真空衰减法测试无菌药品包装密封完整性过程中关键参数的考察  

Investigation on Key Parameters of Vacuum Decay Method for Container Closure Integrity Testing of Sterile Product Packaging System

作　　者：王冬伟 张博 于晓慧 董云帆 许凯 WANG Dongwei;ZHANG Bo;YU Xiaohui;DONG Yunfan;XU Kai(NMPA Key Lab.of Quality Control for Pharmaceutical Packaging,Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan 250101)

机构地区：[1]山东省医疗器械和药品包装检验研究院,国家药品监督管理局药品包装材料质量控制重点实验室,山东济南250101

出　　处：《中国医药工业杂志》2023年第2期268-276,共9页Chinese Journal of Pharmaceuticals

基　　金：2022年山东省药品监督管理局医疗器械化妆品检验检测能力提升研究课题——疫苗用预灌封注射器组合件密封完整性研究(SDNMPAFZLX202209)。

摘　　要：研究了影响真空衰减法测试无菌药品包装密封完整性时的关键参数。首先,确定了影响真空衰减法测试结果的关键参数,即试验环境、腔体死腔体积、腔体密封性、腔体材质和过程参数;然后通过设计和制定研究方案,对关键参数的影响逐一开展试验进行验证。结果表明,测试结果会受到上述关键参数的影响。推荐将试验环境控制在23℃、相对湿度45%;选用的腔体应尽量贴合试验样品的外形尺寸,并定期更换密封圈;腔体和阴性样品的材质推荐选用性能较稳定、灵敏度高的不锈钢材质;阴性样品应尽量在待测样品的基础上制备实心或不漏的样品;过程参数的设置需要在不同包装形式和不同内容物的基础上,充分考虑样品可能的泄漏风险点。实际测试时还需要合理设计和选择关键参数,以保证测试结果的科学性。The key parameters of vacuum decay method for the container closure integrity testing of sterile product packaging system were studied.The key parameters,namely test environment,the residual chamber volume,the sealing property of chamber,the chamber material and the process parameters,that could affect the test results were determined.Then,the tests were carried out to verify the influence of above key parameters by designing and developing research programs.The data showed that the test results could be affected by the above key parameters.It was recommended to control the test environment of 23℃and the relative humidity of 45%.The selected chamber should conform to the overall dimensions of the test samples as much as possible,and the sealing ring should be replaced regularly.It was also recommended to select stainless steel material with stable performance and high sensitivity for chamber and negative samples.The negative samples should be solid or leak free based on the tested samples.The setting of process parameters should take the possible leakage risk points of samples on the basis of different packaging forms and different contents into consideration.And in the actual test,reasonable design and selection of key parameters were required to ensure scientificity of the test results.

关 键 词：容器密封完整性 真空衰减法 无菌药品 死腔体积 腔体材质 过程参数 

分 类 号：R95[医药卫生—药学]