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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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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
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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  • A Commentary on "Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit"
  • Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
  • A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
  • Environmental and Personnel Monitoring Programs--A Risk-Based Case Study of Cutibacterium acnes
  • Practical Applications of Biofluorescent Particle Counting in Environmental Monitoring Investigations
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  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
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Keywords

  • Rapid microbiology
  • Environmental Monitoring
  • Biofluorescent particle counters

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