In this paper, published in the PDA Journal, the M3 collaboration 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 which any change is measured against. We examine why attempts to correlate newer units of measure used by Bio-Fluorescent Particle Counters, namely the Auto-Fluorescent Units (AFUs), to the traditional CFUs are not necessarily appropriate. The paper 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.
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Challenges encountered in the implementation of bio-fluorescent particle counting systems as a routine microbial monitoring tool
This article published in the PDA Journal of Pharmaceutical Science and Technology discusses challenges encountered when implementing bio-fluorescent particle counting systems as a routine microbial monitoring tool , and the perspective from a consortium of four industry working groups on navigating these challenges.
Alternative and rapid micro methods (ARMM): Practical applications of bio-fluorescent particle counting in Environmental Monitoring investigations
Investigations into environmental monitoring (EM) excursions can be prolonged and do not always result in clear root causes or CAPAs. This paper outlines how bio-fluorescent particle counting (BFPC) can be used in investigations to eliminate the inherent delays of culture-based methods. The application for investigations supplements routine EM; acting as a risk reduction tool enabling real-time detection of viable microorganisms in air samples − supporting root cause analysis and remedial actions. The paper includes guidance on how to use the technology, a real case study involving a mold excursion, and examples of business benefits achieved by various companies.
Environmental monitoring (EM): Continuous microbiological EM for process understanding and reduced interventions in aseptic manufacturing
This paper provides recommendations for quality oversight, manufacturing operations, and industry perspective of regulatory expectations to enable aseptic facilities to move toward real-time and continuous microbiological environmental monitoring, thereby reducing interventions and future replacement of Grade A settle plates and nonremote active air sampling. The replacement of traditional monitoring with biofluorescent particle-counting systems provides an improvement in process understanding and product safety and reduces operator manipulations, assuring product quality and real-time process verification. The future state pharmaceutical technology roadmaps include gloveless isolators with real-time and continuous monitoring for aseptic manufacturing.