Article CommentaryCommentary
Risk-Based Selection of Environmental Classifications for Biopharmaceutical Operations
Nick Bevan, Tim Corbidge, David Estape, Lars Hovmand Lyster and Jorgen Magnus
PDA Journal of Pharmaceutical Science and Technology July 2021, 75 (4) 374-390; DOI: https://doi.org/10.5731/pdajpst.2019.010660
Nick Bevan
1Alexion Pharma International Operations UC, Blanchardstown, Dublin, Ireland;
Tim Corbidge
2BioPhorum, London, UK;
David Estape
3CRB GmbH, Basel, Switzerland;
Lars Hovmand Lyster
4Novo Nordisk, Bagsvaerd, Denmark; and
Jorgen Magnus
5Bayer Wuppertal, Germany

References
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 4
July/August 2021
Risk-Based Selection of Environmental Classifications for Biopharmaceutical Operations
Nick Bevan, Tim Corbidge, David Estape, Lars Hovmand Lyster, Jorgen Magnus
PDA Journal of Pharmaceutical Science and Technology Jul 2021, 75 (4) 374-390; DOI: 10.5731/pdajpst.2019.010660
Jump to section
- Article
- Abstract
- 1. Introduction
- 2. Practical Definition of the Terms Closed, Functionally Closed, Briefly Exposed, and Open Systems
- 3. Methodology Scope
- 4. Building a Model to Determine the Environmental Requirements for a Given Process Step
- 5. Risk-Based Approach to Assigning a Clean room
- 6. Assigning the Environmental Classification Based on the Risk Assessment
- 7. Conclusion
- Disclaimer
- Conflict of Interest Declaration
- Appendix 1: Growth Potential
- References
- Figures & Data
- References
- Info & Metrics
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