title: 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.
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.
authors.affiliation: Pharmaceutical Production Department, Merial Société Anonyme Simplifiée, Toulouse, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Chancel
authors.forename: Raoul
authors.initials: R
authors.lastname: Grissely
authors.forename: Magnus
authors.initials: M
authors.lastname: Stering
authors.forename: Luc
authors.initials: L
authors.lastname: Pisarik
mesh_terms: D006801:Humans; D008954:Models, Biological; D008962:Models, Theoretical; D011312:Pressure