环氧乙烷灭菌过程等效应用探讨  

Discussion on Application of Ethylene Oxide Sterilization Process Equivalence

作　　者：冯坤 张晓光 邓萍萍 杨萌 FENG Kun;ZHANG Xiao-guang;DENG Ping-ping;YANG Meng(Tianjin Fareast Medical Co.,Ltd.,Tianjin 301508;Center for Medical Device Evaluation and Inspection,Tianjin 300191)

机构地区：[1]天津市远东医材有限公司,天津301508 [2]天津市医疗器械审评查验中心,天津300191

出　　处：《中国医疗器械信息》2023年第21期32-35,共4页China Medical Device Information

摘　　要：目的:探讨在实际应用中环氧乙烷灭菌过程等效的应用情况。方法:使用同一厂家生产的6m^(3)和30m^(3)环氧乙烷灭菌设备对一次性医用外科口罩为代表的防护类产品进行的过程等效验证。结果:一次性使用医用外科口罩在6m^(3)设备上确认得到的工艺参数可以等效到30m^(3)设备上。结论:企业可通过过程等效验证对口罩类防护产品进行紧急环氧乙烷灭菌。Objective:To discuss the application of ethylene oxide sterilization process equivalence.Methods:6m^(3) and 30m^(3) ethylene oxide sterilization equipment produced by the same manufacturer were used in process equivalence verification on the prevention product family represented by disposable surgical masks.Results:The process parameters confirmed on the 6m^(3) equipment can be equivalent to 30m^(3) on the disposable surgical mask.Conclusion:Enterprises can perform emergency ethylene oxide sterilization of mask-type prevention products through process equivalence verification.

关 键 词：环氧乙烷灭菌 无菌 一次性使用医用外科口罩 过程等效 

分 类 号：Q93-334[生物学—微生物学]