Abstract
The authors have, in this report, assembled information which others may find useful in evaluating their filtration processes. We emphasize that there is no single “right way” to validate a filtration process. Substantial diversity of scientific opinion exists in at least two areas which are crucial to a complete technical understanding of the sterilization of liquids by filtration. These areas of controversy are the mechanism of microbial retention and the predictive abilities of the various nondestructive integrity test procedures. In spite of the technical uncertainties, technical studies have been conducted to increase confidence that a filtration process does deliver the desired degree of sterility assurance. Different aspects of these individual studies are presented in this report. It is hoped that they will be helpful to others who are in the process of designing such studies.
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