医疗器械环氧乙烷灭菌关键质量控制点探析

Key Quality Control Points in Ethylene Oxide Sterilization of Medical Devices

目的提高医疗器械环氧乙烷灭菌的安全性和有效性。方法分析材料的耐受性、灭菌温度、相对湿度、环氧乙烷浓度、作用时间、包装材料等关键质量控制点对医疗器械环氧乙烷灭菌效果的影响。结果环氧乙烷灭菌材料的适应性较好,适宜的灭菌条件为温度30~60℃,相对湿度40%~80%,环氧乙烷浓度300~1 000 mg/L,灭菌时间应至少为医疗器械半周期的2倍,包装材料应根据自身产品特点选择。结论生产企业在采用环氧乙烷对医疗器械进行灭菌时,必须准确把握材料的耐受性、灭菌温度、相对湿度、环氧乙烷浓度、作用时间、物品包装材料等关键质量控制点,才能达到预期的灭菌效果。

Objective To improve the safety and effectiveness of ethylene oxide sterilization of medical devices.Methods The effect of key quality control points such as material tolerance,sterilization temperature,relative humidity,ethylene oxide concentration,action time and packaging materials on ethylene oxide sterilization of medical devices were analyzed.Results The ethylene oxide sterilization material has good adaptability.The suitable sterilization conditions were as follows:the temperature was in the range of30-60℃,the relative humidity was in the range of 40%-80%,the ethylene oxide concentration was in the range of 300-1 000 mg/L,the sterilization time should be at least twice the half cycle of medical devices,and the packaging materials should be selected according to their product characteristics.Conclusion When using ethylene oxide to sterilize medical devices,manufacturers must accurately grasp the key quality control points such as material tolerance,sterilization temperature,relative humidity,ethylene oxide concentration,action time and article packaging materials as to achieve the expected sterilization effect.