Specifikime të plota teknike të sistemeve të sterilizimit HZBOCON ETO

Në HZBOCON, we deliver industrial-scale, turnkey ETO sterilization solutions. For comprehensive corporate details and global partnerships, please visit hzbocon.com.

1. Company Profile & Compliance Standards

With over 20 years of expertise, HZBOCON is a trusted partner for medical device manufacturers worldwide. Our systems are fully compliant with ISO 11135 dhe ISO 13485 standards, and hold CE/MDR certifications. We provide the only Chinese-manufactured ETO systems currently serving the highly regulated US market, ensuring robustness in both PED and ATEX environments.

2. Sterilizer Design & Structural Integrity

Our sterilizers feature a horizontal rectangular chamber design (SS316L internal, SS304 external) with 8mm thickness. Built for a 30+ year lifespan, the systems are modular, allowing for future expansion of preconditioning and aeration units. Reliability is guaranteed by a stringent leak rate (not exceeding 2Kpa after 12 hours) and pneumatic inflatable door gaskets with real-time pressure monitoring.

3. Precision Environmental & Process Control

HZBOCON systems excel in environmental stability. The preconditioning phase maintains temperature and humidity with ±2-3°C/±5%RH accuracy, supported by an internal circulation system that exceeds 60 cycles per hour. During sterilization, our fully automatic injection system manages gas concentrations between 400-1000mg/L, controlled by a high-precision PID loop. Safety is maintained through continuous pressure monitoring and automatic N2 replacement processes.

4. Aeration & Residual Management

We prioritize product safety through efficient aeration. The process uses fresh air exchanges (7-15 times/hour) at controlled temperatures (30-60°C) to ensure EO residuals strictly meet ISO 10993-7 kërkesat. Ciklet tona automatike të larjes së ajrit garantojnë që produkti përfundimtar të jetë i sigurt për daljen në treg.