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Article CommentaryCommentary

Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program

Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher Phillion
PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662
Derek Willison-Parry
1BioPhorum, London, UK;
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  • For correspondence: derek@biophorum.com
Stephen Yang
2Merck & Co., Inc, Kenilworth, NJ;
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Ren-Yo Forng
3Amgen, Thousand Oaks, CA;
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Tim Cirbo
4Eli Lilly, Indianapolis, IN;
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Aileen Mcmeel
5Pfizer, New York, NY;
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Brian Kiler
6Roche, Basel, Switzerland; and
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Christopher Phillion
7Takeda, Cambridge, MA
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Article Information

vol. 74 no. 2 249-263
DOI 
https://doi.org/10.5731/pdajpst.2018.009662
PubMed 
31732692

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 9, 2020.

Article Versions

  • previous version (November 15, 2019 - 07:57).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Derek Willison-Parry1,*,
  2. Stephen Yang2,
  3. Ren-Yo Forng3,
  4. Tim Cirbo4,
  5. Aileen Mcmeel5,
  6. Brian Kiler6 and
  7. Christopher Phillion7
  1. 1BioPhorum, London, UK;
  2. 2Merck & Co., Inc, Kenilworth, NJ;
  3. 3Amgen, Thousand Oaks, CA;
  4. 4Eli Lilly, Indianapolis, IN;
  5. 5Pfizer, New York, NY;
  6. 6Roche, Basel, Switzerland; and
  7. 7Takeda, Cambridge, MA
  1. ↵*Corresponding Author: BioPhorum, The Gridiron Building, 1 Pancras Square, London N1C 4AG, United Kingdom. E-mail: derek{at}biophorum.com
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PDA Journal of Pharmaceutical Science and Technology: 74 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 2
March/April 2020
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Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler, Christopher Phillion
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 249-263; DOI: 10.5731/pdajpst.2018.009662

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Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler, Christopher Phillion
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 249-263; DOI: 10.5731/pdajpst.2018.009662
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Categories of Disinfectants and How They Differ
    • 3. Regulatory expectations with Regard to Disinfectant Efficacy Testing
    • 4. The Value of Environmental Monitoring Trending to Disinfectant Efficacy Testing
    • 5. Challenge Organism Selection for Disinfectant Efficacy Testing
    • 6. Challenge Surface Selection
    • 7. Leveraging Disinfectant Efficacy Data for Multiple Facilities
    • 8. Critical Parameters and the Holistic Management of a Disinfectant Efficacy Study Validation Program
    • 9. How to Bring a New Material into the Program
    • 10. Conclusion
    • Conflict of Interest Declaration
    • References
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  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
  • Expanding the Use of Moist Heat for Terminal Sterilization
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Keywords

  • BioPhorum
  • Disinfectant efficacy
  • Cleaning
  • Cleaning requirements
  • Control awareness

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