摘要
本文查阅了国内外法规与要求,从药品包装系统密封性评价的角度出发,分类汇总了微生物挑战法(浸没式)挑战菌、介质充填量、真空压力条件、测试时间、挑战温度等影响因素,汇总相关研究进展,同时对容器密封完整性评价研究及微生物挑战法(浸没式)提出展望,以期为国内无菌药品包装系统的密封性研究提供有益的参考。
This paper reviews domestic and foreign regulations and requirements,and from the perspective of sealing evaluation of pharmaceutical packaging systems,classifies and summarizes the influencing factors such as microbial challenge method(immersion type),medium filling amount,vacuum pressure conditions,test time,challenge temperature,etc.,summarizes the relevant research progress,and puts forward the prospect of container sealing integrity evaluation research and microbial challenge method(immersion type),in order to provide a useful reference for the tightness research of domestic aseptic pharmaceutical packaging system.
作者
咸富荣
王静
张芳芳
XIAN Furong;WANG Jing;ZHANG Fangfang(Shanghai Food and Drug Packaging Materials Testing Institute,Shanghai 201203,China)
出处
《中国药品标准》
CAS
2023年第5期459-464,共6页
Drug Standards of China
基金
国家药典委药包材密封性完整性指导原则课题项目(2019Y04)
药典综函[2022]328号。
关键词
包装系统密封性
微生物挑战法(浸没式)
文献调研
汇总分析
影响因素
研究进展
packaging system tightness
microbial challenge method(immersion)
literature research
aggregate analysis
influencing factors
research progress
