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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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Abstract

The transition from traditional growth-based microbial detection methods to continuous bio-fluorescent particle counting methods represents a paradigm shift, because the results will be non-equivalent in terms of microbial counts, and a continuous, rather than periodic, data stream will be available. Bio-fluorescent particle counting technology, a type of rapid microbiological method, uses the detection of the intrinsic fluorescence of microbial cells to enumerate bioburden levels in air or water samples, continuously. The reported unit is commonly referred to as an autofluorescence unit, which is not dependent upon growth, as is the traditional method. The following article discusses challenges encountered when implementing this modern technology, and the perspective from a consortium of four industry working groups on navigating these challenges.

  • Autofluorescence unit (AFU)
  • Bio-fluorescent particle counting (BFPC)
  • Environmental monitoring (EM)
  • Modern microbiological method process analytical technology (PAT)
  • Rapid microbiological method (RMM)
  • Water monitoring
  • © PDA, Inc. 2023
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PDA Journal of Pharmaceutical Science and Technology: 77 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 1
January/February 2023
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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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