RT Journal Article
SR Electronic
T1 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
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 71
OP 79
VO 64
IS 1
A1 Olivier Chancel
A1 Raoul Grissely
A1 Magnus Stering
A1 Luc Pisarik
YR 2010
UL http://journal.pda.org/content/64/1/71.abstract
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