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OtherCommentary

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 M Cundell, Victoria Navarro and Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology July 2022, pdajpst.2021.012726; DOI: https://doi.org/10.5731/pdajpst.2021.012726
Allison Scott
1 Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705 USA / PEMM;
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  • For correspondence: a.scott.x4@biovigilant.azbil.com
Ans Vanbroekhoven
2 Sanofi, Cipalstraat 8, 2440 Geel Belgium / BioPhorum;
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  • For correspondence: ans.vanbroekhoven@sanofi.com
Cedric Joossen
3 Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium / OWBA;
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  • For correspondence: cjoossen@its.jnj.com
Chris Knutsen
4 Bristol-Myers Squibb, New Brunswick, NJ, USA / BioPhorum;
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  • For correspondence: chris.knutsen@bms.com
David Govezensky
5 Bio-Technology General (Israel) Ltd., POB 571, Be'er Tuvia Industrial Zone, Kiryat Malachi 8310402, Israel / BioPhorum;
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  • For correspondence: david.govezensky@btgil.com
Hans-Joachim Anders
6 Novartis Pharma Stein AG, Schaffhauserstrasse 101, 4332 Stein, Switzerland / OWBA;
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  • For correspondence: hans-joachim.anders@novartis.com
James Cannon
7 Mettler-Toledo Thornton, Inc., 900 Middlesex Turnpike, Building 8, Billerica, MA 01821 / PEMM;
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  • For correspondence: jim.cannon@mt.com
Joanny Salvas
8 Pfizer, Kirkland, QC, Canada / BioPhorum;
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  • For correspondence: joanny.salvas@pfizer.com
Michael Dingle
9 TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126 USA / PEMM;
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  • For correspondence: michael.dingle@tsi.com
Patrick Hutchins
9 TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126 USA / PEMM;
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  • For correspondence: patrick.hutchins@tsi.com
Petra Merker
10 Bayer AG, MAllerstr. 178, D-13353 Berlin, Germany / BioPhorum;
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  • For correspondence: petra.merker@bayer.com
Philip Villari
11 Merck & Co., Inc., Kenilworth, NJ, USA / BioPhorum / PEMM;
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  • For correspondence: philip_villari@merck.com
Stephanie Ramsey
12 Amgen, Inc., One Amgen Center Dr., Thousand Oaks, CA 91320 / BioPhorum;
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  • For correspondence: sramse01@amgen.com
Anthony M Cundell
13 Microbiological Consulting, LLC., 105 Lee Rd, Scarsdale, NY 10583 USA / PEMM;
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  • For correspondence: tonycundell@gmail.com
Victoria Navarro
14 Pfizer, S. S. de los Reyes, Madrid, Spain / BioPhorum;
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  • For correspondence: victoria.navarrolahoz@pfizer.com
Margit Franz-Riethdorf
15 BioPhorum Operations Group Ltd
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  • For correspondence: margit.franz-riethdorf@biophorum.com
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Article Information

pdajpst.2021.012726
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 
  • Received January 26, 2022
  • Accepted July 15, 2022
  • Published online July 15, 2022.

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  • You are currently viewing a previous version of this article (July 15, 2022 - 11:02).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2022, Parenteral Drug Association

Author Information

  1. Allison Scott1 (a.scott.x4{at}biovigilant.azbil.com),
  2. Ans Vanbroekhoven2 (ans.vanbroekhoven{at}sanofi.com),
  3. Cedric Joossen3 (cjoossen{at}its.jnj.com),
  4. Chris Knutsen4 (chris.knutsen{at}bms.com),
  5. David Govezensky5 (david.govezensky{at}btgil.com),
  6. Hans-Joachim Anders6 (hans-joachim.anders{at}novartis.com),
  7. James Cannon7 (jim.cannon{at}mt.com),
  8. Joanny Salvas8 (joanny.salvas{at}pfizer.com),
  9. Michael Dingle9 (michael.dingle{at}tsi.com),
  10. Patrick Hutchins9 (patrick.hutchins{at}tsi.com),
  11. Petra Merker10 (petra.merker{at}bayer.com),
  12. Philip Villari11 (philip_villari{at}merck.com),
  13. Stephanie Ramsey12 (sramse01{at}amgen.com),
  14. Anthony M Cundell13 (tonycundell{at}gmail.com),
  15. Victoria Navarro14 (victoria.navarrolahoz{at}pfizer.com) and
  16. Margit Franz-Riethdorf15,16 (margit.franz-riethdorf{at}biophorum.com)
  1. 1 Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705 USA / PEMM;
  2. 2 Sanofi, Cipalstraat 8, 2440 Geel Belgium / BioPhorum;
  3. 3 Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium / OWBA;
  4. 4 Bristol-Myers Squibb, New Brunswick, NJ, USA / BioPhorum;
  5. 5 Bio-Technology General (Israel) Ltd., POB 571, Be'er Tuvia Industrial Zone, Kiryat Malachi 8310402, Israel / BioPhorum;
  6. 6 Novartis Pharma Stein AG, Schaffhauserstrasse 101, 4332 Stein, Switzerland / OWBA;
  7. 7 Mettler-Toledo Thornton, Inc., 900 Middlesex Turnpike, Building 8, Billerica, MA 01821 / PEMM;
  8. 8 Pfizer, Kirkland, QC, Canada / BioPhorum;
  9. 9 TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126 USA / PEMM;
  10. 10 Bayer AG, MAllerstr. 178, D-13353 Berlin, Germany / BioPhorum;
  11. 11 Merck & Co., Inc., Kenilworth, NJ, USA / BioPhorum / PEMM;
  12. 12 Amgen, Inc., One Amgen Center Dr., Thousand Oaks, CA 91320 / BioPhorum;
  13. 13 Microbiological Consulting, LLC., 105 Lee Rd, Scarsdale, NY 10583 USA / PEMM;
  14. 14 Pfizer, S. S. de los Reyes, Madrid, Spain / BioPhorum;
  15. 15 BioPhorum Operations Group Ltd
  1. ↵* Corresponding author; email: margit.franz-riethdorf{at}biophorum.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (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 M Cundell, Victoria Navarro, Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology Jul 2022, pdajpst.2021.012726; 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 M Cundell, Victoria Navarro, Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology Jul 2022, pdajpst.2021.012726; DOI: 10.5731/pdajpst.2021.012726
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Keywords

  • Auto-Fluorescence Unit (AFU)
  • Bio-fluorescent particle counting (BFPC)
  • Environmental monitoring (EM)
  • Modern Microbiological Method
  • Process Analytical Technology (PAT)
  • Rapid microbiological method (RMM)

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