无菌药品生产企业微生物洁净室微生物污染的鉴定与结果分析

Identification and result analysis of microbial contamination in microbial clean room of aseptic drug manufacturing enterprise

目的:利用DNA测序技术对天津地区5家药品生产企业微生物洁净室采集到的微生物菌株进行测序鉴定和结果分析,为药品微生物污染追踪溯源提供技术支持。方法:采用革兰氏染色技术、VITEKⅡ生化鉴定和分子测序鉴定技术,对我市5家无菌药品生产企业微生物洁净室(A/B和A/C级洁净区)采集到的90株细菌和6株霉菌共计96株菌进行鉴定和分析。结果:通过96株菌株的鉴定结果,发现葡萄球菌属细菌数最多,占全部分离株的50.0%,芽孢杆菌属占18.8%,库克氏菌属占10.4%。其中表面微生物有52株,占54.2%,沉降菌有20株,占20.8%,浮游菌有24株,占25.0%。结论:利用DNA测序技术对采集到的环境菌株进行鉴定结果更为准确可靠,菌株的采集位置及鉴定结果能有效地为无菌药品企业微生物污染情况进行整体分析和风险控制。

Objective:DNA sequencing technology was used to identify and analyze the microbial strains collected from the microbial clean rooms of five pharmaceutical manufacturers in Tianjin,which provided technical support for tracing the source of drug microbial contamination.Methods:Ninety-six strains of 90 strains of bacteria and 6 strains of molds collected from microbiological laboratories(A/B and a/C clean areas)of 5 sterile drug manufacturers in our city were identified and analyzed by Gram staining technology,VITEKⅡbiochemical identification and molecular sequencing identification technology.Results:Ninety-six strains were identified,the most of them were staphylococcus,accounting for 50.0%of all isolates,18.8%of Bacillus,10.4%of cooke.There were 52 strains of surface microorganisms(54.2%),20 strains of sedimentation bacteria(20.8%)and 24 strains of planktonic bacteria(25.0%).Conclusion:The results of DNA sequencing are more accurate and reliable,and the location and identification results of the collected environmental strains can be used for the overall analysis and risk control of microbial contamination in aseptic pharmaceutical enterprises,we will strengthen environmental control and management of microbial clean rooms in manufacturing enterprises.