OBJECTIVE:To provide reference for eliminating the safety accidents occurred in the production process of Amika-cin sulfate injection (called“Amikacin”in short). METHODS:The safety assessment index system of Amikacin production pro-cess with hierarchical structure was established,and the weight of each index was calculated by analytic hierarchy process(AHP). Then,fuzzy comprehensive evaluation(FCE)was used to assess the safety of Amikacin production process in a large-scale pharma-ceutical enterprises from southwest China. The improvement suggestions were put forward according to assessment results(as stan-dard score of related index). RESULTS & CONCLUSIONS:The safety evaluation index system of Amikacin production process is divided into 3 levels of target layer,criterion layer and index layer;criterion layer included 6 first indicators of personnel factor, technological factor,material factor,equipment factor,environmental factor and management factor;index layer included 24 sec-ondary indicators of staff quality,process complexity,inflammability,equipment location,workshop internal environment and safe-ty management,etc. AHP demonstrated that the weight of 6 first indicators were 0.291,0.066,0.109,0.109,0.045,0.308,respec-tively. FCE showed that standard scores of personnel factor,process factor,equipment factor and management factor were higher than others,being 0.804,0.828,0.816,0.818,respectively,which indicated good safety. The standard scores of material factor and environmental factor were lower,being 0.772 and 0.695,which indicated general safety. On the whole,standard score of FCE as-sessment of Amikacin production process was 0.828,indicating good safety. Because the safety assessment of material factor and en-vironmental factor are lower than others,it is suggested to strengthen the valves,flanges and gaskets check and real-time monitor-ing,and improve the lighting and ventilation facility.%目的：为消除硫酸阿米卡星注射液（简称“阿米卡星”）生产过程中的安全事故隐患提供参考。方法：建立具有递阶层次结构的阿米卡星生产过程安全评价指标体系，以层次分析法计算该指标体系中各指标的相对权重，再运用模糊综合评价法对西南某大型制药企业的阿米卡星的生产过程进行安全性评价，并根据评价结果（如相关指标的标准分值等）提出改进建议。结果与结论：所建立的阿米卡星生产过程的安全评价指标体系包括目标层、准则层、指标层3个层次结构，其中准则层由人员因素、工艺因素、物料因素、设备因素、环境因素与管理因素等6个一级指标组成，指标层由分别与之对应的人员素质、工艺复杂性、易燃性、设备摆放、车间内部环境与安全管理组织等24个二级指标组成。经层次分析法分析表明，6个一级指标的相对权重分别为0.291、0.066、0.109、0.109、0.045、0.308。经模糊综合评价法评价显示，其中人员因素、工艺因素、设备因素与管理因素的标准分值较高，分别为0.804、0.828、0.816、0.818，表明其安全等级均“较高”；而物料因素和环境因素的标准分值则较低，分别为0.772、0.695，表明其安全等级均“一般”。总体来看，阿米卡星生产过程的模糊评价标准分值为0.828，表明其安全等级“较高”。针对物料因素和环境因素的安全级别相对较低的情况，建议加强对阀门、法兰、垫片的检查和实时监控，同时改进照明、通风及基础设施等。
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