TY - JOUR 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 DO - 10.5731/pdajpst.2021.012726 SP - pdajpst.2021.012726 AU - Allison Scott AU - Ans Vanbroekhoven AU - Cedric Joossen AU - Chris Knutsen AU - David Govezensky AU - Hans-Joachim Anders AU - James Cannon AU - Joanny Salvas AU - Michael Dingle AU - Patrick Hutchins AU - Petra Merker AU - Philip Villari AU - Stephanie Ramsey AU - Anthony M Cundell AU - Victoria Navarro AU - Margit Franz-Riethdorf Y1 - 2022/01/01 UR - http://journal.pda.org/content/early/2022/07/15/pdajpst.2021.012726.abstract N2 - 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. ER -