RT Journal Article
SR Electronic
T1 Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2021.012726
DO 10.5731/pdajpst.2021.012726
A1 Allison Scott
A1 Ans Vanbroekhoven
A1 Cedric Joossen
A1 Chris Knutsen
A1 David Govezensky
A1 Hans-Joachim Anders
A1 James Cannon
A1 Joanny Salvas
A1 Michael Dingle
A1 Patrick Hutchins
A1 Petra Merker
A1 Philip Villari
A1 Stephanie Ramsey
A1 Anthony M Cundell
A1 Victoria Navarro
A1 Margit Franz-Riethdorf
YR 2022
UL http://journal.pda.org/content/early/2022/07/15/pdajpst.2021.012726.abstract
AB 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 intrinsic fluorescence of microbial cells to enumerate bioburden levels in air or water samples, continuously. The reported unit is commonly referred to as an auto-fluorescence 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.