中国药物警戒 ›› 2012, Vol. 9 ›› Issue (4): 211-214.

• 管理及工作研究 • 上一篇    下一篇

医药工业洁净室洁净空气微生物定性分析与探讨

吕洪浩1，李俊杰1，徐慰倬2   

  1. 1 天津市药品检验所，天津300070；
    2 沈阳药科大学，辽宁 沈阳110016
  • 收稿日期:2011-11-08 出版日期:2012-04-10 发布日期:2015-08-10
  • 作者简介:吕洪浩，男，工程师，洁净监测、药品质量控制。

Qualitative Analysis and Study of the Microorganisms in Clean Air within Clean Room of the Pharmaceutical Industry

LV Hong-hao1, LI Jun-jie1, XU Wei-zhuo2   

  1. 1 Tianjin Institute for Drug Control, Tianjin 300070, China;
    2 Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2011-11-08 Online:2012-04-10 Published:2015-08-10

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摘要： 目的探讨医药工业洁净室洁净空气中微生物分布情况。方法对部分洁净室洁净空气进行沉降菌检测，采用形态学观察，生理生化反应检测以及16S rDNA序列测定等技术对微生物进行分析。结果通过实验共获得放线菌1株，真菌4株，细菌10株。结论一般洁净空气中以细菌为主，有少量真菌及放线菌，企业生产者应掌握这些菌的分布情况，分析这些菌落形成的原因，对洁净室环境做出针对性控制手段以保证产品质量。

关键词: 洁净室, 微生物, 分析

Abstract: Objective To study the distribution of the microorganisms in clean air within clean room of the pharmaceutical industry. MethodsTest method for settling microbe was used in the clean air of some clean rooms. The microorganisms isolated were analysed by morphological observation, physiological and biochemical tests and 16S rDNA sequence analysis. ResultsA strain of actinomycete, four strains of fungi and ten strains of bacteria were derived in the experiment. ConclusionThe clean air mainly consists of bacteria, a small amount of fungi and actinomycetes. Professionals of enterprise should master the distribution of bacteria, fungi and actinomycetes, analyze the causes of formation of the colony forming unit and take targeted methods of control for the environment of the clean room to guarantee the quality of products.

Key words: clean room, microorganisms, analysis