药企环境菌库在实际工作中的应用  

Application of Environmental Bacterial Bank in Pharmaceutical Enterprises in Practical Work

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.,Fuling 408100,China;College of Life Science and Technology,Yangtze Normal University,Fuling 408100,China)

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6期22-25,共4页Industrial Microbiology

摘　　要：建立药品生产洁净区环境菌库有助于为性能测试、消毒剂效果评价、环境微生物污染控制、同源性分析、制药用水系统质量控制及生产工艺反馈等提供数据支持。基于此,文章对环境菌库数据进行整理,并分析微生物的分布情况及变化,采取相应的措施,以期为微生物的污染控制提供指导。通过对环境菌库数据进行整理和分析,完善性能测试,主动控制微生物的污染,对消毒剂效果进行评价以及对生产工艺进行反馈等手段,从被动调查上升到主动预防,有效地减少了微生物的污染。首先,建立企业环境菌库,能够为制药企业的相关工艺验证(例如无菌灌装模拟试验、消毒剂效果评价等)提供环境菌和可靠的评价;其次,对菌库的数据进行分析,可以及时发现异常趋势,并采取有效的措施,降低微生物污染的风险,提高质量管理体系的有效性;最后,持续不断地对环境菌库进行更新补充,形成动态管理的环境菌库,能够为洁净环境中的微生物控制提供有效的数据保障。Establishing an environmental microbial library in a clean area for drug production can help provide data support for performance testing,disinfectant effect evaluation,environmental microbial pollution control,homology analysis,quality control of pharmaceutical water systems,and production process feedback.Therefore,the paper organizes the data of environmental bacterial banks,analyzes the distribution and changes of microorganisms,and takes corresponding measures to provide guidance for microbial pollution control.By organizing and analyzing environmental microbial data,improving performance testing,actively controlling microbial pollution,evaluating the effectiveness of disinfectants,and providing feedback on production processes,we have effectively reduced microbial pollution from passive investigation to active prevention.Firstly,we should establish a corporate environmental bacterial bank that can provide environmental bacteria and effective evaluation for pharmaceutical companies'related process validation(such as sterile filling simulation experiments,disinfectant effect evaluation,etc.);Secondly,by analyzing the data of the bacterial bank,anomalies and trends can be identified in a timely manner,and effective measures can be taken to reduce the risk of microbial pollution and improve the effectiveness of the quality management system;Finally,continuously updating and supplementing the environmental microbial bank to form a dynamically managed environmental microbial library can provide effective data protection for microbial control in clean environments.

关 键 词：污染控制 环境菌库 微生物 微生物溯源 

分 类 号：TQ460.1[化学工程—制药化工]