30 m³ eto gas sterilizer
30 m³ eto gas sterilizer
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.ModelInternal Chamber Dimensions (L×W×H) (mm) ±1%Nominal Volume (m³)
Power (kW)Weight (kg)Power Supply
1BCS-11400*700*10001m³161000380V/50Hz
2BCS-21650*1000*12002m³162000380V/50Hz
3BCS-31400*1350*17003.0m³163000380V/50Hz
4BCS-4.52000*1350*17004.5m³274000380V/50Hz
5BCS-52250*1350*17005m³274500380V/50Hz
6BCS-62700*1350*17006m³275000380V/50Hz
7BCS-83500*1350*17008m³276000380V/50Hz
8BCS-104500*1350*170010m³437000380V/50Hz
9BCS-155500*1350*200015m³569000380V/50Hz
10BCS-207500*1350*200020m³8112000380V/50Hz
11BCS-269600*1350*200026m³8114000380V/50Hz
12BCS-2812500*1350*170028m³9014000380V/50Hz
13BCS-3011300*1350*200030m³9017000380V/50Hz
14BCS-30-25600*2700*200030m³-29016000380V/50Hz
15BCS-3513000*1350*200035m³10023000380V/50Hz
16BCS-35-26000*2700*220035m³-210022000380V/50Hz
17BCS-40-26650*2700*220040m³-210023000380V/50Hz
18BCS-4812850*1400*270048m³10028000380V/50Hz
19BCS-5213900*1400*270052m³15028000380V/50Hz
20BCS-55-27500*2700*270055m³-215027000380V/50Hz
21BCS-57-29650*2700*220057m³-215028000380V/50Hz
22BCS-63-28650*2700*270063m³-215029000380V/50Hz
23BCS-70-29700*2700*270070m³-215532000380V/50Hz
24BCS-78-210750*2700*270078m³-216535000380V/50Hz
25BCS-86-211800*2700*270086m³-216538000380V/50Hz
26BCS-101-217050*2700*2200101m³-220045000380V/50Hz
27BCS-120-220200*2700*2200120m³-220049000380V/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

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