文章摘要
韩晗,徐敏凤,魏佳鸣.湿热灭菌课题的相关研究与思考[J].中国药品标准,2019,(4):298-304
湿热灭菌课题的相关研究与思考
Research and consideration on the subject of moist heat sterilization
投稿时间:2019-01-11  修订日期:2019-06-24
DOI:
中文关键词: 湿热灭菌,决策树,FMEA风险评估,生物负载/生物指示剂法,湿热灭菌的工艺验证
英文关键词: Moist heat sterilization, Decision tree, FMEA risk analysis, Bioburden/Biological indicator Method, Moist heat sterilization process validation
基金项目:
作者单位E-mail
韩晗 上海市食品药品包装材料测试所 hanhan@shpmcc.com 
徐敏凤 上海市食品药品包装材料测试所 hanhan@shpmcc.com 
魏佳鸣 上海市食品药品包装材料测试所  
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中文摘要:
      2017年上海市食品药品包装材料测试所作为协作单位承担了委托自国家药典委员会的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。通过调阅和分析国外法规文献,对灭菌器使用厂家进行调研,并利用决策树和FMEA风险评估工具进行研究,以及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。该修订稿已实现与国际上其他通用标准初步接轨,并为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。
英文摘要:
      In 2017, the Shanghai Food and Drug Packaging Materials Testing Institute, as a collaborating unit, undertook the reform of the drug and medical device approval system of the National Pharmacopoeia Commission, and the moisture sterilization part of the sterilization method (subject No. ZG2017-4-03) research mission. Through the review and analysis of foreign regulatory literature, the sterilizer manufacturers are investigated, and the decision tree and FMEA risk assessment tools are used for researching and the questionnaires are conducted at the manufacturer's scope. Finally, a revised version of the sterilization method for moist heat sterilization is formed.. The revised draft has achieved initial integration with other international standards and provides practical guidance for the sterility assurance work of manufacturers such as sterile pharmaceuticals and medical devices.
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