Christine Troutman – Director of Scientific Operations - MicronView

What is a Biofluorescent Particle Counter (BFPC)?
A BFPC is an advanced device that detects and counts airborne particles based on their biofluorescent properties. These counters use an internal laser to differentiate biological particles (viable) from inert particles, offering rapid detection of contamination in critical environments across a variety of industries.

How does a BFPC work?
BFPCs detect bioaerosols by analyzing the fluorescent properties of particles. The process involves particle collection, where the BFPC draws air through a sample chamber, isolating particles for analysis. A concentrated laser then scans each particle and excites biological molecules such as NADH and riboflavin within viable particles, causing them to fluoresce. Sensors detect this emitted fluorescence, distinguishing biological particles from inert ones based on their fluorescent properties. Software then analyzes the data, providing real-time insights into viable particle counts and sizes.

What industries benefit from using BFPCs?
Pharmaceutical and biotechnology industries are the primary users, especially in areas requiring aseptic manufacturing like sterile dug and cell and gene therapy production. BFPCs are also valuable in research labs, healthcare, food and beverage, and cosmetic industries. BFPCs are also a great tool for before and after studies and investigations across many applications.

How do BFPCs compare to traditional growth-based methods like settle plates and active air samplers?
Traditional methods like settle plates and active air samplers rely on culturing viable microorganisms over several days to determine contamination levels. This is an estimate and only semi-quantitative, resulting in a count of CFUs (Colony Forming Units).  BFPCs, on the other hand, provide real-time detection of viable particles without the need for incubation. These counts are measured in AFUs (Auto Fluorescent Units), a different unit of measurement than the CFU. This allows for immediate decision-making and intervention if contamination is detected. While traditional methods remain valuable for species identification and compliance verification, BFPCs excel in rapid monitoring and minimizing time-to-response for contamination events.

How widely are BFPCs accepted in regulated environments?
BFPCs have gained significant traction in regulated industries as a complementary method to traditional microbial monitoring. Regulatory frameworks such as EU GMP Annex 1 now explicitly recognize the importance of continuous viable particle monitoring, which aligns with the core functionality of BFPCs. They are increasingly used to enhance environmental monitoring strategies in pharmaceutical production, supporting both sterility and compliance.

Are BFPCs suitable for use in isolators?
Yes, BFPCs can be ideal for isolators due to the options for compact designs and the ability to provide continuous monitoring. For example, the Remote BAMS can integrate with existing air supply systems or operate independently with external blowers, making this unit highly versatile for isolator use.

How do BFPCs help with Annex 1 compliance?
Annex 1 emphasizes the need for continuous viable monitoring in aseptic environments. BFPCs fulfill this requirement by offering real-time viable particle counts. Additionally, instruments with features like built-in gelatin filters allow for further microbial identification, satisfying Annex 1’s emphasis on investigating contamination sources.

What validation steps are required for a BFPC in regulated environments?
Validation involves Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure the BFPC performs consistently and accurately under specified conditions. The IQ and OQ procedure for BFPCs is very straightforward. The PQ process involves comparing the BFPC with the users current environmental monitoring methodology. MicronView’s BAMS has been validated under the guidelines of USP <1223>, reducing the validation burden of the end user.

What are the maintenance requirements for a BFPC?
Maintenance typically involves a simple yearly calibration.

What role does a built-in gelatin filter play in BFPCs?
A gelatin filter captures bioaerosols during sampling, enabling subsequent microbial species identification through culture or molecular analysis. This feature is important for investigating contamination events and satisfying regulatory expectations for species identification.

How do BFPCs integrate with data management systems?
Modern BFPCs come equipped with advanced software for data collection, analysis, and reporting. They can integrate seamlessly with existing environmental monitoring systems, simplifying compliance with audit requirements and facilitating real-time decision-making.

What are the future trends for BFPCs in environmental monitoring?
As technology advances, BFPCs are likely to become even more compact, efficient, and integrated with AI-driven analytics for predictive contamination modeling. Their role in supporting automated manufacturing and risk-based monitoring strategies will continue to grow, especially as regulatory expectations for real-time monitoring and a desire for greater accuracy than is possible with traditional methods expand.