaluation. The number and distribution of PCDs should be sufficient. If the selected EPCD is used for routine sterilization process monitoring, it should be placed on the product load according to the plan and procedure.

b) Based on the D value, ST time, and KT time of the biological indicator, set a shorter exposure time. Other parameters should be tested at the lower limit of routine sterilization process parameters. The test method should refer to Appendix A of GB18281.2. After the exposure time ends, remove the product, IPCD, and EPCD for microbial cultivation and observe the results.

The cultivation results should show that the resistance of the PCD is greater than or equal to the biological load resistance of the hardest-to-sterilize location in the product:

IPCD and EPCD should be partially negative; a fully negative or fully positive result would indicate test failure.The resistance of the IPCD should be greater than the product, and the resistance of the EPCD should be greater than or equal to that of the IPCD.

If the results do not meet expectations, investigate the cause. Typically, adjustments to the PCD resistance or sterilization parameters are needed, followed by retesting until the results align with expectations. If all three (product, IPCD, and EPCD) show no microbial growth, reduce the EO exposure time appropriately and test again. If all show microbial growth, increase the EO exposure time and retest.

## 3.4.1.3 Half-Cycle Testing

After successfully completing short-cycle testing, run three consecutive consistent half-cycle tests to demonstrate the effectiveness (SAL = 10^-6) and reproducibility of the EO sterilization process. The evaluation method is as follows:

Set the biological indicator  sterility as the standard, and set other sterilization process parameters to the lower limit of routine sterilization parameters (e.g., pre-treatment transfer time within the specified range). Gradually halve the sterilization exposure time of the initial sterilization process and remove biological indicators from the PCD after different sterilization times. Cultivate them in a sterile environment until sterility is confirmed. The shortest sterilization time (critical time) thus determined will be the half-cycle time, and at least two more tests should be conducted with the same shortest time.

All three test results should show complete inactivation of all biological indicators (initial colony count no less than 1脳10^6) to confirm the minimum effective EO exposure time. The exposure time in the routine sterilization process should be at least twice this minimum time.

The biological indicator cultivation results should show all IPCDs and EPCDs negative. If the short-cycle test shows that the EPCD  resistance is greater than that of the IPCD, the EPCD may show partial positivity.

If the results do not meet expectations, investigate the cause and usually adjust the sterilization parameters before retesting until the results align with expectations.

Example:

Assume the first half-cycle sterilization exposure time is 4 hours. If sterile, reduce the exposure time to 2 hours for the next test; if microbial growth occurs, increase the exposure time based on the 4-hour exposure.

Assume the second half-cycle sterilization exposure time is 2 hours. If sterile, reduce the exposure time to 1 hour for the next test; if microbial growth occurs, extend the exposure time to 3 hours.

Assume the third half-cycle sterilization exposure time is 3 hours. If sterile, repeat the 3-hour test twice. If all results are sterile, confirm 3 hours as the minimum effective time. If microbial growth occurs, repeat the test with 4-hour exposure, and if all results are sterile, confirm 4 hours as the minimum effective time.

## 3.4.1.4 Full Cycle Testing

During full cycle testing, set the EO exposure time to twice the half-cycle minimum effective time, and other parameters to the upper limit of routine sterilization parameters to verify the reliability and reproducibility of the sterilization process.

The number of temperature and humidity sensors used should meet the requirements of Appendix C in GB18279.1, evenly distributed within the sterilization load. Temperature sensor placement points should include both the cold and hot spots within the sterilizer chamber during the Operational Qualification (OQ).

After the test, the cultivation results of the product and EPCD should show complete sterility (all negative).

## IF YOU WANT TO KNOW MORE

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

| ISO 11135:2014 | Sterilization of health-care products    Ethylene oxide    Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 14161:2009 | Sterilization of health care products    Biological indicators    Guidance for the selection, use and interpretation of results |
| ISO 10993-7:2008 | Biological evaluation of medical devices    Part 7: Ethylene oxide sterilization residuals |
| ISO 11737-1:2018 | Sterilization of health care products    Microbiological methods    Part 1: Determination of a population of microorganisms on products |
| ISO 11737-2:2009 | Sterilization of medical devices    Microbiological methods    Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| AAMI TIR16:2017 | Microbiological aspects of ethylene oxide sterilization |

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## Ethylene Oxide Sterilization
[Skip to content](https://zjbocon.com/routine-monitoring-control-and-release-of-ethylene-oxide-sterilization/#content)

![Ethylene oxide sterilization chamber](https://zjbocon.com/wp-content/uploads/2024/10/tp2.jpg)

## Routine Monitoring and Control

The purpose of routine monitoring and control of EO (Ethylene Oxide) sterilization is to demonstrate that the confirmed and specified sterilization process has been applied to the product. Data from each sterilization cycle should be recorded and retained to prove that the confirmed sterilization process specifications have been met. This should include at least the following content:

a) Evidence that the environmental temperature of the product has reached the minimum confirmed temperature when entering the pretreatment (if used). This can be achieved by allowing the load to acclimate to the environment for a specified minimum time. If the storage temperature is known, there is no need to determine the temperature of the product before entering the pretreatment area. If the product has been exposed to extreme temperatures, such as during transportation, the product may need to be stored for a period before pretreatment to stabilize its internal temperature and humidity within an acceptable range.

b) Monitoring and recording of the temperature and humidity in the pretreatment area (if used) at specified locations.

c) The start time of the pretreatment for each sterilization load and the time the load is removed from the pretreatment area (if used).

d) The time interval between removing the sterilization load from the pretreatment area (if used) and the start of the sterilization cycle.

e) Indicators of proper operation of the gas circulation system in the chamber during the gas exposure phase (if used).

f) The temperature and pressure inside the chamber throughout the sterilization cycle.

g) The humidity inside the chamber during the processing phase, as measured by pressure or directly.

h) Confirmation that gaseous EO has been introduced into the sterilization chamber.

i) The pressure rise inside the sterilization chamber and the amount or concentration of EO used.

j) The processing time.

k) The exposure time.

l) Time, temperature, and pressure changes (if applicable) during the aeration phase and/or venting operations (if used).

## EO Sterilization Release

### a) Biological Indicator Method

If biological indicators (confirmed EPCD) are used, they should be distributed throughout the sterilization load, including the most difficult-to-sterilize locations or locations known to be related to these difficult spots. If pretreatment is used, the biological indicators should be placed before the pretreatment.

The biological indicators should be removed from the sterilization load after the sterilization cycle ends and cultured as soon as possible to allow the biological indicators to revive. If they are not cultured in a timely manner, the effects of exposure to residual EO during delayed revival should be evaluated.

The growth of the biological indicators should be analyzed to determine if the growth is not due to failure to meet the physical process specifications, which would require repeating the confirmation process.

b) Parameter Release Method

Parameter release relies on proving that all physical process parameters meet the specifications for release without the use of biological indicators. It is based solely on measurements and records of physical process parameters and serves as a sufficient declaration of the sterilization process  adequacy.

Parameter release is only permissible when all process parameters are specified, controlled, and directly monitored. Therefore, when parameter release is used, there should be equipment for direct measurement of temperature and humidity inside the chamber and for direct analysis of EO concentration, to collect and record the sterilization process parameters and confirm that the sterilization process complies with the specifications.

In addition to proving that the sterilization process parameters meet the sterilization specifications, parameter release also requires measuring and recording the following additional data:

Measuring the temperature inside the chamber at least from two locations throughout the sterilization cycle.

Directly measuring the humidity inside the chamber during the processing phase.

Determining the EO concentration by direct analysis of the sterilization chamber  gas at specified time intervals, to fully verify that the required conditions are met throughout the exposure period.

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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[PQ in Ethylene oxide sterilization chamber](https://zjbocon.com/ethylene-oxide-sterilization-chamber/ "PQ in Ethylene oxide sterilization chamber")

[Microbial Killing Performance of Ethylene Oxide Sterilizers](https://zjbocon.com/microbial-killing-performance-of-ethylene-oxide-sterilizers/ "Microbial Killing Performance of Ethylene Oxide Sterilizers")

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## ETO Sterilization Testing
[Skip to content](https://zjbocon.com/eto-sterilization-chamber-testing/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/ETO-STERILIZER-FAT-225x300.webp)

## Temperature and Humidity Distribution Testing

The temperature setting range of the ETO Sterilization Chamber should be between 30-60degrees celsius. It is recommended to perform temperature distribution testing of the sterilizer  internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.

### a) Internal Surface Temperature Test of ETO Sterilization Chamber:

- During the test, the sterilization chamber should be empty, but auxiliary devices required for sterilization can be installed. The sterilization chamber door should be closed.
- The temperature of any preheating stage as specified by the sterilizer manufacturer should be recorded. The temperature of all internal surfaces of the sterilization chamber should not exceed the set temperature of the sterilization phase by 卤5degrees celsius.

### b) Temperature and Humidity Test in the ETO Sterilization Chamber:

- During the test, the ETO Sterilization Chamber should be empty, but auxiliary devices required for sterilization can be installed. The sterilization chamber door should be closed.
- Use temperature and humidity sensors placed in specified positions to compare with the control temperature inside the chamber. The temperature sensors should be placed at locations likely to represent the maximum temperature differences, such as unheated parts of the chamber, near the cabinet doors, and near steam or gas entry points. Other sensors should be evenly distributed throughout the usable volume of the sterilization chamber, including the middle, top, bottom, front, and rear. The number of sensors should meet the requirements in Appendix C of GB18279.1.
- The position of each measurement should be recorded, and the temperature and humidity in different areas of the sterilization chamber should be recorded to identify potential hot spots and cold spots.
- The indoor temperature range of the sterilization chamber when empty should not exceed 卤2degrees celsius of the set temperature or 卤3degrees celsius of the average temperature inside the chamber.

## Vacuum Pumping Rate

- The vacuum system during the vacuum pumping phase should be able to evacuate the empty sterilization chamber to -75 kPa or lower. A pressure gauge should be connected to the vacuum test inlet to observe whether it meets the required standard.
- The manufacturer should confirm the time required to reach -50 kPa and -75 kPa under empty load conditions. A timing device can be used to monitor the vacuum pumping phase, and the preset parameters should be reached within the specified time.

## ETO Sterilization Cabinet Leakage Test

The ETO Sterilization Cabinet leakage test includes both vacuum (negative pressure) leakage testing and pressure (positive pressure) leakage testing (if applicable). When the sterilizer  working pressure is greater than 5 kPa, a pressure (positive pressure) leakage test should be performed.

- The vacuum leakage test should be conducted before the sterilant injection phase and the humidification phase, with the testing method following the provisions of Appendix D.1 of YY0503. The preset pressure during the test should be less than -20 kPa and at least 20 kPa lower than the preset sterilization pressure. Once the preset pressure is reached, all valves connected to the sterilization chamber should be closed, and the vacuum pump should stop working. The pressure in the sterilization chamber should be monitored, and the pressure rise within 5 minutes should not exceed 0.3 kPa/min. The pressure variation during the entire test should not exceed 0.1 kPa/min.
- Positive pressure leakage testing (if applicable) should be conducted before the vacuum pumping phase. The preset pressure for the test should be within 10% of the sterilizer  preset working pressure. The pressure drop within 5 minutes should not exceed 0.3 kPa/min. At the same time, according to the method in Appendix D.2 of YY0503, the sterilization time should be set to at least 65 minutes, using inert gas (such as air) to replace EO gas and run a normal sterilization cycle. After the sterilization phase reaches temperature stability for 2 minutes, the pressure in the sterilization chamber should be recorded. It should be recorded again after 60 minutes 卤 1 minute. The pressure variation rate should not exceed 0.1 kPa/min.Auxiliary System Verification

During the operational verification, the performance of related auxiliary systems should be confirmed, including but not limited to: the quality of steam provided, the ability of the EO vaporizer to reach the minimum gas input temperature, the reliability of the sterilizer  air filtration and water supply systems, and the ability of the steam generator to maintain the required supply quality under maximum sterilization load conditions.

Examples of acceptable auxiliary system performance: a) When steam is injected during the processing phase, the humidity in the sterilization chamber should show a noticeable change, and the chamber should maintain pressure within 卤2.5 kPa of the set pressure. b) The temperature of the injected EO gas should be higher than the minimum value set for the vaporizer (usually 10.7degrees celsius at atmospheric pressure) to ensure that the EO injected is in gaseous form, not liquid. c) The filtration effectiveness of the air filtration system should meet the requirement of a filtration rate of at least 99.5% for particles greater than 0.3 microns. d) The water supply system should use purified water meeting the requirements of the 2020 edition of the Chinese Pharmacopoeia. e) The steam vapor pressure used for humidification in the sterilizer should not exceed 50 kPa.

## ETO Sterilization Cabinet Software

During the sterilization process, the sterilization equipment software will control and monitor the sterilization process and evaluate the parameters of the sterilization cycle. Therefore, during the operational qualification process, the sterilization equipment software should be tested under all failure conditions (such as computerized measurement and control systems). Refer to the sterilizer  user manual and equipment specifications, and test the software system  functions in areas such as alarm handling, error processing, information management, parameter settings, historical record interfaces, sensor control and monitoring, and operational control and monitoring under conditions challenging the equipment  operational limits.

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

## References

[ISO 11135:2014Sterilization of health-care products    Ethylene oxide    Requirements for the development, validation and routine control of a sterilization process for medical devices](https://www.iso.org/obp/ui/#iso:std:iso:11135:ed-2:v1:en)

[Anhui Province medical device ethylene oxide sterilization confirmation work guide](https://mpa.ah.gov.cn/group5/M00/06/C0/wKg8v2VfBqaAY-YsABTsjWADtvQ314.pdf)

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## ETO Sterilization Insights
[Skip to content](https://zjbocon.com/comparing-eto-sterilization-to-other-methods/#content)

![eto sterilizer](https://zjbocon.com/wp-content/uploads/2024/10/banner__.webp)

## eto sterilization technologies vs others: Advantages and Disadvantages

Sterilization is a critical process in infection control, ensuring that medical instruments and devices are free from viable microorganisms. Understanding the various methods available, along with their respective benefits and drawbacks, is essential for healthcare professionals to make informed decisions.

## **1\. Steam Sterilization (Autoclaving)**

**Advantages:**

- **Effectiveness**: Highly effective against all types of microorganisms, including spores.
- **Speed**: Short cycle times lead to rapid processing of instruments.
- **Environmentally Friendly**: Utilizes water and heat, with no harmful residues left behind.
- **Cost-Effective**: Generally lower operational costs than other methods.

**Disadvantages:**

- **Limited Use for Heat-Sensitive Items**: Not suitable for certain materials that cannot withstand high temperatures.
- **Risk of Damage**: May damage some delicate instruments if not monitored correctly.
- **Moisture Issues**: Can leave instruments wet, which may lead to rusting or corrosion.

## **2\. Ethylene Oxide (ETO) sterilization technologies**

**Advantages:**

- **Versatility**: Suitable for heat-sensitive and moisture-sensitive items, including complex devices.
- **Excellent Penetration**: Effectively penetrates packaging materials and device lumens, ensuring thorough sterilization.
- **Minimal Risk of Damage**: Less likely to cause thermal damage compared to steam sterilization.

**Disadvantages:**

- **Long Cycle Times**: Requires extended processing and aeration times.
- **Toxicity**: ETO is toxic and a potential carcinogen, necessitating careful handling and monitoring

## **3\. Hydrogen Peroxide Gas Plasma**

**Advantages:**

- **Low Temperature**: Effective for heat-sensitive instruments, operating at lower temperatures.
- **Rapid Cycle Times**: Typically shorter sterilization cycles compared to ETO.
- **No Toxic Residue**: Leaves no harmful residuals post-sterilization, making it environmentally friendly.

**Disadvantages:**

- **Material Limitations**: Certain materials, such as cellulose and liquids, cannot be processed.
- **Equipment Compatibility**: Some complex instruments with narrow lumens may not be compatible with this method.
- **Requires Specific Packaging**: Necessitates the use of synthetic materials for effective sterilization.

## **4\. Chemical Sterilization (e.g., Peracetic Acid)**

**Advantages:**

- **Quick Processing**: Fast cycle times, typically within 30-45 minutes.
- **Effective Against a Broad Range of Microorganisms**: Good efficacy for various pathogens, including spores.
- **Environmental Benefits**: Produces environmentally friendly by-products.

**Disadvantages:**

- **Material Compatibility**: May not be suitable for all instrument materials, particularly delicate surfaces.
- **Limited Use**: Primarily effective for immerseable instruments only.
- **Safety Hazards**: Requires caution due to potential skin and eye irritation.

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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## EO Gas Sterilization Factors
[Skip to content](https://zjbocon.com/factors-affecting-the-eo-gas-sterilization-process/#content)

There are many Factors Affecting in the EO Gas Sterilization Process, pls view the following:

![ethylene oxide sterilization](https://zjbocon.com/wp-content/uploads/2024/10/Pneumatic_Sliding_Door_Eto_Sterilizer.webp)

## 1\. Gas Concentration

- Within a certain range of gas concentration, the higher the concentration, the better theEO Gas Sterilization effect; beyond 1000 mg/L, the improvement in sterilization effect is not significant.

## 2\. Relative Humidity

- When relative humidity is between 40%-80%, there is no significant difference in sterilization effect; below 40%, the sterilization effect decreases significantly; above 90%, there is no noticeable improvement, and it can easily cause water droplets, which adversely affects sterilization.

## 3\. Temperature

- At temperatures between 30-65degrees celsius, for every increase of 10degrees celsius, the EO Gas Sterilization effect doubles; above 65degrees celsius, there is no significant improvement in sterilization effect.

## Time

- Higher ETO concentration requires a shorter action time; lower ETO concentration requires a longer action time.

### Survival Probability

- The longer the EO Gas Sterilization time, the lower the survival probability of microorganisms in the product (better sterilization effect).
- The EO Gas Sterilization time has a linear relationship with the logarithm of the number of surviving microorganisms (this is the most important theoretical support for determining mortality rate).

## Other Influencing Factors

### Product Characteristics

1. **Product Materials and Structure**:

   - The structure affects gas ingress and egress; some materials are unsuitable for ethylene oxide sterilization, and certain materials need to absorb more moisture/heat.
2. **Packaging Materials**.
3. **Initial Contamination**:

   - Initial quantity and types of contaminating bacteria in the product (methods such as residual probability and direct counting have requirements for initial contamination levels; some products have endotoxin requirements; some microorganisms exhibit resistance to ethylene oxide).

### Process Operations

1. **Vacuum Level**:

   - Affects gas diffusion and penetration, impacts the concentration of gas acting on the product; affects packaging safety and product safety; influences displacement effectiveness and residue.
2. **Loading Conditions**:

   - Affects heat/wet penetration and distribution; influences gas circulation.

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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## ETO Sterilizer Gallery
[Skip to content](https://zjbocon.com/gallery/#content)

ETO Sterilizer ????

# Ethylene Oxide (EO/ETO) Sterilizer Showcase

![ETO Sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-8-300x300.webp)

![EO Sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-7-300x300.webp)

![Ethylene Oxide Sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-3-300x300.webp)

![ETO Sterilization](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-11-300x300.webp)

![Industrial ETO](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-68-225x300.webp)

![EO Equipment](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-63-225x300.webp)

![Sterilizer Chamber](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-56-300x225.webp)

![Sterilizer Detail](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-43-300x225.webp)

![ETO Machine](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-25-225x300.webp)

![Industrial Sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-15-225x300.webp)

![ETO Parts](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-57-300x225.webp)

![EO Sterilizer Unit](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-50-225x300.webp)

![Ethylene Oxide Unit](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-2-225x300.webp)

![Control System](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-67-225x300.webp)

![Machine Photo](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-59-244x300.webp)

![ETO Detail](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-21.webp)

![Sterilization Process](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-12-300x139.webp)

![Industry ETO](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/Industry_ETO_Sterilizer-1-300x300.webp)

脳![](https://zjbocon.com/gallery/)

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## Eto Gas Sterilizer Specs
[Skip to content](https://zjbocon.com/request-for-eto-gas-sterilizer-manufacturer/#content)

![](https://zjbocon.com/wp-content/uploads/2025/11/eto-sterilzer-1024x452.webp)

## 2.1 Appearance and Structure Request For Eto Gas Sterilizer Manufacturer

2.1.1 The overall shape should be precise, with smooth, clean surfaces and uniform color. There should be no burrs, sharp edges, cracks, visible scratches, or unevenness.

2.1.2 All external text, graphics, and symbols must be printed clearly, with precise and durable markings.

2.1.3 Fasteners must be securely installed. All control switches and adjustment knobs (or buttons) should operate smoothly and reliably without obstructions.

## 2.2 Dimensions Request For Eto Gas Sterilizer Manufacturer

2.2.1 The sterilization chamber should adhere to the design dimensions in millimeters, with a tolerance of 卤1%.

2.2.2 To mitigate adverse effects around sterilization loads, the chamber should maintain at least 15 mm of clearance from heated surfaces and 30 mm from unheated surfaces.

## 2.3 Materials and Construction Request For Eto Gas Sterilizer Manufacturer

2.3.1 General Requirements

2.3.1.1 The manufacturer must specify the maximum operating pressure available for user selection.

2.3.1.2 The chamber  inner surface should be partially or fully heated, meeting the requirements in Section 2.13.1.

2.3.1.3 Materials exposed to ethylene oxide (EO) under operating conditions must:

a) Resist corrosion from EO gas and its mixtures.

b) Not react with EO or its known contaminants.

c) Avoid promoting EO polymerization or decomposition.

Stainless steel or corrosion-protected low-carbon steel is recommended for construction.

2.3.1.4 Untreated low-carbon steel must not be used for internal pressure components.

2.3.2 Testing Ports

2.3.2.1 Temperature Ports

Chambers ? 5 m3 must have at least 10 temperature ports. For chambers > 5 m3, add one port for each additional cubic meter. Chambers ? 10 m3 require a minimum of 20 ports.

Each port must maintain at least 100 mm of clearance from internal or external obstacles and conform to GB/T7307-2001 standards for external threads.

2.3.2.2 Vacuum Testing Ports

At least one vacuum testing port must be securely installed, directly connecting to the chamber. The port must meet specified dimensional and safety requirements.

2.3.2.3 Sampling Ports

Chambers must include at least one sampling port for measuring EO concentration or relative humidity, meeting the same standards as vacuum testing ports.

## 2.4 Components, Pipes, and Fittings of Eto Sterilizer Manufacturer

2.4.1 Components

All components connected to the chamber must comply with general material requirements and be easy to clean if they contact EO.

2.4.2 Piping and Fittings

Piping in contact with liquid sterilizers must be seamless and designed to prevent leaks. Joints should be welded, except where disassembly is necessary for maintenance.

2.5 Doors, Controllers, and Interlocks

## 2.5.1 Door Seals

Doors should use seals compliant with material requirements and allow for easy cleaning or replacement.

2.5.2 Automatic and Manual Door Operations

Automatic doors must remain sealed in case of power failure, ensuring safety. Manual doors must require no more than 150 N of force to operate.

## 2.6 Control Valves

Valves must allow maintenance without disconnecting pipes and should include pre-filters with specified efficiency.

## 2.7 Utilities

2.7.1 Water

Atomized water should not be injected directly.

2.7.2 Steam

Steam pressure for humidification should not exceed 50 kPa.

2.7.3 Air and Inert Gases

Air must be dry, oil-free, and filtered to prevent contamination.

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## EO Sterilization Preparation
[Skip to content](https://zjbocon.com/preparation-work-before-eo-sterilization/#content)

we need to prepare berfore the eo sterilization

![](https://zjbocon.com/wp-content/uploads/2025/09/Pecondition-Room-2-1-300x300.webp)

1. **Appearance Inspection:**Check for any damage on the surfaces of the main machine, control rack, and electrical control cabinet.
2. **Power Supply Check:**Ensure the power supply meets the requirements and check the rotation direction of the water pump and vacuum pump.
3. Turn on the power and observe whether the instrument display values are normal; otherwise, cut off the power, inspect and repair before restarting.
4. **Pipeline Inspection:**Check for leaks in the water supply, vacuum, and medication delivery pipelines, and ensure all valves are in standby mode; adjust if necessary.
5. **Set Parameters:**For example, set the dosage amount. Place the medication bottle on an electronic scale (provided by the user), confirm the bottle weight, start the vacuum pump to reach the set pressure value, then open the medication bottle to deliver the medication. Generally, the dosage during eo eo Sterilization is 400  800 mg/L (referring to the pure ethylene oxide input; if it is a mixed gas containing ethylene oxide, ensure that the amount of ethylene oxide delivered meets the dosage requirements). When the delivered weight reaches the standard, the current pressure value corresponds to the dosage amount.
6. Each time before eo Sterilization, verify that the parameter settings meet the needs for the items being sterilized; otherwise, reset the eo Sterilization parameters.

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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[ETO Sterilization Chamber Testing](https://zjbocon.com/eto-sterilization-chamber-testing/ "ETO Sterilization Chamber Testing")

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## Ethylene Oxide Terms
[Skip to content](https://zjbocon.com/terms-and-definitions-of-eto-gas-sterilization/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-11-1024x1024.webp)

For the purposes of this document, the following terms and definitions apply in **ethylene oxide sterilization**

**[3.1 Aeration](https://zjbocon.com/product/aeration-room/)**

![](https://zjbocon.com/wp-content/uploads/2025/09/Aeration-Room-3-300x300.webp)

part of the eto gas sterilization process during which ethylene oxide and/or its

reaction products desorb from the medical device until predetermined levels are reached

Note 1 to entry: This can be performed within the sterilizer and/or in a separate chamber or room.

**3.2 aeration area**

either a chamber or a room in which aeration occurs

**3.3 Bioburden**

population of viable microorganisms on or in product and/or sterile barrier system

\[SOURCE: ISO/TS 11139:2006, definition 2.2\]

**3.4 biological indicator**

test system containing viable microorganisms providing a defined resistance to a specified eto gas sterilization process

**3.5 Calibration**

set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring

system, or values represented by a material measure or a reference material, and the corresponding values realized by standards

**3.6 chemical indicator**

test system that reveals a change in one or more pre-defined process variables

based on a chemical or physical change resulting from exposure to a process

\[SOURCE: ISO/TS 11139:2006, definition 2.6\]

**[3.7 Conditioning](https://zjbocon.com/product/precondition-room/)**

treatment of product within the eto gas sterilizationtion cycle, but prior to ethylene

oxide admission, to attain a predetermined temperature and relative humidity

Note 1 to entry: This part of the ethylene oxide sterilization cycle can be carried out either at atmospheric pressure or under vacuum.

Note 2 to entry: See 3.27, preconditioning

**3.8** **_**_D_**_** **value**

_D_ 10 **value**

time or dose required to achieve inactivation of 90 % of a population of the test microorganism under stated conditions

\[SOURCE: ISO/TS 11139:2006, definition 2.11\] ?

Note 1 to entry: For the purposes of this International Standard, the _D_ value is the exposure time required to achieve 90 % inactivation of the population of the test organism.

**3.9 Development**

act of elaborating a specification

\[SOURCE: ISO/TS 11139:2006, definition 2.13\]

**3.10 dew point**

The temperature at which the saturation water vapour pressure is equal to the

partial pressure of the water vapour in the atmosphere

Note 1 to entry: Any cooling of the atmosphere below the dew point would produce water condensation.

**3.11 Establish**

determine by theoretical evaluation and confirm by experimentation

\[SOURCE: ISO/TS 11139:2006, definition 2.17\]

9ISO 11135-2014

[**3.12 ethylene oxide (EO) injection time**](https://zjbocon.com/product/eto-sterilzer/)

duration of the stage beginning with the first introduction of the EO (mixture) into the chamber to the completion of that injection

**3.13 exposure time**

period for which the process parameters are maintained within their specified tolerances

\[SOURCE: ISO/TS 11139:2006, definition 2.18\]

Note 1 to entry: For the purpose of calculation of cycle lethality, it is the period of ethylene oxide sterilization between the end of EO injection and the beginning of EO removal.

**3.14 Fault**

one or more of the process parameters lying outside of its/their specified

tolerance(s)

\[SOURCE: ISO/TS 11139:2006, definition 2.19\]

**3.15 Flushing**

procedure by which the ethylene oxide is removed from the load and chamber

by either multiple alternate admissions of filtered air, inert gas or steam and evacuations of the chamber or continuous passage of filtered air, inert 10ISO 11135-2014 gas or steam through the load and chamber

**3.16 fractional cycle**

a cycle in which the exposure time to EO gas is reduced compared to that

specified in the ethylene oxide sterilization process

**3.17 half cycle**

a cycle in which the exposure time to EO gas is reduced by 50 % compared to that specified in the ethylene oxide sterilization process

**3.18 health care facility**

governmental and private organizations and institutions devoted to the

promotion and maintenance of health, and the prevention and treatment of

diseases and injuries

EXAMPLE A health care facility can be a hospital, nursing home, extended care facility, free-standing surgical centre, clinic, medical office, or dental office.

