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1.
PDA J Pharm Sci Technol ; 77(6): 514-518, 2023 Dec 07.
Article in English | MEDLINE | ID: mdl-37451837

ABSTRACT

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.


Subject(s)
Microbiological Techniques , Stem Cells , Microbiological Techniques/methods , Colony Count, Microbial
2.
PDA J Pharm Sci Technol ; 77(1): 2-9, 2023.
Article in English | MEDLINE | ID: mdl-35840344

ABSTRACT

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.


Subject(s)
Coloring Agents , Technology , Fluorescence , Environmental Monitoring/methods
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