PT  - JOURNAL ARTICLE
AU  - Olivier Chancel
AU  - Raoul Grissely
AU  - Magnus Stering
AU  - Luc Pisarik
TI  - 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
DP  - 2010 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 71--79
VI  - 64
IP  - 1
4099  - http://journal.pda.org/content/64/1/71.short
4100  - http://journal.pda.org/content/64/1/71.full
SO  - PDA J Pharm Sci Technol2010 Jan 01; 64
AB  - 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.© PDA, Inc. 2010