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;
James Hauschild
2Johnson & Johnson, East Raritan, NJ, USA;
Pieta Ijzerman-Boon
3Merck, Sharp & Dohme, The Netherlands;
Ren-Yo Forng
4Amgen, Thousand Oaks, CA, USA;
Jeff Horsch
5Bristol-Myers Squibb, New Brunswick, NJ, USA;
Lisa Yan
6Takeda Pharmaceutical Company limited, Los Angeles, CA, USA;
Aditya Prasad
7AstraZeneca, Philadelphia, PA, USA;
Robert “Bo” Henry
8Catalent Biologics, Bloomington, IN, USA;
Marja Claassen
3Merck, Sharp & Dohme, The Netherlands;
Philip Villari
9Merck Inc., West Point, PA, USA;
Shebeer Shereefa
10Abbvie, North Chicago, IL, USA;
Jane Wyatt
11Alexion, Blanchardstown, Dublin, Ireland;
Jay S. Bolden
12Eli Lilly, Indianapolis, IN, USA;
Jean-Thierry Pycke
13GSK Vaccines, Belgium; and
Dawood Dassu
14BioPhorum, The Gridiron Building, One Pancras Square, London N1C 4AG

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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 2
March/April 2019
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
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
Jump to section
- 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
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