**3.19 health care product**

medical device(s), including _in vitro_ diagnostic medical device(s), or medicinal product(s), including biopharmaceutical(s)

11ISO 11135-2014

\[SOURCE: ISO/TS 11139:2006, definition 2.20\]

**[3.20 installation qualification](https://zjbocon.com/iq-in-eto-sterilization-process/)**

process of obtaining and documenting evidence that equipment has been provided

and installed in accordance with its specification

\[SOURCE: ISO/TS 11139:2006, definition 2.22\]

**3.21 medical device**

any instrument, apparatus, implement, machine, appliance, implant, _in vitro_ reagent or calibrator, software, material or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of

   diagnosis, prevention, monitoring, treatment or alleviation of disease,

   diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,

   investigation, replacement or modification or support of the anatomy or of a physiological process,

   control of conception,

   disinfection of medical devices,

   providing information for medical purposes by means of _in vitro_ examination of specimens derived from the human body, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means

\[SOURCE: ISO 13485:2003, definition 3.7\]

?

**3.22 microorganism**

entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses

Note 1 to entry: A specific standard might not require demonstration of the

effectiveness of the eto gas sterilization process in inactivating all types of

microorganisms, identified in the definition above, for validation and/or

routine control of the eto gas sterilization process.

**[3.23 operational qualification](https://zjbocon.com/oq-in-eto-sterilization-machine/)**

process of obtaining and documenting evidence that installed equipment

operates within predetermined limits when used in accordance with its

operational procedures

\[SOURCE: ISO/TS 11139:2006, definition 2.27\]

**3.24 overkill approach**

approach using eto gas sterilization process that delivers a minimum of 12 Spore Log

Reduction (SLR) to a biological indicator having a resistance equal to or greater than the product bioburden

**3.25 parametric release**

declaration that product is sterile, based on records demonstrating that the process parameters were delivered within specified tolerances

\[SOURCE: ISO/TS 11139:2006, definition 2.29\]

Note 1 to entry: This method of process release does not include the use of biological indicators.

**[3.26 performance qualification](https://zjbocon.com/ethylene-oxide-sterilization-chamber/)**

process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification

\[SOURCE: ISO/TS 11139:2006, definition 2.30\]

**[3.27 Preconditioning](https://zjbocon.com/eto-sterilization-process/)**

treatment of product, prior to the eto gas sterilization cycle, in a room or chamber to attain specified conditions for temperature and relative humidity

**3.28 process challenge device**

item designed to constitute a defined resistance to aeto gas sterilization process and used to assess performance of the process

\[SOURCE: ISO/TS 11139:2006, definition 2.33\]

Note 1 to entry: For the purpose of this International Standard, a PCD can

be product, simulated product or other device that is inoculated directly or

indirectly. See 7.1.6 and D.7.1.6.

Note 2 to entry: In this International Standard, a distinction is made between an internal PCD and an external PCD. An internal PCD is used to demonstrate that the required product SAL is achieved. A PCD located within the confines of the product or product shipper case is an internal PCD, whereas a PCD located between shipper cases or on the exterior surfaces of the load is an external PCD. An external PCD is an item designed to be used for microbiological

monitoring of routine production cycles.

**3.29 process parameter**

specified value for a process variable

Note 1 to entry: The specification for a eto gas sterilization process includes the

process parameters and their tolerances.

\[SOURCE: ISO/TS 11139:2006, definition 2.34\]

**3.30 process variable**

condition within a ethylene oxide sterilization process, changes in which alter microbicidal effectiveness

EXAMPLE?Time, temperature, pressure, concentration, humidity, wavelength.

\[SOURCE: ISO/TS 11139:2006, definition 2.35\]

**3.31 processing category**

collection of different product or product families that can be sterilized

together

Note 1 to entry: All products within the category have been determined to present an equal or lesser challenge to the ethylene oxide sterilization process than the process challenge device for that group.

**3.32 Product**

result of a process

\[SOURCE: ISO 9000:2005, definition 3.4.2\]

Note 1 to entry: For the purposes of ethylene oxide sterilization standards, product is

tangible and can be raw material(s), intermediate(s), sub-assembly(ies) and

health care products.

**3.33 product family**

group of product possessing characteristics that allow them to be sterilized

using defined process conditions

**3.34 product load volume**

defined space within the usable chamber volume occupied by product

**3.35 recognized culture collection**

depository authority under the Budapest Treaty on _The International_

_Recognition of the Deposit of_

_Microorganisms for the Purposes of Patent and Regulation_

\[SOURCE: ISO/TS 11139:2006, definition 2.38\]

**3.36 reference microorganism**

microbial strain obtained from a recognized culture collection

**3.37 Requalification**

repetition of part of validation for the purpose of confirming the continued acceptability of a specified process

**3.38 reusable medical device**

medical device designated or intended by the manufacturer as suitable for

reprocessing and re-use

Note 1 to entry: This is not a medical device that is designated or intended

by the manufacturer for single use only.

**3.39 Services**

supplies from an external source, needed for the correct function of equipment

EXAMPLE Electricity, water, compressed air, drainage.

\[SOURCE: ISO/TS 11139:2006, definition 2.41\]

**3.40 single-use medical device**

medical device designated or intended by the manufacturer for one-time use only

**3.41 Specify**

stipulate in detail within an approved document

**3.42 Spore-log-reduction** log of initial spore population, _N_ 0, minus the log of the final population, _N_ u

\[SOURCE: ISO 14161:2009, definition 3.19\]

Note 1 to entry: Describing the reduction in the number of spores on a

biological indicator or inoculated item produced by exposure to specified

conditions.

For Direct Enumeration:

SLR = log _N_ 0 log ? _N_ u

where

_N_ 0 is the initial population;

_N_ u is the final population.

For Fraction Negative:

SLR = log _N_ 0    log \[ln ( _q_/ _n_)\]

where

_N_ 0 is the initial population;

_q_ is the number of replicate samples tested;

_n_ is the number of samples negative for growth.

If there are no survivors, the true SLR cannot be calculated. The SLR can be

reported as  済reater than   log _N_ 0 if one surviving organism is used.

**3.43 Sterile**

free from viable microorganisms

\[SOURCE: ISO/TS 11139:2006, definition 2.43\]

**3.44 sterile barrier system**

minimum package that prevents ingress of microorganisms and allows aseptic

presentation of the product at the point of use

\[SOURCE: ISO/TS 11139:2006, definition 2.44\]

**3.45 Sterility**

state of being free from viable microorganisms

Note 1 to entry: In practice, no such absolute statement regarding the absence of microorganisms can be proven.

Note 2 to entry: See 3.47, sterilization.

\[SOURCE: ISO/TS 11139:2006, definition 2.45\]

**3.46 sterility assurance level**

probability of a single viable microorganism occurring on an item after

sterilization

Note 1 to entry: The term SAL takes a quantitative value, generally 10-6or 10-3. When applying this quantitative value to assurance of sterility, an SAL of 10-6has a lower value but provides a greater assurance of sterility than an SAL of 10-3.

\[SOURCE: ISO/TS 11139:2006, definition 2.46\]

**[3.47 Sterilization](https://zjbocon.com/product/eto-sterilzer/)**

validated process used to render product free from viable microorganisms

Note 1 to entry: In a sterilization process, the nature of microbial

inactivation is exponential and thus the survival of a microorganism on an individual item can be expressed in terms of probability. While this

probability can be reduced to a very low number, it can never be reduced to zero. ISO 11135-2014

Note 2 to entry: See 3.46, sterility assurance level.

\[SOURCE: ISO/TS 11139:2006, definition 2.47\]

**[3.48 sterilization cycle](https://zjbocon.com/eto-sterilization-cycle/)**

treatment in a sealed chamber, which includes air removal, conditioning (if used), injection of ethylene oxide, inert gas (if used), exposure to ethylene oxide, removal of ethylene oxide and flushing (if used), and air/inert gas admission

**3.49 sterilization load**

product to be, or that has been, sterilized together using a given

sterilization process

\[SOURCE: ISO/TS 11139:2006, definition 2.48\]

**[3.50 sterilization process](https://zjbocon.com/eto-sterilization-process/)**

series of actions or operations needed to achieve the specified requirements for sterility

\[SOURCE: ISO/TS 11139:2006, definition 2.49\]

Note 1 to entry: This series of actions or operations includes preconditioning

(if necessary), exposure to the ethylene oxide under defined conditions and any necessary post-treatment required for the removal of ethylene oxide and its by-products. It does not include any cleaning, disinfection or packaging operations that precede the sterilization process.

**3.51 sterilization specialist**

person with technical knowledge of the sterilization technology being utilized and its effects upon materials and microorganisms

**3.52 sterilizing agent**

ination of entities having sufficient microbicidal activity to achieve sterility under defined conditions

\[SOURCE: ISO/TS 11139:2006, definition 2.50\]

**3.53 survivor curve**

graphical representation of the inactivation of a population of microorganisms with increasing exposure to a microbicidal agent under stated conditions

\[SOURCE: ISO/TS 11139:2006, definition 2.51\]

**3.54 test for sterility**

technical operation defined in a Pharmacopoeia performed on product following exposure to a sterilization process

\[SOURCE: ISO/TS 11139:2006, definition 2.53\]

**3.55 test of sterility**

technical operation performed as part of development, validation, or

requalification to determine the presence or absence of viable microorganisms on product or portions thereof

\[SOURCE: ISO/TS 11139:2006, definition 2.54\]

**3.56 usable chamber volume**

defined space within the sterilizer chamber, which is not restricted by fixed or mobile parts and which is available to accept the sterilization load

Note 1 to entry: The volume allowed for gas circulation around the load inside

the chamber is not included as usable space.

**[3.57 Validation](https://zjbocon.com/eto-sterilization-2/)**

documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications

\[SOURCE: ISO/TS 11139:2006, definition 2.55\]

**3.58 virgin material**

material that has not been previously used, or subjected to processing other than for its original production

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## ETO Sterilizer Maintenance Guide
[Skip to content](https://zjbocon.com/maintenance-guide-for-eto-sterilizers/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-7-1024x1024.webp)

9.1 During ETO Sterilization, operators are not allowed to leave the operating area and must continuously observe the ETO Sterilization process. If any abnormal phenomena occur, the machine must be immediately shut down, and the power supply should be cut off for inspection.

9.2 Change the circulating water in the heating system every three months. When changing the water, first open all water drainage switches at the bottom of the chamber and the lower part of the door to drain the water completely. After rinsing the piping and water tank with clean water, refill with new circulating water.

9.3 Inspect and clean the air, heating, vaporization, and ethylene oxide system filters at least after every 30 ETO Sterilization cycles, replacing any damaged or malfunctioning filters. (Cleaning mediums can include water, compressed air, or steam.)

9.4 Vacuum pressure gauges, pressure sensors, and other measuring instruments should be calibrated by the local metrology department every six months, according to national metrology laws.

9.5 Sealing gaskets should be replaced every six months.

9.6 Regularly check that all terminal connections in the electrical control system are secure.

9.7 At least once a day, inspect the circulation water, vacuum, ethylene oxide, steam, and vaporization device pipelines for leaks. If any leaks are found, measures must be taken to address them safely.

9.8 Lubricate the door hinges once a week and clean the interior walls, door frame, and hinges to ensure no dirt accumulates on the interior walls or hinges.

9.9 If the ambient temperature around the equipment drops below zero degrees Celsius and the equipment cannot operate continuously, if the heating system has stopped heating for more than three hours, the water in the circulation system should be drained to prevent the system from freezing and cracking.

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

### Share this:

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[eto sterilization process](https://zjbocon.com/eto-sterilization-process/ "eto sterilization process")

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[WeChat](https://zjbocon.com/maintenance-guide-for-eto-sterilizers/#)

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## EO Sterilization Overview
[Skip to content](https://zjbocon.com/eo-sterilization-equipment-and-process-characteristic-patterns-and-effect-analysis/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-68.webp)

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Start cycle phase(Select parameters/sterilization recipe) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Choosing the wrong recipe | Lack of care in choosing the formulation | Invalid cycle. Affects product sterility (re-sterilization) | 1\. Different recipe names | 6 | 5 | 10 | 300 | 1\. Work instructions 2. Careful inspection before the cycle starts 3. Operator training | 2 | 5 | 4 | 40 | 1\. Work instructions 2. Careful inspection before starting the cycle 3. Operator training | user |
| Loss of product/packaging functionality and integrity due to unvalidated cycle parameters | 1\. Different recipe names | 6 | 4 | 10 | 240 | 1\. Work instructions 2. Careful inspection before the cycle starts 3. Operator training | 2 | 4 | 4 | 32 | 1\. Work instructions 2. Careful inspection before starting the cycle 3. Operator training | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Warm-up phase(Cabinet heating) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 5 | 3 | 2 | 30 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. Calibration | user |
| 2 | The temperature inside the cabinet is too high | Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1\. Preventive maintenance 2. Calibration | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Insulation stage(Maintain cabinet temperature) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Circulating water pump overload alarm | 5 | 3 | 2 | 30 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Heating timeout alarm 2. Circulating water pump overload alarm | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. Calibration | user |
| 2 | The temperature inside the cabinet is too high | Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Heating timeout alarm 2. Circulating water pump overload alarm | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1\. Preventive maintenance 2. Calibration | user |
| 3 | Lack of time | Programming Errors | Repeat sterilization | 1\. Automatic cycle inspection | 2 | 4 | 2 | 16 |  |  |  |  |  | none |  |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Pre-vacuum stage(Removing air from the chamber allows the process to proceed below the EO flammability limit) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Not enough air removed | Low vacuum pump efficiency | The cycle is locked in one phase until it is restored and restarted after a standby period | 1\. Pre-vacuum time over limit alarm 2. Vacuum pump overload alarm 3. Automatically detect water flow and shut down the waterless pump | 5 | 3 | 2 | 30 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Wrong valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1\. Pre-vacuum time over limit alarm 2. Vacuum pump overload alarm | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Pressure sensor failure | Flammable Zone Hazard | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 | 2 | 36 | 1\. Preventive maintenance 2. Calibration | 2 | 3 | 2 | 12 | 1\. Preventive maintenance 2. Calibration | user |
| 2 | Too much vacuum | Pressure sensor failure | Product and/or packaging damage (classification) | 1\. Redundant pressure sensor 2. Pressure difference alarm is issued when the pressure difference is greater than 1kpa. | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1\. Preventive maintenance 2. Calibration | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Leak detection stage(Check the tightness of the box) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Cabinet leakage | Gasket leakage | No impact | 1\. Leak test failure alarm 2. Process ends | 10 | 5 | 2 | 100 | 1\. Preventive maintenance | 3 | 5 | 2 | 30 | 1\. Preventive maintenance | user |
| Valve leakage | No impact | 1\. Leak test failure alarm | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Circulation system air duct leakage | No impact | 1\. Leak test failure alarm | 4 | 3 | 2 | 24 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance 2. Calibration | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Nitrogen replacement stage(Fill the chamber with an inert gas to replace oxygen) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Not enough nitrogen entering the chamber | Insufficient nitrogen | The cycle is locked in one phase until it is restored and restarted after a standby period | End of process | 3 | 3 | 2 | 18 |  |  |  |  |  | N/A |  |
| Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | N/A | 6 | 3 | 3 | 54 | 1\. Preventive maintenance | 2 | 3 | 3 | 18 | 1\. Preventive maintenance | user |
| Pressure sensor failure | Flammable Zone Hazard | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| 2 | Too much nitrogen in the cabinet door | Faulty valve | EO concentration is lower than the validated value because during EO injection, if controlled by pressure (resterilization), additional N2 is injected | 1\. Indoor high voltage alarm 2. End of process | 6 | 5 | 4 | 120 | 1\. Preventive maintenance | 2 | 5 | 4 | 40 | 1\. Preventive maintenance | user |
| Pressure transmitter failure | Too much EO gas injected. High EO residue. Extended degassing time me) | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. Calibration | user |
| 3 | The cabinet temperature is higher than the upper limit t |  | Impact on product function (sorting) | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1\. Preventive maintenance 2. Calibration | user |
| 4 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 | 3 | 54 | 1\. Preventive maintenance | 2 | 3 | 3 | 18 | 1\. Preventive maintenance | user |
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. Calibration | user |
| Low carburetor temperature | Affects product sterility (re-sterilization) | 1\. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation | 6 | 4 | 2 | 48 | 1\. Preventive maintenance | 2 | 4 | 2 | 16 | 1\. Preventive maintenance | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Humidification stage(Increasing the humidity of the load by injecting steam) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Insufficient steam | Steam generator failure | Affects product sterility (re-sterilization) | 1\. Alarm when steam pressure is lower than the limit | 6 | 5 | 2 | 60 | 1\. Preventive maintenance | 2 | 5 | 2 | 20 | 1\. Preventive maintenance | user |
| Valve failure | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.Humidification frequency limit alarm | 6 | 5 | 2 | 60 | 1\. Preventive maintenance | 2 | 5 | 2 | 20 | 1\. Preventive maintenance | user |
| Pressure transmitter/humidity sensor failure | Affects product sterility (re-sterilization) | 1\. Redundant pressure/humidity sensor 2. Alarm when pressure/humidity difference exceeds limit | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. Calibration | user |
| Filter clogged | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.Humidification frequency limit alarm | 6 | 5 | 2 | 60 | 1\. Preventive maintenance | 2 | 5 | 2 | 20 | 1\. Preventive maintenance | user |
| 2 | Too much steam injection | Faulty valve | Excessive steam injection, wet cartons (sorting) | 1\. Indoor high voltage alarm 2. End of process | 6 | 5 | 4 | 120 | 1\. Preventive maintenance | 2 | 5 | 4 | 40 | 1\. Preventive maintenance | user |
| Pressure transmitter/humidity sensor failure | Excessive steam injection, wet cartons (sorting) | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. Calibration | user |
| 3 | Temperature is too high | Temperature sensor failure | Impact on product functions (ranking) | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1\. Preventive maintenance 2. Calibration | user |
| 4 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked in one phase until it is restored and restarted after a standby period | 1\. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 4 | 2 | 16 | 1\. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked in one phase until it is restored and restarted after a standby period | 1\. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 | 3 | 54 | 1\. Preventive maintenance | 2 | 3 | 3 | 18 | 1\. Preventive maintenance | user |
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Heating timeout alarm 2. Circulating water pump overload alarm | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. Calibration | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Humidification dwell phase(Balanced humidity) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Lack of time | time out | Affects product sterility (re-sterilization) | 1\. Automatic cycle inspection | 2 | 5 | 2 | 20 | 1\. Preventive maintenance | 1 | 5 | 2 | 10 | 1\. Preventive maintenance | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Nitrogen cushion stage(Fill the chamber with inert gas to dilute the oxygen) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Not enough nitrogen entering the cabinet | Lack of nitrogen | The cycle is locked in one phase until it is restored and restarted after a standby period | 1\. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit | 3 | 3 | 2 | 18 |  |  |  |  | 0 |  |  |
| Valve failure | The cycle is locked in one phase until it is restored and restarted after a standby period | none | 6 | 3 | 3 | 54 | 1\. Preventive maintenance | 2 | 3 | 3 | 18 | user | 1\. Preventive maintenance |
| Pressure sensor failure | Flammable Zone Hazard | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | user | 1\. Preventive maintenance |
| 2 | Too much nitrogen injected into the cabinet | Faulty valve | EO concentration is lower than the validated value because during EO injection, if controlled by pressure (resterilization), additional N2 is injected | 1\. Indoor high voltage alarm 2. End of process | 6 | 5 | 4 | 120 | 1\. Preventive maintenance | 2 | 5 | 4 | 40 | user | 1\. Preventive maintenance |
| Pressure transmitter failure | Too much EO gas injected. High EO residue. (Extend degassing time) | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | user | 1\. Preventive maintenance 2. Calibration |
| 3 | The temperature inside the cabinet exceeds the upper limit | Temperature sensor failure | Impact on product function (sorting) | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | user | 1\. Preventive maintenance 2. Calibration |
| 4 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | user | 1\. Preventive maintenance |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 | 3 | 54 | 1\. Preventive maintenance | 2 | 3 | 3 | 18 | user | 1\. Preventive maintenance |
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | user | 1\. Preventive maintenance 2. Calibration |
| Low carburetor temperature | Affects product sterility (re-sterilization) | 1\. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | user | 1\. Preventive maintenance 2. Calibration |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| EO injection stage(Fill the cabinet with EO gas) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Not enough ethylene oxide is entering the cabinet | Missing EO | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1.EO cylinder hole alarm 2.EO injection timeout alarm | 10 | 5 | 2 | 100 | 1\. Operator training 2. EO weight check before cycle start | 2 | 5 | 2 | 20 | 1\. Operator training 2. EO weight check before cycle start | user |
| Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.EO injection timeout alarm | 6 | 5 | 2 | 60 | 1\. Preventive maintenance | 6 | 5 | 2 | 60 | 1\. Preventive maintenance | user |
| EO pipeline leakage | Batches that exceed the qualification period may be sterilized again | none | 6 | 5 | 3 | 90 | 1\. Preventive maintenance 2. LEL EO detector alarm | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. LEL EO detector alarm | user |
| Pressure sensor failure | EO concentration is lower than the validation value (re-sterilization) | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. Calibration | user |
| 2 | Liquid EO enters the cabinet | Low carburetor temperature | The cycle is locked in one phase until it is restored and restarted after a standby period | 1\. The carburetor temperature is lower than the limit alarm | 6 | 4 | 2 | 48 | 1\. Preventive maintenance | 2 | 4 | 2 | 16 | 1\. Preventive maintenance | user |
| Not enough water in the carburetor due to a faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1\. The carburetor water level is lower than the limit alarm | 6 | 4 | 2 | 48 | 1\. Preventive maintenance | 2 | 4 | 2 | 16 | 1\. Preventive maintenance | user |
| 3 | Too much ethylene oxide input in the cabinet | Faulty valve | Longer quarantine, requiring additional testing | 1\. Indoor high voltage alarm | 6 | 3 | 3 | 54 | 1\. Preventive maintenance 2. EO residual inspection | 2 | 3 | 3 | 18 | 1\. Preventive maintenance 2. EO residual inspection | user |
| Pressure sensor failure | Longer quarantine, requiring additional testing | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 | 2 | 36 | 1\. Preventive maintenance 2. Calibration | 2 | 3 | 2 | 12 | 1\. Preventive maintenance 2. Calibration | user |
| 4 | The temperature inside the cabinet exceeds the upper limit | Temperature sensor failure | Impact on product function (sorting) | 1\. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature difference exceeds limit alarm | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1\. Preventive maintenance 2. Calibration | user |
| 5 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 | 3 | 54 | 1\. Preventive maintenance | 2 | 3 | 3 | 18 | 1\. Preventive maintenance | user |
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. Calibration | user |
| Low carburetor temperature | Affects product sterility (re-sterilization) | 1\. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation | 6 | 4 | 2 | 48 | 1\. Preventive maintenance | 2 | 4 | 2 | 16 | 1\. Preventive maintenance | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Nitrogen cap stage(Add N2 to cover EO) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Not enough nitrogen entering the cabinet | Lack of nitrogen | The cycle is locked in one phase until it is restored and restarted after a standby period | 1\. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit | 3 | 3 | 2 | 18 |  |  |  |  |  | N/A |  |
| Valve failure | The cycle is locked in one phase until it is restored and restarted after a standby period | none | 6 | 3 | 3 | 54 | 1\. Preventive maintenance | 2 | 3 | 3 | 18 | 1\. Preventive maintenance | user |
| Pressure sensor failure | Flammable Zone Hazard | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| 2 | Too much nitrogen injected into the cabinet | Faulty valve | The cabin is under positive pressure. This cycle will end. | 1\. Indoor high voltage alarm 2. End of process | 6 | 5 | 4 | 120 | 1\. Preventive maintenance | 2 | 5 | 4 | 40 | 1\. Preventive maintenance | user |
| 3 | The temperature inside the cabinet exceeds the upper limit | Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature difference exceeds limit alarm | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1\. Preventive maintenance 2. Calibration | user |
| 4 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 | 3 | 54 | 1\. Preventive maintenance | 2 | 3 | 3 | 18 | 1\. Preventive maintenance | user |
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. Calibration | user |
| Low carburetor temperature | Affects product sterility (re-sterilization) | 1\. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation | 6 | 4 | 2 | 48 | 1\. Preventive maintenance | 2 | 4 | 2 | 16 | 1\. Preventive maintenance | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| EO exposure stage(Disinfect the product) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Lack of time | Programming Errors | Repeat sterilization | 1\. Automatic cycle inspection | 2 | 5 | 2 | 20 | 1\. Preventive maintenance | 1 | 5 | 2 | 10 | 1\. Preventive maintenance | user |
| 2 | The box temperature is lower than the lower limit t | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | Heating timeout 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked in one phase until it is resumed and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1\. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 | 3 | 54 | 1\. Preventive maintenance | 2 | 3 | 3 | 18 | 1\. Preventive maintenance | user |
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | 5 | 2 | 60 | 1\. Preventive maintenance 2. Calibration | 2 | 5 | 2 | 20 | 1\. Preventive maintenance 2. Calibration | user |
| 3 | The temperature inside the cabinet exceeds the upper limit | Temperature sensor failure | Affects product sterility (re-sterilization) | 1\. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature alarm | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1\. Preventive maintenance 2. Calibration | user |
| 4 | Not getting a sufficiently homogeneous EO mixture | Circulation fan failure | Affects product sterility (re-sterilization) | 1\. Low speed alarm | 6 | 5 | 3 | 90 | 1\. Preventive maintenance | 2 | 5 | 3 | 30 | 1\. Preventive maintenance | user |
| Product positioning very close to the cavity wall | Affects product sterility (re-sterilization) | 1.Guardrail is used to prevent the product from contacting the cavity wall | 2 | 5 | 3 | 30 |  |  |  |  | 0 | N/A |  |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| EO Removal Phase(Create vacuum/remove sterilization gas) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Not purging enough gas | Inefficient vacuum pump | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.EO removal timeout alarm 2.Vacuum pump overload alarm 3.Automatically detect water flow and shut down the waterless pump | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.EO removal timeout alarm 2.Vacuum pump overload alarm | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Pressure sensor failure | Lo
| 2 | Exhaust too much gas | Pressure sensor failure | Product and/or packaging damage (classification) | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1\. Preventive maintenance 2. Calibration | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Nitrogen purge stage(Ensure that the indoor environment is not flammable) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Not enough nitrogen entering the chamber | Lack of nitrogen | The cycle is locked in one phase until it is restored and restarted after a standby period | 1\. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit | 3 | 3 | 2 | 18 |  |  |  |  |  | N/A |  |
| Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | none | 6 | 3 | 3 | 54 | 1\. Preventive maintenance | 2 | 3 | 3 | 18 | 1\. Preventive maintenance | user |
| Pressure sensor failure | Flammable Zone Hazard | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Longer quarantines require additional testing | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Air cleaning stage(Create vacuum/remove residual sterilization gas, eliminate residual EO) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Not purging enough gas | Inefficient vacuum pump | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.EO removal timeout alarm 2.Vacuum pump overload alarm 3.Automatically detect water flow and shut down the waterless pump | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.EO removal timeout alarm 2.Vacuum pump overload alarm | 6 | 3 | 2 | 36 | 1\. Preventive maintenance | 2 | 3 | 2 | 12 | 1\. Preventive maintenance | user |
| Pressure sensor failure | Longer isolation time and additional testing required due to less EO gas being removed | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 | 2 | 36 | 1\. Preventive maintenance 2. Calibration | 2 | 3 | 2 | 12 | 1\. Preventive maintenance 2. Calibration | user |
| 2 | Exhaust too much gas | Pressure sensor failure | Product and/or packaging damage (classification) | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 4 | 2 | 48 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1\. Preventive maintenance 2. Calibration | user |
| 3 | Insufficient air in the cabin | Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1\. Gas injection time over limit alarm | 6 | 4 | 3 | 72 | 1\. Preventive maintenance | 2 | 4 | 3 | 24 | 1\. Preventive maintenance | user |
| Filter clogged | The cycle is locked in one phase until it is restored and restarted after a standby period | 1\. Gas injection time over limit alarm | 6 | 4 | 3 | 72 | 1\. Preventive maintenance | 2 | 4 | 3 | 24 | 1\. Preventive maintenance | user |
| Pressure sensor failure | Longer quarantines require additional testing | 1\. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 | 2 | 36 | 1\. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1\. Preventive maintenance 2. Calibration | user |

|     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Removal stage(Remove residue from the product) |
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status |
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization |
| 1 | Aeration time is less than the specified time | Programming Errors | Repeat sterilization | 1\. Automatic cycle inspection | 2 | 3 | 2 | 12 | 1\. Restart your computer regularly | 1 | 3 | 2 | 6 | 1\. Restart your computer regularly | user |

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## ETO Sterilization Preparations
[Skip to content](https://zjbocon.com/preparatory-work-before-eto-sterilization/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/sterilizer-station-design-2.webp)

1. **Appearance Inspection:** Check the main unit, control rack, and electrical control cabinet for any damage on the surface.
2. **Power Supply Inspection:** Ensure the power supply meets requirements, and check the rotation direction of the water pump and vacuum pump.
3. **Power On:** Turn on the power and observe whether the display values on the instruments are normal. If not, cut off the power, perform inspection and repairs, then restart.
4. **Pipeline Inspection:** Check for leaks in the water supply, vacuum, and medication delivery pipelines, and verify that all valves are in standby position; adjust if necessary.
5. **Parameter Setting:** For example, set the medication amount by placing the medication bottle on an electronic scale (scale provided by the user), confirm the weight of the bottle, start the vacuum pump to reach the set pressure value, and open the medication bottle to deliver the medication. Typically, the medication amount during eto Sterilization is 400-800 mg/L (referring to the amount of pure ethylene oxide input; if using a mixture of gases with ethylene oxide, ensure that the amount of ethylene oxide meets this requirement). When the medication weight reaches the standard, the pressure at this point indicates the amount of medication delivered.
6. Before each eto Sterilization cycle, verify that the parameter settings meet the needs of the batch of sterilized items; otherwise, reset the eto Sterilization parameters.

