Bio-fluorescent particle counters (BFPCs) allow the detection and enumeration of microorganisms in the environment and rely on intrinsic fluorescence detection instead of growth – this constitutes a paradigm shift in microbial monitoring. BFPC systems fall into the category of rapid methods, which are encouraged by the new EU Annex 1.
This is why the Modern Microbial Collaboration (M3) wanted to explore the advantages of using a BFPC in a Grade A aseptic processing environment and whether microbial identification is needed in the case of a positive event.
The M3 Collaboration has documented its conclusions in this article published in the PDA Letter.
The opinion piece discusses issues such as:
- The benefits and limitations associated with the transition to non-growth-based air monitoring methods, like BFPCs
- How information about the microbial flora and the ability to perform trend analysis are still available without BFPC identification in Grade A areas
- Why a shift in mindset for microbial identification requirements from BFPC in Grade A environments is needed.
The team’s experience indicates that the value of microbial identification in Grade A has been over-emphasized by regulators and industry and should not be a GMP requirement in situations where more advanced methods are used and that deliver better process knowledge and control.
This article is one of a series published by the M3 Collaboration, which consists of BioPhorum’s Alternative and Rapid Microbiological Methods Bio-Fluorescent Particle Counting team, the Kilmer Community Rapid Microbiology Methods group, the Process and Environmental Monitoring Methods (PEMM) working group and the Online Water Bioburden Analyzer (OWBA) group.