细胞培养洁净厂房的验证及验收  

Validation and acceptance of cleanroom for cell culture

作　　者：宣泽 庞逸辉 徐婷婷 张光华 江志杰 Xuan Ze;Pang Yihui;Xu Tingting;Zhang Guanghua;Jiang Zhijie(Beijing Institute for Drug Control(Beijing Center for Vaccine Control),NMPA Key Lab.for Research and Evaluation of Generic Drugs,Beijing Key Lab.of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院(北京市疫苗检验中心),国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《首都食品与医药》2024年第16期127-129,共3页Capital Food Medicine

摘　　要：细胞培养的首要条件是无菌,必须保证工作环境无微生物污染且不受其他有害因素的影响,因此细胞培养洁净厂房的验证及验收尤为重要.目前对于细胞培养洁净室的验收还没有具体的规定,操作时很难统一,建立细胞培养洁净厂房的验证及验收规范很有必要.依据长期工作实践,笔者拟定了细胞培养洁净厂房的验证及验收规范,供大家参考.The primary condition of cell culture is sterility,and it is necessary to ensure that the working environment is free of microbial contamination and is not affected by other harmful factors,so the verification and acceptance of cell culture clean room is particularly important.At present,there is no specific regulation for the acceptance of cell culture clean room,and it is difficult to standardize the operation,so it is necessary to establish the validation and acceptance specification of cell culture clean plant.According to the long-term work practice,we formulated the cell culture clean room verification and acceptance specifications,for your reference.

关 键 词：细胞培养室 洁净厂房 验收规范 悬浮粒子 微生物 

分 类 号：R197.39[医药卫生—卫生事业管理]