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Integrity Testing

  • Maik W. JornitzEmail author
Chapter
Part of the Advances in Biochemical Engineering book series (ABE, volume 98)

Abstract

To ensure that sterilizing grade filters in aseptic processing worked as required, such filters are integrity tested. Integrity tests, like the bubble point, diffusive flow or pressure hold test, are non-destructive tests, which are correlated to a destructive bacteria challenge test. This correlation verifies the integrity test limits the filters have to pass. Integrity tests are required by regulatory authorities. The post filtration integrity test is a must, pre filtration integrity testing is recommended. The different tests have specific limitations therefore there is no overall, best integrity test, which can be utilized for every filtration system.

Membrane filter FDA EMEA Bacteria challenge test Bubble point test Diffusion test Pressure drop test Water intrusion test Multipoint diffusion test Automatic integrity tester 

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Copyright information

© Springer-Verlag Berlin Heidelberg 2006

Authors and Affiliations

  1. 1.12 Manorview WayManorvilleUSA

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