Dosmar M, Wolber P, Bracht K, Tröger H, Waibel P
Sartorius Corporation, Sartorius AG, Bohemia, Long Island, New York.
J Parenter Sci Technol. 1992 Jul-Aug;46(4):102-6.
Sterilizing grade hydrophobic filters are used for the sterile filtration of gases in pharmaceutical and biological applications. Until now the integrity of these membrane filters and their ability to retain bacteria, has been correlated to a solvent based nondestructive integrity test. Current methods use solvents to wet the membranes in order to perform bubble point and diffusion integrity tests. Solvent based integrity tests make it difficult to test in situ following sterilization because of the risk of downstream solvent contamination. A newly developed method, the Water Pressure Integrity Test (WPIT), allows for the integrity testing of hydrophobic filters eliminating the problems associated with traditional test methods employing solvents. A prime advantage of WPIT is that it may be performed in situ post sterilization without any downstream manipulations. The test has been directly correlated to the retention of bacterial challenges. Data will be provided to show the reliability and sensitivity of this easy to perform test.
除菌级疏水过滤器用于制药和生物应用中气体的无菌过滤。到目前为止，这些膜过滤器的完整性及其截留细菌的能力一直与基于溶剂的无损完整性测试相关。目前的方法使用溶剂润湿膜，以进行泡点和扩散完整性测试。基于溶剂的完整性测试由于存在下游溶剂污染的风险，使得在灭菌后进行原位测试变得困难。一种新开发的方法，即水压完整性测试（WPIT），可以对疏水过滤器进行完整性测试，消除了与采用溶剂的传统测试方法相关的问题。WPIT的一个主要优点是它可以在灭菌后原位进行，无需任何下游操作。该测试已直接与细菌挑战的截留相关。将提供数据以显示这种易于执行的测试的可靠性和灵敏度。
