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. This is why the Modern Microbial Collaboration (M3) has published an article in the PDA Journal of Pharmaceutical Science and Technology to help with Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit.
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.
The main article, Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool,describes challenges encountered when implementing this modern technology. One is the non-equivalency of the colony-forming unit (CFU) with the auto-fluorescence unit (AFU).
The new article addresses this topic in more detail. It explores the challenges presented by bio-fluorescent particle counts (BFPC) technology when considering that the traditional CFU is the gold standard against which any change is measured. It examines why attempts to correlate newer units of measure used by BFPCs, namely the AFUs, to the traditional CFUs are not necessarily appropriate. It also looks at 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.
With a deeper understanding of the limitations behind the CFU counts and why there can be no specific correlation between AFU and CFU, appropriate validation strategies and acceptance criteria can be established that will facilitate the adoption of BFPCs more widely. Proper understanding of the demonstrated performance of the new method and appropriately set limits will enable better, more controlled processes and enhance the assurance of quality for the benefit of patients.
Additional publications in this series will discuss proposed validation strategies in more detail and address the determination of baseline AFU counts to establish alert and action levels for air and water monitoring.
Joanny Salvas, Sr Manager, Global Technology & Engineering Manufacturing Intelligence at Pfizer Inc., and a member of the BioPhorum ARMM BFPC team, said, “Validating a new rapid microbial method is always a challenge, but it is especially so when the new method relies on a completely different measuring principle. Collaborating with other thought leader groups and industry partners is key to establishing the best way forward to demonstrate how to effectively leverage the advantages that the use of Bio-Fluorescent Particle Counters could bring.”