制药企业环境菌库建立的探讨  

Discussion on the Establishment of Environmental Bacterial Bank in Pharmaceutical Enterprises

作　　者：郭心怡 林燕 曹长雷[2] 陈文俊 GUO Xinyi;LIN Yan;CAO Changlei;CHEN Wenjun(Hualan Biologogical Engineering Chongqing Co.,LTD.,Chongqing Fuling 408100;College of Life Science and Technology,Yangtze Normal University,408100)

机构地区：[1]华兰生物工程重庆有限公司,重庆涪陵408100 [2]长江师范学院生命科学与技术学院,重庆涪陵408100

出　　处：《工业微生物》2023年第2期86-88,共3页Industrial Microbiology

摘　　要：建立制药企业环境菌库。连续4年从药品生产洁净区环境和操作人员表面、制药用水系统、合并血浆、产品和原/辅料中收集微生物,对微生物进行分离纯化,采用生化鉴定、基因测序分析系统对微生物进行鉴定,再采取适当的方法加以保存,建立企业的环境菌库。通过对4年的微生物数据进行整理和分析,环境菌库共收集了111种微生物,保存了176株微生物,建立了企业环境菌库。建立企业环境菌库,可为开展微生物污染控制、消毒效果评价、污染事件调查和微生物污染溯源提供数据和技术支持。To establish the environmental bacterial bank in pharmaceutical enterprises.Microorganisms were collected from the clean environment of drug production area and the surface of operators,pharmaceutical water system,pooled plasma,products and raw/auxiliary materials for 4 consecutive years.The microorganisms were separated and purified,identified by biochemical identification and gene sequencing analysis system,and then preserved by appropriate methods to establish the environmental bacteria bank of the enterprise.A total of 111 kinds of microorganisms were collected and 176 strains of microorganisms were preserved in the environmental microbial bank through sorting and analyzing the microbial data of 4 years,and the environmental microbial bank of our enterprise was established.The establishment of enterprise environmental bacteria bank can provide data and technical support for microbial pollution control,cleaning and disinfection effect evaluation,pollution incident investigation and microbial contamination traceability.

关 键 词：制药企业 洁净区 环境菌库 微生物 

分 类 号：TQ460[化学工程—制药化工]