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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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Article Information

vol. 73 no. 2 121-134
DOI 
https://doi.org/10.5731/pdajpst.2018.008722
PubMed 
30361285

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 8, 2019.

Article Versions

  • previous version (October 25, 2018 - 06:38).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Jeffrey Weber1,
  2. James Hauschild2,
  3. Pieta Ijzerman-Boon3,
  4. Ren-Yo Forng4,
  5. Jeff Horsch5,
  6. Lisa Yan6,
  7. Aditya Prasad7,
  8. Robert “Bo” Henry8,
  9. Marja Claassen3,
  10. Philip Villari9,
  11. Shebeer Shereefa10,
  12. Jane Wyatt11,
  13. Jay S. Bolden12,
  14. Jean-Thierry Pycke13 and
  15. Dawood Dassu14,*
  1. 1Pfizer, Kalamazoo, MI, USA;
  2. 2Johnson & Johnson, East Raritan, NJ, USA;
  3. 3Merck, Sharp & Dohme, The Netherlands;
  4. 4Amgen, Thousand Oaks, CA, USA;
  5. 5Bristol-Myers Squibb, New Brunswick, NJ, USA;
  6. 6Takeda Pharmaceutical Company limited, Los Angeles, CA, USA;
  7. 7AstraZeneca, Philadelphia, PA, USA;
  8. 8Catalent Biologics, Bloomington, IN, USA;
  9. 9Merck Inc., West Point, PA, USA;
  10. 10Abbvie, North Chicago, IL, USA;
  11. 11Alexion, Blanchardstown, Dublin, Ireland;
  12. 12Eli Lilly, Indianapolis, IN, USA;
  13. 13GSK Vaccines, Belgium; and
  14. 14BioPhorum, The Gridiron Building, One Pancras Square, London N1C 4AG
  1. ↵* Corresponding Author: BioPhorum Operations Group, 5 Westbrook Court, Sharrow Vale Road, Sheffield S11 8YZ, UK; e-mail: dawood{at}biophorum.com
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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
    • References
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  • Environmental and Personnel Monitoring Programs--A Risk-Based Case Study of Cutibacterium acnes
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Keywords

  • Rapid microbiology
  • Environmental Monitoring
  • Biofluorescent particle counters

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