Multisite Qualification of an Automated Incubator and Colony Counter for Environmental and Bioburden Applications in Pharmaceutical Microbiology

Hans Joachim Anders; Daniel Männle; William Carpenter; Wolfgang Eder; Ivana Heckel; Tobias Götzen; Corinne Oechslin; Cedric Joossen; Maria Eugenia Giribets Parra; Jason Rose; Vaishali Shah; David L Jones

doi:10.5731/pdajpst.2022.012742

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Multisite Qualification of an Automated Incubator and Colony Counter for Environmental and Bioburden Applications in Pharmaceutical Microbiology

Hans Joachim Anders, Daniel Männle, William Carpenter, Wolfgang Eder, Ivana Heckel, Tobias Götzen, Corinne Oechslin, Cedric Joossen, Maria Eugenia Giribets Parra, Jason Rose, Vaishali Shah and David L Jones

PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 236-247; DOI: https://doi.org/10.5731/pdajpst.2022.012742

Hans Joachim Anders

1Novartis Pharma Stein AG, Stein CH4332, Switzerland;

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Daniel Männle

1Novartis Pharma Stein AG, Stein CH4332, Switzerland;

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William Carpenter

2Biogen, Durham, NC;

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Wolfgang Eder

3Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany;

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Ivana Heckel

4Lonza, Visp, Valais, Switzerland;

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Tobias Götzen

4Lonza, Visp, Valais, Switzerland;

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Corinne Oechslin

4Lonza, Visp, Valais, Switzerland;

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Cedric Joossen

5Janssen Pharmaceutica NV, Beerse, Belgium;

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Maria Eugenia Giribets Parra

6Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany;

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Jason Rose

7GlaxoSmithKline, Upper Merion, PA;

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Vaishali Shah

8Kite Pharma, Santa Monica, CA; and

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David L Jones

9Rapid Micro Biosystems, Lowell, MA, USA

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For correspondence: djones@rapidmicrobio.com

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vol. 77 no. 3 236-247

DOI

https://doi.org/10.5731/pdajpst.2022.012742

PubMed

36379594

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 (November 15, 2022 - 06:28).
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Author Information

Hans Joachim Anders¹,
Daniel Männle¹,
William Carpenter²,
Wolfgang Eder³,
Ivana Heckel⁴,
Tobias Götzen⁴,
Corinne Oechslin⁴,
Cedric Joossen⁵,
Maria Eugenia Giribets Parra⁶,
Jason Rose⁷,
Vaishali Shah⁸ and
David L Jones⁹,*

¹Novartis Pharma Stein AG, Stein CH4332, Switzerland;
²Biogen, Durham, NC;
³Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany;
⁴Lonza, Visp, Valais, Switzerland;
⁵Janssen Pharmaceutica NV, Beerse, Belgium;
⁶Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany;
⁷GlaxoSmithKline, Upper Merion, PA;
⁸Kite Pharma, Santa Monica, CA; and
⁹Rapid Micro Biosystems, Lowell, MA, USA

↵*Corresponding Author: Rapid Micro Biosystems, Lowell, MA, USA; E-mail: djones{at}rapidmicrobio.com

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Multisite Qualification of an Automated Incubator and Colony Counter for Environmental and Bioburden Applications in Pharmaceutical Microbiology

PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 236-247; DOI: 10.5731/pdajpst.2022.012742

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Multisite Qualification of an Automated Incubator and Colony Counter for Environmental and Bioburden Applications in Pharmaceutical Microbiology

PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 236-247; DOI: 10.5731/pdajpst.2022.012742

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Keywords

Automation
Colony Counter
Environmental monitoring
Bioburden testing
Performance Qualification
Method validation
contact plate
Rapid Microbial Methods (RMMs)

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