摘要
目的对洁净室核心区域进行动态微生物监测,分析影响动态微生物控制的因素,探索无菌检查的规范操作规程。方法依据中国药典2015年版4部9205药品洁净实验室微生物监测和控制指导原则以及GB/T16293-4-2010对无菌检查洁净区核心区域进行动态微生物监测,包括沉降菌、浮游菌和表面微生物。结果初步建立了有效控制动态微生物的方法。结论动态微生物监测更能反映真实的环境情况,操作人员应重视无菌操作过程中的细节,减少微生物污染。
OBJECTIVE Dynamic microbial monitoring is performed in the core district of the clean room, analyze the factors affecting the dynamic microbial control, and explore the standard operation process of sterility test. METHODS By adopting Chapter 9205 which was the guiding principles of monitoring and controlling microorganism in drug clean room in Chinese Pharmacopoeia(2015) and the national standard of GB/T16293-4-2010, carry out dynamic microbial monitoring in the core district of the clean room, including precipitating bacterial, floating bacteria and microorganism in the surface. RESULTS An effective way of controlling microorganism was established tentatively. CONCLUSION Dynamic microbial monitoring is more able to present the real environment situation, and the laboratory technician should pay more attention to the details in the process of aseptic operation so as to reduce microbial contamination.
作者
卢蓉娜
LU Rongna(Food and Drug Administration of Shunde District,Foshan,Guangdong 528300,China)
出处
《今日药学》
CAS
2018年第12期820-823,共4页
Pharmacy Today
关键词
洁净室
动态
微生物监测
影响因素
clean room
dynamic
microbial monitoring
affecting factors
