关于医疗器械生产企业无菌检测室设置问题的探讨  

Discussion on Microbiological Laboratory Layout in Medical Devices Industry

作　　者：马云鹏[1,2] 叶桦[1] 

机构地区：[1]复旦大学药学院,上海201203 [2]微创医疗器械(上海)有限公司

出　　处：《中国药事》2012年第3期245-247,270,共4页Chinese Pharmaceutical Affairs

摘　　要：目的结合医疗器械生产企业的实际情况,提出完善《医疗器械生产质量管理规范》对无菌检测室要求的建议。方法讨论无菌检测室功能,分析法规要求的不足及操作可行性。结果与结论为防止潜在的交叉污染,无菌室和微生物限度实验室可选择空间隔离,亦可选择同室错时的方法;阳性对照室既应考虑到建造的房间,也需包括生物安全柜。Objective Based on the current medical device industry levels and status,some suggestions were made to improve the microbiological laboratory layout under GMP for medical devices.Methods The functions of each laboratory were discussed,related GMP and implementation feasibility were analyzed.Results and Conclusion Both isolated spaces between sterility test room and microbiological limit room replaced by one room introducing reasonable time sharing for both tests were accepted in order to avoid potential cross contaminations;positive control room requirements should also include biosafety cabinet besides structural room.

关 键 词：医疗器械 医疗器械生产质量管理规范 无菌检测室 交叉污染 

分 类 号：R955[医药卫生—药学]