Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation

Sven Deutschmann; Mousumi Paul; Marja Claassen-Willemse; Jonas van den Berg; Pieta IJzerman-Boon; Viviane Grunert da Fonseca; Ellen Brunbech; Lynn Johnson; Chris Knutsen; Lucile Plourde; Joanny Salvas; Philip Villari; Lisa Wysocki

doi:10.5731/pdajpst.2021.012672

Research ArticleTechnology/Application

Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation

Sven Deutschmann, Mousumi Paul, Marja Claassen-Willemse, Jonas van den Berg, Pieta IJzerman-Boon, Viviane Grunert da Fonseca, Ellen Brunbech, Lynn Johnson, Chris Knutsen, Lucile Plourde, Joanny Salvas, Philip Villari and Lisa Wysocki

PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 211-235; DOI: https://doi.org/10.5731/pdajpst.2021.012672

Sven Deutschmann

1Roche Diagnostics GmbH, Penzberg, Germany;

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Mousumi Paul

2Merck & Co., Inc., Kenilworth, NJ;

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Marja Claassen-Willemse

3MSD, Oss, The Netherlands;

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Jonas van den Berg

4Roche Diagnostics GmbH, Mannheim, Germany;

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Pieta IJzerman-Boon

3MSD, Oss, The Netherlands;

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Viviane Grunert da Fonseca

5Roche Diagnostics GmbH, Penzberg, Germany;

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Ellen Brunbech

6Novo Nordisk A/S, Bagsvaerd, Denmark;

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Lynn Johnson

7Takeda, Lexington, MA;

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Chris Knutsen

8Bristol-Myers Squibb, New Brunswick, NJ;

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Lucile Plourde

9Sanofi Pasteur, Marcy-l'Etoile, France;

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Joanny Salvas

10Pfizer, Kirkland, QC, Canada; and

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Philip Villari

2Merck & Co., Inc., Kenilworth, NJ;

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Lisa Wysocki

11GlaxoSmithKline, Collegeville, PA

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vol. 77 no. 3 211-235

DOI

https://doi.org/10.5731/pdajpst.2021.012672

PubMed

36697213

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online June 8, 2023.

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previous version (January 25, 2023 - 06:55).
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Author Information

Sven Deutschmann¹,
Mousumi Paul²,
Marja Claassen-Willemse³,
Jonas van den Berg⁴,
Pieta IJzerman-Boon³,
Viviane Grunert da Fonseca⁵,
Ellen Brunbech⁶,
Lynn Johnson⁷,
Chris Knutsen⁸,
Lucile Plourde⁹,
Joanny Salvas¹⁰,
Philip Villari² and
Lisa Wysocki¹¹

¹Roche Diagnostics GmbH, Penzberg, Germany;
²Merck & Co., Inc., Kenilworth, NJ;
³MSD, Oss, The Netherlands;
⁴Roche Diagnostics GmbH, Mannheim, Germany;
⁵Roche Diagnostics GmbH, Penzberg, Germany;
⁶Novo Nordisk A/S, Bagsvaerd, Denmark;
⁷Takeda, Lexington, MA;
⁸Bristol-Myers Squibb, New Brunswick, NJ;
⁹Sanofi Pasteur, Marcy-l'Etoile, France;
¹⁰Pfizer, Kirkland, QC, Canada; and
¹¹GlaxoSmithKline, Collegeville, PA

*Corresponding Author: BioPhorum Operations Group Limited, 5 Westbrook Ct., Sharrowvale Rd., Sheffield, S11 8YZ, United Kingdom. E-mail: margit.franz-riethdorf{at}biophorum.com

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Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation

PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 211-235; DOI: 10.5731/pdajpst.2021.012672

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Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation

PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 211-235; DOI: 10.5731/pdajpst.2021.012672

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Keywords

Alternative and rapid microbiological methods
Alternative sterility test
Method validation
Microbiological method transfer
Regulatory filing
Statistical methodology

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