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

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## EtO Chamber Testing Guidelines
[Skip to content](https://zjbocon.com/eto-sterilization-chamber-temperature-distribution-testing/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-54-225x300.webp)

## C.1 Temperature Testing of Inner Surfaces in the eto Sterilization Chamber

### C.1.1

The temperature of representative areas on the inner surfaces should be measured and recorded using temperature recording instruments that comply with the requirements of Appendix B.

### C.1.2

Each inner surface must be measured at least once (i.e., a minimum of 6 synchronous measurement points). For sterilizers with a total volume between 300 L and 8000 L, each surface should be measured at least 2 times. For every additional 4000 L of total volume, an additional 6 synchronous measurement points should be added.

### C.1.3

This test should be conducted with the eto sterilization chamber empty and doors closed, although auxiliary devices necessary for the eo sterilization process may be installed in the chamber.

### C.1.4

The temperature specified for any preheating stage by the manufacturer should be recorded.

## C.2 Temperature Testing of Empty eto Sterilization Chamber

### C.2.1

Using temperature recording instruments that comply with Appendix B, the temperature of representative areas in the usable space of the eo sterilization chamber should be recorded.

### C.2.2

There should be at least 6 synchronous measurement points. For sterilizers with a total volume between 300 L and 8000 L, at least 12 simultaneous measurements should be made; for every additional 4000 L, an additional 6 synchronous measurement points should be added. Note that the measurement area should include regions within the usable Ethylene oxide sterilization chamber space where temperature fluctuations may be extremely large (areas with extreme temperature variations), such as unheated areas near the sterilization chamber door and areas close to the steam injection points.

### C.2.3

During testing, the sterilization chamber should be empty but may have auxiliary devices necessary for the Ethylene oxide sterilization process installed, with the doors of the Ethylene oxide sterilization chamber closed.

### C.2.4

Throughout the entire Ethylene oxide sterilization cycle, the location of each temperature measurement should be recorded, detailing the temperatures in various areas of the eo sterilization chamber.

**Note:** This test may use non-toxic, non-flammable gases or mixtures as substitutes for the sterilizing agent injected into the eto sterilization chamber via the ethylene oxide injection system (including vaporizer).

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

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[OQ IN ETO STERILIZATION MACHINE](https://zjbocon.com/oq-in-eto-sterilization-machine/ "OQ IN ETO STERILIZATION MACHINE")

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## Ethylene Oxide Sterilizer Testing
[Skip to content](https://zjbocon.com/microbial-killing-performance-of-ethylene-oxide-sterilizers/#content)

**Note 1:** The Ethylene Oxide sterilization conditions must be obtained through validation confirmation and should be verified with monitoring and routine control during each sterilization cycle. The requirements for validation and routine control are outlined in GB 18279.

**Note 2:** This testing method is also applicable to A class Ethylene Oxide sterilizers equipped with preset [Ethylene Oxide sterilization](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/) programs.

![Microbial Killing Performance of Ethylene Oxide Sterilizers](https://zjbocon.com/wp-content/uploads/2024/10/banner__.webp)

## E.1 Equipment

### E.1.1

Four process challenge devices are required as follows:

- The process challenge device consists of a stainless steel tube and a semi-closed chamber loaded with contaminated carriers. The steel tube and chamber are connected using O-ring seals and threaded connections. The only pathway into the chamber is through the length of the tube.
- The tube length is 4.55 m (nominal), with an inner diameter of 3.0 mm (nominal), giving a length-to-diameter ratio of 1500:1. The total internal volume is approximately 32 mL, of which 0.85 mL is the volume of the chamber.

### E.1.2

Eight paper-plastic packaging bags that comply with GB/T19633, YY/T0698.4, and YY/T0698.5.

### E.1.3

Contaminated carriers that comply with GB18281.1 and GB18281.2.

### E.1.4

Appropriate recovery culture media for the contaminated carriers.

### E.1.5

Cultivation pot.

## E.2 Testing Steps

### E.2.1

Select the Ethylene Oxide sterilization program to be tested.

### E.2.2

Place one contaminated carrier in the test chamber of each process challenge device. Wrap each process challenge device with two paper-plastic packaging bags, sealing each bag with a sealing machine.

### E.2.3

The process challenge device does not need initialization but should be maintained at 20degrees celsius 卤 5degrees celsius for at least one hour before testing.

**Note:** This simulates the worst-case conditions.

### E.2.4

Raise the Ethylene Oxide sterilizer to the sterilization temperature, load four wrapped process challenge devices into the Ethylene Oxide sterilizer chamber, and start the test cycle within 15 minutes after loading. The exposure time for the sterilant during the test cycle should be half of the time specified for that Ethylene Oxide sterilization cycle.

### E.2.5

After the test cycle is complete, remove the process challenge devices from the Ethylene Oxide sterilizer.

### E.2.6

Remove the contaminated carriers from the test chamber, culture them according to the manufacturer  instructions, and verify compliance with the requirements of section 2.13.

### E.2.7

Culture one unexposed contaminated carrier from the same batch according to the manufacturer  instructions; it should show the presence of viable microorganisms. If not, the test is considered invalid, and retesting should be conducted.

### E.2.8

Repeat the test two more times.

## IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization

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## Ethylene Oxide Safety
[Skip to content](https://zjbocon.com/safety-requirements-for-using-ethylene-oxide-in-sterilization/#content)

![](https://zjbocon.com/wp-content/uploads/2024/10/Electrical-Scale.png)

01. when Ethylene Oxide in sterilization chamber should be equipped with fire prevention facilities.
02. Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames.
03. The lighting in the sterilization chamber should be explosion-proof, and any electrical appliances that may cause electric sparks should be avoided. Open flames are strictly prohibited.
04. Before sterilizing each type of item, the parameters must be confirmed according to the national standard GB18279-2000.
05. The control section of the sterilizer should be installed separately from the main unit (see diagram D.1).
06. After the displacement (flushing) phase is completed, the sterilized items should not remain in the sealed sterilization chamber for more than 15 minutes. Otherwise, the displacement phase must be repeated before opening the door.
07. After Ethylene Oxide in sterilization is complete, the displacement air must be processed according to the relevant sterilization operation regulations. Before opening the door to remove the items, the axial fan should be turned on to ensure ventilation. Do not immediately take out the items after opening the door to avoid exposure to harmful residual gases in the sterilization chamber.
08. **Medication Alert:** Based on the amount of medication to be administered, set the pressure or weight. When the required dosage is reached, an audible alert will sound. At this point, the operator must immediately close the medication bottle switch and the main unit  dosing valve.
09. Users of ethylene oxide mixed gases must install a pressure regulator (user-installed) at the outlet of the medication bottle to reduce the bottle outlet pressure to below 0.4 MPa, preventing high pressure from causing leaks in the dosing pipeline.
10. Before disconnecting or opening any part of the sterilant supply system, it is necessary to clean the system (except for the gas tank supply system).
11. If the air pressure of the door seal gasket in the sterilization chamber falls below 0.45 MPa during the sterilization process, the air supply to the rubber seal should be shut off, and a backup pressure source should be connected to ensure the rubber seal has a pressure greater than 0.45 MPa. At the same time, the ethylene oxide leak handling procedure should be activated to evacuate and clean the sterilization chamber. Then, measures should be taken to restore the original air source.
12. If the workplace ventilation system fails, the equipment should be shut down and not restarted. If the failure occurs while the sterilizing agent has already entered the chamber, the operator should only enter the chamber to contact the sterilized items after the sterilant removal and flushing procedures have been fully completed.
13. After each work cycle, the ethylene oxide pipeline system should be cleaned. Cleaning media can include water, compressed air, or steam. The user should install local exhaust systems in areas where sterilizing gas may accumulate, such as near the sterilizer door, the storage area for sterilized items, and the sterilant storage area. The exhaust system should not discharge any substances that could cause danger.

**Note:** Regardless of whether the equipment is in normal operation, malfunction, or maintenance state, if personnel need to enter the sterilizer chamber, the door must be lowered to the ground or supported. It should be confirmed that the door is locked and cannot be closed. Personnel should take or safely store the key before entering the chamber.

## Contact

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## Know more about us

[Comparing ETO, Gamma, and Steam Sterilization for Spices](https://zjbocon.com/sterilization-for-spice/)

[Understanding ETO Sterilizer Performance: Keys to Efficiency](https://zjbocon.com/understanding-eto-sterilizer-performance-keys-to-efficiency/)

[Ethylene Oxide Leak Handling when using eto sterilizer](https://zjbocon.com/ethylene-oxide-leak-handling-when-using-eto-sterilizer/)

[Safety Requirements for Using Ethylene Oxide in sterilization](https://zjbocon.com/safety-requirements-for-using-ethylene-oxide-in-sterilization/)

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## Ethylene Oxide Leak Management
[Skip to content](https://zjbocon.com/ethylene-oxide-leak-handling-when-using-eto-sterilizer/#content)

1. If a leak is detected in the eto sterilizer dosing pipeline during the administration process, immediately close the medication bottle, switch and the dosing valve on the main unit. Turn on the axial fan to ensure proper ventilation, and then proceed with repairs.
2. During the sterilization process, if there is a noticeable change in pressure in the eto sterilizer chamber, indicating a leak or seepage, immediately activate the vacuum pump to evacuate all ethylene oxide gas from the eto sterilizer. Then, disconnect the power supply, conduct an inspection, and take appropriate action. If necessary, open windows for ventilation, turn on the axial fan, and continue with the process.

* * *

## **Handling of Personnel Exposure to Ethylene Oxide**

1. **Inhalation Exposure**: Excessive inhalation of ethylene oxide can cause respiratory irritation, dizziness, weakness, nausea, vomiting (either immediately or later), chest pain, and neurotoxic reactions. If overexposure occurs, immediately move to an outdoor area to inhale fresh air and seek medical attention as soon as possible.
2. **Eye Exposure**: Liquid ethylene oxide splashed into the eyes can cause serious eye injuries, and high concentrations of ethylene oxide gas can cause severe eye irritation. In case of accidental exposure, immediately flush the eyes with clean water for at least 10 minutes, and then seek medical treatment.
3. **Skin Exposure**: Liquid ethylene oxide can cause skin irritation, dermatitis, and blisters. If skin contact with liquid ethylene oxide occurs, immediately wash the affected area with water for at least 15 minutes, remove contaminated clothing, and wash the area with soap and water. Seek medical attention as soon as possible.
4. **Gastrointestinal Exposure**: Gastrointestinal exposure to ethylene oxide is an uncommon route, but if liquid ethylene oxide enters the digestive system, it can be corrosive and cause severe irritation and burns to the mucous membranes. In such cases, drink 1  2 cups of water and induce vomiting by touching the back of the throat (do not induce vomiting in unconscious individuals). Seek medical attention immediately.

* * *

![](https://zjbocon.com/wp-content/uploads/2025/09/Ethylene-Oxide-Sterilizer-Installation-Guide-3-1024x473.webp)

## **Storage Environment for Ethylene Oxide** when using eto sterilizer

1. Cool, low-temperature (?25degrees celsius), well-ventilated environment.
2. Keep away from light, and direct sunlight, and avoid collisions.
3. Keep away from sources of fire.
4. Use explosion-proof electrical equipment in storage areas.

## Contact

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[Protection function OF eTO chamber SYSTEM](https://zjbocon.com/eto-sterilizer-system/ "Protection function OF eTO chamber SYSTEM")

[Ethylene Oxide Sterilizer Installation Guide](https://zjbocon.com/ethylene-oxide-sterilizer-installation-guide/ "Ethylene Oxide Sterilizer Installation Guide")

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## ETO Sterilizer Efficiency
[Skip to content](https://zjbocon.com/understanding-eto-sterilizer-performance-keys-to-efficiency/#content)

![](https://zjbocon.com/wp-content/uploads/2025/11/eto-sterilzer-1024x452.webp)

3.4.1 eto sterilizer machine Temperature Setting Range

The temperature setting range for the eto sterilizer is: 30 to 70degrees celsius, with a control error of ?2degrees celsius.

3.4.2 Temperature Uniformity of the ethylene oxide machine

The temperature uniformity of the eto sterilizer must meet the following requirements:

When the volume of the sterilization chamber is ?5m3, at least 10 measurement points must be placed.

When the volume is >5m3, for every additional 1m3, one more measurement point should be added.

When the volume is ?10m3, at least 20 measurement points must be set inside the chamber, with the test temperature ?40degrees celsius, and the temperature difference between each measurement point must not exceed 卤3degrees celsius.

3.4.3 Sterilization Chamber Leakage Rate

3.4.3.1

Testing should be conducted before the injection phase of the sterilizing agent and the humidification phase (if using an inserted temperature and pressure display device). The pressure should be preset by the manufacturer, and the test pressure should be less than -20 kPa and at least 20 kPa lower than the preset sterilization pressure.

3.4.3.2

If the pressure during any stage of the sterilization cycle is below atmospheric pressure, after reaching the preset pressure, all valves connected to the sterilization chamber should be closed, and the vacuum pump should stop working. The pressure in the sterilization chamber should be monitored for at least 5 minutes, during which the pressure rise must not exceed 0.3 kPa/min.

3.4.3.3

When the working pressure of the eo chamber is greater than 5 kPa, a positive pressure leakage test should also be conducted, which should be performed before the vacuum stage. By pressurizing with inert gas (such as air) to within 10% of the preset working pressure, the pressure in the sterilization chamber should be monitored for at least 5 minutes, during which the pressure drop must not exceed 0.3 kPa/min.

3.4.4 eto sterilizer machine Vacuum Rate

Under no-load conditions, the eo chamber should reach -15 kPa from atmospheric pressure in ?6 minutes; reach -50 kPa in ?30 minutes; and reach -75 kPa in ?40 minutes.

3.4.5 Humidification Effect of the eto sterilizer machine

Under no-load conditions, when the relative humidity is ?40% RH, the eo sterilization machine should have the capability to increase the relative humidity to at least 75% or higher through the humidification system.

3.4.6 Pressure Setting Range of the Sterilization Chamber

The pressure setting range for the sterilization chamber is -0.08 MPa to +0.08 MPa.

3.4.7 Maximum Noise Level of the eto sterilizer machine

The maximum noise level (A-weighted) produced by the eto sterilization chamber should be ?65 dB.

3.4.8 Appearance and Structure of the ethylene oxide sterilizer

3.4.8.1

The shape should be upright, with a smooth and clean surface, uniform color, and free of burrs, sharp edges, and cracks. There should be no obvious scratches or defects such as bumps.

3.4.8.2

All text, graphics, symbols, etc., on the surface should be printed clearly, with markings that are clear, accurate, and durable.

3.4.8.3

Fasteners should be installed securely, and all control switches and adjustment knobs (buttons) should operate flexibly and reliably, without any obstruction.

Contact

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Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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## ETO Sterilizer Ready
[Skip to content](https://zjbocon.com/12m3-eto-sterilizer-is-ready-to-send-to-our-customer/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-69-1024x768.webp)![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-33-1024x768.webp)![](https://zjbocon.com/wp-content/uploads/2025/09/Industry_ETO_Sterilizer-6.webp)

Contact

Phone:[+8619975258603](https://wa.me/8619975258603)

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Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

## 5.1 Normal Operating Conditions

### 5.1.1 The normal working environment for the sterilizer should meet the following conditions:

a) Ambient temperature: 5 ? to 40 ?;

b) Relative humidity: ? 80 % RH;

c) Atmospheric pressure: 70 kPa to 106 kPa;

### 5.1.2 Rated Operating Conditions of the Sterilizer

The rated operating conditions for each model of the sterilizer are shown in Table 2.

| Model | Supply Voltage | Frequency | Power (kW) | Current (A) |
| --- | --- | --- | --- | --- |
| BCS-1 | 380V | 50Hz | 16 | 24 |
| BCS-2 |  |  | 16 | 24 |
| BCS-3 |  |  | 16 | 24 |
| BCS-4.5 |  |  | 27 | 41 |
| BCS-5 |  |  | 27 | 41 |
| BCS-6 |  |  | 27 | 41 |
| BCS-8 |  |  | 27 | 41 |
| BCS-10 |  |  | 43 | 65 |
| BCS-15 |  |  | 56 | 85 |
| BCS-20 |  |  | 81 | 123 |
| BCS-26 |  |  | 81 | 123 |
| BCS-28 |  |  | 90 | 137 |
| BCS-30 |  |  | 90 | 137 |
| BCS-30-2 |  |  | 90 | 137 |
| BCS-35 |  |  | 100 | 152 |
| BCS-35-2 |  |  | 100 | 152 |
| BCS-40-2 |  |  | 100 | 152 |
| BCS-48 |  |  | 100 | 152 |
| BCS-52 |  |  | 150 | 228 |
| BCS-55-2 |  |  | 150 | 228 |
| BCS-57-2 |  |  | 150 | 228 |
| BCS-63-2 |  |  | 150 | 228 |
| BCS-70-2 |  |  | 155 | 236 |
| BCS-78-2 |  |  | 165 | 251 |
| BCS-86-2 |  |  | 165 | 251 |
| BCS-101-2 |  |  | 200 | 304 |
| BCS-120-2 |  |  | 200 | 304 |

- The power supply socket is a three-phase 380V, three-hole socket with a grounding wire.
- The power plug is a three-phase 380V, three-prong plug with a grounding wire.
- A yellow-green outer wire is used to connect to the protective conductor terminal.

## 5.2 Storage Environment of the 12m3 eto sterilizer

The sterilizer should be stored in an indoor environment with temperatures between -20? and +55?, relative humidity ? 80% RH, free from corrosive gases, and well-ventilated.

**Note:** Before storage, all water in the circulating water system must be drained to keep the system in a dry state.

## 5.3 Transportation Conditions of the 12m3 eto sterilizer

The sterilizer should be transported unpackaged, and when hoisting the sterilizer, it should be lifted using the device  own lifting rings. During transport by vehicle, it should be secured as per regulations.

## 5.4 Disposal of Decommissioned 12m3 Sterilizers

After decommissioning, the sterilizer should be disposed of by a qualified recycling company.

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## Sterilizer Installation Guide
[Skip to content](https://zjbocon.com/ethylene-oxide-sterilizer-installation-guide/#content)

The installation and layout diagram of the ethylene oxide eto sterilizer can be found in Appendix C, Figure C.1.

![](https://zjbocon.com/wp-content/uploads/2025/09/eto-Sterilization-1024x559.webp)![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-37-1024x768.webp)![](https://zjbocon.com/wp-content/uploads/2025/09/eo-scrubber-62-1024x475.webp)

### 7.1 Before Installing the ethylene oxide eto sterilizer

Users must introduce a 380V three-phase four-wire power supply along with a protective grounding wire into the control room. The cable connecting the power supply to the sterilizer should be selected according to Table 3. An external switch and an air circuit breaker should be configured based on the rated power of the equipment. The external switch and air circuit breaker should be located near the equipment.

#### Table 3: Configuration Requirements for Connecting the Power Supply to the Sterilizer  Cable and Air Circuit Breaker

| Model | Air Circuit Breaker Current (A) | Copper Cable Cross-Section Area (?) |
| --- | --- | --- |
| BCS-1 | 30 | 4 |
| BCS-2 | 30 | 4 |
| BCS-3 | 30 | 4 |
| BCS-4.5 | 51 | 6 |
| BCS-5 | 51 | 6 |
| BCS-6 | 51 | 6 |
| BCS-8 | 51 | 6 |
| BCS-10 | 82 | 16 |
| BCS-15 | 106 | 16 |
| BCS-20 | 154 | 25 |
| BCS-26 | 154 | 25 |
| BCS-28 | 171 | 35 |
| BCS-30 | 171 | 35 |
| BCS-30-2 | 171 | 35 |
| BCS-35 | 190 | 50 |
| BCS-35-2 | 190 | 50 |
| BCS-40-2 | 190 | 50 |
| BCS-48 | 190 | 50 |
| BCS-52 | 285 | 70 |
| BCS-55-2 | 285 | 70 |
| BCS-57-2 | 285 | 70 |
| BCS-63-2 | 285 | 70 |
| BCS-70-2 | 294 | 70 |
| BCS-78-2 | 313 | 95 |
| BCS-86-2 | 313 | 95 |
| BCS-101-2 | 380 | 120 |
| BCS-120-2 | 380 | 120 |

### 7.2

All protective grounding terminals within the equipment must be securely and reliably connected to the introduced protective grounding wire.

### 7.3

The sterilization chamber should be installed separately from the control section. The sterilization chamber of the ethylene oxide eto sterilizer must be installed in a separate working area, which should have water supply, drainage, and ventilation facilities to ensure proper ventilation. The ventilation system should opt for explosion-proof axial flow fans. The floor in the working area should be flat and solid, and the body of the sterilizer should be placed steadily. The concrete thickness of the working area floor should not be less than 60 mm.

### 7.4

If required by the user, a non-recirculating local exhaust system should be used to eliminate fugitive emissions (e.g., exhaust devices in front of the ethylene oxide eto sterilizerdoor). The corresponding configurations should be made on-site according to actual conditions.

### 7.5

During installation, the minimum distance from one side (or both sides) of the equipment to the wall (column) should be 0.5 m, and there should be a distance of at least 3 m at both ends for loading and unloading purposes to allow for transport vehicle operations.

### 7.6

The installation of all pipelines should ensure no leakage, especially for medication supply lines and vacuum lines; otherwise, safety hazards may occur.

### 7.7

The exhaust gas drawn from the vacuum pump should first enter the exhaust treatment box, be dissolved in water, and then be discharged through the drainage outlet of the exhaust treatment box into a neutralization treatment pool (which should be prepared by the user). After neutralization, it should be discharged into a closed dedicated drainage system. The diameter of the drainage system piping should be larger than the vacuum pump outlet diameter (see Figures A.2-2 and D.1).

### 7.8

The discharge outlet of the safety valve should use a pipe of appropriate diameter to direct the gas into the neutralization pool for neutralization before being discharged through the dedicated drainage pipe (see Figure A.2-2).

### 7.9

Main components of the sterilizer, such as the chamber, control frame assembly, electrical control cabinet, vacuum system piping, hot water system piping, ethylene oxide system piping, and vaporization system piping, shall be delivered as separate modules and connected on-site by specialized personnel from our factory.

### 7.10

The minimum distance between the control frame and the electrical control cabinet should be 1 meter to prevent noise hazards to operating personnel caused by sound pressure generated by the pump and vacuum pump.

### 7.11

The steam source must be provided by the user, with a required steam pressure of 0.25-0.4 MPa, steam temperature of 135-150degrees celsius, and a rated evaporation capacity greater than 3.5 kg/h.

### 7.12

The ethylene oxide gas cylinder must be provided by the user. The outlet pressure of the ethylene oxide gas cylinder must not exceed 0.4 MPa.

### 7.13

Installation of the ethylene oxide eto sterilizer will be assisted by specialized personnel from our factory, and these professionals will be responsible for equipment debugging.

Contact

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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[Introduction to Ethylene Oxide Sterilizers](https://zjbocon.com/introduction-to-ethylene-oxide-sterilizers/ "Introduction to Ethylene Oxide Sterilizers")

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## Loading ETO Sterilizers
[Skip to content](https://zjbocon.com/how-to-loading-sterilization-product-when-using-eto-gas-sterilizer/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/Sterilizer_Chamber_Conveyor.webp)Sterilizer-chamber-conveyor![](https://zjbocon.com/wp-content/uploads/2025/09/Sterilizer-chamber-conveyor-5-768x1024.webp)Sterilizer-chamber-conveyor![](https://zjbocon.com/wp-content/uploads/2025/09/Sterilizer-chamber-conveyor-2-1024x576.webp) Sterilizer-chamber-conveyor

## 8.4.1 Closing the eto gas sterilizer Discharge Door

1. For double-door eto gas sterilizer, before loading sterilization goods, follow the closing procedure for the discharge door, and inflate the sealing gasket of the discharge door until the pressure reaches above 0.45 MPa to ensure a proper seal.
2. Manually adjust the direction control valve to close the air source of the cylinder at the discharge door end, allowing the pneumatic system to supply air only to the loading door cylinder. Ensure that the air pressure is greater than 0.45 MPa.
3. Before loading sterilization goods, first open the air belt valve on the loading door to release air from the air belt. After a delay of 30 seconds, prepare for the indicator light to turn on.

## 8.4.2 Opening the Loading Door

1. After confirming safety, operate the loading door rise button to lift the door body, raising it approximately 120 mm.
2. The operator pulls the door handle to open the door, rotating it approximately 95掳 to 100掳.
3. When the door body collides with the limit block, confirm safety, then press the loading door down button to release the air from the cylinder, allowing the door body to fall to the ground or onto a support. At this point, the door body should not rotate.
4. Once the door body has lowered to position, the door opening operation is complete.

## 8.4.3 Loading Sterilization Items

Use a forklift to load sterilization items into the sterilization cabinet. Items should be neatly stacked with reasonable spacing, leaving a height of no less than 100 mm between the items and the top of the chamber.

## 8.4.4 Closing the Loading Door

1. After confirming that the sterilization items are fully loaded, in a state of confirmed safety, press the loading door rise button to raise the door body approximately 120 mm.
2. The operator pulls the door handle to rotate the door, aligning it with the door frame after rotating approximately 95掳 to 100掳.
3. After confirming safety, press the loading door down button to exhaust the cylinder, allowing the door body to settle on the door catch hook.
4. Once the door is closed properly, the indicator light will turn on (flashing state).
5. Open the valve to inflate the air belt; once the sealing of the air belt is completed, the indicator light will remain continuously lit, indicating the door closing operation is complete.

**Note:** Sterilization operations can only commence after the door is securely closed.

## IF YOU WANT TO KNOW MORE

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

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## 30 m3 Gas Sterilizer
[Skip to content](https://zjbocon.com/30-m%c2%b3-eto-gas-sterilizer/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-25-768x1024.webp)30 m3 eto gas sterilizer![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-57-1024x768.webp)30 m3 eto gas sterilizer![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-68.webp)30 m3 eto gas sterilizer

## 1.3 30 m3 eto gas sterilizer Composition

The 30 m3 eto gas sterilizer consists of the sterilizer housing, auxiliary equipment (heating and thermal cycling device, vacuum extraction device, dosing and vaporization device, humidification device, sealing device, residual gas processing device), and monitoring and control device.

## 1.4 Classification

Based on the size of the eto gas sterilizer, there are two types: Class A and Class B.

- **Class A eto gas sterilizer**   User-programmable sterilizer with a sterilization chamber volume > 1 m3, suitable for sterilizing in the medical device manufacturing industry.
- **Class Beto gas sterilizer**   A sterilizer with one or more preset sterilization cycles and size limitations, with a sterilization chamber volume ? 1 m3, suitable for sterilizing clinical medical devices.

