White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing

Scott Ewan; Min Jiang; Chris Stevenson; Olivia Henderson; Steve Klohr; Martha Wessel; Pinky Mehta; Stefanie Adler; Cindy Lake; John Walsh; Tony Polomene; Valja Everaert

doi:10.5731/pdajpst.2015.01071

EditorialBPOG Special Section

White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing

Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

Scott Ewan

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For correspondence: scott@biophorum.com

Min Jiang

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Chris Stevenson

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Olivia Henderson

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Steve Klohr

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Martha Wessel

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Pinky Mehta

Roles: (Janssen)

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Stefanie Adler

Roles: (Janssen)

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Cindy Lake

Roles: (Merck)

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John Walsh

Roles: (Pfizer)

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Tony Polomene

Roles: (Pfizer)

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Valja Everaert

Roles: (Pfizer)

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1.↵
FDA Guidance for Industry: Container and Closure Integrity Testing in lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products, February 2008.

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White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing

Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene, Valja Everaert

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: 10.5731/pdajpst.2015.01071

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White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing

Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene, Valja Everaert

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: 10.5731/pdajpst.2015.01071

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[1] 1.↵
FDA Guidance for Industry: Container and Closure Integrity Testing in lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products, February 2008.

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Parenteral Drug Association, Inc.