药品洁净区环境微生物监测分析报告

Monitoring and Analysis Report on Environmental Microorganism in Drug Clean Area

目的:采集药品洁净区中的环境微生物进行鉴定分析,并形成有利于质量管理的环境微生物信息库,从根本上降低污染风险,避免环境菌株影响检品的检验结果,以保障药品检验的准确性。方法:参照医药工业洁净区中沉降菌及浮游菌的采集方法对药品检验洁净区中的环境微生物进行采集,应用全自动微生物检测系统进行鉴定分析。结果:采集共131株环境微生物样本中,检出微生物63株。结论:对药品检验洁净区中实行环境微生物监测,可以更清晰的了解洁净区的污染情况,便于确定警戒限与纠偏限,建立环境微生物信息库,选择有效的消毒剂。

Objective: T Environmental microorganisms in clean areas of drug testing are collected for identification and analysis, thus to form an environmental microbial information database, which is good for quality management and can reduce the risk of pollution fundamentally and avoid environmental strains affecting the test results of drug testing, so as to ensure the accuracy of drug testing. Methods: The collection method of settling bacteria and planktonic bacteria in the pharmaceutical industry clean area was referred to have a collection of the environmental microorganism in the drug clean area from March to November 2020. The automatic microbial detection system was applied for the identification analysis. Result: 131 microorganisms had been collected from March to November in the drug clean area. 56 microorganisms were detected with specific bacteria through the VITEK2 Compact automatic ID;while 7 microorganisms were mold. Conclusion:The implementation of environmental microbiological monitoring in clean areas of drug testing can help get a more clear knowledge of the pollution situation in the clean area, good for determination of warning limit and correction limit, thus to establish environmental microbiological information database and select effective disinfectants.