## 1.5 Model Difference Table

**Table 1: Models and Basic Parameters of Ethylene Oxide Sterilizers**

|     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- |
| Serial No. | Model | Internal Chamber Dimensions (L脳W脳H) (mm) 卤1% | Nominal Volume (m3) | Power (kW) | Weight (kg) | Power Supply |
| 1 | BCS-1 | 1400\*700\*1000 | 1m3 | 16 | 1000 | 380V/50Hz |
| 2 | BCS-2 | 1650\*1000\*1200 | 2m3 | 16 | 2000 | 380V/50Hz |
| 3 | BCS-3 | 1400\*1350\*1700 | 3.0m3 | 16 | 3000 | 380V/50Hz |
| 4 | BCS-4.5 | 2000\*1350\*1700 | 4.5m3 | 27 | 4000 | 380V/50Hz |
| 5 | BCS-5 | 2250\*1350\*1700 | 5m3 | 27 | 4500 | 380V/50Hz |
| 6 | BCS-6 | 2700\*1350\*1700 | 6m3 | 27 | 5000 | 380V/50Hz |
| 7 | BCS-8 | 3500\*1350\*1700 | 8m3 | 27 | 6000 | 380V/50Hz |
| 8 | BCS-10 | 4500\*1350\*1700 | 10m3 | 43 | 7000 | 380V/50Hz |
| 9 | BCS-15 | 5500\*1350\*2000 | 15m3 | 56 | 9000 | 380V/50Hz |
| 10 | BCS-20 | 7500\*1350\*2000 | 20m3 | 81 | 12000 | 380V/50Hz |
| 11 | BCS-26 | 9600\*1350\*2000 | 26m3 | 81 | 14000 | 380V/50Hz |
| 12 | BCS-28 | 12500\*1350\*1700 | 28m3 | 90 | 14000 | 380V/50Hz |
| 13 | BCS-30 | 11300\*1350\*2000 | 30m3 | 90 | 17000 | 380V/50Hz |
| 14 | BCS-30-2 | 5600\*2700\*2000 | 30m3-2 | 90 | 16000 | 380V/50Hz |
| 15 | BCS-35 | 13000\*1350\*2000 | 35m3 | 100 | 23000 | 380V/50Hz |
| 16 | BCS-35-2 | 6000\*2700\*2200 | 35m3-2 | 100 | 22000 | 380V/50Hz |
| 17 | BCS-40-2 | 6650\*2700\*2200 | 40m3-2 | 100 | 23000 | 380V/50Hz |
| 18 | BCS-48 | 12850\*1400\*2700 | 48m3 | 100 | 28000 | 380V/50Hz |
| 19 | BCS-52 | 13900\*1400\*2700 | 52m3 | 150 | 28000 | 380V/50Hz |
| 20 | BCS-55-2 | 7500\*2700\*2700 | 55m3-2 | 150 | 27000 | 380V/50Hz |
| 21 | BCS-57-2 | 9650\*2700\*2200 | 57m3-2 | 150 | 28000 | 380V/50Hz |
| 22 | BCS-63-2 | 8650\*2700\*2700 | 63m3-2 | 150 | 29000 | 380V/50Hz |
| 23 | BCS-70-2 | 9700\*2700\*2700 | 70m3-2 | 155 | 32000 | 380V/50Hz |
| 24 | BCS-78-2 | 10750\*2700\*2700 | 78m3-2 | 165 | 35000 | 380V/50Hz |
| 25 | BCS-86-2 | 11800\*2700\*2700 | 86m3-2 | 165 | 38000 | 380V/50Hz |
| 26 | BCS-101-2 | 17050\*2700\*2200 | 101m3-2 | 200 | 45000 | 380V/50Hz |
| 27 | BCS-120-2 | 20200\*2700\*2200 | 120m3-2 | 200 | 49000 | 380V/50Hz |

## Sterilization Cycle and Automatic Control

### 2.10.7.1

The 30 m3 eto gas sterilizer should be equipped with an automatic controller that can automatically control the sterilization cycle.

### 2.10.7.2 Class A eto gas sterilizer:

- The automatic controller should be able to program preset conditions for each stage of the sterilization cycle.
- During the sterilization cycle, it must not change the preset variables.

### 2.10.7.3 Class B eto gas sterilizer:

- The manufacturer applies the automatic controller to program the preset conditions for each stage of the sterilization cycle.
- The manufacturer should provide methods to shorten the sterilization time for verification purposes, which can only be performed using a special key, password, or tool. Once the sterilization time is shortened, there should be a fault indication at the end of the operating cycle.

### 2.10.7.4

The controller should only be accessible using a special key, password, or tool. Additionally: a) For Class A sterilizers, access to the controller and setting of operational cycle variables should require a special key, password, or tool.

b) For Class B sterilizers, only the manufacturer can program new operational cycles.

### 2.10.7.5

During maintenance, testing, or emergencies, the program of the automatic controller should be operable manually. The manual device used should differ from the special key, password, or tool specified in section 2.10.7.4. When manual operation is performed due to maintenance, testing, or emergencies, the automatic program should stop automatically. The manual operation system should not pose a safety threat, allowing only one stage to be selected sequentially at a time.

### 2.10.7.6

Upon successful completion of each specified sterilization cycle, the automatic controller should indicate that the cycle is complete.

## IF YOU WANT TO KNOW MORE

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## ETO Sterilization Machines
[Skip to content](https://zjbocon.com/eto-sterile-machine-manufacturer-in-china/#content)

Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd( eto sterile machine manufacturer in china) was established in 2006. The office is located in Hangzhou; And the factory is situated in Jiaxing. HZBOCON primarily engages in the research and development, production, and sales of eto sterile machine, the main advantage is control system of sterilization.

![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-20.webp)

![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-9-1024x1024.webp)ETO STERILIZER-HZBOCON![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-6-1024x1024.webp)ETO STERILIZER-HZBOCON![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-4-1024x1024.webp)ETO STERILIZER-HZBOCON![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-2-1024x1024.webp)ETO STERILIZER-HZBOCON![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-12-1024x1024.webp)ETO STERILIZER-HZBOCON![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-10-1024x1024.webp)ETO STERILIZER-HZBOCON![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-8-1024x1024.webp)ETO STERILIZER-HZBOCON![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-7-1024x1024.webp)ETO STERILIZER-HZBOCON![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-3-1024x1024.webp)ETO STERILIZER-HZBOCON

**What is an ETO sterilizer machine?**

An ETO (Ethylene Oxide) sterilizer machine is a device used to sterilize medical equipment and supplies through the use of ethylene oxide gas. It is commonly utilized in healthcare settings for items that cannot withstand high temperatures and moisture.

**How does the ETO sterilization process work?**

Pls view our website to know about the answer [Eto sterilizer    ETO STERILIZER](https://zjbocon.com/product/eto-sterilzer/)

**What types of materials can be sterilized using ETO?**

Plastics

Rubber

Instruments with tubes

Heat-sensitive items

 ︹€ ..

**What are the advantages of using ETO sterilization?**

Effective at low temperatures

Ability to penetrate complex geometries and porous materials

Suitable for heat-sensitive medical instruments

Broad spectrum of microbial activity

**How long does the ETO sterilization process take?**

The duration of the ETO sterilization cycle can vary but typically ranges from 8 to 12 hours, including preconditioning, exposure, and aeration phases. Specific times depend on the type of materials being sterilized and the manufacturer  recommendations.

## IF YOU WANT TO KNOW MORE eto sterile machine manufacturer in china

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## Bocon ETO Sterilizers
[Skip to content](https://zjbocon.com/advanced-bocon-eto-sterilizers-in-china/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-54-225x300.webp)

01. According to international standards, when the negative pressure exceeds 50 kPa, it is classified as a pressure vessel. Therefore, we strictly adhere to the design and manufacturing standards for pressure vessels in the production of our ethylene oxide sterilizers. We have rigorously controlled everything from the height of the water jacket to the thickness of the casing to ensure that it can maintain normal operating conditions under a pressure of 90 kPa throughout the year. To comply with pressure vessel manufacturing specifications, after welding each casing, we use stress-relief equipment to weaken and reduce welding stress. This ensures the quality of the water jacket welds and their flexibility, allowing each device to operate stably over the long term and maintain stability under prolonged negative pressure conditions. Additionally, through X-ray inspection, we can effectively guarantee the design life of the equipment to be 20 years.
02. The pressure holding test is conducted in a room temperature environment. At -90 kPa, the pressure is maintained for 10 hours, with a pressure variation not exceeding 2 kPa; at +80 kPa, the pressure is similarly held for 10 hours, with the same pressure variation limit. These measures fully ensure safety and stability.
03. We use a patented heating water jacket that features energy-saving and consumption-reducing characteristics, along with a high heating rate.
04. bocon eto sterilizer uses a patented external air-filled sealing ring, which ensures sealing effectiveness without the need for oiling. It has a protection function during power outages, continuously ensuring seal integrity. This sealing ring has a long service life, effectively reducing users   costs and safety risks.
05. The thickness of the bocon eto sterilizer casing is made using pressure vessel plates, with no discrepancies. The entire unit weighs more than 10 tons above industry standards, effectively ensuring the realization of our design philosophy. There are documented records available, and this cost has a significant impact on price differences.
06. Our company  vacuum pump adopts the German brand  siemens   bipolar vacuum pump, with flow components made of 316L material (to ensure the ability to maintain -90 kPa vacuum performance over the long term). In addition, we have equipped functions like water temperature and flow monitoring. The core components determine the device  lifespan and the longevity and stability of its performance.
07. Our dosing system is equipped with an electronic scale and specialized instruments imported from the USA, capable of pressure control as well as weight control, to achieve true flow and temperature readings. The powerful dosing rate greatly enhances work efficiency and shortens cycle times, ensuring that no impurities or liquids enter the chamber, effectively guaranteeing the equipment  performance.
08. We utilize energy-efficient magnetic fans as circulation devices, featuring high airflow and high pressure, eliminating the need for water cooling and energy consumption, with low power usage that effectively reduces operational costs. Compared to industry counterparts, this significantly improves safety and stability.
09. All our company  circulation pumps, vaporization pumps, and fans are equipped with explosion-proof motors and use new energy-saving technologies, effectively lowering operating costs and greatly enhancing safety.
10. During the humidification process, we employ a unique design that effectively filters out impurities and moisture from steam, ensuring that no moisture enters the interior of the chamber.
11. The harmless exhaust system employs two flanged double-eccentric butterfly valves (non-liner butterfly valves), effectively ensuring the system  lifespan, safety, and stability.
12. The air filter utilizes a 20-core high-precision stainless steel filter, ensuring a transition from -90 kPa to -10 kPa within 30 minutes. Compared to simpler filters used by industry peers, our filters guarantee higher filtration precision and rate.
13. Our control system is a comprehensive control system optimized based on domestic and international client needs and suggestions. It uses genuine international first-line brand electrical components and can connect with enterprise MES systems and databases to meet future upgrade requirements. The system can set various parameters and is widely applicable across different processes and products, ensuring the accuracy of data collection and recording.
14. We were the first in the industry to develop a control system that supports parameter release processes, fully meeting new standards for parameter release while retaining most of the foresight. Alarming items, summary items, and configurable parameters number in the hundreds, while it can store hundreds of process menus.
15. All software for our control systems is either independently developed or uses licensed software, completely eliminating potential risks associated with non-compliant usage for customers.
16. The uniformity of the device  no-load temperature performance reaches an average temperature variance of 卤2?, and the spatial humidity uniformity reaches an average temperature variance of 卤5% RH.
17. All sensors can be calibrated online without the need for disconnection.

## IF YOU WANT TO KNOW MORE about bocon eto sterilizer

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## CNY 2025 Holiday
[Skip to content](https://zjbocon.com/hzbocon-2025-cny-holiday-jan-26th-feb-4th/#content)

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## Ethylene Oxide Sterilizers
[Skip to content](https://zjbocon.com/introduction-to-ethylene-oxide-sterilizers/#content)

![](https://zjbocon.com/wp-content/uploads/2024/11/ethylene-oxide-sterilization-21.webp)

**Introduction to Ethylene Oxide Sterilizer**

Ethylene Oxide (EO) sterilizers are critical devices used in various industries, including healthcare, pharmaceuticals, and laboratories, to sterilize heat- and moisture-sensitive items. These sterilizers utilize ethylene oxide gas, a highly effective sterilizing agent, to eliminate bacteria, viruses, fungi, and spores. In this article, we l explore how ethylene oxide sterilizer work, their applications, benefits, and safety measures.

* * *

**How Do Ethylene Oxide Sterilizer Work?**

Ethylene oxide sterilizers operate by exposing items to EO gas in a controlled environment. The process involves several key steps:

1. **Preconditioning:**The sterilizer adjusts temperature and humidity to optimal levels (typically 30-60degrees celsius and 30-80% humidity) to enhance sterilization effectiveness.
2. **Vacuum Phase:**Air is removed from the chamber to create a vacuum, ensuring proper gas penetration.
3. **Gas Injection:**Ethylene oxide gas is introduced into the chamber at a specific concentration.
4. **Sterilization Phase:**Items are exposed to the gas for a set period (usually 1-6 hours) to ensure complete microbial elimination.
5. **Aeration:**Residual EO gas is removed through multiple air washes, and items are placed in a well-ventilated area to eliminate any remaining traces.

* * *

**Key Applications of Ethylene Oxide Sterilizers**

Ethylene oxide sterilizers are widely used in industries where traditional heat-based sterilization methods are unsuitable. Common applications include:

- **Medical Devices:**Surgical instruments, catheters, implants, and other heat-sensitive equipment.
- **Pharmaceuticals:**Sterilization of drugs and biologics that cannot withstand high temperatures.
- **Laboratory Equipment:**Tools like petri dishes, pipettes, and other labware.
- **Industrial Uses:**Sterilization of packaging materials, cosmetics, and certain food products.

* * *

**Advantages of Ethylene Oxide Sterilization**

1. **Broad-Spectrum Efficacy:**EO gas effectively kills all microorganisms, including resistant spores.
2. **Low-Temperature Process:**Ideal for heat-sensitive materials that cannot tolerate steam or dry heat sterilization.
3. **Deep Penetration:**EO gas can penetrate complex shapes and porous materials, ensuring thorough sterilization.
4. **Versatility:**Suitable for a wide range of materials, including plastics, metals, and rubber.

* * *

**Safety Considerations for Ethylene Oxide Sterilizers**

While ethylene oxide is highly effective, it is also toxic and flammable, requiring strict safety protocols:

1. **Proper Ventilation:**Ensure the sterilizer is installed in a well-ventilated area with an efficient exhaust system.
2. **Personal Protective Equipment (PPE):**Operators must wear gloves, masks, and goggles to minimize exposure.
3. **Regular Monitoring:**Conduct routine checks to measure EO gas levels in the workplace and ensure they remain within safe limits.
4. **Training:**Staff should be trained in handling EO sterilizers and emergency procedures.

* * *

**Maintenance and Care for EO Sterilizers**

To ensure optimal performance and longevity of ethylene oxide sterilizers, follow these maintenance tips:

- **Regular Inspections:**Check seals, valves, and sensors for wear and tear.
- **Calibration:**Periodically calibrate temperature, humidity, and gas concentration sensors.
- **Cleaning:**Keep the sterilization chamber clean to prevent contamination.
- **Record-Keeping:**Maintain logs of sterilization cycles and maintenance activities.

* * *

**Why Choose Ethylene Oxide Sterilizers?**

Ethylene oxide sterilizers are indispensable for industries requiring reliable, low-temperature sterilization. Their ability to sterilize a wide range of materials without damaging them makes them a preferred choice for medical and pharmaceutical applications. By adhering to safety guidelines and proper maintenance practices, EO sterilizers can provide safe and effective sterilization for years to come.

**Keywords for ethylene oxide sterilizer:**

ethylene oxide sterilizer, EO sterilization, medical device sterilization, low-temperature sterilization, ethylene oxide gas, sterilization equipment, pharmaceutical sterilization, laboratory sterilization, ethylene oxide safety, sterilization process.

## IF YOU WANT TO KNOW MORE about bocon eto sterilizer

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## Ethylene Oxide Sterilization
[Skip to content](https://zjbocon.com/how-does-ethylene-oxide-gas-sterilization-kill-microorganisms/#content)

## **How Does Ethylene Oxide Gas Sterilization Work?**

The effectiveness of ethylene oxide gas sterilization lies in its ability to disrupt the cellular structure of microorganisms. Here  a step-by-step breakdown of how it works:

![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-11-1024x1024.webp)

### 1.**Penetration of EO Gas**

Ethylene oxide gas is highly penetrative, meaning it can easily reach microorganisms even in hard-to-access areas, such as crevices, pores, and complex device designs. This ensures thorough sterilization of the entire item.

### 2.**Alkylation: The Key Mechanism**

The primary way ethylene oxide kills microorganisms is through a chemical process called**alkylation**. EO gas reacts with the DNA, RNA, and proteins of microbial cells, disrupting their cellular functions. Specifically, it:

- **Damages DNA:**EO gas alkylates the nucleic acids in DNA, preventing microorganisms from reproducing.
- **Disrupts Proteins:**It alters essential proteins and enzymes, rendering them nonfunctional.
- **Destroys Cell Membranes:**EO gas disrupts the cell walls and membranes, leading to cell death.

### 3.**Irreversible Damage**

The alkylation process causes irreversible damage to the microorganisms   cellular components. Once their DNA, proteins, and membranes are compromised, the microorganisms cannot survive or replicate.

* * *

## **The Sterilization Process**

To ensure complete sterilization, ethylene oxide gas sterilization follows a carefully controlled process:

1. **Preconditioning:**The items are exposed to controlled temperature and humidity to prepare them for sterilization.
2. **Vacuum Phase:**Air is removed from the sterilization chamber to create a vacuum, allowing EO gas to penetrate deeply.
3. **Gas Exposure:**EO gas is introduced into the chamber at a specific concentration and maintained for a set period (typically 1-6 hours).
4. **Aeration:**After sterilization, the items are aerated to remove any residual EO gas, ensuring they are safe for use.

* * *

## **Why is Ethylene Oxide Gas Sterilization So Effective?**

1. **Broad-Spectrum Efficacy:**EO gas is effective against all types of microorganisms, including bacteria, viruses, fungi, and even highly resistant spores.
2. **Low-Temperature Process:**It operates at low temperatures (30-60degrees celsius), making it ideal for heat-sensitive materials.
3. **Deep Penetration:**EO gas can sterilize complex and porous materials that other methods cannot reach.
4. **Versatility:**It is suitable for a wide range of materials, including plastics, rubber, and metals.

* * *

**Applications of Ethylene Oxide Gas Sterilization**

## Ethylene oxide gas sterilization is used in various industries, including:

- **Medical Devices:**Surgical instruments, catheters, implants, and other heat-sensitive equipment.
- **Pharmaceuticals:**Sterilization of drugs and biologics that cannot withstand high temperatures.
- **Laboratory Equipment:**Tools like petri dishes, pipettes, and other labware.
- **Industrial Uses:**Sterilization of packaging materials, cosmetics, and certain food products.

* * *

## **Safety Considerations**

While ethylene oxide gas sterilization is highly effective, it requires strict safety measures due to the toxic and flammable nature of EO gas:

- **Proper Ventilation:**Ensure the sterilization area is well-ventilated to prevent gas accumulation.
- **Personal Protective Equipment (PPE):**Operators should wear gloves, masks, and goggles to minimize exposure.
- **Monitoring:**Regularly check EO gas levels in the workplace to ensure they remain within safe limits.
- **Training:**Staff must be trained in handling EO sterilizers and emergency procedures.

## IF YOU WANT TO KNOW MORE about bocon eto sterilizer

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## High-Precision EO Sterilizers
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![High-Precision EO Sterilizers](https://zjbocon.com/wp-content/uploads/2024/11/ethylene-oxide-sterilization-5.webp)

In the ever-evolving world of medical technology, ensuring the safety and sterility of sensitive equipment is paramount. Enter**high-precision Ethylene Oxide (EO) sterilizers**, the cutting-edge solution for medical sterilization that combines advanced technology with unparalleled accuracy.

### Why High-Precision EO Sterilizers?

High-precision EO sterilizers are specifically designed to meet the demanding needs of modern medical devices and sensitive equipment. Unlike traditional sterilization methods, EO sterilization is gentle yet highly effective, making it ideal for heat- and moisture-sensitive instruments such as:

- Surgical tools
- Implantable devices
- Electronics-integrated medical equipment
- Single-use devices

With their ability to penetrate complex geometries and delicate materials, EO sterilizers ensure thorough sterilization without compromising the integrity of the equipment.

### The Benefits of EO Sterilization for Sensitive Equipment

1. **Gentle Yet Effective**: EO sterilization operates at lower temperatures, making it safe for heat-sensitive materials while achieving a sterility assurance level (SAL) of 10^-6.
2. **Versatility**: From polymers to metals, EO sterilizers can handle a wide range of materials used in medical devices.
3. **Precision Control**: Advanced EO sterilizers offer precise control over temperature, humidity, and gas concentration, ensuring consistent and reliable results.
4. **Regulatory Compliance**: High-precision EO sterilizers meet stringent global standards, including ISO 11135 and FDA regulations, ensuring compliance for medical device manufacturers.

### Applications in Medical Sterilization

High-precision EO sterilizers are transforming the medical sterilization landscape, particularly for:

- **Implantable Devices**: Ensuring sterility for pacemakers, stents, and joint replacements.
- **Diagnostic Equipment**: Safely sterilizing sensitive electronic components in imaging and monitoring devices.
- **Single-Use Devices**: Guaranteeing the safety of disposable medical tools and kits.

### The Future of Medical Sterilization

As the demand for advanced medical devices grows, so does the need for reliable and precise sterilization methods. High-precision EO sterilizers are at the forefront of this trend, offering a solution that balances effectiveness, safety, and compliance.

For medical device manufacturers and healthcare providers, investing in high-precision EO sterilization technology is not just a choice 攊t  a necessity to ensure patient safety and meet regulatory requirements.

### Looking for EO Sterilization Services?

If you 檙e in need of high-precision EO sterilization for sensitive medical equipment, explore our state-of-the-art sterilization solutions. Our advanced EO sterilizers are designed to deliver unmatched performance, ensuring your devices are safe, sterile, and ready for use.

**Contact us today**to learn more about how our EO sterilization services can meet your needs and elevate your medical device manufacturing process.

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## Ethylene Oxide Sterilization
[Skip to content](https://zjbocon.com/what-can-be-sterilized-by-ethylene-oxide/#content)

Ethylene Oxide (EO) gas sterilization is a highly effective method for sterilizing a wide range of items that are sensitive to heat, moisture, or radiation. ETO Sterile Medical Machines and ETO sterilizers are widely used in healthcare, pharmaceuticals, and industrial settings due to their ability to penetrate complex materials and ensure thorough sterilization.

![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-25-768x1024.webp)

## What Can Be Sterilized by Ethylene Oxide?

Medical Devices:

Surgical instruments

Catheters and stents

Implantable devices (e.g., pacemakers, joint replacements)

Endoscopes and other delicate equipment

Pharmaceutical Products:

Drug delivery devices

Packaging materials

Containers and closures

Industrial Applications:

Electronic components

Plastic and rubber materials

Laboratory equipment

EO gas sterilization is ideal for items that cannot withstand high temperatures or moisture, making it a preferred choice for heat-sensitive materials. ETO Sterile Medical Machines ensure a safe and efficient sterilization process, while ETO sterilizers provide reliable results for critical applications.

## Why Choose EO Gas Sterilization?

Penetrates complex shapes and materials

Effective at low temperatures

Suitable for a wide range of applications

Ensures compliance with industry standards

Discover how ETO Sterile Medical Machines and ETO sterilizers can meet your Sterilized by Ethylene Oxide needs. Whether for medical, pharmaceutical, or industrial use, EO gas sterilization offers a proven solution for ensuring safety and quality.

**Contact us today**to learn more about how our EO sterilization services can meet your needs and elevate your medical device manufacturing process.

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/)

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## Ventilated Autoclave Sterilizer
[Skip to content](https://zjbocon.com/product/ventilated-autoclave-sterilizer/#content)

[馃攳](https://zjbocon.com/product/ventilated-autoclave-sterilizer/#)

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![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/03/autoclave_1.webp)

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[Autoclave Sterilizer](https://zjbocon.com/product-category/autoclave-sterilizer/)

# ventilated autoclave sterilizer

**Primary Applications:**

These sterilizer are mainly used in pharmaceutical factories and laboratories for sterilizing pre-filled syringes, PP cups, blood product bags, cartridge bottles, instruments, and liquids.

Category: [Autoclave Sterilizer](https://zjbocon.com/product-category/autoclave-sterilizer/)

- [Description](https://zjbocon.com/product/ventilated-autoclave-sterilizer/#tab-description)
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**Basic Functions of ventilated autoclave sterilizer:**

autoclave sterilizerutilize a process that combines clean steam and air pressure for sterilization. This method effectively controls the pressure balance and back-pressure protection of both the equipment and the products. It has gained widespread application and achieved excellent results in sterilization fields where maintaining and protecting the shape and sealing of items is crucial. The forced convection fan and airflow guide plate structure ensure uniform mixing of unsaturated steam inside the chamber, guaranteeing consistent sterilization temperatures. The equipment is equipped with internal cooling coils, and the cooling and drying of products are achieved by introducing cooling water into the condensation coils to condense the mixed gases inside the sterilization chamber. Cold air flows over the products to cool them, while the moisture on the product surfaces evaporates, ultimately achieving the goals of cooling and drying. For products with higher drying requirements, a hot air drying function can be added.

**Main Structure of** autoclave sterilizer **:**

The main unit of this series of ventilatedautoclavesterilizers features a horizontal rectangular structure, with a 316L stainless steel inner chamber and a fully stainless steel brushed outer cover. It includes standard GMP validation interfaces.

| Serial Number | Technical Parameters | Design Specifications |
| --- | --- | --- |
| 1 | Container Design Life | Inner tank: 316L stainless steel, jacket: Q345R container plate, lifespan: 8 years (20,000 sterilization cycles) |
| 2\* | Inner Chamber Design Pressure | -0.1 ~ 0.3 MPa |
| 3\* | Jacket Design Pressure | 0.3 MPa |
| 4 | Built-in Steam Generator (optional) | 0.3 MPa |
| 5 | Design Temperature | 144鈩  |
| 6 | Maximum Working Temperature | 139鈩  |
| 7 | Maximum Working Pressure | 0.23 MPa |
| 8\* | Inner Chamber Safety Valve Opening Pressure | 0.28 MPa |
| 9 | Jacket Safety Valve Opening Pressure | 0.28 MPa |
| 10 | Inner Chamber Design Safety Pressure | 0.38 MPa |
| 11 | Jacket Design Safety Pressure | 0.5 MPa |
| 12 | Temperature Display Accuracy | 0.1鈩  |
| 13 | Pressure Display Accuracy | 0.1 KPa |
| 14 | Sterilization Temperature Control Accuracy | 卤0.2鈩  |
| 15 | Temperature Uniformity | 卤1鈩  |
| 16\* | Pulsation Mode | Multiple negative pressure pulsation + one cross-pressure pulsation + multiple positive pressure pulsations |
| 17\* | Negative Pressure Pulsation Amplitude and Times | Amplitude: -80 ~ 0 KPa, Times: 1 ~ 99 |
| 18\* | Cross-Pressure Pulsation Times | Amplitude: -80 ~ 80 KPa, Times: 1 |
| 19 | Positive Pressure Pulsation Times | 1 ~ 3 |

### 2\. Main Performance Features

1. Motorized door with automatic opening and closing, using inflation pressure to drive the sealing ring for automatic sealing.
2. Double-door pass-through design, equipped with pressure safety interlock and temperature door safety interlock, ensuring effective isolation between the sterilization area and the sterile item storage area through dual door interlocking.
3. \*Brand new high-quality tear-resistant silicone rubber circular hollow door sealing ring, surface treated with polytetrafluoroethylene (PTFE) coating, wear-resistant and smooth, providing better sealing effect and longer service life of up to 1500 cycles. The good fit between this sealing ring and the sidewall of the sealing groove reduces the chance of compressed air leaking into the inner chamber, thus ensuring sterilization effectiveness.

### 2.2 Pressure Vessel (Main Body and Door):

(1) \*Horizontalautoclave sterilizerwith a rectangular cross-section, European (GETINGE) annular reinforced jacket structure. The unique combination of the inner shell and annular jacket enhances the strength and stiffness of the main body, resulting in higher load-bearing capacity and lower stress concentration compared to integrated jackets. This design provides superior loading capability, especially under pulsating alternating pressure and temperature loads, leading to longer fatigue life of the vessel. (2) The bottom surface of the inner chamber has a certain slope to ensure the discharge of condensate.

(3) Materials in contact with steam such as the inner tank and door panels are made of 316L stainless steel; door teeth and main body stops are also made of 316L stainless steel, while the jacket is made of high-quality carbon steel specifically designed for pressure vessels.

(4) \*Sealing groove structure: The sealing groove is directly welded onto the annular jacket at both ends (GETINGE structure), preventing cracks often caused by excessive rigidity in corner arcs of integrated flange structures, and the jacket is close to both end faces, improving drying efficiency.

