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目前制药工业中除菌过滤器完整性测试普遍以水为介质来进行,但在实际生产中这样的检测方法有很多缺点。通过确定乙醇与水的泡点和扩散流的对应关系,间接建立了乙醇泡点和扩散流与细菌截留试验之间的联系,最终确定了乙醇完整性测试的泡点和扩散流值,同时得出乙醇泡点和扩散流测试程序。
At present, the sterilization filter integrity test in the pharmaceutical industry is generally conducted with water as a medium, but there are many disadvantages to such a detection method in actual production. By determining the correspondence between the bubble point and the diffusion flow of ethanol and water, the relationship between the bubble point and diffusion flow of ethanol and the bacteria retention test was indirectly established. Finally, the bubble point and diffusion flow rate of the ethanol integrity test were determined. Ethanol bubble point and diffusion flow test program.