| 杨玲玲,李小燕,朱毅忠.微生物洁净室环境菌库建立方法探讨[J].中国药事,2021,35(7):763-767 |
| 微生物洁净室环境菌库建立方法探讨 |
| Discussion on the Method of Establishing Environmental Bacteria Bank in Microbial Clean Rooms |
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| DOI：10.16153/j.1002-7777.2021.07.006 |
| 中文关键词: 洁净室 环境菌 VITEK2 compact鉴定系统 |
| 英文关键词: clean rooms environmental bacteria VITEK2 compact identification system |
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| 摘要点击次数: 1041 |
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| 中文摘要: |
| 目的：本研究通过对洁净实验室环境菌的收集及鉴定，为超标结果调查分析、药品检出菌溯源分析及洁净环境菌数据库的建立与分析提供数据支持。方法：在洁净实验室、操作人员等监控点采集沉降菌、浮游菌及表面微生物，采用VITEK2 compact鉴定系统进行鉴定分型。结果：经过对不同洁净级别和微生物种类的分析，共收集获得环境菌53株，其中芽孢杆菌属、库克氏菌属和葡萄球菌属细菌分别占全部分离株的17.0%、15.1%和13.2%。结论：基本了解洁净室环境微生物构成，初步建立洁净室环境微生物数据库。建议洁净实验室规范人员更衣进场程序和洁净区行为，制定有效的清洁消毒程序，加强环境监控，定期分析监控数据，研究数据变化趋势，出现异常数据，应及时采取措施，使洁净区处于良好的受控状态。 |
| 英文摘要: |
| Objective: To collect and identify the environmental bacteria in clean rooms, and to provide data for the investigation and analysis of the results of exceeding the standard, traceability analysis of drug-detecting bacteria and establishment and analysis of clean environmental bacteria database. Methods: Settling bacteria, plankton bacteria and surface microorganisms were collected in clean laboratories, operators and other monitoring points, and the identification and clarification were carried out by using the VITEK2 compact identification system. Results: A total of 53 bacterial isolations were identified from the controlled environment. The isolation ratios of Bacillus spp., Kocuria spp. and Staphylococcus spp. in total isolations were 17.0%, 15.1% and 13.2%, respectively after analysis of different cleanness levels and microbial species. Conclusion: Basic knowledge about the environmental microorganism composition in clean rooms was gained, and the database of environmental microbiology in clean rooms was preliminarily established. It is suggested that pharmaceutical enterprises should control the number of personnel in the clean areas, standardize the personnel's dressing procedures and clean area behavior, formulate effective cleaning and disinfection procedures, strengthen environmental monitoring, regularly analyze monitoring data, study datum trends and take measures in time to deal with abnormal data so as to keep the clean areas in a good state of control. |
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