(5) \*The longitudinal seam of the inner tank is welded using plasma automatic welding technology, with robotic automatic welding for the jacket. Post-welded components undergo vibration aging treatment to relieve stress and eliminate welding stress, effectively enhancing the structural stability and performance of the main body and door assemblies.

(6) The surface of the inner tank and door is polished to a mechanical mirror finish with Ra 0.6, providing strong corrosion resistance.

### 2.3\* Siemens Programmable Logic Controller (PLC) and Color Touch Screen:

The entire process is automatically controlled by a program, displaying operational status, temperature, pressure, and time parameters.

### 2.4 Communication Verification Interface:

Equipped with a communication verification interface with standard size DN25, optional DN40.

### 2.5 Programs Supported:

Pre-filled syringes, PP aluminum-plastic packaging, PP cups, instruments, stainless steel tanks, sterile clothing, glassware, liquids, culture media, and custom programs.

### 2.6 Sterilization Temperature:

Adjustable from 105-136鈩 , freely set to 134鈩 , 121鈩 , or 113鈩 .

### 2.7 Real-time Data Printing:

Real-time printing of process data via built-in mini printer and paperless recorder. The thermal printer records may not be suitable for long-term preservation. It prints the sterilizer  temperature, pressure, sterilized items, sterilization time, and operator information (including curve printing).

### 2.8\* Piping System:

Pipes that come into contact with pure steam and connect to the inner chamber are made of 316L stainless steel, secured with clamps, and all welds are done using automatic pipe welding machines. Pneumatic valves have a fault-free operating life of 鈮  4 million cycles.

### 2.9 Automatic Drainage Temperature Control System:

Drainage temperature 鈮  55鈩 .

### 2.10 Air Filter:

The filter housing should be made of 316L stainless steel, and the filter element should be hydrophobic PTFE, with a filtration precision of 鈮  0.22 microns, achieving a sterilization rate of 99.97%.

### 3\. Safety Devices and Alarm System

1. **Automatic Overpressure Protection Alarm Function**:

   - The pressure control for the jacket, inner chamber, and evaporator (if present) utilizes imported analog pressure transmitters for intelligent control, replacing manually adjustable mechanical pressure switches. This system continuously monitors pressure data and automatically triggers protection and alarms in case of overpressure.
2. **Safety Valves**:

   - Safety valves are installed on the jacket, sterilization chamber, and evaporator (if present). If the safety opening pressure is exceeded, these valves will automatically open to relieve pressure.
3. **Over-temperature and Under-temperature Alarm Function**:

   - The temperature control within the inner chamber employs A-grade precision PT100 sensors to collect temperature data in real time. If the temperature exceeds the set threshold, automatic protection and alarms are triggered. Similarly, if the temperature drops below the sterilization temperature, protection and alarms are also activated.
4. **Compressed Air Low Pressure Alarm**:

   - A pressure switch detects the pressure of the compressed air. If the pressure falls below 0.4 MPa, an automatic alarm is triggered.

### 4\. Other Functional Features

1. **Pressure Holding Test Function**:

   - The system can achieve a vacuum down to -0.09 MPa or lower, maintaining pressure for 10 minutes with a leakage rate of 鈮  1.3 kPa/10 minutes.
2. **Connection Seals**:

   - Connection seals for piping and valves should be made from high-temperature resistant polytetrafluoroethylene (PTFE). Insulation layers should use ceramic fiber blankets, while external decorative panels should be made from SUS30408 stainless steel.

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## Bocon at CMEF 2023
[Skip to content](https://zjbocon.com/hzbocon-will-attend-cmef-on-4-8-4-11/#content)

Hangzhou Bocon Mechanical And Electrical Equipment Co.Ltd

Zhejiang Bocon Intelligent Equipment Co., Ltd

Booth number: 1.1H-1.1S53

Product: Ethylene oxide sterilizer

location: National Exhibition and Convention Center

Welcome to visit our booth.

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## Ethylene Oxide Sterilizers
[Skip to content](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/#content)

[馃攳](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/#)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-3-600x600.webp)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-1-600x600.webp)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-3-600x600.webp)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-12-600x600.webp)

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![pneumatic sliding door ethylene oxide sterilizer](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-3.webp)

[![pneumatic sliding door ethylene oxide sterilizer - Image 2](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-1.webp)

[![pneumatic sliding door ethylene oxide sterilizer - Image 3](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-3.webp)

[![pneumatic sliding door ethylene oxide sterilizer - Image 4](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-12.webp)

[Eto Sterilizer](https://zjbocon.com/product-category/eto-sterilizer/)

# pneumatic sliding door ethylene oxide sterilizer

The ethylene oxide sterilizer machine (Eto sterilizer) was developed and designed by BOCON, with sizes of 1-128m3?1-36 US pallets) (1-44 Euro pallets)    PS: European Pallet Size (1200 x 800 mm) & US Pallet Size (1200 x 1000 mm)

In order to do ETO sterilization in optimum conditions, we can offer the following services: FAT, SAT, DQ, IQ, OQ, and support for PQ.

Following customer requests, we can supply: Pre-conditioning, Sterilization, Degassing Chambers, EO Scrubber, and EO Energy Recycling.

Category: [Eto Sterilizer](https://zjbocon.com/product-category/eto-sterilizer/)

- [Description](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/#tab-description)
- [Reviews (0)](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/#tab-reviews)

### Industry ethylene oxide gas sterilizer Turnkey EO Sterilization Project

A turnkey project is a complete project that is designed, built, and tested by a single provider. In the context of ETO sterilization, a turnkey project typically involves designing and building a complete ETO sterilization facility, including :

\\* [ETO sterilizer chamber](https://zjbocon.com/ethylene-oxide-gas-sterilizer/)

\\* preheating room

\\* Aeration Room

\\* Scrubber

\\* Sterilization conveyor system

\\* control system cabinet

\\* local control box

\\* etc

### **Why Ethylene Oxide Sterilization? Key Advantages**

ethylene oxide gas sterilizer are the gold standard for materials that cannot withstand high heat or radiation. Here  why industries rely on them:

1. **Broad Material Compatibility**

EO effectively sterilizes plastics, rubber, electronics, and multi-layer packaging without compromising structural integrity.
2. **Deep Penetration Power**

Reaches intricate geometries (e.g., catheters, endoscopes) and porous materials that steam or UV light cannot.
3. **Low-Temperature Process**

Operates at 37degrees celsius  63degrees celsius, ideal for heat-sensitive medical devices and lab equipment.
4. **Regulatory Compliance**

Meets ISO 11135, FDA, and EU MDR standards for medical device sterilization.

* * *

### **How EO Gas Sterilization Works: A 4-Step Process**

Modern EO sterilizers, like those from ZJBOON, automate critical phases to ensure safety and efficiency:

1. **Preconditioning**

Adjusts humidity (40%  80%) and temperature to optimize gas diffusion.
2. **Gas Injection**

EO concentration is precisely controlled in a sealed chamber.
3. **Exposure Phase**

Maintains optimal conditions for 1  6 hours to eliminate bacteria, viruses, and spores.
4. **Aeration & Residual Removal**

Advanced vacuum cycles and catalytic converters reduce EO residues to <1 ppm, complying with OSHA and EPA limits.

* * *

### **Applications Across Industries**

1. **Medical Device Manufacturing**

Sterilize surgical kits, implants, and syringes without thermal degradation.
2. **Pharmaceuticals**

Ensure sterility in drug packaging and biotech equipment.
3. **Aerospace & Electronics**

Decontaminate sensitive components prone to moisture damage.
4. **Food Packaging (Non-EU Markets)**

Treat spices and herbs in regions where EO is approved (e.g., USA, Asia).

* * *

### **Safety First: Mitigating EO Risks with Technology**

While EO is a known carcinogen, next-gen sterilizers integrate safeguards to protect workers and end-users:

- **AI-Powered Leak Detection**: Real-time sensors monitor chamber integrity.
- **Closed-Loop Catalytic Abatement**: Converts residual EO into CO鈧  and water, achieving >99.9% destruction efficiency.
- **Automated Ventilation**: Post-sterilization aeration cycles ensure products meet ISO 10993-7 residue limits (<4 渭g/cm虏).

ZJBOON  systems exceed OSHA  permissible exposure limit (PEL) of 1 ppm over 8 hours, aligning with global occupational safety standards.

* * *

### Choosing the Right ethylene oxide gas sterilizer: 5 Critical Factors

1. **Chamber Size**

Opt for scalable solutions (1  100 m3) to handle bulk loads or niche applications.
2. **Customization**

Prioritize suppliers offering tailored cycles for unique materials or throughput needs.
3. **Certifications**

Verify ISO 13485 (medical devices) and EPA compliance for environmental safety.
4. **Energy Efficiency**

Look for systems with heat recovery and low gas consumption to cut operational costs.
5. **After-Sales Support**

Ensure access to calibration, validation, and emergency repair services.

* * *

### **Future Trends in EO Sterilization**

- **Smart IoT Integration**: Remote monitoring and predictive maintenance via cloud platforms.
- **Green EO Alternatives**: Research into hybrid systems using ozone or nitrogen dioxide for reduced environmental impact.
- **Single-Use Device Compatibility**: Compact sterilizers for disposable medical products.

* * *

### **Why Partner with ZJBOON?**

As a leader in industrial sterilization,[ZJBOON](https://lke.cloud.tencent.com/lke#/link-info/redirect?target=https://zjbocon.com)delivers:

- **30+ Years of Expertise**: CE, and ISO-certified EO sterilizers.
- **Turnkey Solutions**: Custom chambers, validation support, and global logistics.
- **Eco-Friendly Design**: Catalytic abatement systems and energy-saving modes.

* * *

## Our Partners

![Partner 1](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-1.webp)

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![Partner 2](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-2.webp)

![Partner 12](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-12.webp)

![Partner 7](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-7.webp)

![Partner 6](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-6.webp)

![Partner 3](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-3.webp)

![Partner 5](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-5.webp)

![Partner 9](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-9-1.webp)

![Partner 4](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/Partners-4.webp)

### Download BOCON EtO sterilizer Catalogue

[![BOCON EtO sterilizer Catalogue](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/BOCON-EtO-sterilizer-Catalogue.webp)](https://zjbocon.com/wp-content/uploads/2025/11/BOCON-ETO-STERILIZER.pdf)

[Dowload BOCON EtO sterilizer Catalogue](https://zjbocon.com/wp-content/uploads/2024/10/catalog_hzbocon.pdf)

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[Pneumatic Revolving Door ethylene oxide sterilizer](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/ "Pneumatic Revolving Door ethylene oxide sterilizer")

[Overall Lifting Door ethylene oxide sterilizer](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/ "Overall Lifting Door ethylene oxide sterilizer")

[Hospital / Laboratory ETO Sterilizer](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/ "Hospital / Laboratory ETO Sterilizer")

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Eto Sterilizer [**Eto sterilizer**](https://zjbocon.com/product/eto-sterilzer/)


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## Ethylene Oxide Sterilizer
[Skip to content](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/#content)

[馃攳](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/#)

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[![Overall Lifting Door ethylene oxide sterilizer - Image 2](<Base64-Image-Removed>)](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-5.webp)

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[Eto Sterilizer](https://zjbocon.com/product-category/eto-sterilizer/)

# Overall Lifting Door ethylene oxide sterilizer

The ethylene oxide sterilizer machine (Eto sterilizer) was developed and designed by BOCON, with sizes of 1-128m3?1-36 US pallets) (1-44 Euro pallets)    PS: European Pallet Size (1200 x 800 mm) & US Pallet Size (1200 x 1000 mm)

In order to do ETO sterilization in optimum conditions, we can offer the following services: FAT, SAT, DQ, IQ, OQ, and support for PQ.

Following customer requests, we can supply: Pre-conditioning, Sterilization, Degassing Chambers, EO Scrubber, and EO Energy Recycling.

Category: [Eto Sterilizer](https://zjbocon.com/product-category/eto-sterilizer/)

- [Description](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/#tab-description)
- [Reviews (0)](https://zjbocon.com/product/overall-lifting-door-ethylene-oxide-sterilizer/#tab-reviews)

### Industry ethylene oxide gas sterilizer Turnkey EO Sterilization Project

A turnkey project is a complete project that is designed, built, and tested by a single provider. In the context of ETO sterilization, a turnkey project typically involves designing and building a complete ETO sterilization facility, including :

\\* [ETO sterilizer chamber](https://zjbocon.com/ethylene-oxide-gas-sterilizer/)

\\* preheating room

\\* Aeration Room

\\* Scrubber

\\* Sterilization conveyor system

\\* control system cabinet

\\* local control box

\\* etc

|     |     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| volume | pallet | inner size | Pneumatic Sliding Door size | Pneumatic Revolving Door size | Overall Lifting Door size | inner | door | weight/T |
| 1m3 | / | 1400\*700\*1000 | 1750\*1270\*1520 | / | / | 6mm | 6mm | 1t |
| 2m3 | / | 1650\*1000\*1200 | 2070\*2520\*1720 | 2000\*1570\*1720 | / | 6mm | 6mm | 2t |
| 3.0m3 | 1\*(1200\*1000锛  | 1400\*1350\*1700 | 1820\*3220\*2220 | 1750\*1920\*2220 | 1820\*1910\*3950 | 6mm | 8mm | 3t |
| 4.5m3 | 2\*(1200\*800锛  | 2000\*1350\*1700 | 2420\*3220\*2220 | 2350\*1920\*2220 | 2420\*1910\*3950 | 6mm | 8mm | 4t |
| 5m3 | 2\*(1200\*1000锛  | 2250\*1350\*1700 | 2670\*3220\*2220 | 2600\*1920\*2220 | 2670\*1910\*3950 | 8mm | 6mm | 4.5t |
| 6m3 | 3\*(1200\*800锛  | 2700\*1350\*1700 | 2670\*3220\*2220 | 2600\*1920\*2220 | 2670\*1910\*3950 | 8mm | 6mm | 5t |
| 8m3 | 3\*(1200\*1000锛  | 3500\*1350\*1700 | 3920\*3220\*2220 | 3850\*1920\*2220 | 3920\*1910\*3950 | 8mm | 6mm | 6t |
| 10m3 | 4\*(1200\*1000锛 <br>5\*(1200\*800锛  | 4500\*1350\*1700 | 4920\*3220\*2220 | 4850\*1920\*2220 | 4920\*1910\*3950 | 6mm | 8mm | 7t |
| 15m3 | 5\*(1200\*1000锛 <br>6\*(1200\*800锛  | 5500\*1350\*2000 | 5920\*3220\*2520 | 5850\*1920\*2520 | 5920\*1910\*4550 | 8mm | 8mm | 9t |
| 20m3 | 7\*(1200\*1000锛  | 7500\*1350\*2000 | 7920\*3220\*2520 | 7850\*1920\*2520 | 7920\*1910\*4550 | 8mm | 8mm | 12t |
| 26m3 | 9\*(1200\*1000锛 <br>11\*(1200\*800锛  | 9600\*1350\*2000 | 10020\*3220\*2520 | 9950\*1920\*2520 | 10020\*1910\*4550 | 8mm | 8mm | 14t |
| 28m3 | 10\*(1250\*1220锛  | 12500\*1350\*1700 | 12945\*3220\*2270 | / | / | 8mm | 8mm | 14t |
| 30m3 | 13\*(1200\*800锛  | 11300\*1350\*2000 | 11720\*3220\*2520 | 11650\*1920\*2520 | 11720\*1910\*4550 | 8mm | 8mm | 17t |
| 30m3-2 | 10\*(1200\*1000) | 5600\*2700\*2000 | 6020\*5920\*2520 | 5950\*3270\*2520 | 6020\*3260\*4550 | 8mm | 8mm | 16t |
| 35m3 | 15\*(1200\*800锛  | 13000\*1350\*2000 | 13420\*3220\*2520 | 13550\*1920\*2520 | 13420\*1910\*4550 | 8mm | 8mm | 23t |
| 35m3-2 | 14\*(1200\*800锛  | 6000\*2700\*2200 | 6470\*6180\*2780 | 6470\*3410\*2780 | 6470\*3340\*5070 | 8mm | 8mm | 22t |
| 40m3-2 | 12\*(1200\*1000锛  | 6650\*2700\*2200 | 7110\*6260\*2780 | 7110\*3450\*2780 | 7110\*3380\*5130 | 8mm | 10mm | 23t |
| 48m3 | 12\*(1200\*1000锛  | 12850\*1400\*2700 | 13270\*3480\*3270 | 13200\*2050\*3220 | 13270\*2040\*6070 | 8mm | 10mm | 28t |
| 52m3 | 13\*(1200\*1000锛  | 13900\*1400\*2700 | 14320\*3320\*3220 | 14250\*1970\*3220 | 14320\*1960\*5950 | 8mm | 10mm | 28t |
| 55m3-2 | 14\*(1200\*1000锛  | 7500\*2700\*2700 | 7960\*6260\*3280 | 7960\*3450\*3280 | 7960\*3380\*6130 | 8mm | 10mm | 27t |
| 57m3-2 | 18\*(1200\*1000锛  | 9650\*2700\*2200 | 10110\*6260\*2780 | 10110\*3450\*2780 | 10110\*3380\*5130 | 8mm | 10mm | 28t |
| 63m3-2 | 16\*(1200\*1000锛  | 8650\*2700\*2700 | 9110\*6260\*3280 | 9110\*3450\*3280 | 9110\*3380\*6130 | 8mm | 10mm | 29t |
| 70m3-2 | 18\*(1200\*1000锛  | 9700\*2700\*2700 | 10160\*6260\*3280 | 10160\*3450\*3280 | 10160\*3380\*6130 | 8mm | 10mm | 32t |
| 78m3-2 | 20\*(1200\*1000锛  | 10750\*2700\*2700 | 11210\*6260\*3280 | 11210\*3450\*3280 | 11210\*3380\*6130 | 8mm | 10mm | 35t |
| 86m3-2 | 22\*(1200\*1000锛  | 11800\*2700\*2700 | 12260\*6180\*3280 | 12260\*3410\*3280 | 12260\*3340\*6070 | 8mm | 10mm | 38t |
| 101m3-2 | 32\*(1200\*1000锛  | 17050\*2700\*2200 | 17510\*3300\*2780 | 17510\*3300\*2780 | 17510\*3300\*5070 | 8mm | 10mm | 45t |
| 118m3-2 | 38\*(1200\*1000锛  | 20200\*2700\*2200 | 20660\*6180\*2780 | 20660\*3450\*2780 | 20660\*3380\*5070 | 8mm | 10mm | 49t |

### Download BOCON EtO sterilizer Catalogue

[![BOCON EtO sterilizer Catalogue](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/BOCON-EtO-sterilizer-Catalogue.webp)](https://zjbocon.com/wp-content/uploads/2024/10/catalog_hzbocon.pdf)

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[pneumatic sliding door ethylene oxide sterilizer](https://zjbocon.com/product/ethylene-oxide-gas-sterilizer/ "pneumatic sliding door ethylene oxide sterilizer")

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## Ethylene Oxide Sterilizer
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[Eto Sterilizer](https://zjbocon.com/product-category/eto-sterilizer/)

# Pneumatic Revolving Door ethylene oxide sterilizer

The ethylene oxide sterilizer machine (Eto sterilizer) was developed and designed by BOCON, with sizes of 1-128m3?1-36 US pallets) (1-44 Euro pallets)    PS: European Pallet Size (1200 x 800 mm) & US Pallet Size (1200 x 1000 mm)

In order to do ETO sterilization in optimum conditions, we can offer the following services: FAT, SAT, DQ, IQ, OQ, and support for PQ.

Following customer requests, we can supply: Pre-conditioning, Sterilization, Degassing Chambers, EO Scrubber, and EO Energy Recycling.

Category: [Eto Sterilizer](https://zjbocon.com/product-category/eto-sterilizer/)

- [Description](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/#tab-description)
- [Reviews (0)](https://zjbocon.com/product/pneumatic-revolving-door-ethylene-oxide-sterilizer/#tab-reviews)

### Industry ethylene oxide gas sterilizer Turnkey EO Sterilization Project

A turnkey project is a complete project that is designed, built, and tested by a single provider. In the context of ETO sterilization, a turnkey project typically involves designing and building a complete ETO sterilization facility, including :

\\* [ETO sterilizer chamber](https://zjbocon.com/ethylene-oxide-gas-sterilizer/)

\\* preheating room

\\* Aeration Room

\\* Scrubber

\\* Sterilization conveyor system

\\* control system cabinet

\\* local control box

\\* etc

**Introduction**

Hangzhou Bocon, a prominent manufacturer of ethylene oxide (EO) sterilizers, has established itself as a trusted name in the sterilization industry. With a strong online presence through its websites**hzbocon.com**and**zjbocon.com**, the company offers cutting-edge sterilization solutions tailored to the needs of healthcare, pharmaceutical, and industrial sectors. This article explores Hangzhou Bocon  expertise, product offerings, and commitment to innovation in EO sterilization technology.

**1\. What is an Ethylene Oxide Sterilizer?**

Ethylene Oxide sterilizers are essential for low-temperature sterilization, making them ideal for heat-sensitive medical instruments, pharmaceuticals, and electronic devices. EO gas effectively penetrates packaging to eliminate microorganisms, including bacteria, viruses, and spores, ensuring thorough sterilization without damaging sensitive materials \[1\]\[6\].

**2\. Hangzhou Bocon  Expertise in EO Sterilization**

Hangzhou Bocon specializes in designing and manufacturing advanced EO sterilizers that meet the highest industry standards. The company  products are known for their:

- **Reliability**: Ensuring consistent and effective sterilization results.

 撀 **Safety**: Incorporating advanced safety features to protect users and the environment.
- **Innovation**: Utilizing the latest technology to enhance efficiency and performance.

**3\. Product Offerings**

Hangzhou Bocon offers a wide range of EO sterilizers, including:

- [Compact Models](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/): Ideal for small-scale operations or laboratories.
- **Industrial-Scale Units**: Designed for large-scale sterilization needs in healthcare and pharmaceutical industries.
- **Custom Solutions**: Tailored to meet specific customer requirements, ensuring optimal performance for unique applications.

**4\. Commitment to Quality and Compliance**

Hangzhou Bocon adheres to stringent quality control measures and complies with international standards for EO sterilization. The company  products are rigorously tested to ensure they meet safety, efficiency, and environmental regulations \[4\]\[6\].

**5\. Why Choose Hangzhou Bocon?**

- **Proven Track Record**: Years of experience in the sterilization industry.
- **Customer-Centric Approach**: Dedicated to providing personalized solutions and exceptional customer service.
- **Global Reach**: Serving clients worldwide with reliable and efficient sterilization equipment.

### Partners

### Download BOCON EtO sterilizer Catalogue

[![BOCON EtO sterilizer Catalogue](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2024/10/BOCON-EtO-sterilizer-Catalogue.webp)](https://zjbocon.com/wp-content/uploads/2024/10/catalog_hzbocon.pdf)

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## Related products

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Eto Sterilizer [**Eto sterilizer**](https://zjbocon.com/product/eto-sterilzer/)

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Eto Sterilizer [**Hospital / Laboratory ETO Sterilizer**](https://zjbocon.com/product/hospital-laboratory-eto-sterilizer/)

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Eto Sterilizer [**ETO sterilizer hot air system**](https://zjbocon.com/product/eto-sterilizer-hot-air-system/)


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## ETO Sterilization Methods
[Skip to content](https://zjbocon.com/performance-qualification-pq-mpq-in-eto-sterilization/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-6-1024x1024.webp)

## **Methods**

### **1\. Bioburden Method: Lethality Confirmation**

- **? Direct Count/Enumeration Method**
- **? Fraction-Negative Method**

### **2\. Overkill Method: Demonstrating ?12-Log Reduction**

- **? Half-Cycle Method**
- **? Cycle Development Method**

### **Key Terms**

- **Bioburden**
- **12-log reduction**
- **D-value**

### **Methods Overview**

#### **1\. Half-Cycle Method (Basic Principle    Run Count)**

- Theoretical initial bioburden: 10?
- **Test Criteria:**
  - 1 run with survivors allowed ( partial cycle   or  short cycle  )
  - 3 half-cycles with zero survivors required

#### **2\. Cycle Calculation Method**

- Requires**known initial bioburden & lethality rate**
- Method selection basis: See_Fraction-Negative Method_

#### **3\. Direct Count Method**

- Requires**known initial bioburden**
- **Test Criteria:**
  - 1 run without sterilant (control)
  - 1 run demonstrating ?4-log reduction
  - 3 runs with intermediate reduction levels

#### **4\. Fraction-Negative Method**

- Requires**known initial bioburden**
- **Statistical Models:**
  - **A3.2 HSKP**(Holcomb-Spearman-Karber Procedure)
  - **A3.3 SMCP**(Stumbo-Murphy-Cochran Procedure)

### **Types of Biological Indicators (BIs)**

- **Strip/Disk BI**

Strip/Disk BI _Microorganism-coated carrier (e.g., paper/filter disk) requiring transfer to growth media for incubation._
- **Ampoule-Based BI**

_Glass ampoule containing spores and separate growth medium (requires manual crushing to activate)._
- **Self-Contained BI**

_Integrated unit: Spore strip + growth medium in a single vial (activation by compression)._

## IF YOU WANT TO KNOW MORE

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Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## Performance Qualification Overview
[Skip to content](https://zjbocon.com/performance-qualificationpq-ppq-in-eo-sterilization/#content)

![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-3-1024x1024.webp)

|     |
| --- |
| **Physical Performance Qualification (PPQ)**<br>   It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.<br>**How many runs should the PPQ process perform?**<br>   To demonstrate process reproducibility, at least 3 runs are required;<br>   If 3 half-cycles were run during the MPQ process, then at least 1 additional run with full exposure time shall be performed. |

### **Reference Standards:**

- **ISO 11135:2014**(Medical device EO sterilization validation)
- **FDA Guidance (2007)**: Sterility Assurance for Terminal Sterilized Products
- **EU GMP Annex 1 (2022)**: Sterilization process validation requirements.

## **How is Reproducibility Demonstrated?**

| **No.** | **Process Step** | **Item** | **Method** |
| --- | --- | --- | --- |
| **1** | Preconditioning | Temperature and humidity of the sterilized load are within the specified range at the end of preconditioning | Measure inside the load |
| **2** | Loading | The time interval between the end of preconditioning and the start of sterilization should be within the specified range | Verify recorded time data |
| **3** | eo Sterilization | Ethylene oxide (EO) is introduced into the sterilizer in gaseous form | Measure gas injection temperature |
| **4** | eo Sterilization | Pressure increase due to EO gas injection is within the specified range | Measure pressure during gas injection |
| **5** | eo Sterilization | EO gas concentration inside the sterilizer is within the specified range | Weigh the gas canister before/after injection and calculate the difference**or**directly measure gas concentration inside the chamber |
| **6** | eo Sterilization | Product temperature inside the load is within the specified range during the exposure phase | Measure product temperature |
| **7** | Aeration | Product temperature inside the load is within the specified range during the aeration phase | Measure product temperature |

When evaluating the execution of PPQ testing, the following aspects should be noted:

   Does the number of temperature and humidity probes meet requirements?

   Are the (temperature and humidity) probes placed inside the loaded packages and positioned at the worst-case locations (most difficult-to-sterilize positions)?

   Is the temperature of the product load within the specified range?

## IF YOU WANT TO KNOW MORE

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Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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## ETO Sterilization Re-qualification
[Skip to content](https://zjbocon.com/eto-sterilization-re-qualification/#content)

## ETO Sterilization Re-qualification Requirements

### 1\. Re-qualification Frequency

 ⒙ **Minimum annual requirement**

   At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed

   The scope of re-qualification must be determined and documented

   The review procedure shall be documented

### 2\. Is Re-qualification Needed if No Product Changes Occur?

 ⒙ **Yes, re-qualification is still required**

### 3\. Re-qualification Items

 ⒙ **Based on certain preconditions, the following options are available**:

- Full re-qualification
- No need for physical or microbial re-validation
- Small-scale microbial performance validation

## **Prerequisites for Re-qualification**

a) The following must be reviewed/tested:

b) Whether any**significant changes**affecting product sterility have occurred in:

- Product design
- Manufacturing/packaging materials
- PCD (Process Challenge Device)
- Suppliers
- Manufacturing areas/facilities
- Load configurations or manufacturing processes

c)**Bioburden trend analysis**of products;

d) Whether**temperature distribution studies**and sterilizer operation demonstrate significant changes since last qualification;

e) Whether**temperature distribution and recirculation checks**in preconditioning chambers or aeration zones show significant changes since last qualification;

f) Whether ETO Sterilization **process history**since last validation demonstrates reproducibility;

g) Whether**change control and preventive maintenance records**confirm no equipment modifications affecting the process;

h) Whether**no alterations to the ETO Sterilization process**affecting sterility have occurred;

i) If**ETO Sterilization process specifications changed**, re-qualification must include verification of**EO residue limits**compliance with regulatory requirements.

