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Research ArticleResearch

Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing

Jeffrey Weber, James Hauschild, Pieta Ijzerman-Boon, Ren-Yo Forng, Jeff Horsch, Lisa Yan, Aditya Prasad, Robert “Bo” Henry, Marja Claassen, Philip Villari, Shebeer Shereefa, Jane Wyatt, Jay S. Bolden, Jean-Thierry Pycke and Dawood Dassu
PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 121-134; DOI: https://doi.org/10.5731/pdajpst.2018.008722
Jeffrey Weber
1Pfizer, Kalamazoo, MI, USA;
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James Hauschild
2Johnson & Johnson, East Raritan, NJ, USA;
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Pieta Ijzerman-Boon
3Merck, Sharp & Dohme, The Netherlands;
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Ren-Yo Forng
4Amgen, Thousand Oaks, CA, USA;
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Jeff Horsch
5Bristol-Myers Squibb, New Brunswick, NJ, USA;
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Lisa Yan
6Takeda Pharmaceutical Company limited, Los Angeles, CA, USA;
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Aditya Prasad
7AstraZeneca, Philadelphia, PA, USA;
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Robert “Bo” Henry
8Catalent Biologics, Bloomington, IN, USA;
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Marja Claassen
3Merck, Sharp & Dohme, The Netherlands;
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Philip Villari
9Merck Inc., West Point, PA, USA;
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Shebeer Shereefa
10Abbvie, North Chicago, IL, USA;
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Jane Wyatt
11Alexion, Blanchardstown, Dublin, Ireland;
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Jay S. Bolden
12Eli Lilly, Indianapolis, IN, USA;
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Jean-Thierry Pycke
13GSK Vaccines, Belgium; and
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Dawood Dassu
14BioPhorum, The Gridiron Building, One Pancras Square, London N1C 4AG
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  • For correspondence: dawood@biophorum.com
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Abstract

This paper provides recommendations for quality oversight, manufacturing operations, and industry perspective of regulatory expectations to enable aseptic facilities to move toward real-time and continuous microbiological environmental monitoring, thereby reducing interventions and future replacement of Grade A settle plates and nonremote active air sampling. The replacement of traditional monitoring with biofluorescent particle-counting systems provides an improvement in process understanding and product safety and reduces operator manipulations, assuring product quality and real-time process verification. The future state pharmaceutical technology roadmaps include gloveless isolators with real-time and continuous monitoring for aseptic manufacturing.

LAY ABSTRACT: This paper advocates the use of an alternative and relatively new method of monitoring the air for contamination in biopharmaceutical manufacturing facilities. The alternative method is based on a type of instrument the authors refer to as a biofluorescent particle counter (BFPC). The BFPC method has the advantage of being able to detect airborne microorganisms continuously and to record the actual time of detection. The replacement of traditional monitoring with BFPC systems can provide better data, which can be used to improve the understanding of contamination risks in complex manufacturing processes, ultimately providing more confidence in product safety. The authors present data showing the suitability of BFPC. This immediate result is very useful for picking up early any possible contamination and should, therefore, provide a better way to monitor and control the risk of contamination. As traditional monitoring methods require manual manipulation, an additional advantage of BFPC systems is that they can reduce manual manipulations. Elimination of all interventions is a goal in the industry, because although they are tightly controlled, interventions are an unwanted potential source of contamination.

  • Rapid microbiology
  • Environmental monitoring
  • Biofluorescent particle counters
  • © PDA, Inc. 2019
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PDA Journal of Pharmaceutical Science and Technology: 73 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 2
March/April 2019
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Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing
Jeffrey Weber, James Hauschild, Pieta Ijzerman-Boon, Ren-Yo Forng, Jeff Horsch, Lisa Yan, Aditya Prasad, Robert “Bo” Henry, Marja Claassen, Philip Villari, Shebeer Shereefa, Jane Wyatt, Jay S. Bolden, Jean-Thierry Pycke, Dawood Dassu
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 121-134; DOI: 10.5731/pdajpst.2018.008722

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Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing
Jeffrey Weber, James Hauschild, Pieta Ijzerman-Boon, Ren-Yo Forng, Jeff Horsch, Lisa Yan, Aditya Prasad, Robert “Bo” Henry, Marja Claassen, Philip Villari, Shebeer Shereefa, Jane Wyatt, Jay S. Bolden, Jean-Thierry Pycke, Dawood Dassu
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 121-134; DOI: 10.5731/pdajpst.2018.008722
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  • Article
    • Abstract
    • Introduction to Biofluorescent Particle Counting
    • Opportunities and Challenges of Settle Plates and Active Air Sampling
    • Role of the Bfpc In Manufacturing
    • Potential Implementation Strategy
    • Data Collection and Presentation
    • Grade A Manufacturing Areas, Restricted Access Barrier System, and Isolators
    • Data Sets
    • Grade B/C/D Areas
    • Regulatory Perception
    • Business Benefits
    • Conclusions
    • Conflicts of Interest Declaration
    • Acknowledgements
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  • Practical Applications of Biofluorescent Particle Counting in Environmental Monitoring Investigations
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Keywords

  • Rapid microbiology
  • Environmental Monitoring
  • Biofluorescent particle counters

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