A Systematic Approach for the Evaluation, Validation and Implementation of Automated Colony Counting Systems

Sven Deutschmann; Bill Carpenter; Caroline Duignan; Chris Knutsen; Joanny Salvas; Lisa Wysocki; Lucile Plourde; Lynn Johnson; Wolfgang Eder; Margit Franz-Riethdorf

doi:10.5731/pdajpst.2021.012646

OtherTechnology/Application

A Systematic Approach for the Evaluation, Validation and Implementation of Automated Colony Counting Systems

Sven Deutschmann, Bill Carpenter, Caroline Duignan, Chris Knutsen, Joanny Salvas, Lisa Wysocki, Lucile Plourde, Lynn Johnson, Wolfgang Eder and Margit Franz-Riethdorf

PDA Journal of Pharmaceutical Science and Technology March 2022, pdajpst.2021.012646; DOI: https://doi.org/10.5731/pdajpst.2021.012646

Sven Deutschmann

1 Roche Diagnostics GmbH, Penzberg, Germany;

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Bill Carpenter

2 Biogen Inc., RTP, North Carolina, USA;

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Caroline Duignan

3 GlaxoSmithKline, GSK Medicines Research Centre, Stevenage, UK;

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Chris Knutsen

4 Bristol-Myers Squibb, New Brunswick, NJ, USA;

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Joanny Salvas

5 Pfizer, Kirkland, QC, Canada;

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Lisa Wysocki

6 GlaxoSmithKline, Collegeville, PA, USA;

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Lucile Plourde

7 Sanofi Pasteur, Marcy-lEtoile, France;

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Lynn Johnson

8 Takeda, Lexington, MA, USA;

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Wolfgang Eder

1 Roche Diagnostics GmbH, Penzberg, Germany;

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Margit Franz-Riethdorf

9 BioPhorum Operations Group Ltd

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For correspondence: margit.franz-riethdorf@biophorum.com

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 2025

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A Systematic Approach for the Evaluation, Validation and Implementation of Automated Colony Counting Systems

Sven Deutschmann, Bill Carpenter, Caroline Duignan, Chris Knutsen, Joanny Salvas, Lisa Wysocki, Lucile Plourde, Lynn Johnson, Wolfgang Eder, Margit Franz-Riethdorf

PDA Journal of Pharmaceutical Science and Technology Mar 2022, pdajpst.2021.012646; DOI: 10.5731/pdajpst.2021.012646

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A Systematic Approach for the Evaluation, Validation and Implementation of Automated Colony Counting Systems

Sven Deutschmann, Bill Carpenter, Caroline Duignan, Chris Knutsen, Joanny Salvas, Lisa Wysocki, Lucile Plourde, Lynn Johnson, Wolfgang Eder, Margit Franz-Riethdorf

PDA Journal of Pharmaceutical Science and Technology Mar 2022, pdajpst.2021.012646; DOI: 10.5731/pdajpst.2021.012646

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Keywords

Alternative and rapid microbiological method
Automated colony counting
Data integrity improvement
Environmental monitoring bioburden testing
Equipment Qualification
Microbiological Method Validation

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