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以丁醇为润湿介质的除菌过滤器完整性测试研究 被引量:2

Study of Integrity Test of Sterile Filter with Butanol As Wetted Medium
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摘要 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.
作者 田宏伟
出处 《医药工程设计》 2010年第3期16-19,共4页 Pharmaceutical Engineering Design
关键词 除菌过滤器 完整性测试 起泡点 扩散流 细菌截留 润湿介质 丁醇 sterile filter integrity test bubble point diffusion flow bacteria retention wetted medium butanol
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参考文献3

  • 1叶莺莺等.药品生产验证指南(2003).北京:化学工业出版社,2003:123.130.
  • 2Frederick J.Carteton,James P.Agalloco.无菌制药工艺的验证[M].上海:上海科学普及出版社,1998.
  • 3Technical Report 26: Sterilizing Filtration of Liquid. PDA Journal of Pharmaceutical Science& Technology, 1998: 12-18, 28.

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