### **Regulatory Standards**

- **ISO 11135:2014** _(Sec. 9.2: Requalification criteria)_
- **FDA 21 CFR 211.113** _(Sterilization process controls)_
- **EU GMP Annex 1:2022** _(Sec. 8.5: Revalidation requirements)_

## **ETO Sterilization Re-qualification Requirements**

The re-qualification shall**include a review of chamber performance and annual engineering changes**to ensure the original IQ/OQ results remain valid. The review must cover:

- **Preconditioning zone temperature/humidity profiles**(if applicable);
- **Actual empty chamber humidity profiles**;
- **Aeration zone temperatures**(if applicable);
- **Additionally, even if process specifications are met**, inspections must be triggered by:

  - Adverse trends in equipment performance,
  - Sterility failures;
  - To determine if re-validation is warranted.
- **Sterilization experts**shall define the scope of required**physical and microbial re-validation**based on review outcomes.

## **Critical Considerations for Sterilization Re-qualification**

### **1\. Handling Significant Changes**

   If**major changes**are identified during re-qualification, re-execution of IQ/OQ/PQ may be required:

- **IQ (Installation Qualification)**: Verify modified equipment/software installation.
- **OQ (Operational Qualification)**: Retest impacted functional parameters.
- **PQ (Performance Qualification)**: Re-validate sterilization efficacy under new conditions.

### **2\. Additional Requirements for Parametric Release**

For facilities using**parametric release**(relying on process data rather than BI testing):

a)**Re-validation frequency**: Must be performed**at least annually**;

b)**Re-validation scope**: Must include**microbiological studies**to confirm:

## **Situations Requiring Full Requalification (IQ/OQ/PQ):**

a)**Major maintenance of the sterilizer**;

b)**Structural, location, or environmental changes**;

c)**Unexplained sterility failures**;

d)**Changes in EO supply/delivery, diluent, or chamber load configuration**.

## **Exemption from Physical or Microbial Re-qualification**

When the following conditions are met:

- **No changes**in product, packaging, equipment/services, or processes;
- **Chamber performance and engineering review**are qualified;
- **Routine sterilization processes**have operated reliably during the period;

?**Professional judgment**may determine that physical or microbial re-qualification is**not required**until the next review.

## **Limited-Scale Microbial Performance Qualification**

 ⒙ **May be required in specific cases**, such as:

- Verifying continued suitability of BIs relative to product bioburden;
- Providing evidence that no**unintended changes**occurred since the previous (re)qualification study after a defined time interval.

 ⒙ **General requirements (at minimum)**:
- One**short-cycle or half-cycle run**;
- Including**temperature and humidity measurements**of sterilized items.

## IF YOU WANT TO KNOW MORE

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## EO Sterilization Issues
[Skip to content](https://zjbocon.com/common-ethylene-oxide-eo-sterilization-non-conformities-in-medical-device-manufacturing/#content)

**Introduction**

Ethylene Oxide (EO) sterilization remains a preferred method for medical devices incompatible with radiation or moist heat. However, it  a top source of**quality management system deficiencies**during FDA/ISO audits. Proactively addressing these non-conformities is essential for**sterile medical device registration**and compliance.

* * *

![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-4-1024x1024.webp)

## I. Sterilization Validation Failures

_Critical gaps in proving process effectiveness:_

- ?**Undefined processes**: Missing sterilization parameters in design documentation.
- ?**SAL omissions**: Sterility Assurance Level (SAL) not specified in reports.
- ?**Unapproved/incomplete reports**: Lack evaluative conclusions or raw test data.
- ?**Software validation gaps**: No data for sterilizer software systems.
- ?**Revalidation issues**: Triggers/cycles undefined; changes made without revalidation.
- ?**Parameter mismatches**: Conflicts between protocols, records, or physical equipment IDs.
- ?**Aeration flaws**: Unclear conditions/duration in documentation.

> ?**Fix**: Align with ISO 11135. Validate ALL critical parameters (load configs, BI placement, gas dosage).

* * *

## II. Warehouse & Storage Risks

_EO safety and material control violations:_

- ?**Poor facility controls**: Weeds, stagnant water, or debris in production zones.
- ?**Inadequate aeration**: Missing/undersized rooms; poor ventilation or exhaust.
- ??**Unsafe EO storage**: Non-dedicated zones; cylinders stored haphazardly without:

  - Temperature/humidity monitoring
  - Fire controls or leak detection
- ?**Material management gaps**: Unlabeled sterile items; no environmental monitors.

* * *

## III. Sterilization Process Control Errors

_Deviations during execution:_

- ?**Poor traceability**: Ambiguous batch numbering; missing device IDs/logs.
- ??**Missing critical parameters**in logs:

  - Gas injection time, EO dosage, vacuum cycles
  - BI lot numbers, temperature/humidity data
- ?**Uncontrolled deviations**: Parameters not matching validated specs or work instructions.
- ?**Missing safety systems**: No gas leak detectors or load diagrams in SOPs.

* * *

## IV. Residual Control Oversights

_Patient safety risks from EO residues:_

- ?**Missing validation**: No data supporting residue removal methods.
- ?**Incomplete records**: Raw test data or equipment IDs absent.
- ??**Non-compliant limits**: Unsubstantiated EO residue thresholds.

* * *

## V. Documentation & Personnel Gaps

_Systemic compliance weaknesses:_

- ?**Uncontrolled documents**: Obsolete SOPs; unnumbered forms; unsigned records.
- ???**Equipment neglect**: Using faulty sterilizers; unlabeled piping; expired calibrations.
- ???**Untrained staff**: No competency assessments for sterilization operators.

* * *

## VI. Supply Chain & Sales Issues

_Traceability breakdowns:_

- ?**Incomplete sales records**: Missing batch IDs, expiration dates, or client details.
- ?**Expired contracts**: EO service agreements not renewed.
- ?**Sample deviations**: Retained sample quantities mismatched with procedures.

## IF YOU WANT TO KNOW MORE

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## 93rd CMEF 2025
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## ETO Sterilization Safety
[Skip to content](https://zjbocon.com/eto-sterilization-safety-guidelines-best-practices-for-using-ethylene-oxide-as-a-sterilant/#content)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-622c653/zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-4-1024x1024.webp)

Ethylene oxide ( **ETO STERILIZATION**) is widely used as a low-temperature sterilant in industries like healthcare, pharmaceuticals, and biotechnology. However, due to its **toxic**, **flammable**, and **potentially carcinogenic** properties, it  critical to follow strict safety protocols. This article outlines the essential safety guidelines for safely operating **ETO STERILIZATION** systems.

* * *

## **1\. Regulatory Compliance for ETO STERILIZATION**

To ensure a safe and compliant **ETO STERILIZATION** process, companies must adhere to local, national, and international safety standards. Some key regulations include:

- **OSHA**: Occupational Safety and Health Administration  regulations for worker safety when using ETO.
- **EPA**: Environmental Protection Agency guidelines for hazardous air pollutants.
- **FDA**: FDA guidelines for medical device sterilization using **ETO STERILIZATION**.
- **ISO 11135**: International standard for the validation and control of **ETO STERILIZATION** processes.
- **ANSI/AAMI ST41**: Standard for sterilizing medical devices with **ETO STERILIZATION**.

* * *

## **2\. Ventilation and Exhaust Systems for ETO STERILIZATION**

### **Proper Ventilation**

**ETO STERILIZATION** involves the use of volatile organic compounds (VOCs) like ethylene oxide, which can be harmful if inhaled. Adequate ventilation is essential to prevent **ETO** buildup in the sterilization room and surrounding areas.

### **Local Exhaust Ventilation (LEV)**

Install a local exhaust ventilation system to capture any potential **ETO gas leaks** during sterilization cycles, maintenance, or emergencies.

* * *

## **3\. Continuous Gas Monitoring During ETO STERILIZATION**

### **ETO Gas Detection**

Install continuous **ETO gas detectors** to monitor the concentration of ethylene oxide in the air. Calibration of these detectors is crucial for ensuring accurate readings.

### **Alarm Systems**

Equip **ETO STERILIZATION** systems with alarms that alert operators when **ETO** gas concentrations exceed safety limits. The threshold is typically set at 1 ppm (parts per million) for an 8-hour time-weighted average (TWA).

* * *

## **4\. Personal Protective Equipment (PPE) for ETO STERILIZATION Operators**

### **Protective Clothing**

Operators handling **ETO STERILIZATION** systems must wear **impermeable lab coats** or coveralls to protect against skin exposure to EO.

### **Respiratory Protection**

When working in areas where **ETO gas concentrations** might be higher than recommended, operators should use **respirators** fitted with filters suitable for ethylene oxide.

### **Gloves and Safety Goggles**

In addition to protective clothing, operators should wear **chemical-resistant gloves** and **safety goggles** to avoid direct contact with **ETO**.

* * *

## **5\. Safe Handling and Storage of ETO Gas**

### **Safe Storage Practices**

Store **ETO gas cylinders** in well-ventilated, cool, dry, and secure areas away from direct sunlight, heat sources, or flammable materials. Storage areas should be clearly labeled as hazardous.

### **Handling Protocols**

Only trained personnel should handle **ETO cylinders**. Ensure that all valves, regulators, and connections are properly maintained to prevent gas leaks.

### **Safety Data Sheets (SDS)**

Always have the **ETO Safety Data Sheet (SDS)** available, which provides important information on handling, first aid, emergency response, and potential hazards.

* * *

## **6\. Leak Prevention and Detection in ETO STERILIZATION Systems**

### **Regular Leak Checks**

Regularly inspect sterilization chambers, gas supply lines, and seals for **ETO gas leaks**. Ensure that any possible leak points are promptly addressed to prevent exposure.

### **Leak Testing Procedures**

Before, during, and after each sterilization cycle, perform **leak testing** to detect any **ETO gas leaks**. This ensures that sterilization equipment is functioning safely.

* * *

## **7\. Exposure Limits and Air Quality Control During ETO STERILIZATION**

### **Workplace Exposure Limits (PEL)**

The permissible exposure limit (PEL) for **ETO gas** in the workplace is generally 1 ppm over an 8-hour workday, with a short-term exposure limit (STEL) of 5 ppm. It  essential to ensure that **ETO STERILIZATION** operations stay within these limits.

### **Air Quality Management**

Use **scrubbers** or **chemical filters** to remove **ETO gas** from exhaust air before releasing it into the atmosphere. This helps minimize the environmental impact and keeps air quality safe.

* * *

## **8\. Emergency Response and First Aid for ETO Exposure**

### **Spill Containment Procedures**

Create clear procedures for handling **ETO gas leaks** or spills. Ensure that only qualified personnel perform cleanup operations and that the environment is protected from contamination.

### **First Aid Measures**

Trained personnel should know how to respond to **ETO exposure**:

- **Inhalation**: Move the affected person to fresh air immediately and seek medical attention.
- **Skin Contact**: Wash the affected area with water and remove contaminated clothing. If irritation persists, seek medical assistance.

### **Fire Safety**

Since **ETO gas** is flammable, ensure that fire extinguishers (specifically **Class B**) are available in areas where **ETO STERILIZATION** occurs.

* * *

## **9\. Training and Standard Operating Procedures (SOPs) for ETO STERILIZATION**

### **Operator Training**

All operators must undergo thorough training on the proper use of **ETO STERILIZATION** systems, including handling **ETO gas**, monitoring its concentration, and using PPE.

### **Standard Operating Procedures (SOPs)**

Establish and follow comprehensive SOPs that cover the entire **ETO STERILIZATION** process 攆rom setup and operation to maintenance and emergency response. These SOPs should be reviewed and updated regularly.

* * *

## **10\. Environmental and Waste Disposal Considerations for ETO STERILIZATION**

### **Environmental Protection**

**ETO STERILIZATION** has a significant environmental impact due to the greenhouse gases involved. Use **scrubbers** and other gas management systems to prevent the release of **ETO** into the atmosphere.

### **Disposal of ETO Residues**

Dispose of **ETO residues** by using **incineration** or **gas recovery systems** to ensure safe and environmentally responsible disposal.

* * *

### **Conclusion**

**ETO STERILIZATION** is an effective method for sterilizing medical devices and pharmaceuticals, but it comes with inherent safety risks. To ensure safe operation, it is crucial to follow strict safety guidelines including proper ventilation, gas detection, personal protective equipment (PPE), and emergency response procedures. Regular training, compliance with regulatory standards, and the use of best practices can greatly minimize risks and protect both operators and the environment.

By adhering to these safety guidelines, **ETO STERILIZATION** can continue to be a safe and effective method for sterilization in a wide range of industries.

## IF YOU WANT TO KNOW MORE

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Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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## Testing ETO Gas Sterilization
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![](https://zjbocon.com/wp-content/uploads/2025/09/eto-sterilizer-11-1024x1024.webp)

When it comes to **ETO gas sterilization**, testing is an essential part of ensuring the effectiveness and safety of the sterilization process. **ETO GAS STERILIZATION TEST MATERIALS** play a key role in verifying that the ethylene oxide (EO) gas is properly sterilizing medical devices, pharmaceuticals, and other sensitive products. This guide will explain how to test **ETO gas sterilization test materials**, the standards that apply, and the tools you need to ensure successful sterilization cycles.

## **1\. What Are ETO GAS STERILIZATION TEST MATERIALS?**

**ETO GAS STERILIZATION TEST MATERIALS** are materials or devices used to validate and monitor the effectiveness of the **ETO gas sterilization process**. These materials ensure that the **ETO gas** penetrates through packaging and reaches all surfaces of the items being sterilized. Testing is essential for ensuring that the sterilization process kills bacteria, viruses, and other pathogens without compromising the integrity of the product.

### **Types of ETO Gas Sterilization Test Materials:**

- **Biological Indicators (BIs)**: These are microorganisms that are more resistant to sterilization than the materials being sterilized. They act as a control to ensure the sterilizer is functioning correctly.
- **Chemical Indicators (CIs)**: These indicators change color when exposed to a certain level of **ETO gas** and are used to monitor the conditions of the sterilization process.
- **Physical Indicators**: These include temperature and pressure gauges used during the sterilization cycle.
- **Sterilization Pouches and Packs**: Specifically designed materials that are used to monitor gas penetration during the process.

* * *

## **2\. How to Perform ETO Gas Sterilization Testing**

Testing **ETO gas sterilization test materials** involves a series of steps to ensure that the sterilization process is carried out effectively and safely. The key steps include **selection, placement, and validation** of test materials in the sterilization chamber.

### **Step 1: Select the Right ETO Gas Sterilization Test Materials**

To test the **ETO sterilization process**, select **biological indicators** (BIs) and **chemical indicators** (CIs) that are specifically designed for EO gas sterilization. The **biological indicators** should be chosen based on their resistance to **ETO gas**, and they are often used to test for microbial inactivation.

### **Step 2: Place the Test Materials Correctly**

Place the **ETO gas sterilization test materials** in areas within the sterilization load where penetration of the gas is most difficult. These areas may include:

- **Inside the sterilization packs**
- **In the center of a load**
- **In pockets or folds in the sterilization packaging**

Make sure the **BIs** and **CIs** are placed in a representative sample of the load to ensure the entire batch is properly sterilized.

### **Step 3: Run the ETO Gas Sterilization Cycle**

Start the **ETO sterilization cycle**, following the specific temperature, time, and humidity conditions for **ETO gas sterilization**. For effective testing, the cycle should match the parameters used for regular sterilization runs.

### **Step 4: Post-Sterilization Testing**

After the sterilization cycle, examine the **ETO gas sterilization test materials**:

- For **BIs**, incubate the biological indicators to check for microbial growth. If growth occurs, this indicates that the sterilization process was not effective.
- For **CIs**, look for a color change that confirms exposure to the necessary **ETO gas concentration**.
- For **physical indicators**, check if the temperature and pressure parameters fall within the required ranges.

* * *

## **3\. Standards for Testing ETO Gas Sterilization**

There are several standards and guidelines to ensure the correct testing and validation of **ETO gas sterilization**:

### **ISO 11135:2014**

- **ISO 11135** is the international standard for **ETO gas sterilization**. This standard outlines the requirements for testing the sterilization process, including the validation of sterilizers, monitoring systems, and test materials.

### **USP (United States Pharmacopeia) <1211>**

- **USP <1211>** provides guidelines for testing sterilization processes, including the use of **ETO**. It outlines the requirements for **biological indicator testing** and validation methods for **ETO sterilization**.

### **AAMI ST41**

- The **AAMI ST41** standard focuses on the use of **ETO gas** in sterilization processes, including the testing and monitoring of the **ETO gas sterilization cycle**. It specifies testing for both **biological** and **chemical indicators** to ensure effective sterilization.

* * *

## **4\. Common Challenges in ETO Gas Sterilization Testing**

While **ETO gas sterilization** is highly effective, certain challenges may arise when testing **ETO gas sterilization test materials**:

### **1\. Incomplete Sterilization**

If **ETO gas** doesn 檛 properly penetrate the sterilization packaging or hard-to-reach areas, **incomplete sterilization** can occur. This can be identified through **biological indicator** failure or **chemical indicator** discoloration. Ensure proper placement of test materials to avoid this issue.

### **2\. Incorrect ETO Gas Concentration**

Insufficient **ETO gas** concentration can lead to **ineffective sterilization**. Regular calibration of **ETO gas monitors** and **sterilizer equipment** is essential for accurate testing.

### **3\. Overexposure or Contamination**

Overexposing the **ETO gas sterilization test materials** can result in damage to the materials or inaccurate test results. Always follow the prescribed cycle parameters to avoid overexposure.

* * *

## **5\. Benefits of ETO Gas Sterilization Testing**

### **1\. Ensures Effective Sterilization**

By using **ETO gas sterilization test materials**, you can confirm that the sterilization cycle was effective and that all microorganisms have been inactivated.

### **2\. Compliance with Regulatory Standards**

Regular testing ensures compliance with industry regulations and standards, such as **ISO 11135**, **USP <1211>**, and **AAMI ST41**.

### **3\. Continuous Process Monitoring**

Testing provides ongoing monitoring of the **ETO gas sterilization process**, allowing for early detection of any issues with the sterilization cycle.

* * *

## **Conclusion: Importance of Testing ETO Gas Sterilization Test Materials**

Testing **ETO gas sterilization test materials** is an essential step in ensuring the success of **ETO gas sterilization**. By carefully selecting and placing the appropriate test materials, following regulatory guidelines, and monitoring the sterilization process, you can confirm that your **ETO sterilization process** is effective and safe.

Regular testing not only ensures compliance with international standards but also helps maintain the highest levels of safety and quality control for medical devices, pharmaceuticals, and other sterilized products.

For more detailed guidance on **ETO gas sterilization** testing or to purchase test materials, contact a reputable sterilization service provider or equipment supplier.

## IF YOU WANT TO KNOW MORE

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Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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## EtO Emissions Control
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![](https://zjbocon.com/wp-content/uploads/2025/09/eo-gas-scrubber-1024x1024.webp)

Effective **EtO emissions control** is essential for sterilization, chemical manufacturing, and industrial operations handling **ethylene oxide (EtO)**. Modern abatement technologies help facilities meet regulatory requirements, improve safety, and minimize environmental impact. This guide provides an optimized, SEO-ready overview of primary **EtO control technologies**, including wet scrubbers, thermal oxidizers, dry bed scrubbers, catalytic oxidizers, flares, bubbling scrubbers, and integration considerations.

### **5.1 EO [Scrubber](https://zjbocon.com/product/eo-scrubber/) / Packed Tower**

Wet scrubbers, also known as packed towers, are effective devices for removing pollutants like EtO from industrial gas streams. These systems utilize a low-pH scrubbing liquid 攖ypically a water and acid mixture 攖o absorb EtO. The acid catalyzes the conversion of EtO into Monoethylene Glycol (MEG).

**How It Works:**Contaminated gas enters the bottom of the tower and flows upward through a bed of packing material. Simultaneously, spray nozzles distribute the scrubbing liquid evenly downward over the packing. This design maximizes gas-liquid contact surface area, ensuring efficient absorption. The packing material, made from EtO- and acid-resistant plastics or metals, randomizes gas flow and promotes liquid dispersion via surface tension. A mist eliminator at the top captures any entrained droplets before clean air exits. The absorbed EtO, now in liquid form, collects in a reservoir at the tower bottom and is pumped to a holding tank for complete conversion to MEG.

**Key Design Factor:**The primary variable determining tower size is the airflow rate; the packed bed must provide sufficient residence time for complete EtO absorption. Consistent control relies on maintaining stable liquid flow rates and pH levels.

**Advantages:**

- Handles high-temperature and high-humidity gas streams.
- Minimal fire or explosion risk.
- Capable of treating large air volumes.
- Can achieve >99% destruction efficiency for high inlet concentrations.

**Disadvantages:**

- Corrosion potential from acidic liquid and carryover.
- Risk of piping freeze-up in cold climates.
- Potential fouling of packing and liquid due to poor water quality.
- High power consumption.
- Requires waste liquid disposal and ongoing acid replenishment.
- Safety precautions needed for maintenance.

* * *

### **5.2 Thermal Oxidizers**

Thermal oxidizers destroy volatile organic compounds (VOCs), including EtO and other hazardous air pollutants (HAPs), through high-temperature combustion. Systems operate between 760degrees celsius (1,400Fahrenheit) and 820degrees celsius (1,510Fahrenheit), converting pollutants into carbon dioxide (CO?) and water vapor.

**How It Works:**For safety, high-concentration EtO streams are first routed through a water balancing tank or flame arrester. The gas then enters a combustion chamber where natural gas burners initiate oxidation; the EtO itself contributes to the heat release. In regenerative thermal oxidizers (RTOs), ceramic heat exchangers capture and reuse energy from the exhaust, significantly improving fuel efficiency. The EtO-laden air is held at high temperature for a designed residence time to ensure complete oxidation before release.

**Advantages:**

- Very high (>99%) destruction efficiency for concentrated streams.
- Relatively small physical footprint.
- Potential for energy recovery (especially in RTOs).
- Simple operational mechanics.

**Disadvantages:**

- Not suitable for very high airflow, low-concentration streams.
- High fuel gas consumption (unless regenerative).
- Potential safety concerns regarding explosion risks.
- May produce nitrogen oxides (NOx) as combustion byproducts.

* * *

### **5.3 Dry Bed Scrubber**

Dry bed scrubbers use vessels filled with chemically impregnated polymer beads (reactant media) to permanently remove EtO via chemisorption and chemical reaction, converting it into a harmless polymer.

**How It Works:**Contaminated air passes through the fixed bed of media, where EtO molecules adhere to the bead surfaces and react. The system is sized to provide adequate residence time for the reaction at a specific airflow rate. A support screen at the bed  outlet prevents media carryover. These systems are highly effective, achieving >99% destruction efficiency for inlet concentrations above ~5 ppmv.

**Advantages:**

- Modular design allows for easy expansion.
- Low operational complexity; only requires a fan.
- Lower capital and operating cost compared to some systems.
- Permanent EtO conversion; generates non-hazardous waste.
- Safe operation and maintenance.

**Disadvantages:**

- Cannot handle streams with excessive humidity or high temperature.
- Media has finite capacity and requires periodic replacement.
- Not suitable for concentrations >5,000 ppmv due to exothermic reaction risks.

* * *

### **5.4 Thermal Flare**

Flares are used in refineries, chemical plants, and similar facilities to safely destroy EtO from process vents, safety valve releases, or combined waste streams in closed-vent systems.

**How It Works:**A pilot flame, sustained by fuel gas, is maintained at all times. The EtO stream (often vaporized and diluted) is introduced into this combustion zone. The system constantly monitors and adjusts the burn rate to maintain a minimum net heating value, ensuring stable combustion and >99% destruction efficiency. The EtO breaks down into CO? and water. Flares can be vertical or horizontal, with some models incorporating waste-heat recovery systems.

**Advantages:**

- Can handle highly variable, intermittent, or complex mixed streams.
- Effective for high-energy, high-VOC processes.
- Potential for heat recovery.

**Disadvantages:**

- Very high fuel/utility usage.
- Visible flame may cause light pollution or public concern.
- Complex maintenance and integration.
- Risk of flashback, requiring safeguards like flame arresters, purge systems, and velocity monitoring.

* * *

### **5.5 Bubbling Scrubbers**

Bubbling scrubbers, or bubble tank scrubbers, use a low-pH acid/water solution to chemically convert EtO to MEG through a direct bubbling contact method.

**How It Works:**Low-flow EtO gas is pumped to the bottom of a series of reaction tanks (often two stages). Perforated diffusers create fine bubbles that rise through the liquid, providing residence time for the reaction to occur. A centrifugal blower maintains negative pressure, pushing gases through the stages. As MEG is produced, the liquid level and specific gravity rise, which are key monitoring parameters. Tanks are periodically regenerated by transferring the MEG solution for neutralization and disposal.

**Advantages:**

- Intrinsically safe liquid-based system.
- High (99-99.9%) efficiency for high-concentration, low-flow streams.
- Simple design with few points of failure.
- Consistent control when parameters are stable.

**Disadvantages:**

- Not suitable for high-airflow applications.
- Involves handling of acids and bases.
- Ongoing cost for acid and waste MEG solution management.
- **Note:**Distinct from passive balancing tanks (peak shavers) which only store, not treat, EtO-laden water.

* * *

### **5.6 Catalytic Oxidizer**

Catalytic oxidizers control VOCs like EtO by promoting oxidation at temperatures significantly lower than thermal oxidizers, using a precious metal or metal oxide catalyst.

**How It Works:**The process gas is heated to a catalyst activation temperature (typically 150degrees celsius to 400degrees celsius / 300Fahrenheit to 750Fahrenheit) before passing over the catalyst bed. In the presence of excess oxygen, the catalyst promotes the complete oxidation of EtO to CO? and water vapor. Heat exchangers can be added for energy recovery. This technology is ideal for low-concentration EtO streams.

**Advantages:**

- Lower operating temperatures mean reduced fuel consumption and higher energy efficiency.
- Minimizes formation of thermal NOx and CO.
- Can achieve 99-99.9% destruction efficiency.
- More environmentally friendly operation.

**Disadvantages:**

- Catalyst is sensitive to poisoning from sulfur, silicon, phosphorous, or heavy metals.
- Generally larger footprint than thermal oxidizers.
- Higher capital cost and periodic catalyst replacement expense.

