Establishment of CNC regional microbial database and microbial population analysis for pharmaceutical enterprises / 中国生物制品学杂志

ABSTRACT

@#Objective To establish CNC(controlled not classified)area microbial database of pharmaceutical enterprises,conduct correlation analysis with microbial distribution in clean area to achieve good microbial control in the clean area,especially in the core aseptic operation area,and improve the sterility assurance level of pharmaceutical enterprises.MethodsThe CNC area of a manufacturing workshop from pharmaceutical enterprise was selected as the research object,the airborne microbe,settling microbe,personal and environmental surface microorganisms were sampled one by one in the CNC area according to the route of personnel and materials entering the clean area. After the microorganisms were cultured and purified,the 16S rRNA sequencing method was used to identify the strains. Microbiomeanalyst online analysis software was used for data analysis.ResultsThe number of microorganisms in the CNC area of pharmaceutical enterprises was large and the species were rich. A total of 4 080 microorganisms were collected,which distributed in 47 genera. Gram-positive bacteria accounted for 84. 4%,mainly belonging to Staphylococcus,Micrococcus,Microbacterium. Gram-negative bacteria accounted for 15. 6%,and the distribution of Acinetobacter was much higher than other gram-negative bacteria. The Alpha diversity index was used to characterize the richness of microbial populations. The richness of microbial populations of airborne microbe and settling microbe was the highest,followed by environmental surface microorganisms,and the microbial population richness of personnel surface microorganism was the lowest. The number of microorganisms in the personnel's hood and chest was relatively small,and the number of microorganisms in the personnel's soles of feet and hands was relatively large. There were relatively few types of microorganisms on the surface of personnel,and staphylococcus showed an absolute advantage. The microbial distribution in CNC area was correlated with the microbial distribution in Class B and C clean areas of the same production workshop. Most of the microorganisms collected in Class B and C clean areas were included in the microbial population in CNC area. Class B and C clean areas were similar to CNC area,both of which were dominated by Staphylococcus and Micrococcus. The distribution proportion of Acinetobacter in Class B and C clean areas decreased compared with that in CNC area.ConclusionThe CNC area microbial database of the pharmaceutical enterprises has been established and the microbial population that is easy to enter the clean area has been determined,providing reliable technical support for the good microorganism control in the clean area