摘要
目的针对抽负压冻干制剂包装系统建立一套准确、可靠且简单易操作的包装系统密封性检查方法。方法根据包装系统内部负压特点及密封完整性要求,按照《化学药品注射剂包装系统密封性研究技术指南(试行)》及美国药典(USP)1207《容器密封完整性测试》,建立了一种新的通过监测包装内部压力变化来评价密封完整性的确定性的研究方法。结果该方法进行了方法学验证,采用了1.1、1.6、4.7及9.9μm标准漏孔模拟阳性样品进行验证,运用数学模型验证了准确性。结论该方法是基于抽负压冻干制剂包装特点而开发的新方法,针对性较强,方法准确、可靠,具有优于常规方法的高灵敏度,可应用于药品生产企业日常生产过程中的包装密封性监测,为行业提供了一个高效、可及性较好的密封性检查方法,以确保药品质量安全有效。
OBJECTIVE To establish a set of accurate,reliable and easy to operate sealing inspection method for packaging systems of negative pressure lyophilized preparations.METHODS According to the packaging system internal negative pressure characteristics and seal integrity requirements,in accordance with<the Study Requirements of Technical Guide for Research on the Integrity of Packaging Systems for Chemical Injections(Trial)>and USP 1207,a new deterministic method for evaluating sealing integrity by monitoring pressure changes in packaging was developed.RESULTS Methodology validation was carried out,the standard leaky simulated positive samples of 1.1,1.6,4.7 and 9.9μm were used for verification,and the accuracy was verified by mathematical model.CONCLUSION The new method is based on the packaging characteristics of vacuum lyophilized preparations,which is accurate,reliable and has higher sensitivity than the conventional methods.It can be applied to the monitoring of packaging tightness in the daily production process of drug manufacturers to ensure the quality of drugs.
作者
郭燕燕
兰婉玲
张小春
张莞英
范能全
任学毅
江燕
赵代国
GUO Yanyan;LAN Wanling;ZHANG Xiaochun;ZHANG Wanying;FAN Nengquan;REN Xueyi;JIANG Yan;ZHAO Daiguo(Sichuan Institute for Drug Control,Chengdu 611731,China;Chongqing Institute for Food and Drug Control,Chongqing 401121,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2023年第23期2133-2137,共5页
Chinese Pharmaceutical Journal
基金
四川省科技厅科研项目资助(2021YFG0089)。
关键词
负压衰减法
冻干制剂包装
密封完整性
确定性方法
密封性检查
negative pressure attenuation method
lyophilized preparation packaging
seal integrity
deterministic method
tightness check