## IF YOU WANT TO KNOW MORE

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Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

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[Code Compliance: Ethylene Oxide (ETO)](https://zjbocon.com/code-compliance-ethylene-oxide-eto/ "Code Compliance: Ethylene Oxide (ETO)")

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## Sterilization Methods Comparison
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![](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-7-225x300.webp)

| **Sterilization Method** | **Advantages** | **Disadvantages** |
| --- | --- | --- |
| **Steam** | Non-toxic to patients, personnel, and environment. Cycle is easy to control and monitor. Fast microbial kill. Penetrates medical packaging and device lumens. | Harmful to heat-sensitive instruments/devices. Microsurgical instruments damaged by repeated exposure. May leave instruments wet, causing rust. Potential for burns. Incompatible with most medical devices due to heat sensitivity of plastics. Cannot fully destroy pyrogens on endotoxin-contaminated products. |
| **Ethylene Oxide (EO)** | Penetrates packaging materials and device lumens. Optimal material compatibility (Low temp).  淧roduct can be sterilized in its sealed final packaging.   Simple operation and monitoring. Broad microbicidal activity. Low temperature. Sterility assurance and therapeutic effect. Allows immediate product release after processing (Parametric Release), shortening turnaround time, helping to get products to market quickly. Customizable number of single-use disinfectable products. Always meets product and regulatory requirements. | Requires aeration time to remove ETO residues. ETO is toxic, carcinogenic, and flammable. ETO emissions are regulated by US states and Europe. Long cycle/aeration time. |
| **Hydrogen Peroxide (H?O?)** | Safe for environment and healthcare personnel. Leaves no toxic residues. Used for heat- and moisture-sensitive items (process temperature $<50^{\\circ}\\text{C}$). Easy to operate, set up, and monitor. Compatible with most medical devices. Only requires a power socket. Microbicidal efficacy data. Capable of sterilizing electronic components and batteries. Short aeration time. | Cannot sterilize cellulose (paper), linen, and liquids. Few validated single-use medical devices. Size limitations (fewer single-use disinfectable products). $\\text{H}\_2\\text{O}\_2$ concentration $>1 \\text{ ppm TWA}$ may be toxic. |
| **Dry Heat** | No risk of metal corrosion after sterilization. No need for aeration time and residual testing. | Slow sterilization process. Sterilization process is difficult to control within a precise temperature range. |
| **Formaldehyde** | Faster cycle time compared to EtO. Lower cost per cycle than EtO. Most items can be used immediately after sterilization. | Vapor is extremely irritating to the eyes. Working temperature is higher than EtO. Formaldehyde residue may remain on sterilized items, potentially harmful to patients. $\\text{RH}$ needs to be $\\sim 75\\%$ for efficacy, as the gas must dissolve in the water film around bacteria. Toxicity. Not FDA approved; recognized only in certain countries. |
| **Nitrogen Dioxide (NO2)** | Used for heat-sensitive items. Compatible with most plastics. X-ray internal sterilization potential. No cytotoxic residues. Short cycle time (6-12 hours, including aeration). Safe and easy to bring indoors 攔educes manufacturing time and cost. | Poor penetration; can penetrate primary packaging but not final packaging. Limited experience (limited industry development); compatibility, product performance, residues, microbial efficacy, and scalability must be assessed. Incompatible with cardboard. Few validated single-use medical devices. FDA not determined to be adequate. |

|     |     |     |     |
| --- | --- | --- | --- |
| Feature | Gamma Ray | Electron Beam (E-beam) | X-ray |
| Mode of Action | Isotropic photons; Avg. energy 1.25MeV | Electron; Typically 10MeV energy | Photons with almost the same direction; 90% of photon energy approx. 0.3MeV |
| Advantages | Compatible with various medical materials. Product can be sterilized in sealed final packaging. Penetrates medical packaging. No residue on sterilized product. No emission regulation. Cold method (minimal temp rise). Easy control. High penetration. Advanced technique. Products can be released immediately (no batch-to-batch testing). | High dose rate and Sterility Assurance Level (SAL) for immediate release. Can penetrate various materials, including foils. Process allows temperature control during irradiation. Well-controlled dose range. Fast process (one minute for small volumes) for immediate full sterilization. Minimal atmospheric impact (small ozone release). Does not require local radioactive source. | Increased photon energy penetration, similar to Gamma. Fast and efficient targeted treatment, facilitating scale-up from cartons to whole pallets. Flexibility (mix products with different dose requirements in same cycle). Reduced material degradation, processing time, and max product dose vs. Gamma/E-beam. |
| Disadvantages | Individual plastics need assessment. Must avoid Teflon, PFA, PTFE, PP. Adverse effect on gels and adhesives. Requires a nuclear reactor (expensive). Limited dose flexibility. Lower dose rate than E-beam. | Expensive construction cost for E-beam sterilization facility. Penetration is lower than Gamma. Risk of radiolytic byproducts (e.g., ?OH) which may damage raw materials/API/packaging when sterilizing finished products or $\\text{API}$s using ? particles. | Limited experience (limited industry development). Compatibility, performance, residues, microbial efficacy, and scalability must be assessed. |
| Largest Processing Unit | Pallets or boxes | Boxes | Pallets or boxes |
| Typical Dose Range (Medical Device Density) | 25-40kGy; Ideal: 25-50kGy | 25-50kGy; Ideal 25-60kGy | 25-35kGy; Ideal: 25-40kGy |
| Dose Rate | A few kGy/h | A few 1000kGy/h | A few kGy/h to a few hundred kGy/h |
| Typical Max Temp | 45?C-50?C | 50?C | 35?C-40?C |

## IF YOU WANT TO KNOW MORE

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Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/)

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## Sterilization Method Compatibility
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This table provides compatibility guidelines for various polymers across common sterilization methods

**Compatibility Key:**

**Good:** Recommended

**Fair:** Acceptable, with potential limitations

**Poor:** Not recommended

|     |     |     |     |     |     |     |     |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Polymer Category | Polymer | Abbreviation | Autoclave | Dry Heat | Ethylene Oxide (EtO) | Gamma Irradiation | Electron Beam |
| Biopolymers | Poly(L-lactide) | PLLA | Fair | Good | Good | Good | Good |
|  | Polylactic acid | PLA | Poor | Fair | Good | Good | Good |
|  | Polyhydroxybutyrate | PHB | Poor | Poor | Good | Fair | Fair |
|  | Polyglycolic acid | PGA | Good | Good | Good | Good | Good |
|  | Poly(lactic-co-glycolic acid) | PLGA | Poor | Poor | Good | Fair | Fair |
|  | Polycaprolactone | PCL | Fair | Good | Good | Good | Good |
| Elastomers | Silicones | VMQ, PMQ, PVMQ | Good | Good | Good | Good | Good |
|  | Urethane thermoplastic elastomer | TPU | Poor | Fair | Good | Good | Good |
|  | Copolyester thermoplastic elastomer | TPC | Poor | Good | Good | Good | Good |
|  | Polyamide thermoplastic elastomer | ??? | Poor | Poor | Good | Good | Good |
|  | Styrenic thermoplastic elastomer | TPS | Poor | Poor | Good | Good | Good |
|  | Olefinic thermoplastic elastomer | ??? | Poor | Fair | Good | Good | Good |
| Fluoropolymers | Polytetrafluoroethylene鹿 | PTFE | Fair | Fair | Good | Poor | Poor |
|  | Fluorinated ethylene propylene | FEP | Good | Good | Good | Fair | Fair |
|  | Perfluoro alkoxy | PFA | Good | Good | Good | Good | Good |
|  | Ethylene chlorotrifluoroethylene | ECTFE | Good | Good | Good | Good | Good |
|  | Ethylene tetrafluoroethylene | ETFE | Good | Good | Good | Good | Good |
|  | Polyvinyl fluoride | PVF | Good | Good | Good | Good | Good |
|  | Polyvinylidene difluoride | PVF2 | Good | Good | Good | Good | Good |
| High-temp Thermoplastics | Polysulfones | PSU | Good | Good | Good | Good | Good |
|  | Polyphenylene sulfide | PPS | Good | Good | Good | Good | Good |
|  | Liquid crystalline polymer | LCP | Good | Good | Good | Good | Good |
|  | Polyetherimide | PEI | Fair | Fair | Good | Good | Good |
|  | Polyamide-imide | PAI | Fair | Fair | Good | Good | Good |
|  | Polyetheretherketone | PEEK | Good | Good | Good | Good | Good |
| Polyamides | Nylon 6, Nylon 66 | PA6, PA66 | Fair | Fair | Good | Fair | Fair |
|  | Aromatic | AP | Good | Good | Good | Good | Good |
|  | Nylon 12, 6/12 | PA12 | Poor | Poor | Good | Fair | Fair |
| Polyesters | Poly butylene terephthalate | PBT | Fair | Fair | Good | Good | Good |
|  | Poly ethylene terephthalate | PET | Poor | Poor | Good | Good | Good |
|  | Copolyesters |    | Poor | Poor | Good | Good | Good |
| Polyolefins | High-density polyethylene | HDPE | Poor | Poor | Good | Good | Good |
|  | Low-density polyethylene | LDPE | Poor | Poor | Good | Good | Good |
|  | Ultrahigh molecular weight polyethylene | UHMWPE | Poor | Poor | Good | Good | Good |
|  | Polypropylene鹿 | PP | Good | Fair | Good | Fair | Fair |
|  | Polypropylene copolymers | PPC | Good | Fair | Good | Fair | Fair |
|  | Cyclo olefin copolymer | COC | Fair | Fair | Good | Good | Good |
|  | Polyvinyl chloride plasticized 1,2 | PVC | Fair | Fair | Good | Good | Good |
|  | Polyvinyl chloride unplasticized 1,2 | PVC | Poor | Poor | Good | Fair | Fair |
| Polystyrene / Styrenics | Polystyrene | PS | Poor | Poor | Good | Good | Good |
|  | Acrylonitrile butadiene styrene copolymer (Abs) | ABS | Poor | Poor | Good | Good | Good |
|  | Styrene-acrylonitrile copolymer (San) | SAN | Poor | Poor | Good | Good | Good |
|  | Acrylonitrile styrene acrylate | ASA | Poor | Poor | Good | Good | Good |
|  | Methacrylate acrylonitrile butadiene styrene copolymer | MABS | Poor | Poor | Good | Good | Good |
|  | Styrene-butadiene copolymer | SBC | Poor | Poor | Good | Good | Good |
|  | Acrylics 1,2 | PMMA | Poor | Poor | Good | Good | Good |
|  | Polycarbonates 1,2 | PC | Fair | Fair | Good | Good | Good |
|  | High heat polycarbonates | PC | Good | Good | Good | Good | Good |
|  | Polyurethanes | PU, PUR | Poor | Poor | Good | Good | Good |
|  | Acetals | POM | Good | Good | Good | Poor | Poor |

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## Sterilization Compatibility Table
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![](https://zjbocon.com/wp-content/uploads/2024/11/eto-sterilizer-hzbocon-6-1024x1024.png)

| **Material** | **STEAM (at least a part of the packaging needs to be permeable to steam)** | **EO/FORM (at least a part of the packaging needs to be permeable to gas)** | **Hydrogen Peroxide (Plasma) (natural fibre based materials are incompatible)** | **Gamma/E-Beam or Beta radiation (impermeable material may be used)** | **Dry Heat (max temp) (impermeable material may be used)** |
| --- | --- | --- | --- | --- | --- |
| **Materials with gas and steam permeability** |  |  |  |  |  |
| Medical grade paper | V | V | no | V | V ($160^{\\circ}C$) |
| Flush spunbond non-woven materials of polyethylene | V (max. T $127^{\\circ}C$) not suitable for hospitals | V | V | V | no |
| Wet laid non-wovens (pulp and plastic fibres) | V | V | no | V | no |
| SMS (Spunbond Meltblown Spunbond) non-woven materials of polypropylene | V | V | V | no | no |
| **Films and composite films** |  |  |  |  |  |
| PET/PP films (Laminated) | V | V | V | no | no |
| PET/PE films (Laminated) | no | V | V | V | no |
| Aluminium laminates and composites, i.e. high barrier materials | V | V | see suppliers specification | V | V |
| APET film (Amorphous Polyethylene Terephthalate) | no | V | see suppliers specification | V | no |
| E/P (Ethylene-Propylene Copolymer) | see suppliers specification | V | see suppliers specification | see suppliers specification | see suppliers specification |
| HDPE film (High Density Polyethylene) | V ($121^{\\circ}C$) | V | see suppliers specification | V | no |
| LDPE film (Low Density Polyethylene) | no | V | V | V | no |
| PA film (component) (Polyamide) | V | V | V | V | V |
| PE film (component) (Polyethylene) | no | V | V | V | no |
| PP film (component) (Polypropylene) | V | V | no | no | no |
| PET film (component) (Polyethylene Terephthalate) | V | V | V | V | V |
| PETG (PETG-Foam-, PETG-PE) film (PET Glycol) | no | V | see suppliers specification | V | no |
| PS film (Polystyrene) | no | V | see suppliers specification | V | no |
| HIPS film (High Impact Polystyrene) | no | V | see suppliers specification | V | no |
| PC film (Polycarbonate) | V | V | see suppliers specification | V | V |
| PVC film (Poly Vinyl Chloride) | no | V | see suppliers specification | no | no |
| TPU film (Thermoplastic Polyurethane) | no | V | see suppliers specification | V | V |

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## Medical Innovations Showcase
[Skip to content](https://zjbocon.com/hzbocon-showcases-advanced-medical-innovations-at-russian-healthcare-week-2025-in-moscow/#content)

**MOSCOW, Russia    December 12, 2025**    HZBOCON today issued a statement confirming the highly successful conclusion of its participation in the **Russian Healthcare Week 2025** (RH Week 2025), held at the Crocus Expo in Moscow from December 8  11.

The exhibition served as a critical platform for HZBOCON to showcase its advanced **Next-Generation Eto Sterilizer** at **Booth 5D120**, attracting significant interest from medical professionals, hospital administrators, and potential distribution partners across Russia and neighboring countries.

![](https://zjbocon.com/wp-content/uploads/2025/12/russia-health-week-5-768x1024.webp)![](https://zjbocon.com/wp-content/uploads/2025/12/russia-health-week-7-768x1024.webp)![](https://zjbocon.com/wp-content/uploads/2025/12/russia-health-week-1-768x1024.webp)![](https://zjbocon.com/wp-content/uploads/2025/12/russia-health-week-6-768x1024.webp)![](https://zjbocon.com/wp-content/uploads/2025/12/russia-health-week-8-768x1024.webp)![](https://zjbocon.com/wp-content/uploads/2025/12/russia-health-week-2-768x1024.webp)![](https://zjbocon.com/wp-content/uploads/2025/12/russia-health-week-9-768x1024.webp)![](https://zjbocon.com/wp-content/uploads/2025/12/russia-health-week-4-768x1024.webp)![](https://zjbocon.com/wp-content/uploads/2025/12/russia-health-week-3-768x1024.webp)

### **Looking Ahead**

HZBOCON plans to leverage the momentum generated by the exhibition. The company is accelerating its regulatory and certification processes in collaboration with local partners to ensure the rapid deployment of the Eto Sterilizer across the Russian Federation in early 2026.

HZBOCON extends its gratitude to the organizers of Russian Healthcare Week and to all the visitors who made the event a resounding success.

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## ETO Sterilizers Guide
[Skip to content](https://zjbocon.com/understanding-what-is-eto-sterilizers-a-comprehensive-guide/#content)

Sterilization is a crucial process in many industries, particularly in healthcare, where maintaining a sterile environment is essential to patient safety. The presence of harmful microorganisms can lead to infections and complications, making sterilization a non-negotiable aspect of medical procedures. Among the various methods available, one of the most effective is through the use of ETO sterilizers. In this guide, we will explore everything you need to know about ethylene oxide (ETO) sterilization, its benefits, and its applications. Understanding the nuances of ETO sterilization can help healthcare providers and industries maintain the highest standards of hygiene and safety.

![Chemical structure of ethylene oxide](https://ggg-static-g--ggg---mediasem.3ue.com/contentshake/articles/ai-images/2d8ccdba-df35-4382-af3e-cf6e6a89f60e/c4cad76f-dbdd-490c-b90d-005f42103f38)Ethylene oxide is a colorless gas with a faint, sweet odor, known for its versatility in industrial applications. It is highly flammable and is primarily used to produce other chemicals, such as antifreeze and detergents. However, one of its most significant uses is in the sterilization of medical equipment and supplies, due to its ability to disrupt the DNA of microorganisms, effectively killing them. Its efficacy in eliminating microorganisms makes it an invaluable asset in maintaining sterile environments, particularly in settings where traditional methods may not suffice. This ability to penetrate complex materials and reach areas that other methods cannot makes ethylene oxide an indispensable tool in sterilization.

Beyond its industrial applications, ethylene oxide  role in sterilization highlights its importance in public health. The chemical  ability to sterilize without causing heat damage is critical for preserving the integrity of sensitive medical instruments and devices. Moreover, its gaseous nature allows it to permeate packaging materials, providing a comprehensive sterilization solution that ensures all surfaces and internal components are treated. This makes ethylene oxide an essential component in the production and maintenance of sterile medical environments, ultimately safeguarding patient health.

## How Do ETO Sterilizers Work?

### The Sterilization Process

ETO sterilizers use ethylene oxide gas to sterilize equipment and supplies, employing a meticulous process to ensure thorough sterilization. The process involves several stages that are carefully controlled to achieve optimal results:

1. Preconditioning: The items to be sterilized are placed in a preconditioning room to stabilize their temperature and humidity. This step is crucial as it prepares the items for effective gas penetration by ensuring a uniform environment.
2. Sterilization: The items are then transferred to the ETO sterilizer chamber. Ethylene oxide gas is introduced, and the chamber is maintained at specific temperature, humidity, and pressure conditions to ensure effective sterilization. The parameters are carefully monitored to maximize the efficacy of ethylene oxide in reaching and neutralizing all microorganisms.
3. Aeration: After sterilization, the items are moved to an aeration room where they are ventilated to remove any residual ethylene oxide gas. This step is essential to ensure that the items are safe for handling and use, as any remaining gas could be harmful.

Each stage of the ETO sterilization process is integral to achieving comprehensive sterilization. The preconditioning phase ensures that the environment is conducive to gas penetration, while the sterilization phase utilizes the unique properties of ethylene oxide to reach even the most inaccessible areas of the items being treated. Finally, the aeration phase guarantees that any residual gas is safely removed, minimizing potential hazards.

### Why ETO Sterilization?

![Medical equipment being sterilized](https://ggg-static-g--ggg---mediasem.3ue.com/contentshake/articles/ai-images/2d8ccdba-df35-4382-af3e-cf6e6a89f60e/7fed921c-1578-4d1e-b257-0fcf3a0f86f6)ETO sterilization is particularly effective because it penetrates the packaging and reaches complex parts of medical instruments that other sterilization methods might not. This makes it ideal for sterilizing heat- or moisture-sensitive items, which could be damaged by more conventional methods such as steam sterilization. The ability of ethylene oxide to sterilize at low temperatures is a significant advantage, preserving the integrity of delicate materials.

Moreover, ETO sterilization is versatile and adaptable, making it suitable for a wide range of applications beyond healthcare. Its ability to sterilize a variety of materials without causing damage ensures that it remains a preferred method in industries where maintaining the quality and functionality of products is paramount. This adaptability, combined with its thoroughness, underscores the value of ETO sterilization in settings where other methods may fall short.

## Applications of ETO Sterilization

### Medical Industry

The primary application of ETO sterilization is in the medical industry, where maintaining sterility is essential for patient safety and infection control. It is used to sterilize a variety of critical items, including:

- Surgical Instruments: Delicate instruments that can be damaged by heat are effectively sterilized by ethylene oxide without compromising their functionality or precision.
- Plastic Devices: Such as catheters and syringes, which can melt under high temperatures, are safely sterilized without risking deformation or degradation.
- Electronic Equipment: Devices that could be harmed by moisture or heat are treated with ETO to ensure they remain operational and safe for use.

ETO sterilization is also invaluable in the production and distribution of disposable medical supplies, ensuring that these items are free from contamination when they reach healthcare facilities. By maintaining the sterility of these critical components, ETO sterilization contributes significantly to patient safety and the prevention of healthcare-associated infections.

### Other Industries

While its primary use is in healthcare, ETO sterilization is also used in other industries due to its effectiveness and versatility:

- Pharmaceuticals: To ensure the sterility of drugs and supplements, ETO sterilization is employed to prevent contamination and preserve efficacy.
- Food Packaging: To sterilize packaging materials and extend shelf life, ethylene oxide ensures that food products remain safe and fresh for consumption over extended periods.
- Cosmetics: In the production of sterile cosmetic products, ETO sterilization prevents microbial contamination, ensuring product safety and consumer confidence.

In these industries, the ability of ETO sterilization to penetrate complex and multi-layered materials provides a reliable means of ensuring product safety and quality. By addressing the unique sterilization needs of each sector, ethylene oxide continues to be an essential tool in maintaining high standards of hygiene and safety across various fields.

## Benefits of Using ETO Sterilizers

### Comprehensive Sterilization

ETO sterilizers provide a comprehensive sterilization solution, capable of eliminating all forms of microbial life, including bacteria, viruses, and fungi. This makes it indispensable in environments where sterility is non-negotiable, such as hospitals and laboratories. The thoroughness of ETO sterilization ensures that even the most resilient microorganisms are neutralized, reducing the risk of infection and contamination.

The ability to achieve such a high level of sterilization is particularly important in healthcare settings, where the presence of even a single microorganism can have severe consequences. By providing a reliable and effective sterilization method, ETO sterilizers help maintain the highest standards of patient care and safety.

### Compatibility with a Wide Range of Materials

Unlike other sterilization methods, ETO sterilization is compatible with a wide range of materials, including plastics, metals, and rubber, without causing damage. This versatility allows it to be used across various applications, providing a flexible solution for sterilization needs. The ability to sterilize diverse materials without compromising their properties is a key advantage of ethylene oxide.

This compatibility extends to complex devices and instruments, ensuring that they remain functional and safe for use after sterilization. By preserving the integrity of sensitive materials, ETO sterilization helps maintain the quality and performance of critical equipment and supplies.

### Preservation of Product Integrity

The low-temperature process ensures that the physical and chemical properties of the items being sterilized are preserved, maintaining their integrity and usability. This is especially important for heat-sensitive items that could be damaged by traditional sterilization methods. By preserving product integrity, ETO sterilization ensures that items remain effective and safe for their intended use.

In industries where product quality and performance are paramount, the ability of ETO sterilization to maintain the original characteristics of items is crucial. This preservation of integrity extends the lifespan and usability of products, contributing to overall efficiency and cost-effectiveness.

While ETO sterilization is highly effective, it requires careful handling due to the toxic and flammable nature of ethylene oxide. Here are some essential safety considerations:

- Proper Ventilation: Ensuring adequate ventilation during and after the sterilization process is critical to prevent the buildup of ethylene oxide gas, which can pose health risks to workers.
- Personal Protective Equipment (PPE): Workers should wear appropriate PPE, including gloves and masks, to protect against exposure to ethylene oxide gas, reducing the risk of adverse health effects.
- Regular Monitoring: Continuous monitoring of ethylene oxide levels in the sterilization and aeration areas is necessary to ensure safety standards are met and to promptly address any potential leaks or issues.

Additionally, facilities must implement strict safety protocols and provide regular training to workers to ensure they are aware of the risks and know how to manage them effectively. By prioritizing safety, facilities can minimize the potential hazards associated with ETO sterilization and protect both workers and the surrounding environment.

## Regulations and Standards

### Compliance with International Standards

ETO sterilization must comply with international standards to ensure safety and effectiveness. Key standards include:

- ISO 11135: Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process. Adhering to these standards ensures that the process is carried out safely and effectively, minimizing risks.
- ANSI/AAMI ST41: Provides guidelines for the use of ethylene oxide as a sterilant in healthcare facilities. Compliance with these guidelines helps maintain high standards of patient care and safety.

Meeting these international standards is crucial for ensuring that ETO sterilization processes are consistent, reliable, and safe. Facilities must regularly review and update their procedures to align with the latest standards and best practices.

### Environmental Impact

Ethylene oxide is a potent greenhouse gas. Therefore, facilities using ETO sterilizers must adhere to environmental regulations to minimize emissions and environmental impact. Implementing measures such as emission control systems and regular monitoring can help reduce the environmental footprint of ETO sterilization.

Sustainable practices, such as recycling and waste reduction, can further mitigate the environmental impact of ETO sterilization. By prioritizing environmental responsibility, facilities can balance the need for effective sterilization with the imperative to protect the planet.

## Choosing the Right ETO Sterilizer

When selecting an ETO sterilizer, consider the following factors to ensure it meets your specific needs:

- Chamber Size: Ensure the sterilizer can accommodate the volume and size of items you need to process. A sterilizer that is too small may lead to inefficient processing, while one that is too large can be unnecessarily costly.
- Cycle Time: Evaluate the speed of the sterilization cycle to meet your operational needs. Faster cycle times can enhance productivity, but it  essential to ensure that the speed does not compromise the effectiveness of sterilization.
- Safety Features: Look for sterilizers equipped with advanced safety features, such as automatic shut-off and gas detection systems. These features can enhance safety and provide peace of mind by promptly addressing any potential issues.

Additionally, consider the manufacturer  reputation and support services, as these can significantly impact the reliability and longevity of the sterilizer. By carefully assessing your options and selecting the right equipment, you can ensure that your sterilization processes are efficient, effective, and safe.

## Conclusion

ETO sterilizers play an essential role in various industries by providing a reliable and effective means of sterilizing equipment and supplies. Understanding the process, applications, and safety considerations is crucial for anyone involved in sterilization activities. By following regulations and selecting the right equipment, facilities can ensure the safety and sterility of their products, ultimately protecting end-users.

Ethylene oxide sterilization, with its ability to reach the most challenging areas and treat sensitive materials, remains a cornerstone of modern sterilization techniques. Its careful application ensures that it continues to serve industries safely and effectively. As industries evolve, the role of ETO sterilization will continue to be vital in maintaining high standards of hygiene and safety, underscoring its importance in safeguarding public health.

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## ETO Sterilizer Requirements
[Skip to content](https://zjbocon.com/essential-utilities-and-service-requirements-for-eto-sterilizers/#content)

* * *

The successful operation of an **Ethylene Oxide (ETO) sterilizer** requires more than just the machine itself; it demands a robust infrastructure of essential utilities, safety systems, and ongoing technical support. Ensuring these requirements are met is critical for process efficiency, operator safety, and regulatory compliance (such as ISO 11135).

Below is a comprehensive guide to the key services and infrastructure necessary for a high-performing ETO sterilization suite.

* * *

![](https://zjbocon.com/wp-content/uploads/2024/11/eto-sterilizer-hzbocon-5-1024x1024.png)

## 1\. Core Utilities for the Sterilization Cycle

These utilities are directly involved in the chemical process and the physical environment of the sterilization chamber.

- **Ethylene Oxide (EO) Gas Supply:** The primary sterilant, typically provided in 100% EO cartridges or pressurized cylinders (e.g., EO/CO? mixtures).
- **Heating Systems (Steam/Electricity):** Precise temperature control is vital. Systems use steam or hot water jackets to maintain the chamber between **37degrees celsius and 55degrees celsius**. Many facilities require a **Pure Steam Generator** to prevent load contamination.
- **Humidification:** Since EO is only effective in a moist environment, water/steam is injected during preconditioning to reach specific relative humidity (RH) levels.
- **Vacuum System:** A high-performance vacuum pump skid is necessary to evacuate air (initial phase) and remove residual gas (post-cycle aeration).
- **Compressed Air:** Clean, dry compressed air is required to actuate pneumatic valves and facilitate fresh air pulses during the aeration and purging phases.

## 2\. Safety and Environmental Infrastructure

Because Ethylene Oxide is both toxic and highly flammable, specialized safety systems are non-negotiable.

### Ventilation and Exhaust Systems

- **Dedicated Room Exhaust:** Maintains **negative pressure** in the ETO suite to prevent gas migration to adjacent workspaces.
- **Sterilizer Exhaust System:** A specialized line that directs gas from the chamber to an abatement system (scrubber or catalytic oxidizer) to ensure safe environmental discharge.

### EO Monitoring and Detection

- **Gas Detection Systems:** Continuous ambient air monitoring with sensors and alarms to detect any EO leaks in real-time, ensuring worker safety.

## 3\. Pre- and Post-Sterilization Logistics

Efficient workflow requires dedicated spaces for:

- **Preconditioning Rooms:** Where products are stabilized at specific temperatures and humidity levels before entering the sterilizer.
- **Aeration Rooms:** Heated, ventilated spaces used to off-gas residual EO from sterilized products and packaging.

## 4\. Compliance and Support Services

To maintain **Sterility Assurance Levels (SAL)** and equipment longevity, ongoing technical services are required.

### Validation Services (IQ/OQ/PQ)

Rigorous validation ensures the process meets international standards:

- **Installation Qualification (IQ):** Verifies that the equipment is installed according to manufacturer and safety specifications.
- **Operational Qualification (OQ):** Confirms the system operates correctly within its defined parameters.
- **Performance Qualification (PQ):** The most critical phase, proving the process consistently achieves a **$10^{-6}$ SAL** using biological indicators (BIs).

### Maintenance and Calibration

- **Preventative Maintenance:** Scheduled replacement of gaskets, filters, and pump seals to prevent leaks and downtime.
- **Sensor Calibration:** Routine calibration of temperature, pressure, and humidity sensors to ensure cycle repeatability.

### Training and Documentation

- **Staff Training:** Comprehensive programs covering gas handling, emergency response, and cycle data interpretation.
- **Audit-Ready Documentation:** Electronic or physical logs tracking cycle parameters, maintenance history, and employee exposure records.

## IF YOU WANT TO KNOW MORE

Phone:[+8619975258603](https://wa.me/8619975258603)

Email:[hayley@hzbocon.com](mailto:hayley@hzbocon.com)

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China

Website:[hzbocon.com](https://www.hzbocon.com/) [zjbocon.com](https://zjbocon.com/)

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## Bocon ETO Sterilizer Series
[Skip to content](https://zjbocon.com/featured-system-the-bocon-eto-sterilizer-series/#content)

![Bocon ETO Sterilizer Delivery Step 1](https://zjbocon.com/wp-content/uploads/2026/02/Featured-System-The-Bocon-ETO-Sterilizer-Series-3.webp)PHASE 01

![Bocon ETO Sterilizer Delivery Step 2](https://zjbocon.com/wp-content/uploads/2026/02/Featured-System-The-Bocon-ETO-Sterilizer-Series-4.webp)PHASE 02

![Bocon ETO Sterilizer Delivery Step 3](https://zjbocon.com/wp-content/uploads/2026/02/Featured-System-The-Bocon-ETO-Sterilizer-Series-5.webp)PHASE 03

![Bocon ETO Sterilizer Installation Step 4](https://zjbocon.com/wp-content/uploads/2026/02/Featured-System-The-Bocon-ETO-Sterilizer-Series-1.webp)PHASE 04

![Bocon ETO Sterilizer Installation Step 5](https://zjbocon.com/wp-content/uploads/2026/02/Featured-System-The-Bocon-ETO-Sterilizer-Series-2.webp)PHASE 05

Industrial Grade ETO Sterilization Solutions

[Explore Bocon ETO Sterilizer Details ?](https://zjbocon.com/product/eto-sterilzer/)

**Why Leading Manufacturers Integrate Bocon Systems:**

**Looking to upgrade your sterilization capacity?** [Explore the Technical Specifications of the Bocon ETO Sterilizer Series ?](https://zjbocon.com/product/eto-sterilzer/)

**Headline: From Logistics to Operational Readiness: A Look at Our Latest ETO Installation**

Moving a multi-ton, high-precision ETO (Ethylene Oxide) sterilization chamber requires more than just heavy lifting 攊t requires engineering finesse. ??

