Vacuum Decay Container Closure Integrity Leak Test Method Development and Validation for a Lyophilized Product-Package System

Jayshree Patel; Brian Mulhall; Heinz Wolf; Steven Klohr; Dana Morton Guazzo

doi:10.5731/pdajpst.2011.00780

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Vacuum Decay Container Closure Integrity Leak Test Method Development and Validation for a Lyophilized Product-Package System

Jayshree Patel, Brian Mulhall, Heinz Wolf, Steven Klohr and Dana Morton Guazzo

PDA Journal of Pharmaceutical Science and Technology September 2011, 65 (5) 486-505; DOI: https://doi.org/10.5731/pdajpst.2011.00780

Jayshree Patel

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Brian Mulhall

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Heinz Wolf

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Steven Klohr

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Dana Morton Guazzo

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For correspondence: dguazzo@rxpax.com

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vol. 65 no. 5 486-505

DOI

https://doi.org/10.5731/pdajpst.2011.00780

PubMed

22293838

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online October 5, 2011.

Author Information

Jayshree Patel1,
Brian Mulhall2,
Heinz Wolf3,
Steven Klohr4 and
Dana Morton Guazzo5,*

¹Analytical & Bioanalytical Development, Bristol-Myers Squibb Company, New Brunswick, NJ;
²Whitehouse Analytical Laboratories, LLC, Whitehouse, NJ;
³Packaging Technologies & Inspection, LLC, Tuckahoe, NY;
⁴Analytical & Bioanalytical Development, Bristol-Myers Squibb Company, New Brunswick, NJ, and
⁵RxPax, LLC, Bridgewater, NJ

↵* Corresponding author: RxPax, LLC, 920 Ardsley Lane, Bridgewater, NJ 08807; Phone: 908.507.3905; Email: dguazzo{at}rxpax.com

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Vacuum Decay Container Closure Integrity Leak Test Method Development and Validation for a Lyophilized Product-Package System

Jayshree Patel, Brian Mulhall, Heinz Wolf, Steven Klohr, Dana Morton Guazzo

PDA Journal of Pharmaceutical Science and Technology Sep 2011, 65 (5) 486-505; DOI: 10.5731/pdajpst.2011.00780

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Vacuum Decay Container Closure Integrity Leak Test Method Development and Validation for a Lyophilized Product-Package System

Jayshree Patel, Brian Mulhall, Heinz Wolf, Steven Klohr, Dana Morton Guazzo

PDA Journal of Pharmaceutical Science and Technology Sep 2011, 65 (5) 486-505; DOI: 10.5731/pdajpst.2011.00780

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