技术方法

中试研发洁净区环境菌库的建立

  • 章孟学 ,
  • 郭璇 ,
  • 王菲 ,
  • 庞宇 ,
  • 赵芳 ,
  • 孙帅军 ,
  • 杨顺福 ,
  • 孙成金
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  • 国药中生生物技术研究院有限公司质量管理部, 北京 101111

网络出版日期: 2025-08-16

Establishment of environmental bacterial bank in pilot clean area of research and development

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  • Quality Management Department, National Vaccine and Serum Institute, Beijing 101111,China

Online published: 2025-08-16

摘要

目的 通过对中试研发洁净区环境菌进行监测、收集及鉴定,建立洁净区环境菌库。方法 对中试研发洁净区进行环境监测,将收集到的环境菌(沉降菌、浮游菌和表面微生物)采用形态观察、染色镜检结合基因型微生物鉴定(细菌16S核糖体RNA测序分析)的方式进行鉴定。结果 共分离到89株环境菌,涵盖16个属,其中芽孢杆菌属占29%,葡萄球菌属占27%,微球菌属占12%。结论 初步建立中试研发洁净区环境菌库,为开展微生物污染溯源提供技术支持。

本文引用格式

章孟学 , 郭璇 , 王菲 , 庞宇 , 赵芳 , 孙帅军 , 杨顺福 , 孙成金 . 中试研发洁净区环境菌库的建立[J]. 国际生物制品学杂志, 2024 , 47(6) : 360 -364 . DOI: 10.3760/cma.j.cn311962-20240419-00017

Abstract

Objective To establish an environmental bacterial bank in clean area by monitoring, collection and identification of environmental bacteria in pilot clean area of research and development.Methods Static and dynamic environmental monitoring was carried out in the pilot clean area of research and development, and the collected environmental bacteria (settling microbe, airborne microbe and surface microbe) were identified by morphological observation, staining microscopy and genotypic microbial identification (bacterial 16S ribosomal RNA sequencing analysis).Results A total of 89 strains of environmental bacteria were isolated, belonging to 16 genera, among which Bacillus sp. accounted for 29%, Staphylococcus sp. accounted for 27% and Micrococcus sp. accounted for 12%.Conclusion The environmental bacterial bank in pilot clean area of research and development is initially established, which provides technical support for microbial contamination traceability.
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