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Article CommentaryCommentary

Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool

Allison Scott, Ans Vanbroekhoven, Cedric Joossen, Chris Knutsen, David Govezensky, Hans-Joachim Anders, James Cannon, Joanny Salvas, Michael Dingle, Patrick Hutchins, Petra Merker, Philip Villari, Stephanie Ramsey, Anthony Cundell, Victoria Navarro and Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology January 2023, 77 (1) 2-9; DOI: https://doi.org/10.5731/pdajpst.2021.012726
Allison Scott
1PEMM/Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705;
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Ans Vanbroekhoven
2BioPhorum/Sanofi, Cipalstraat 8, 2440 Geel, Belgium;
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Cedric Joossen
3OWBA/Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium;
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Chris Knutsen
4BioPhorum/Bristol-Myers Squibb, New Brunswick, NJ;
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David Govezensky
5BioPhorum/Bio-Technology General (Israel) Ltd., POB 571, Be'er Tuvia Industrial Zone, Kiryat Malachi 8310402, Israel;
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Hans-Joachim Anders
6OWBA/Novartis Pharma Stein AG, Schaffhauserstrasse 101, 4332 Stein, Switzerland;
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James Cannon
7PEMM/Mettler-Toledo Thornton, Inc., 900 Middlesex Turnpike, Building 8, Billerica, MA 01821;
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Joanny Salvas
8BioPhorum/Pfizer, Kirkland, Quebec, Canada;
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Michael Dingle
9PEMM/TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126;
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Patrick Hutchins
9PEMM/TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126;
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Petra Merker
10BioPhorum/Bayer AG, Müllerstr. 178, D-13353 Berlin, Germany;
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Philip Villari
11BioPhorum/PEMM/Merck & Co., Inc., Kenilworth, NJ;
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Stephanie Ramsey
12BioPhorum/Amgen, Inc., One Amgen Center Dr., Thousand Oaks, CA 91320;
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Anthony Cundell
13PEMM/Microbiological Consulting, LLC., 105 Lee Rd, Scarsdale, NY 10583;
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Victoria Navarro
14BioPhorum/Pfizer, S. S. de los Reyes, Madrid, Spain; and
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Margit Franz-Riethdorf
15BioPhorum Operations Group Limited, 5 Westbrook Court, Sharrowvale Road, Sheffield, S11 8YZ, United Kingdom
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  • For correspondence: margit.franz-riethdorf@biophorum.com
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Article Information

vol. 77 no. 1 2-9
DOI 
https://doi.org/10.5731/pdajpst.2021.012726
PubMed 
35840344

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 6, 2023.

Article Versions

  • previous version (July 15, 2022 - 11:02).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2023

Author Information

  1. Allison Scott1,
  2. Ans Vanbroekhoven2,
  3. Cedric Joossen3,
  4. Chris Knutsen4,
  5. David Govezensky5,
  6. Hans-Joachim Anders6,
  7. James Cannon7,
  8. Joanny Salvas8,
  9. Michael Dingle9,
  10. Patrick Hutchins9,
  11. Petra Merker10,
  12. Philip Villari11,
  13. Stephanie Ramsey12,
  14. Anthony Cundell13,
  15. Victoria Navarro14 and
  16. Margit Franz-Riethdorf15,*
  1. 1PEMM/Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705;
  2. 2BioPhorum/Sanofi, Cipalstraat 8, 2440 Geel, Belgium;
  3. 3OWBA/Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium;
  4. 4BioPhorum/Bristol-Myers Squibb, New Brunswick, NJ;
  5. 5BioPhorum/Bio-Technology General (Israel) Ltd., POB 571, Be'er Tuvia Industrial Zone, Kiryat Malachi 8310402, Israel;
  6. 6OWBA/Novartis Pharma Stein AG, Schaffhauserstrasse 101, 4332 Stein, Switzerland;
  7. 7PEMM/Mettler-Toledo Thornton, Inc., 900 Middlesex Turnpike, Building 8, Billerica, MA 01821;
  8. 8BioPhorum/Pfizer, Kirkland, Quebec, Canada;
  9. 9PEMM/TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126;
  10. 10BioPhorum/Bayer AG, Müllerstr. 178, D-13353 Berlin, Germany;
  11. 11BioPhorum/PEMM/Merck & Co., Inc., Kenilworth, NJ;
  12. 12BioPhorum/Amgen, Inc., One Amgen Center Dr., Thousand Oaks, CA 91320;
  13. 13PEMM/Microbiological Consulting, LLC., 105 Lee Rd, Scarsdale, NY 10583;
  14. 14BioPhorum/Pfizer, S. S. de los Reyes, Madrid, Spain; and
  15. 15BioPhorum Operations Group Limited, 5 Westbrook Court, Sharrowvale Road, Sheffield, S11 8YZ, United Kingdom
  1. ↵* Corresponding Author: BioPhorum Operations Group Limited, 5 Westbrook Ct., Sharrowvale Rd., Sheffield, S11 8YZ, United Kingdom; E-mail: margit.franz-riethdorf{at}biophorum.com
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PDA Journal of Pharmaceutical Science and Technology: 77 (1)
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Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
Allison Scott, Ans Vanbroekhoven, Cedric Joossen, Chris Knutsen, David Govezensky, Hans-Joachim Anders, James Cannon, Joanny Salvas, Michael Dingle, Patrick Hutchins, Petra Merker, Philip Villari, Stephanie Ramsey, Anthony Cundell, Victoria Navarro, Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology Jan 2023, 77 (1) 2-9; DOI: 10.5731/pdajpst.2021.012726

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Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
Allison Scott, Ans Vanbroekhoven, Cedric Joossen, Chris Knutsen, David Govezensky, Hans-Joachim Anders, James Cannon, Joanny Salvas, Michael Dingle, Patrick Hutchins, Petra Merker, Philip Villari, Stephanie Ramsey, Anthony Cundell, Victoria Navarro, Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology Jan 2023, 77 (1) 2-9; DOI: 10.5731/pdajpst.2021.012726
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Keywords

  • Autofluorescence unit (AFU)
  • Bio-fluorescent particle counting (BFPC)
  • Environmental monitoring (EM)
  • Modern microbiological method process analytical technology (PAT)
  • Rapid microbiological method (RMM)
  • Water monitoring

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