Published by global regulatory and industry experts.
Check out industry papers being published by global regulatory and 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.
Source — PDA Journal of Pharmaceutical Science and Technology
- 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 >
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 >