质量提取法测试西林瓶包装系统密封性

Mass Extraction Method for the Package Integrity Testing of Vials

建立了质量提取法测定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,优化抽真空、检测微漏的测试时间,进行方法学验证。结果表明,采用本研究建立的方法测定西林瓶包装系统完整性,孔径与流量线性关系良好,检测限为0.2 μm、定量限为0.5 μm,方法具有较高的灵敏度、良好的准确性、日间稳定性和耐用性。本研究建立的方法能够有效测试西林瓶包装系统密封性,为建立西林瓶包装系统密封性检测标准提供参考。

This study established a mass extraction method to test the package integrity of the injection vials.On the basis of rationally setting parameters and preparing negative and positive samples,the test time for vacuuming and detection of micro-leakage was optimized,and the method validation was carried out.In this paper,the results of the mass extraction method to test the package integrity of the injection vials showed that the sample pore size had a good linear relationship with the flow rate,and the detection and the quantification limits were 0.2 and 0.5 μm,respectively.The mass extraction method for the package integrity testing of the injection vials had high sensitivity,good accuracy,daytime stability,and durability.The method established in this study can effectively test the integrity of the vial packaging system and provide an experimental reference for establishing the test standard for the integrity of the vial packaging system.