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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.


biotrak-accepted-jun2024-small.jpgSource — Fill-Finish Isolator Manufacturers

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

Source — PDA Letter of Pharmaceutical Science and Technology

  • 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 acnesRead 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 >

Source — BioPhorum

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

Source — PEMM Group

PEMM (Process and Environmental Monitoring Methods) 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