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疫苗生产车间环境监测微生物的数据库建立及分析

  • 陈佩 彭兴梅 户美玲 江莉 谢峥 彭爱华
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  • 610023 成都,四川大学生物治疗国家重点实验室(陈佩、彭爱华);610023 成都生物制品研究所有限责任公司质量检定室 (陈佩、户美玲、江莉、谢峥),细菌性疫苗一室(彭兴梅)

网络出版日期: 2025-08-16

Database establishment and analysis of environmental monitoring microorganism in vaccine production workshop

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  • State Key Laboratory of Biotherapy, Sichuan University, Chengdu 610023, China; *Quality Control Department, Chengdu Institute of Biological Products Co., Ltd., Chengdu 610023, China

Online published: 2025-08-16

摘要

目的  建立疫苗生产车间环境监测微生物数据库,分析生产车间微生物的分布情况。 方法  从2012至2016年,每年按一定频次对乙型脑炎减毒活疫苗生产洁净车间进行动态环境监测。对收集的微生物进行鉴别和分类,建立微生物数据库。对5年的数据进行统计和分析。结果  2012—2016年,A级洁净区微生物阳性率均为0.00%;B级洁净区微生物阳性率分别为2.89%、1.32%、1.27%、1.03%和1.04%;C级洁净区微生物阳性率分别为12.96%、10.14%、7.63%、4.43%和4.56%;D级洁净区微生物阳性率分别为31.20%、33.41%、28.04%、19.58%、22.02%。洁净区表面菌阳性率(1.21%~2.62%)低于沉降菌阳性率(2.29%~4.02%)和浮游菌阳性率(2.09%~3.67%);沉降菌阳性率和浮游菌阳性率相似。里拉/藤黄微球菌、葡萄球菌属、蜡样芽胞杆菌容易出现在洁净车间环境中。结论  建立的环境监测微生物数据库和对微生物的分布情况分析,对于疫苗生产过程的无菌控制具有指导意义。

本文引用格式

陈佩 彭兴梅 户美玲 江莉 谢峥 彭爱华 . 疫苗生产车间环境监测微生物的数据库建立及分析[J]. 国际生物制品学杂志, 2017 , 40(4) : 161 -164 . DOI: 10.3760/cma.j.issn.1673/4211.2017.04.002

Abstract

Objective  To establish a database and analyze distribution of environmental monitoring microorganism in vaccine production workshop. Methods  From 2012 to 2016, dynamic environmental monitoring was performed for clean workshops of live attenuated Japanese encephalitis vaccine at certain frequency. The collected microorganisms were identified and classified. A microbial database was established. Statistical analysis of the 5 year data was performed. Results The positive rates of microorganisms in grade A clean zone during 2012-2016 were 0.00%. The positive rates of microorganisms in grade B clean zone were 2.89%, 1.32%, 1.27%, 1.03% and 1.04%, 12.96%, 10.14%, 7.63%, 4.43% and 4.56% in grade C clean zone, and 31.20%, 33.41%, 28.04%, 19.58% and 22.02% in grade D clean zone, respectively. The positive rates of surface bacteria (1.21%-2.62%) were lower than those of sedimentation bacteria (2.29%-4.02%) and planktonic bacteria (2.09%-3.67%). The positive rates of sedimentation bacteria and planktonic bacteria were similar. Micrococcus luteus/lylae, Staphylococcus, and Bacillus cereus Appeared more often in clean workshops. Conclusion  The establishment of environmental monitoring microbial database and analysis of microbial distribution play an important role for aseptic?control during vaccine production.
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