Bio-fluorescent particle counter (BFPC) technology has been used in the pharmaceutical industry for more than a decade and even earlier in bioterrorism detection. However, despite encouragement and guidance from regulators on implementing process analytical technologies and rapid microbiological methods (that can provide early warning information through real-time monitoring), the transition to modern technologies like BFPC systems has been slow.
To increase the pace of change, a collaboration of four industry working groups started work in 2021 to support the adoption of modern microbiological methods and is currently concentrating on the BFPC technology. This Modern Microbial Methods, or M3, collaboration consists of BioPhorum’s Fill-Finish BFPC team, the Kilmer Community Rapid Microbiology Methods group, the Online Water Bioburden Analyzer (OWBA) working group and the Process and Environmental Monitoring Methods (PEMM) working group.
The M3 collaboration recently published a paper in the PDA Journal of Pharmaceutical Science and Technology entitled Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool. This article provides a commentary on potential challenges slowing down the adoption of BFPC systems, thoughts on navigating them, and supporting information.
The challenges covered are:
- The non-equivalency of an auto-fluorescent unit of measurement compared to a colony-forming unit
- The validation of modern microbial methods that report in a non-growth-based unit (e.g., auto-fluorescent unit)
- Setting alert and action levels
- The qualification strategy for BFPC systems
- The perceived risk of regulatory inspectional observations and lack of acceptance
- Internal communication
In a risk-averse industry like sterile pharmaceutical manufacturing, there is a tendency to look for reasons why a new technology should not be implemented instead of why it should be. However, this paper suggests that careful consideration of modern technologies should be undertaken because the benefits – such as patient safety and risk reduction – can be significant compared to methods with known limitations that have remained unchanged for many decades. Also, an early awareness of potential challenges can help navigate the successful adoption of these new technologies.
Further publications from the group will provide more details on these challenges, with the current paper acting as an umbrella document under which the later articles will sit. The current paper will also be presented in October in a webinar led by BioPhorum. Details and registration can be found here.