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 2
OP 9
DO 10.5731/pdajpst.2021.012726
VO 77
IS 1
A1 Scott, Allison
A1 Vanbroekhoven, Ans
A1 Joossen, Cedric
A1 Knutsen, Chris
A1 Govezensky, David
A1 Anders, Hans-Joachim
A1 Cannon, James
A1 Salvas, Joanny
A1 Dingle, Michael
A1 Hutchins, Patrick
A1 Merker, Petra
A1 Villari, Philip
A1 Ramsey, Stephanie
A1 Cundell, Anthony
A1 Navarro, Victoria
A1 Franz-Riethdorf, Margit
YR 2023
UL http://journal.pda.org/content/77/1/2.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 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.