环氧乙烷灭菌设备物理参数校准及结果分析

Test and Result Analysis of Ethylene Oxide Sterilization Equipment

环氧乙烷灭菌设备是一种利用环氧乙烷气体进行灭菌的设备,因环氧乙烷灭菌效果良好而广泛应用于医疗器械的灭菌。为了保证灭菌效果,对环氧乙烷灭菌过程的监测和评价显得尤为重要。本文依据JJF(鄂)68-2020《环氧乙烷灭菌设备校准规范》,采用具有防爆功能的温度、湿度、压力记录器对环氧乙烷灭菌设备物理参数进行了校准,并对充入环氧乙烷和氮气的两种校准条件的结果进行对比分析。结果显示,采用氮气等惰性气体进行环氧乙烷替代,可以进一步提高环氧乙烷灭菌设备校准的安全性,避免计量人员受到环氧乙烷气体的毒性危害,具有可行性。采用物理检测对环氧乙烷设备的温度、相对湿度和压力的物理参数进行校准,成本低廉并有助于发现设备本身存在的故障和问题。

Ethylene oxide sterilization equipment is a kind of equipment that uses ethylene oxide gas to sterilize.It is widely used in the sterilization of medical instruments because of its good sterilization effect.In order to ensure the sterilization effect, it is particularly important to monitor and evaluate the sterilization process of ethylene oxide.There are chemical monitoring and biological monitoring methods commonly used to monitor the sterilization effect of ethylene oxide, but due to the limitations of these two monitoring methods, physical detection method has certain advantages in this paper.According to JJF(E) 68-2020 "Specification for Calibration of Ethylene Oxide Sterilization Equipment", the temperature, humidity and pressure recorders with explosion-proof function were used to calibrate the physical parameters of ethylene oxide sterilization equipment, and the results of two calibration conditions filled with ethylene oxide and nitrogen were compared and analyzed.The results showed that: Using nitrogen and other inert gases to replace ethylene oxide can further improve the safety of ethylene oxide sterilization equipment calibration, and avoid the toxicity of ethylene oxide gas to the metering personnel.Three sets of ethylene oxide sterilization equipment were monitored and the results were analyzed, and the physical detection was mainly used to monitor and calibrate the physical parameters of the temperature, relative humidity and pressure of the ethylene oxide equipment, which was low cost and helpful to find the faults and problems of the equipment itself.