药品洁净室生物负载信息的采集与分析  

Collection and Analysis of Bioburden Information in Pharmaceutical Clean Room

作　　者：陈伟盛[1] 朱荣峰[1] 关倩明[1] 

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国药师》2015年第6期1046-1048,共3页China Pharmacist

摘　　要：目的:对洁净室生物负载信息进行采集,了解洁净室的微生物负载状况,查找洁净室中微生物控制的薄弱环节及风险,提高洁净室管理效率。方法:按照GB/T 16293-2010及本所实验室的环境菌检测规程,对洁净室主要区域(微生物限度检查、无菌1室、无菌2室、阳性接种)及进入该区域人员的浮游菌和表面菌进行采集与鉴定,获取生物负载信息。结果:初步建立生物负载数据信息,发现洁净室主要的生物负载是微球菌与葡萄球菌,真菌检出率约为5%。结论:洁净室需要加强控制人流物流,并且存在样品消毒不彻底的风险。Objective： To collect the bioburden information in clean room to understand the bioburden status, find out weak points and risks in microbial control and improve the management efficiency in clean room. Methods： According to GB/T 16293-2010 and the standard operation practice （SOP） in our lab, the bioburden information was obtained by the collection and identification of airborne microbe and surface bacteria in the four main areas of clean room （microbial limit test room, sterile room 1 and 2, positive room） and on the person entered clean room. Results： The preliminarily established bioburden information indicated that the main microorganism in clean room was Micrococcus and Staphylococcus. The detection rate of fungi was about 5% in clean room. Conclusion： The movement of people and goods in clean room should be strengthened, and samples should be with thorough disinfection.

关 键 词：生物负载 洁净室 风险评估 微生物鉴定 

分 类 号：TQ460.72[医药卫生—药物分析学]