摘要
Abstract
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Key words
pollution control/environmental bacteria bank/microorganism/microbial traceability
