色水法检测小容量注射剂包装系统密封性的方法对比及优化  

Comparison and Optimization of Dye Ingress Method for Package Integrity Assessment of Small Volume Injection Packaging System

作　　者：邓雯卿 张珅 王青青 吴英姿 DENG Wenqing;ZHANG Shen;WANG Qingqing;WU Yingzi(Shenzhen Kangtai Biological Products Co.,Ltd.,Shenzhen 518106)

机构地区：[1]深圳康泰生物制品股份有限公司,广东深圳518106

出　　处：《中国医药工业杂志》2024年第8期1121-1128,共8页Chinese Journal of Pharmaceuticals

摘　　要：建立了色水法测定预灌封注射器包装系统和西林瓶包装系统的密封性。在合理设置参数及制备阴性、阳性样品的基础上,优化了真空度、负压保持时间、预灌封注射器包装系统处理方式,并进行方法验证。结果表明,采用本方法测定预灌封注射器包装系统、西林瓶包装系统密封性的灵敏度为10~15μm,且其灵敏度在同等条件下优于USP、EP和国际标准化组织中的方法。该法能有效测试预灌封注射器包装系统和西林瓶包装系统的密封性,为建立色水法检测预灌封注射器包装系统和西林瓶包装系统密封性的标准提供了参考。A dye ingress method was established to assess the package integrity of prefilled syringes and vials.On the basis of setting rational parameters as well as preparing negative and positive samples,the vacuum,negative pressure holding time and the processing method of the prefilled syringe packaging system were optimized,and the method was verified.The results showed that the sensitivity of this method for assessment the integrity of the prefilled syringe packaging system and the vial packaging system was 10-15μm,and was better than those in the USP,EP and International Organization for Standardization under the same conditions.This method could effectively assess the integrity of the prefilled syringe packaging system and the vial packaging system,which provided a reference for establishing the test standard for the prefilled syringe packaging system and the vial packaging system by dye ingress method.

关 键 词：色水法 预灌封注射器 西林瓶 包装系统密封性 

分 类 号：R917[医药卫生—药物分析学] TQ460.6[医药卫生—药学]