以丁醇为润湿介质的除菌过滤器完整性测试研究

Study of Integrity Test of Sterile Filter with Butanol As Wetted Medium

叙述了以水为介质进行的除菌过滤器的完整性测试在制药工业实际生产中的缺点;由于供应商提供的水的泡点或者扩散流值是与细菌截留试验相关的,在科学的完整性测试理论的支持下,合理的进行试验设计,通过确定丁醇与水的泡点和扩散流的比值,间接建立了丁醇泡点和扩散流与细菌截留试验的关系,最终确定了丁醇完整性测试的泡点和扩散流值,同时得出丁醇泡点和扩散流测试程序。

The problems existed in the integrity test of sterile filter with water as the medium used in pharmaceutical industry was stated. Because the bubble point of water provided by suppler is correlative with the test of bacteria retention, the appropriate test was designed under the support of integrity test theory. Through the ratio of bubble points and diffusion values between butanol and water, the relations of the bubble point and the diffusion value of butanol with the test of bacteria retention was indirectly obtained. The bubble point and the diffusion value of butanol in the integrity test was finally determined and the procedure of integrity test for butanol bubble point and diffusion value was established.