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Research ArticleTechnology/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 and Wolfgang Eder
PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 509-526; DOI: https://doi.org/10.5731/pdajpst.2021.012646
Sven Deutschmann
1Roche Diagnostics GmbH, Penzberg, Germany;
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Bill Carpenter
2Biogen Inc., RTP, NC;
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Caroline Duignan
3GlaxoSmithKline, GSK Medicines Research Centre, Stevenage, United Kingdom;
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Chris Knutsen
4Bristol-Myers Squibb, New Brunswick, NJ;
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Joanny Salvas
5Pfizer, Kirkland, Canada;
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Lisa Wysocki
6GlaxoSmithKline, Collegeville, PA;
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Lucile Plourde
7Sanofi Pasteur, Marcy-l’Etoile, France;
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Lynn Johnson
8Takeda, Lexington, MA; and
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Wolfgang Eder
9Roche Diagnostics GmbH, Penzberg, Germany
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Abstract

For several years, automated colony counting systems have been available with varying degrees of automation. Ever more sophisticated instruments are now increasingly used in microbiological laboratories of pharmaceutical quality control. In addition to the colony counting device, the instruments are now also equipped with robotic systems performing the entire handling of the petri dishes, e.g., automated internal transportation of petri dishes from the incubator chamber to the instrument’s enumeration device and back. Moreover, the subjective evaluation of microbial enumeration tests by analysts is replaced with a more accurate and precise process. This leads to significant improvements to data integrity compliance. Automated colony counting systems also often enable cost reduction in the microbiological laboratory, e.g., by not requiring a contemporaneous verification by a second analyst. They also enable direct integration of count data into an existing laboratory information management system, reducing the hands-on time, costs per test and also preventing human errors caused by manual transcription. Altogether, these instruments will lead to improved monitoring and assurance of control of biopharmaceutical processes and manufacturing environments, as well as shortened cycle times in the supply chain. Regulators are encouraging the biopharmaceutical industry to adopt these innovative systems. For example, this year a BioPhorum member company received the first health authority approvals from EU, US, CH, Canada, Australia, and China for the use of automated colony counting systems for in-process bioburden testing and the release of drug substance lots, with an incubation time reduced by about 50%. Although these approvals are for release testing of drug substance lots, the instruments can also be used for environmental monitoring, testing of water samples, etc. This article describes a systematic 9-step approach to the evaluation, equipment qualification, and deployment of automated colony counting systems, which can be applied by biopharmaceutical companies wanting to take advantage of their numerous benefits.

  • Alternative and rapid microbiological method
  • Automated colony counting
  • Data integrity improvement
  • Environmental monitoring bioburden testing
  • Equipment qualification microbiological method validation
  • Product bioburden testing
  • Water bioburden testing
  • © PDA, Inc. 2022
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PDA Journal of Pharmaceutical Science and Technology: 76 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 6
November/December 2022
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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
PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 509-526; 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
PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 509-526; DOI: 10.5731/pdajpst.2021.012646
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  • Article
    • Abstract
    • Introduction
    • Approach to Adoption of Automated Colony Counting (ACC) Systems: Applying a 9-Step Framework
    • Step 1: Identify Operational/Business Need
    • Step 2: Define the Application
    • Step 3: Assess Requirements
    • Step 4: Compare Options and Technologies—Landscaping and Candidate(s) Selection
    • Step 5: Develop a Business Case: Technical, Quality and Business Evaluation and Justification
    • Step 6: Perform Proof-of-Concept Studies/Feasibility Studies/Prevalidation Studies
    • Step 7: Validate at Pilot or Primary Site
    • Step 8: Deploy Global/Company-Wide Qualification of Additional Laboratories
    • Step 9: Define Regulatory Filings and Implementation Strategy
    • Disclaimer
    • Conflicts of Interest Declaration
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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
  • Product bioburden testing
  • Water bioburden testing

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