湿热灭菌课题的相关研究与思考

Research and consideration on the subject of moist heat sterilization

2017年上海市食品药品包装材料测试所作为协作单位受国家药典委员会的委托承担了药品医疗器械审批制度改革有关药品标准研究子课题——灭菌法(课题编号:ZG2017-4-03)中湿热灭菌部分的研究任务。通过借鉴国内外法规文献的经验,结合我国无菌药品生产实际情况,利用决策树和FMEA风险评估工具进行研究,并在厂家范围进行问卷调查,最后形成灭菌法湿热灭菌部分的修订稿。修订稿通过增加非无菌产品单元的概率、灭菌杀灭力值的控制意义,产品灭菌前微生物负载的控制等过程控制技术、生物负载/生物指示剂法等内容,对现行版的《中国药典》灭菌法部分进行修订完善(诸如删除流通蒸汽的内容),已使未来的《中国药典》2020年版中湿热灭菌法的内容能够与国际上其他通用标准初步接轨,并为国内无菌药品和医疗器械等生产企业的无菌保障工作起到切实可行的指导作用。

In 2017, Shanghai food and drug packaging materials control center, as a collaborating unit, undertook the moist sterilization research mission of sterilization method of drug standards study sub-subject (No.ZG2017-4-03) of Chinese Pharmacopoeia Commission′s reform of the drug and medical device approval system.The experiences in the domestic and foreign regulations and literatures were drew on, and the actual situation of aseptic drug production in China was considered. The decision tree and FMEA risk assessment tool were used for research, and the questionnaires survey was made in the manufacturers. Finally, a draft revised version of moist heat sterilization part was formed. The probability of non-sterile product units, the control significance of sterilization killing values, process control techniques such as control of microbial load before product sterilization and bioburden/biological indicator method were added in the draft revised version. The sterilization method in Chinese Pharmacopoeia 2015 was improved with the removal of circulating steam content. That would enable the wet heat sterilization method in Chinese Pharmacopoeia 2020 version to be initially harmonized to other international common standards. That provides a practical guidance on the sterility assurance for domestic sterile drugs and medical devices manufacturers.