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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;
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Tim Corbidge
2BioPhorum, London, UK;
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David Estape
3CRB GmbH, Basel, Switzerland;
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  • For correspondence: david.estape@crbgroup.com
Lars Hovmand Lyster
4Novo Nordisk, Bagsvaerd, Denmark; and
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Jorgen Magnus
5Bayer Wuppertal, Germany
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 75 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 4
July/August 2021
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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
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  • 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
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Keywords

  • Risk-based
  • Closed systems
  • Closed process
  • Room classification
  • Environmental classification
  • Biopharmaceuticals
  • Low bioburden
  • Drug substance manufacture
  • Facility design

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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

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