药品微生物限度检查中微生物污染的鉴定和溯源分析

目的：结合药品微生物限度检验工作的实例，采用多种技术手段对药品微生物污染情况进行分析，寻找药品微生物污染来源，在确保检验结果准确性的同时，为药品微生物污染追踪溯源提供技术支持。方法：采用API鉴定系统、Vitek2 Compact鉴定系统、RiboPrinter系统和FTIR分析系统等方法，对从样品和环境中分离得到的10株菌株进行鉴定分型及同源性分析。结果：4株样品菌和1株环境菌同源，样品中的微生物污染是通过实验人员的手套进行传播，实验人员应注意无菌操作过程。结论：本文采用传统形态学、生化鉴定、FTIR及分子生物学等方法，阐述药品微生物限度检查中微生物污染鉴定和溯源分析的过程和方法，为药品微生物检查的过程控制提供信息，为药品微生物污染的溯源调查提供解决方案。

Objective: To analyze the status of drug contamination by several methods based on practical work and identify the source of drug contamination so as to ascertain the result of microbial limit test and to give technical supports for inspectors to trace the microorganism. Methods: Ten target-bacteria,isolated from drug samples and environment,were identified and characterized during homology analysis by API system,Vitek2 Compact system,RiboPrinter system and FTIR system. Results: Four strains from samples and one strain form environment were the same strain-type.It seemed that the transmission of contamination could be introduced via gloves as a result of non-standard operation.Operators should pay attention to aseptic operation. Conclusion: The process and approaches of microbial contaminant identification and trace analysis were demonstrated using traditional morphological,biochemical,FTIR and molecular biologic methods,which provided information for the process control of drug microbial limit test and gave a support for trace investigation of drug contamination.

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