非最终灭菌无菌灌装生产工艺人员微生物质量风险分析

为最大程度地降低药品无菌工艺生产中微生物污染的风险,以重组溶葡萄球菌酶粉的生产过程为例,利用休哈特控制图、饼图统计工具、失效模式及影响分析(FMEA)风险工具对生产中操作人员可能引入微生物污染的五个因素(手套、前臂、胸口、前额、口罩)进行了监控和风险分析.试验结果表明,口罩的微生物检测结果最差,手套为污染的高风险因素.经过最差条件干预的培养基模拟灌装试验,验证了以预防为主的微生物质量控制措施可以有效控制无菌灌装生产工艺中人员对药品污染的风险.

Quality Risk Analysis of Personnel Microbiological in Non-final Sterilization Aseptic Filling Technology

The recombinant lysostaphin power, a sterile drug of non-final sterilization, belongs to the high risk products. To minimize the risk of contamination of sterile drug, the potential factors that contribute to contamination of the recombinant lysostaphin powder production were investigated. The five important risk factors, such as gloves, forearm, forehead, chest, face masks, which might lead to microbial contamination introduced by operator during the production process, were conducted monitoring and analyzed by Hugh Hart control chart, pie chart statistical tools, failure mode and effects analysis (FMEA) risk tool. The microorganism detection results showed that the face masks and gloves are the highest risk factor. The simulation of filling with medium confirmed that risk can be reduced by taking the personnel measures under conditions for the worst. Aseptic operation standards that mainly based on preventive measures were established. Thus minimize the risk of microbial contamination in aseptic processing of drugs.