Article CommentaryCommentary
Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony-Forming Unit
Joanny Salvas, Petra Merker, Mike Dingle, Cedric Joossen, Chris Knutsen, David Govezensky, Jim Cannon, Philip Villari, Anthony Cundell, Victoria Navarro, Margit Franz-Riethdorf and Allison Scott
PDA Journal of Pharmaceutical Science and Technology November 2023, 77 (6) 514-518; DOI: https://doi.org/10.5731/pdajpst.2022.012790
Joanny Salvas
1Pfizer, Kirkland, QC, Canada/BioPhorum;
Petra Merker
2Bayer AG, Müllerstr. 178, D-13353 Berlin, Germany/BioPhorum;
Mike Dingle
3TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126 USA/PEMM;
Cedric Joossen
4Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium/OWBA;
Chris Knutsen
5Bristol-Myers Squibb, New Brunswick, NJ, USA/BioPhorum;
David Govezensky
6Bio-Technology General (Israel) Ltd., POB 571, Be'er Tuvia Industrial Zone, Kiryat Malachi 8310402, Israel/BioPhorum;
Jim Cannon
7Mettler-Toledo Thornton, Inc., 900 Middlesex Turnpike, Building 8, Billerica, MA 01821/PEMM;
Philip Villari
8Merck & Co., Inc., Kenilworth, NJ, USA/BioPhorum/PEMM;
Anthony Cundell
9Microbiological Consulting, LLC., Rye, NY 10580 USA/PEMM;
Victoria Navarro
10Pfizer, S. S. de los Reyes, Madrid, Spain/BioPhorum;
Margit Franz-Riethdorf
11BioPhorum Operations Group Limited, 5 Westbrook Court, Sharrowvale Road, Sheffield, S11 8YZ, United Kingdom; and
Allison Scott
12Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705 USA/PEMM

References
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- 2.↵European Commission, EudraLex—The Rules Governing Medicinal Product in the European Union, Volume 4–Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products. European Commission, Brussels, 2022. http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
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- Epstein S. S.
- Epstein S. S.
- 4.↵U.S. Pharmacopeial Convention. General Chapter <1223> Validation of Alternative Microbiological Methods. In USP 38—NF 33, USP: Rockville, MD, 2015.
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- Trigui H.,
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 6
November/December 2023
Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony-Forming Unit
Joanny Salvas, Petra Merker, Mike Dingle, Cedric Joossen, Chris Knutsen, David Govezensky, Jim Cannon, Philip Villari, Anthony Cundell, Victoria Navarro, Margit Franz-Riethdorf, Allison Scott
PDA Journal of Pharmaceutical Science and Technology Nov 2023, 77 (6) 514-518; DOI: 10.5731/pdajpst.2022.012790
Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony-Forming Unit
Joanny Salvas, Petra Merker, Mike Dingle, Cedric Joossen, Chris Knutsen, David Govezensky, Jim Cannon, Philip Villari, Anthony Cundell, Victoria Navarro, Margit Franz-Riethdorf, Allison Scott
PDA Journal of Pharmaceutical Science and Technology Nov 2023, 77 (6) 514-518; DOI: 10.5731/pdajpst.2022.012790
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