医疗器械生产企业洁净检测分析  

Cleaning Test for Medical Device Manufacturers

作　　者：梁谋[1] 宣泽[1] 刘欢[1] 付杉杉 李佳 江志杰[1] LIANG Mou;XUAN Ze;LIU Huan;FU Shanshan;LI Jia;JIANG Zhijie(Beijing Institute for Drug Control·NMPA Key Laboratory of Research and Evaluation of Generic Drugs·Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing,China 102206)

机构地区：[1]北京市药品检验所·国家药品监督管理局仿制药研究与评价重点实验室·北京市中药成分分析与生物评价重点实验室,北京102206

出　　处：《中国药业》2022年第6期28-30,共3页China Pharmaceuticals

摘　　要：目的为医疗器械生产企业的高效生产运行提供参考。方法筛选2020年71家医疗器械生产企业洁净检测数据,参照相关标准,收集洁净室数量及面积、温度和相对湿度、换气频率、静压差、沉降菌数、尘埃粒子数,并分析洁净检测现场发现的问题。结果共检测洁净区249个,洁净室2384间,其中十万级洁净室1215间,万级洁净室1169间。各十万级和万级洁净室的温度、相对湿度、换气频率、尘埃粒子数均符合要求;静压差符合要求的房间分别有201间和179间,静压差均以11~20 Pa为主;分别有236间和120间洁净室检出沉降菌,检出菌数分别以1~2个/皿(143间)及1个/皿(56间)为主,检出房间分别以二更间(52间)和缓冲间(40间)较多。结论医疗器械生产企业在日常生产过程中,应加强洁净厂房洁净技术参数的监测和设备的维护管理,注重洁净室(区)的设计和施工,以促进生产的高效运行,保障医疗器械产品的质量。Objective To provide a reference for the efficient production and operation of medical device manufacturers.Methods The cleaning test data of 71 medical device manufacturers in 2020 were selected,and the number and area of clean rooms,temperature and relative humidity,ventilation frequency,static pressure difference,number of sedimentation bacteria and dust particles were collected according to relevant standards,and the problems found in the field of cleaning test site were analyzed.Results A total of 249 clean zones and 2384 clean rooms were tested,including 1215 class 100000 clean rooms and 1169 class 10000 clean rooms.The temperature,relative humidity,ventilation frequency and dust particle number of each class 100000 and class 10000 clean room met the requirements.Among the class 100000 and class 10000 clean rooms,201 and 179 clean rooms which static pressure difference met the requirements,and the static pressure difference was in the range of 11-20 Pa,236 and 120 clean rooms were detected with sedimentation bacteria,mainly one or two each culture vessel(143 clean rooms)and one each culture vessel(56 clean rooms)were detected,respectively.The rooms where sedimentation bacteria were detected were mainly two watch rooms(52 rooms)and buffer rooms(40 rooms).Conclusion In the process of daily production,medical device manufacturers should strengthen the monitoring of cleaning technical parameters and the maintenance management of equipments,and pay attention to the design and construction of clean room(zone),so as to promote the efficient operation of production and ensure the quality of medical device products.

关 键 词：医疗器械 生产企业 洁净室 洁净检测 

分 类 号：R955[医药卫生—药学]