药品微生物检测实验室环境菌库的建立

Establishment of the Environmentally Microbial Library in the Drug Sterility Testing Laboratory

关键词:  环境菌库  溯源分析  微生物污染

Key words:  environmental bacteria library  characterization analysis  microbial contamination

摘要:

目的 建立药品微生物检测实验室环境菌库。方法 从药品微生物检测实验室环境中不同部位、设备材料及活动人员进行连续7个月采样收集获得248株细菌和6株霉菌，对收集的细菌采用全自动微生物生化鉴定仪(Vitek2 Compact)进行鉴定，对生化鉴定无确切结果的90株细菌及6株霉菌均采用3500 MicroSeq基因测序分析系统进行细菌16S rDNA和霉菌LSU rDNA测序鉴定，同时也对某次采样收集的6株金黄色葡萄球菌采用Diversilab系统进行同源性分析。结果 通过整理和分析收集获得的254株菌的鉴定结果，初步建立了药品微生物检测实验室环境菌库。结论 为今后开展污染水平的风险评估和不良事件调查提供技术平台，同时也为制药企业开展建立环境微生物信息库和微生物污染溯源提供技术指导。

Abstract:

OBJECTIVE To establish the environmental bacteria library of pharmaceutical microbial testing laboratory. METHODS 248 strains of bacteria and 6 strains of fungi were collected from the pharmaceutical microbiology testing laboratory from different parts, equipments and materials and the activities of personnel through 7 months working, and those bacteria were identified by biochemical identification method with Vitek2 Compact. Those 90 strains of bacteria without exact results of biochemical identification and 6 strains of fungi were identified by 3500 MicroSeq Gene Sequencing Analysis System for bacterial 16S rDNA and fungal LSU rDNA sequencing, and 6 strains of Staphylococcus aureus of a sampling collection were analyzed of homology with Diversilab system. RESULTS The environmental bacteria library was initially established by sorting and analyzing of the identification results of the collected 254 strains of microorganisms. CONCLUSION A technology platform is provided to evaluate the risk of pollution and to investigate the adverse events in the future. Technical guidance is also provided to the pharmaceutical companies which are establishing the data base of environmental microorganisms and tracing of microbial contamination.