Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony-Forming Unit.
| Autor: | Salvas J; Pfizer, Kirkland, QC, Canada/BioPhorum., Merker P; Bayer AG, Müllerstr. 178, D-13353 Berlin, Germany/BioPhorum., Dingle M; TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126 USA/PEMM., Joossen C; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium/OWBA., Knutsen C; Bristol-Myers Squibb, New Brunswick, NJ, USA/BioPhorum., Govezensky D; Bio-Technology General (Israel) Ltd., POB 571, Be'er Tuvia Industrial Zone, Kiryat Malachi 8310402, Israel/BioPhorum., Cannon J; Mettler-Toledo Thornton, Inc., 900 Middlesex Turnpike, Building 8, Billerica, MA 01821/PEMM., Villari P; Merck & Co., Inc., Kenilworth, NJ, USA/BioPhorum/PEMM., Cundell A; Microbiological Consulting, LLC., Rye, NY 10580 USA/PEMM., Navarro V; Pfizer, S. S. de los Reyes, Madrid, Spain/BioPhorum., Franz-Riethdorf M; BioPhorum Operations Group Limited, 5 Westbrook Court, Sharrowvale Road, Sheffield, S11 8YZ, United Kingdom; and margit.franz-riethdorf@biophorum.com., Scott A; Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705 USA/PEMM. |
|---|---|
| Jazyk: | angličtina |
| Zdroj: | PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2023 Dec 07; Vol. 77 (6), pp. 514-518. Date of Electronic Publication: 2023 Dec 07. |
| DOI: | 10.5731/pdajpst.2022.012790 |
| Abstrakt: | Adopting emerging microbiological methods is often desirable because it enables more advantageous, real-time monitoring practices. However, when the newer method measures contamination based on a different detection principle and provides results that are based on different units of measure, a paradigm shift is necessary. That shift can be one of the most difficult challenges in any such project and requires careful consideration. In this article, we explore the challenges presented by the bio-fluorescent particle counting (BFPC) technology, when considering that the traditional colony-forming unit (CFU) is the gold standard that any change is measured against. We examine why attempts to correlate newer units of measure used by biofluorescent particle counters, namely the auto-fluorescent units (AFUs), to the traditional CFUs are not necessarily appropriate. The article explores in depth why there is no consistent correlation factor between the two units of measure, and why that should not be a barrier to fully leveraging, implementing, and using such modern technologies in routine monitoring. (© PDA, Inc. 2023.) |
| Databáze: | MEDLINE |
| Externí odkaz: |
|