At **Bocon**, we don 檛 just manufacture industry-leading sterilizers; we ensure they are integrated into your facility with absolute precision. We recently completed a full-scale installation for a medical device manufacturer, covering:

? **Specialized Logistics:** Safe transport and dual-crane unloading. ? **Technical Maneuvering:** Precision positioning within the workshop. ? **Turnkey Integration:** Ensuring seamless alignment with gas scrubbers and aeration systems.

Our goal is simple: To minimize your facility  downtime and ensure your sterilization plant is ready for **ISO 11135** validation and high-throughput production.

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[Code Compliance: Ethylene Oxide (ETO)](https://zjbocon.com/code-compliance-ethylene-oxide-eto/ "Code Compliance: Ethylene Oxide (ETO)")

[Sterilization Methods for Syringe Filters](https://zjbocon.com/sterilization-methods-for-syringe-filters/ "Sterilization Methods for Syringe Filters")

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## ETO Sterilization Plant Turkey
[Skip to content](https://zjbocon.com/project-spotlight-35m%c2%b3-high-capacity-eto-sterilization-plant-in-turkey/#content)

* * *

# 35m3 High-Capacity ETO Sterilization Plant in Turkey

Bocon recently completed the turnkey installation of a **35m3 ETO sterilization system** for a medical device leader in Turkey, marking another milestone in our global expansion.

### Massive Capacity, Optimized Throughput

The 35m3 chamber is engineered for high-volume pallet sterilization. By processing more units per cycle, our client in Turkey has significantly reduced operational costs and increased supply chain speed.

![35m3 ETO Sterilization Chamber Turkey](https://zjbocon.com/wp-content/uploads/2026/02/35m%C2%B3-High-Capacity-ETO-Sterilization-Plant-in-Turkey-2.webp)

### Precision Control & Safety

Our proprietary control interface ensures every cycle meets **ISO 11135** standards. The system provides real-time monitoring of gas concentration, humidity, and temperature for 100% sterilization efficacy.

![Bocon ETO Control System Panel](https://zjbocon.com/wp-content/uploads/2026/02/35m%C2%B3-High-Capacity-ETO-Sterilization-Plant-in-Turkey-1.webp)

#### Key Project Specifications:

- **Volume:** 35m3 Industrial Grade
- **Compliance:** CE, ISO 11135, FDA Ready
- **Components:** Siemens PLC, High-precision sensors, Explosion-proof design
- **Location:** Turkey (Full On-site Commissioning)

### Advanced Engineering Components

As seen in our Turkish facility installation, Bocon integrates multifunctional heating tanks and robust pneumatic systems to maintain stable environments for sensitive medical materials.

![Pneumatic and Heating Systems Detail](https://zjbocon.com/wp-content/uploads/2026/02/35m%C2%B3-High-Capacity-ETO-Sterilization-Plant-in-Turkey-3.webp)

### Ready for Global Distribution

The system is now fully operational, providing the client with reliable, automated sterilization that passes all international regulatory audits.

![Completed 35m3 ETO Plant View](https://zjbocon.com/wp-content/uploads/2026/02/35m%C2%B3-High-Capacity-ETO-Sterilization-Plant-in-Turkey-5.webp)

## Scale Your Sterilization Potential

From 1m3 to 100m3, Bocon provides customized ETO solutions worldwide.

[View ETO Sterilizer Technical Data ?](https://zjbocon.com/product/eto-sterilzer/)

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## Sterilization Compatibility Overview
[Skip to content](https://zjbocon.com/9276-2/#content)

![](https://zjbocon.com/wp-content/uploads/2026/01/eto_sterilizer_hzbocon_2-1024x1024.webp)

# Sterilization Compatibility of Sterile Barrier Systems

**Technical White Paper**

## 1\. Introduction

The compatibility between sterile barrier systems (SBS) and sterilization processes
is a critical engineering consideration in medical device packaging design.
Inappropriate material-process combinations may lead to insufficient sterilant
penetration, material degradation, or loss of microbial barrier integrity.


This technical white paper focuses on material compatibility principles for
commonly applied sterilization technologies, with particular emphasis on
ethylene oxide (EtO) and low-temperature sterilization processes used for
complex and heat-sensitive medical devices.


## 2\. Sterile Barrier System Requirements

- Permeability to the selected sterilizing agent
- Resistance to thermal, physical, and chemical stresses
- Post-sterilization microbial barrier integrity
- Stability during storage, transport, and handling

## 3\. Sterilization Processes and SAL Considerations

Sterilization processes are validated to achieve a defined Sterility Assurance Level (SAL),
typically 10-6 for medical devices.
Achieving this level of assurance requires alignment between device design,
packaging materials, and sterilization system capability.


## 4\. Overview of Applicable Sterilization Technologies

### 4.1 Ethylene Oxide (EtO) Sterilization

Ethylene oxide sterilization is widely applied for devices sensitive to heat and moisture.
Typical EtO processes operate at 30  60degrees celsius under controlled humidity conditions,
enabling effective sterilization of complex geometries and porous packaging systems.


From an engineering perspective, industrial
[ethylene oxide sterilization systems](https://zjbocon.com/product/eto-sterilzer/)
are designed as integrated solutions combining sterilization chambers,
gas circulation, humidity control, and emission management.


**Figure 1.** Relationship between EtO process parameters
and sterile barrier material permeability.


### 4.2 Low-Temperature Oxidative Sterilization

Vaporized hydrogen peroxide (VHP) and hydrogen peroxide gas plasma systems
provide rapid cycle times and low operating temperatures.
However, their strong oxidative properties impose stricter limitations
on compatible packaging materials compared with EtO sterilization.


## 5\. Material Compatibility Analysis

### 5.1 Porous Materials for Gas Sterilization

Medical grade paper and polyolefin non-woven materials are commonly used
in sterile barrier systems for EtO sterilization due to their controlled
porosity and ability to maintain microbial barrier performance after sterilization.


**Table 1.** Typical packaging materials and compatibility
with EtO and low-temperature sterilization processes.


### 5.2 Films and Composite Structures

Impermeable films and laminated composite materials are widely used in
pouches, reels, and blister packaging.
Compatibility depends on polymer composition, laminate structure,
and resistance to sterilization-induced thermal and chemical stress.


## 6\. Engineering Implications for Sterilization System Design

Packaging material compatibility must be evaluated together with
sterilizer performance, including gas distribution uniformity,
load configuration, and post-sterilization aeration efficiency.


This is particularly important for large-scale production using
[industrial EtO sterilization equipment](https://zjbocon.com/product/eto-sterilzer/),
where process robustness and residue control are critical.


## 7\. Engineering Capability Statement

Engineering teams delivering
[EtO sterilization systems](https://zjbocon.com/product/eto-sterilzer/)
must integrate packaging compatibility considerations into
system design, validation strategy, and environmental control.


## Download

[Download the BOCON Ethylene Oxide Sterilizer Product Catalog (PDF)](https://zjbocon.com/wp-content/uploads/2025/11/BOCON-ETO-STERILIZER.pdf)

**Table 2. Comparison of ethylene oxide and low-temperature oxidative sterilization**
**from a packaging material perspective**

| Comparison Aspect | Ethylene Oxide (EtO) | VHP / H?O? Plasma | Engineering Implications |
| --- | --- | --- | --- |
| Operating Temperature | 30  60 degrees celsius | < 60 degrees celsius | Both suitable for heat-sensitive devices |
| Packaging Material Range | Broad | Limited | EtO compatible with most porous materials |
| Compatibility with Cellulose | Suitable | Not Suitable | Cellulose reacts with hydrogen peroxide |
| Penetration Capability | High | Limited | EtO penetrates complex loads more effectively |
| Cycle Time | Long | Short | EtO requires aeration; VHP optimized for speed |
| Residual Risk | Requires control | Minimal | EtO needs validated aeration |
| Load Complexity | High tolerance | Limited | VHP penetration constraints |
| Material Degradation Risk | Low | Moderate | Oxidative stress affects polymers |
| Typical Applications | Complex medical devices | Simple, low-mass devices | Process selection driven by design constraints |
| Packaging Design Flexibility | High | Restricted | EtO allows wider material selection |

This comparison highlights that sterilization method selection must consider
packaging material compatibility, load complexity, and residual management
requirements in addition to cycle time.


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## Sterile Barrier Compatibility
[Skip to content](https://zjbocon.com/compatibility-of-sterile-barrier-systems-with-sterilization-processes/#content)

![](https://zjbocon.com/wp-content/uploads/2026/01/eto_sterilizer_hzbocon_4-1024x1024.webp)

# Compatibility of Sterile Barrier Systems with Sterilization Processes

In selecting materials for sterile barrier systems for medical devices, ensuring a **Sterility Assurance Level (SAL) of $10^{-6}$** is paramount. This probability indicates there is less than or equal to one chance in a million that an item remains contaminated after terminal sterilization.

## Critical Material Selection Factors

According to SBA guidance, ten essential aspects must be evaluated to maintain the microbial barrier throughout the device  lifecycle:

**Technical Properties:**

- Microbial barrier properties
- Porosity & Physical/chemical traits
- Moisture, Gas, and Light barriers

**Operational Compatibility:**

- Compatibility with the device
- Biocompatibility & Toxicology
- Printing & Labelling systems

**Logistics & Environment:**

- Storage & Transport conditions
- Packing methods (Sealed, Folded, Taped)
- Environmental & Recycling aspects

## Analysis of Sterilization Techniques

| Method | Mechanism | Limitations |
| --- | --- | --- |
| **Heat (Steam/Dry)** | Protein denaturation/oxidation | Aggressive; max 127degrees celsius for many non-wovens |
| **Radiation (Gamma/E-Beam)** | Ionizing DNA damage | Can cause polymer embrittlement or discoloration |
| **Oxidative (VHP/Plasma)** | Surface oxidation | Poor penetration; incompatible with cellulose/paper |
| **Ethylene Oxide (ETO)** | **Alkylation of protein** | **Highly effective for complex, porous loads** |

## Why Ethylene Oxide (ETO) is the Industry Standard

Ethylene Oxide (EO/ETO) is the preferred chemical agent for objects sensitive to temperatures greater than 60degrees celsius or high moisture levels. Key advantages include:

- **Low Temperature Processing:** Typically carried out between 30degrees celsius and 60degrees celsius, preserving the integrity of delicate plastics and electronic components.
- **Superior Penetration:** ETO gas excels at penetrating porous materials like medical-grade paper and polyolefin non-woven materials (e.g., Tyvek).
- **Material Safety:** Unlike radiation, ETO does not cause polymer chain scission or  渁ging   of the packaging material during the cycle.
- **Proven Efficacy:** Effectively kills microorganisms and spores by interfering with normal metabolism and reproductive processes (alkylation).

_Note: For effective ETO sterilization, the use of porous barrier materials is essential to allow gas exchange and post-cycle aeration._

### Optimizing Your ETO Sterilization Workflow

Understanding the interaction between your sterile barrier and the gaseous sterilant is the first step. The second step is utilizing high-precision hardware that can manage gas concentration (200-800 mg/L) and humidity (>30%) with absolute consistency.

[View BOCO Industrial ETO Sterilizer Solutions](https://zjbocon.com/product/eto-sterilzer/)

References: Based on SBA Guidance Document    Compatibility of materials used for Sterile Barrier Systems with sterilization processes.


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## Comparison of Sterilization Methods
[Skip to content](https://zjbocon.com/comparison-of-medical-sterilization-methods/#content)

![](https://cdn-ilbpffd.nitrocdn.com/bohLJiJcgiLJnRpcarhVkxKWAakkhLNM/assets/images/optimized/rev-fd15146/zjbocon.com/wp-content/uploads/2026/02/eto-sterilization-vs.-other-methods.webp)

Sterilization Landscape OverviewSteamPlasmaRadiationETO

| Method | Temperature | Typical Cycle Time | Key Application |
| --- | --- | --- | --- |
| **ETO** | Low (37-63degrees celsius) | 12-24 Hours | Heat-sensitive, Complex Lumens |
| **Steam** | High (121-132degrees celsius) | 30-60 Mins | Reusable Metal Tools |
| **Plasma** | Low (<50degrees celsius) | <75 Mins | Electronics, Delicate Scopes |
| **Radiation** | Ambient | Continuous | Single-use Bulk Plastics |

## 1\. Steam Sterilization (Autoclave)

Steam sterilization uses high-pressure saturated steam to kill microorganisms. It is the oldest and most reliable method for heat-stable items.

#### Pros

- Nontoxic to staff & environment
- Rapidly microbicidal and cycle time
- Low cost per cycle

#### Cons

- Damage heat-sensitive devices
- Risk of rusting & potential burns
- Incompatible with most plastics

## 2\. Gas Plasma Sterilization

Uses low-temperature hydrogen peroxide gas plasma. Excellent for moisture-sensitive items.

#### Pros

- No toxic residuals (Aeration not needed)
- Safe for electronic components
- Simple installation (plug-and-play)

#### Cons

- Not for cellulose, linens, or liquids
- Restricted lumen length/diameter
- Hydrogen peroxide concentration limits

## 3\. Dry Heat Sterilization

Sterilization via hot air. It is slow and requires high temperatures, making it niche for powders or oils.

## 4\. Radiation (Gamma/E-Beam)

#### Pros

- Penetrates final sealed packaging
- Continuous processing (High volume)
- No chemical residues

#### Cons

- High capital investment (Nuclear reactor)
- Can degrade certain plastics/glues
- Complex regulatory licensing

## 5\. Chemical (NO2 / ClO2)

Emerging surface sterilants primarily used for room decontamination and some heat-sensitive items.

## 6\. ETO Sterilization (Ethylene Oxide)

ETO is the gold standard for complex, multi-component medical devices. It is highly effective at low temperatures, ensuring material integrity.

#### Why Choose ETO?

- **Ultimate Compatibility:** Validated for 50,000+ devices.
- **Deep Penetration:** Best for long lumens and complex geometries.
- **Material Care:** Safe for batteries, delicate optics, and polymers.

#### Considerations

- Longer cycle (requires aeration)
- Requires specialized gas handling

Optimize Your Sterilization Process Today

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## Spice Sterilization Methods
[Skip to content](https://zjbocon.com/three-primary-sterilization-methods-for-spices/#content)

![](https://zjbocon.com/wp-content/uploads/2024/10/advantage-and-disadvantage-between-eto-sterilization-irradiation-and-steam-in-spice-sterilization-1-1024x576.webp)

| Method | Chemical Free? | Quality Preservation | Cost Efficiency |
| --- | --- | --- | --- |
| **ETO Gas** | No (Gas used) | High (Preserves color/flavor) | Excellent (High volume) |
| **Irradiation** | Yes | Very High | Expensive |
| **Steam** | Yes | Low (Heat/moisture damage) | Moderate |

## 1\. Ethylene Oxide Sterilization (ETO)

The product is exposed to ETO gas under controlled conditions in a vacuum chamber. This is currently the most versatile choice for large-scale spice processing.

Capacity: 1    35 Tons per cycle (1-36 pallets)

#### ? Advantages

- **Cost-Effective:** Massive cost reduction when processing large volumes.
- **In-house Control:** Purchasing the machine allows you to manage the entire sterilization process yourself.
- **Quality Integrity:** Minimal impact on the spice  essential oils and natural appearance.

#### ?? Disadvantages

- **Cycle Time:** Longer process time (can be optimized with pre-heating and aeration rooms).
- **Regulatory:** Requires specific safety protocols for gas handling.

## 2\. Irradiation (Gamma Rays / E-Beam)

Exposing spices to high-energy radiation to eliminate bacteria and pathogens.

#### ? Advantages

- **Highest Efficacy:** Extremely effective at killing all microorganisms.
- **Chemical-Free:** No chemical residues left on the spices.

#### ?? Disadvantages

- **Consumer Perception:** Requires  淚rradiated   labeling which may be unappealing to customers.
- **High Costs:** Expensive equipment and potential damage to packaging materials.

## 3\. Steam Sterilization

A natural process using hot water steam in a controlled environment to heat the product.

#### ? Advantages

- **Clean Label:** 100% natural, no chemicals or radiation involved.
- **Fast:** Relatively quick processing time.

#### ?? Disadvantages

- **Quality Loss:** High heat can change the color and flavor profile.
- **Moisture Risk:** Can result in caking, molding, or clumping if not handled perfectly.

### Ready to Scale Your Spice Sterilization?

Our industrial ETO sterilization machines offer the lowest cost-per-ton for large volume spice processing.

[Explore Industrial ETO Solutions ?](https://zjbocon.com/eto-sterilizer-products)

Customized solutions for 1 to 36 pallets. High density spice optimization available.

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## Syringe Filter Sterilization
[Skip to content](https://zjbocon.com/sterilization-methods-for-syringe-filters/#content)

**Sterile syringe filters** are critical components in pharmaceuticals, fermentation, biological products, and the food & beverage industry. Choosing the correct sterilization method is essential to ensure the maximum safety and integrity of your filtered products.

| Feature | ETO Sterilization | Gamma Sterilization |
| --- | --- | --- |
| **Mechanism** | Metabolic Destruction | DNA Alteration |
| **Residue Control** | Requires Aeration & Scrubbing | Zero Residue |
| **Equipment Safety** | Flammable Gas Handling | Irradiation Shielding |
| **Visual Integrity** | No Change | Potential Slight Yellowing |

## 1\. ETO (Ethylene Oxide) Sterilization

![BOCON Ethylene Oxide Sterilization Process](https://zjbocon.com/wp-content/uploads/2025/09/ethylene-oxide-sterilization-64.webp)

#### ? Performance Advantages

ETO sterilization causes microbial death by disrupting bacterial metabolism. It is the industry standard for heat-sensitive plastics, ensuring the syringe filter  structure remains intact.

#### ?? Safety & Residue Management

Toxic Residues: Must be carefully aerated to bring concentrations below national safety standards.

**BOCON Solution:** We offer professional [EO Scrubber systems](https://zjbocon.com/product/eo-scrubber/) designed to effectively neutralize EO gas residues, ensuring a safe working environment and environmental compliance.


## 2\. Gamma Ray Sterilization

#### ? Key Advantages

- **Non-toxic:** Zero chemical residue and no ventilation required.
- **Immediate Usage:** Syringe filters can be dispatched or used immediately after irradiation.
- **High Efficacy:** Deep penetration leads to complete cell activity loss in microorganisms.

#### ?? Limitations

- **Physical Change:** Post-sterilization, white syringe filters may appear slightly yellowish.
- **Capital Cost:** High initial investment for equipment and infrastructure.

**Pro Tip:** Slight yellowing after Gamma sterilization is a common physical reaction and does not affect the filtration performance or sterility of the syringe filter.


### Reliable Sterilization Solutions by BOCON

Looking for high-efficiency ETO sterilizers or professional residue treatment systems? We provide end-to-end solutions for medical and laboratory industries.

[Explore Our ETO Sterilization Solutions ?](https://zjbocon.com/product/eto-sterilzer/)

ISO Certified \| Advanced Safety Systems \| Global Technical Support

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## Ethylene Oxide Compliance
[Skip to content](https://zjbocon.com/code-compliance-ethylene-oxide-eto/#content)

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## 1\. Receiving and Unloading Procedures

Compliance with subsection 14.2 is mandatory for both full and empty ETO containers.

#### Safety Checkpoints

- Vehicle engines must be **OFF**, brakes set, and wheels chocked.
- No smoking or open flames within 25 ft (7.62 m).
- Containers must be kept **UPRIGHT** at all times.

#### Handling Prohibitions

- **NO Stacking:** Containers must never be stacked or rolled.
- **Forklift Safety:** Do not lift drums by placing forks under chime rings.

## 2\. Storage Standards

**Indoor Storage Limit:** The maximum quantity of ETO in a sterilization building is 10,000 lb (4536 kg).

#### Indoor Areas

- Classified for ignition source control (Class I, Div 2).
- Spot heating limit: 125Fahrenheit (51.7degrees celsius).

#### Outdoor Areas

- 25% of perimeter must be open to atmosphere.
- Clear of dry vegetation for 15 ft (4.6 m).
- Provide protection from vehicle damage.

## 3\. Piping Systems & Gas Dispensing

All metallic piping must comply with **ASME B31.3 (Process Piping)** and have a minimum melting point of 1500Fahrenheit (815.6degrees celsius).

**? Critical Gas Detection:** Indoor dispensing areas must have a continuous gas detection system. Alarms must trigger when levels exceed 25% of the LFL (7500 ppm).

#### Ventilation Rate

Mechanical ventilation must operate continuously at no less than 1 scf/min t虏 of floor area.

#### Shutoff Valves

Each system requires two remotely operated shutoff valves. The first must be within 5 ft (1.5 m) of the container.

## 4\. Disposal and Emission Control

Compliance with Section 14.9 ensures environmental safety and effective ETO neutralization.

#### Wet Scrubbers

Must be designed so solution cannot enter process lines. Pure liquid ETO must never feed directly into gas-treatment scrubbers.

#### Catalytic Converters

Must include automatic shutdown if temperature exceeds catalyst supplier limits.

**BOCON Compliance Solution:** To meet California  stringent emission standards, our [EO Scrubber Systems](https://zjbocon.com/product/eo-scrubber/) are engineered to provide maximum neutralization efficiency, preventing any solution backflow and maintaining 25% LFL safety interlocks.

## 5\. Construction & Fire Safety

- **Explosion Venting:** Structures must have non-combustible construction and explosion control per Section 6.10.
- **Fire Suppression:** ETO storage areas must be protected by a **Deluge System** in accordance with NFPA 16.
- **Bonding:** All piping must be bonded to an earth ground to control static electricity.

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## Ethylene Oxide Audit Checklist
[Skip to content](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#content)

# Ethylene Oxide Sterilization Audit Checklist (ISO 11135)

This professional audit checklist is designed for medical device manufacturers and quality auditors to evaluate **Ethylene Oxide (EO) sterilization processes**. It ensures full compliance with **ISO 11135-1** and **ISO 13485** standards.

[1\. Scope](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec1) [2\. Responsibilities](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec2) [3\. Evaluation Approach](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec3) [4\. QM Systems](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec4) [5\. Agent Characterization](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec5) [6\. Process/Equipment](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec6) [7\. Product Definition](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec7) [8\. Process Definition](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec8) [9\. Validation (IQ/OQ/PQ)](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec9) [10\. Routine Monitoring](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec10) [11\. Product Release](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec11) [12\. Effectiveness](https://zjbocon.com/ethylene-oxide-sterilization-audit-checklist-iso-11135/#sec12)

## 1\. Scope

This checklist is applicable for sterilization processes for medical products carried out with ethylene oxide. For sterile products of **Risk Class III**, documentation of design and validation must be examined. A sterilization assessment must be carried out based on at least one product file.

## 2\. Responsibilities and Authority

### Lead Auditor

Responsible for the examination of the QM system regarding ISO 13485 and Council Directive 93/42/EWG. The lead auditor supervises the audit team and ensures DQS process compliance.

### Technical Expert

Responsible for product-specific evaluation, specifically focusing on design documentation and the validation of sterilization procedures.

## 3\. Approach to the Evaluation

The goal is to examine fulfillment of **ISO 11135-1**. Results must be formulated in the audit report with reference to this checklist.

**Evaluation Key:** 1 = Fulfilled \| 2 = Partially (Acceptable) \| 3 = Partially (Not Acceptable) \| 4 = Not Fulfilled \| NA = Not Applicable


| Clause | Audit Question / Requirement | Evaluation |
| --- | --- | --- |
| 4\. Quality Management Systems |
| 4.1 Documentation |
| 4.1.1 | Have procedures for the design, validation, routine control and product release from sterilization been specified? |  |
| 4.1.2 | Are all documents and records according to ISO 11135-1 reviewed, approved and controlled? |  |
| 4.2 Management Responsibility |
| 4.2.1 | Are responsibilities and authorities specified and assigned to qualified persons? |  |
| 4.2.2 | Is there a contract agreement if several organizations are involved? |  |
| 4.3 Product Realization |
| 4.3.1-2 | Are procedures for purchasing, identification and traceability specified? |  |
| 4.3.3 | Is a system for calibration of all equipment and testing instruments specified? |  |
| 4.4 Measurement, Analysis and Improvement |
| 4.4 | Are procedures for control of nonconforming product and corrective/preventive actions specified? |  |
| 5\. Sterilizing Agent Characterization |
| 5.1 | Are the composition, storage conditions and storage length specified for the EO agent? |  |
| 5.2 | Is the microbicidal effectiveness worked out if non-standard compositions are used? |  |
| 5.3 | Assessment of effects on the product according to Section 7. |  |
| 5.4.1 | Documented environmental effect evaluations and monitoring actions? |  |
| 5.4.2 | Observance of local/national regulations regarding EO emission and disposal? |  |
| 6\. Process and Equipment Characterization |
| 6.1.2 | Does characterization include preconditioning, cycle, and ventilation? |  |
| 6.1.3 | Does cycle include air removal, EO addition, maintenance, and rinsing? |  |
| 6.1.4 | Is (pre)treatment carried out under controlled humidity and temperature? |  |
| 6.1.5-6 | Are process variables (temp, humidity, EO conc, time) specified with tolerances? |  |
| 6.2.1-2 | Equipment specification documented including description of all monitoring instruments? |  |
| 6.2.3 | Software evidence of correspondence with specifications (ISO 9000-3)? |  |
| 6.2.4 | Does control function failure NOT affect the recording function? |  |
| 7\. Product Definition |
| 7.1.1-2 | Actions taken for new/changed products or loading configurations? Equivalence documented? |  |
| 7.1.3-5 | Permeation/removal of EO in parts most difficult to sterilize proven? |  |
| 7.2.1-5 | Product safety: influence of multiple sterilization, biological safety (ISO 10993), and EO residues? |  |
| 7.3.1-2 | Bioburden estimation (ISO 11737-1) and cleaning efficiency evaluation (ISO 17664)? |  |
| 8\. Process Definition |
| 8.1-4 | Sterilization process specified and supported by IQ/PQ documentation? |  |
| 8.5-7 | Microbial effectiveness determined (Annex A/B)? BI indicators comply with ISO 11138? |  |
| 8.8-9 | Chemical indicators (ISO 11140) and sterility exams (ISO 11737-2) compliance? |  |
| [9\. Validation (IQ, OQ, PQ)](https://zjbocon.com/qualification-services/) |
| 9.1 Installation Qualification (IQ) |
| 9.1.1-6 | Equipment compliance, technical schemes, and installation site specifications established? |  |
| 9.2 Operation Qualification (OQ) |
| 9.2.1-2 | Proof of equipment ability to perform within tolerances; calibration confirmed? |  |
| 9.3 Performance Qualification (PQ) |
| 9.3.1-3 | Consistent function evidence, microbiological PQ, and physical PQ (3 consecutive runs)? |  |
| 9.4 | Changes to loading configuration evaluated for SAL impact? |  |
| 9.5.1-6 | Validation report review and approval; parametric release criteria specified? |  |
| 10\. Routine Monitoring and Control |
| 10.1 | Monitoring of temperature, pressure, humidity, EO concentration, and gas circulation? |  |
| 10.2 | Parametric release: 2-point temperature measurement and direct EO analysis? |  |
| 11\. Product Release from Sterilization |
| 11.1 | Documented criteria for conformity (data records vs specification)? |  |
| 11.2 | Handling of nonconforming products (ISO 13485) if variables or BI fail? |  |
| 12\. Maintaining Process Effectiveness |
| 12.1-2 | Periodic efficiency proof and preventive maintenance planning? |  |
| 12.3.1-8 | Reassessment procedure (annual for parametric release); BI suitability checks? |  |
| 12.4.1-3 | Assessment of changes (equipment/product/agent) and validation extent definition? |  |

* * *

_Disclaimer: This checklist is a guide. Always refer to the official ISO 11135:2014 standard for regulatory submissions._

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