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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 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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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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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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  • Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
  • Case Study: Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working towards alignment with USP<790> Visible Inspection of Injections
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Keywords

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

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