论文部分内容阅读
目的从无菌药品生产的各个环节分析存在微生物污染的因素,有利于进行微生物污染控制,从而保证药品的无菌水平。方法采用鱼刺图法从无菌生产的人员、设备、物料、工艺、厂房与设施与其他6个方面分析微生物污染的因素。结论通过对无菌药品生产可能发生微生物污染的因素分析,为无菌药品生产企业提供参考。
Aim To analyze the factors of microbial contamination in all aspects of the production of aseptic drugs and to control the microbial contamination so as to ensure the sterility of the drugs. Methods Fishbone method was used to analyze the factors of microbial contamination from the aseptic production personnel, equipment, materials, process, plant and facilities and the other six aspects. Conclusion Through the analysis of the factors that may lead to microbial contamination in the production of aseptic drugs, it provides a reference for the manufacturers of aseptic drugs.