How and Why Would You Do a Pressure Holding Test on an Aseptic Installation for which You Want to Check the Integrity? Theory and Practical Example

Olivier Chancel; Raoul Grissely; Magnus Stering; Luc Pisarik

Abstract

This paper uses the Boyle-Mariotte Law to restate a few general principles and applies them to rationalise pressure holding tests on sterile installations. The authors offer a methodology to achieve this, as well as a few mathematical models to determine test durations and acceptance limits, as functions of the breach sizes to be considered and the measurement instruments used. Apart from the theoretical approach, readers are offered a few examples to illustrate the models.

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