摘要
目的:分析国内无菌药品包装系统的密封完整性研究中存在的焦点问题,给出解决问题的建议,以期为国内无菌药品包装系统的密封完整性研究提供有益参考。方法:通过对照国内外法规、标准要求,深入理解和分析无菌药品包装系统密封完整性研究中的重点概念的涵义和应用;通过查阅和调研相关文献以及基于实践的经验,汇总分析了解决密封完整性研究焦点问题的实例,并给出研究中应注意的问题;结合目前国内药品包装系统密封完整性研究现状,绘制了药品包装系统密封完整性研究流程图。结果与结论:无菌药品包装系统的密封完整性研究是一项复杂且系统的工作,对关键问题的准确理解、分析是开展研究工作的前提,密封完整性研究流程图的绘制能够简化、方便研究工作的开展。
Objective:To analyze the key problems existing in the research on the container-closure integrity for the domestic sterile pharmaceutical packing system, so as to provide suggestions for solving the problems and useful references for the related researches. Methods:Domestic and foreign regulations and standard requirements were compared, the meaning and application of key concepts in the research on container-closure integrity of sterile pharmaceutical packaging systems were investigated and analyzed in depth;relevant literature and practical experience was consulted and researched, the examples on solving the key problems of containerclosure integrity were summarized and analyzed;the current research status of the container-closure integrity of the pharmaceutical packaging system in China was combined, and a flow chart of the container-closure integrity of the pharmaceutical packaging system was drawn. Results and Conclusion:The research on the containerclosure integrity of the sterile pharmaceutical packaging system is a complex and systematic work, and it is in the premise of the accurate understanding and analysis of the key issues. The drawing of the container-closure integrity research flow chart could simplify and facilitate the development of the research.
作者
王冬伟
张博
张翔
熊巍
李文丽
韩乃水
张静
Wang Dongwei;Zhang Bo;Zhang Xiang;Xiong Wei;Li Wenli;Han Naishui;Zhang Jing(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,NMPA Key Laboratory of Quality Control for Pharmaceutical Packaging,Jinan 250101,China)
出处
《中国药事》
CAS
2022年第2期133-138,共6页
Chinese Pharmaceutical Affairs
关键词
无菌药品
药品包装系统
密封完整性
最大允许泄露限度
微生物挑战法
sterile product
packaging systems
container-closure integrity
maximum allowable leak limit
microbial challenge method
