非最终灭菌无菌灌装生产工艺人员微生物质量风险分析

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

关键词:  无菌灌装  质量风险分析  休哈特控制图  失效模式及影响分析

Key words:  aseptic filling  quality risk analysis  shewhart control chart  failure mode and effect analysis

摘要:

为最大程度降低无菌工艺药品的微生物污染风险，以重组溶葡萄球菌酶粉的生产为例进行分析，利用休哈特控制图、饼图统计工具和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污染微生物的五个因素（手套、前臂、胸口、前额、口罩）进行监控和风险分析，发现口罩的微生物检测结果最差，手套污染为高风险因素；通过培养基模拟灌装确认，采取最差条件干预措施可降低风险，建立预防措施为主的人员无菌操作规范，最大程度降低无菌工艺药品的微生物污染风险。

Abstract:

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.