Published by industry experts.

Check out industry papers being published by industry experts featuring the Annex 1 ready BioTrak™ Real-Time Viable Particle Counter, the biofluorescent particle counter everyone is talking about. It's the only accepted method to replace active and passive air sampling in Grade A.

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Source — Fill-Finish Isolator Manufacturers

• Biofluorescent Particle Counters are Gaining Momentum (Cytiva). Read article >

Source — PDA Letter of Pharmaceutical Science and Technology

• Ensuring Data Integrity in Pharmaceutical Microbiology Laboratories—Challenges and the Role of Rapid Microbial Methods. Read article >
   
• Equivalence Testing of BFPCs in Grade A Environments—Challenges and Alternative Strategy Industry Position Statement. Read article >

Source — PDA Journal of Pharmaceutical Science and Technology

• Considerations for the Validation of Non-CFU Based Bio-Fluorescent Particle Counting Technologies. Read abstract >
   
• Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit. Read abstract >
   
• Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool. Read abstract >
   
• A Discussion on Bio-fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team. Read abstract >
   
• Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes. Read abstract >
   
• Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing. Read abstract >
   
• Practical Applications of Bio-Fluorescent Particle Counting in Environmental Monitoring Investigations. Read abstract >

Modern Microbial Methods (M3) Collaboration Blog Series

The M3 Collaboration is a cross-working group comprised of leading pharma industry experts.

• Mar 2026 — Post #2: M3 provides an orientation to BFPC, including tech overview and differences from culture-based methods. View post >
   
• Feb 2026 — Post #1: M3 announces launching of monthly blog series focused on bio-fluorescent particle counting (BFPC). View post >

Source — BioPhorum

• A Clear Path to Implementing Alternative and Rapid Microbiological Methods. Read abstract >

​Source — Process and Environmental Monitoring Methods (PEMM) Group

PEMM Group is a collaborative group comprised of leading pharma industry experts.

Read what this group is saying in summary about meeting with the FDA Emerging Technology Team to discuss bio-fluorescent particle counting (BFPC) technology. Source: PDA Journal of Pharmaceutical Science and Technology. Read abstract >

Learn More About the BioTrak™ Real-Time Viable Particle Counter, the BFPC that everyone is talking about.