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Research ArticleMeeting Proceedings

A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team

Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis and Mike Dingle
PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 207-212; DOI: https://doi.org/10.5731/pdajpst.2020.012419
Allison Scott
1Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705;
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  • For correspondence: a.scott.x4@biovigilant.azbil.com
Ren-Yo Forng
2Amgen, One Amgen Center Drive, Thousand Oaks, CA 91320-1799;
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Mike Russ
3Genentech/Roche, 1 Antibody Way, Oceanside, CA 92056;
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Gilberto Dalmaso
4GDM Pharma Consulting, Via Ca’ Bianca, 2 Alpo di Villafranca di Verona, Italy;
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Scott Hooper
5Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033;
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Philip Villari
6Merck & Co., Inc., 770 Sumneytown Pike, Mailstop WP78-210, West Point, PA 19486;
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James Cannon
7Mettler-Toledo Thornton, Inc., 900 Middlesex Turnpike, Building 8, Billerica, MA 01821;
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James Francis
8Micron View Limited, 1568 W. Bluff Rd., Orange, TX 77632; and
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Mike Dingle
9TSI, Inc., 500 Cardigan Road, Shoreview, MN 55126.
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Article Information

vol. 75 no. 2 207-212
DOI 
https://doi.org/10.5731/pdajpst.2020.012419
PubMed 
33452049

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 1, 2021.

Article Versions

  • previous version (January 15, 2021 - 10:29).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2021

Author Information

  1. Allison Scott1,*,
  2. Ren-Yo Forng2,
  3. Mike Russ3,
  4. Gilberto Dalmaso4,
  5. Scott Hooper5,
  6. Philip Villari6,
  7. James Cannon7,
  8. James Francis8 and
  9. Mike Dingle9
  1. 1Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705;
  2. 2Amgen, One Amgen Center Drive, Thousand Oaks, CA 91320-1799;
  3. 3Genentech/Roche, 1 Antibody Way, Oceanside, CA 92056;
  4. 4GDM Pharma Consulting, Via Ca’ Bianca, 2 Alpo di Villafranca di Verona, Italy;
  5. 5Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033;
  6. 6Merck & Co., Inc., 770 Sumneytown Pike, Mailstop WP78-210, West Point, PA 19486;
  7. 7Mettler-Toledo Thornton, Inc., 900 Middlesex Turnpike, Building 8, Billerica, MA 01821;
  8. 8Micron View Limited, 1568 W. Bluff Rd., Orange, TX 77632; and
  9. 9TSI, Inc., 500 Cardigan Road, Shoreview, MN 55126.
  1. ↵*Corresponding Author: Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705; Telephone: 15202411179. E-mail: a.scott.x4{at}biovigilant.azbil.com
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PDA Journal of Pharmaceutical Science and Technology: 75 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 2
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A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis, Mike Dingle
PDA Journal of Pharmaceutical Science and Technology Mar 2021, 75 (2) 207-212; DOI: 10.5731/pdajpst.2020.012419

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A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
Allison Scott, Ren-Yo Forng, Mike Russ, Gilberto Dalmaso, Scott Hooper, Philip Villari, James Cannon, James Francis, Mike Dingle
PDA Journal of Pharmaceutical Science and Technology Mar 2021, 75 (2) 207-212; DOI: 10.5731/pdajpst.2020.012419
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Keywords

  • Bio-fluorescent particle counting (BFPC)
  • Rapid microbiological method (RMM)
  • FDA Emerging Technology Team (ETT)
  • Environmental monitoring
  • Auto-Fluorescence Unit (AFU)

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