Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (4): 211-214.

• Orginal Article • Previous Articles     Next Articles

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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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