无菌过滤系统完整性测试方法探讨

Brief Discussion about the Integrity Test Method of Sterile Filtration System

通过对完整性测试原理的探讨,各种完整性测试操作方法及其适用性的研究,对企业提出一些操作性建议。结论:完整性测试对无菌过滤系统非常重要,企业需要在对各种测试方法深刻了解的基础上选择合适的方法进行测试,以提高完整性测试水平。

Put forward a relatively workable proposal by researching and analysing on the principle of integrity testing, testing operating methods and their applicability.Results：Integrity testing of sterile filtration system is very important. Pharmaceutical companies should choose the suitable testing methods based on a deep understanding of the various testing methods, including, to improve the level of sterile filtration system integrity test.