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OtherCase Studies

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

Hans Joachim Anders, Daniel Mannle, William Carpenter, Wolfgang Eder, Ivana Heckel, Tobias Gotzen, Corinne Oechslin, Cedric Joosen, Maria Eugenia Giribets Parra, Jason Rose, Vaishali Shah and David L Jones
PDA Journal of Pharmaceutical Science and Technology November 2022, pdajpst.2022.012742; DOI: https://doi.org/10.5731/pdajpst.2022.012742
Hans Joachim Anders
1 Novartis Pharma Stein AG, Stein CH4332, Switzerland;
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Daniel Mannle
1 Novartis Pharma Stein AG, Stein CH4332, Switzerland;
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William Carpenter
2 Biogen, Durham, North Carolina, USA;
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Wolfgang Eder
3 Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany;
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Ivana Heckel
4 Lonza, Visp, Valais, Switzerland;
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Tobias Gotzen
4 Lonza, Visp, Valais, Switzerland;
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Corinne Oechslin
4 Lonza, Visp, Valais, Switzerland;
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Cedric Joosen
5 Janssen Pharmaceutica NV, Beerse, Belgium;
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Maria Eugenia Giribets Parra
6 Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany;
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Jason Rose
7 GlaxoSmithKline, Upper Merion, PA, USA;
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Vaishali Shah
8 Kite Pharma, Santa Monica, California, USA;
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David L Jones
9 Rapid Micro Biosystems, Massachusetts, USA
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  • For correspondence: djones@rapidmicrobio.com
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Article Information

pdajpst.2022.012742
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 
  • Received January 28, 2022
  • Accepted September 28, 2022
  • Published online November 15, 2022.

Article Versions

  • You are currently viewing a previous version of this article (November 15, 2022 - 06:28).
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Copyright & Usage 
Copyright © 2022, Parenteral Drug Association

Author Information

  1. Hans Joachim Anders1,
  2. Daniel Mannle1,
  3. William Carpenter2,
  4. Wolfgang Eder3,
  5. Ivana Heckel4,
  6. Tobias Gotzen4,
  7. Corinne Oechslin4,
  8. Cedric Joosen5,
  9. Maria Eugenia Giribets Parra6,
  10. Jason Rose7,
  11. Vaishali Shah8 and
  12. David L Jones9,10 (djones@rapidmicrobio.com)
  1. 1 Novartis Pharma Stein AG, Stein CH4332, Switzerland;
  2. 2 Biogen, Durham, North Carolina, USA;
  3. 3 Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany;
  4. 4 Lonza, Visp, Valais, Switzerland;
  5. 5 Janssen Pharmaceutica NV, Beerse, Belgium;
  6. 6 Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany;
  7. 7 GlaxoSmithKline, Upper Merion, PA, USA;
  8. 8 Kite Pharma, Santa Monica, California, USA;
  9. 9 Rapid Micro Biosystems, Massachusetts, USA
  1. ↵* Corresponding author; email: djones@rapidmicrobio.com

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    Erin M Masucci, James E Hauschild, Helena M Gisler, Erin M Lester, Karin M Balss
    Journal of Applied Microbiology 2024 135 8
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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 2025
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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 Mannle, William Carpenter, Wolfgang Eder, Ivana Heckel, Tobias Gotzen, Corinne Oechslin, Cedric Joosen, Maria Eugenia Giribets Parra, Jason Rose, Vaishali Shah, David L Jones
PDA Journal of Pharmaceutical Science and Technology Nov 2022, pdajpst.2022.012742; DOI: 10.5731/pdajpst.2022.012742
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More in this TOC Section

  • Phase-Incremental Decision Trees for Multi-Phase Feature Selection and Interaction in Biologics Manufacturing
  • Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
  • A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT)
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Keywords

  • Automation
  • Bioburden testing
  • Colony Counter
  • Environmental Monitoring
  • Method validation
  • Rapid Microbial Methods (RMMs)

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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 Mannle, William Carpenter, Wolfgang Eder, Ivana Heckel, Tobias Gotzen, Corinne Oechslin, Cedric Joosen, Maria Eugenia Giribets Parra, Jason Rose, Vaishali Shah, David L Jones
PDA Journal of Pharmaceutical Science and Technology Nov 2022, pdajpst.2022.012742; DOI: 10.5731/pdajpst.2022.012742

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