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.
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http://dx.doi.org/10.5731/pdajpst.2021.012726 | DOI Listing |
PDA J Pharm Sci Technol
December 2024
Pharma QC business, Industrial Applications, bioMérieux, France
Sci Total Environ
October 2024
Environmental Metrology Center, National Institute of Metrology, Beijing 100029, China.
Accurate measurements are critical for timely early warning and effective prevention of epidemics due to the continuing impact of bioaerosols on human health. In recent years, researchers have been focused on developing and calibrating online monitoring instruments. However, there is still a lack of laboratory-generated standard aerosol samples suitable for calibration.
View Article and Find Full Text PDFJ AOAC Int
November 2024
Marketing, Mettler-Toledo, 900 Middlesex Turnpike, BLD 8, Billerica, MA 01821, United States.
Background: The Mettler-Toledo 7000RMS analyzer is a bio-fluorescent particle counter (BFPC) used to monitor real-time bioburden results from purified water (PW).
Objective: Validation of the analyzer using 13 microorganisms and a low-intensity, fluorescent, polystyrene bead.
Methods: During the execution of the validation, a laboratory water system that met PW quality standards was connected to the 7000RMS, and a syringe pump was used to introduce various concentrations of microorganisms and fluorescent polystyrene beads to the analyzer.
PDA J Pharm Sci Technol
December 2023
Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705 USA/PEMM.
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.
View Article and Find Full Text PDFPDA J Pharm Sci Technol
February 2023
BioPhorum Operations Group Limited, 5 Westbrook Court, Sharrowvale Road, Sheffield, S11 8YZ, United Kingdom
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.
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