We are very pleased indeed to see our Gold Channel Principal, TSI Inc., highlighting the ongoing collaboration among major pharmaceutical manufacturing businesses to rapidly advance the adoption of Biofluorescent Particle Counters (BFPC). These companies are uniting to set industry standards and streamline regulatory acceptance.

Mike Dingle, our colleague from TSI and a highly respected industry BFPC expert, has published an article entitled Advancing the Adoption of Biofluorescent Particle Counting. Mike is Senior Product Specialist, TSI Contamination Control, with years of experience supporting critical microbial contamination control in the pharma manufacturing sector. In his paper, he discusses the role of regulatory authorities in the adoption of ARMM and the collaborative impact of BFPC Working Groups. He also spotlights the positive influence of TSI BioTrak User Group meetings as a driver of the exciting future of BFPC technology.

Mike points to the fact that regulatory authorities continue to encourage the use of Alternative and Rapid Microbiological Methods (ARMM), with last summer’s update to EU GMP Annex 1 being just one example. However, though guidance documents have improved in terms of qualitative rapid methods, they still offer minimal direction for quantitative alternative methods, so ARMM adoption in real-life scenarios remains more of a challenge. The solution being embraced by early adopters in a number of major pharmaceutical manufacturing companies is to work together to determine best practice.

Driving such positive change in the industry is highly productive, as these businesses recognise the value of advancing BFPC technology as quickly as possible to remove risk and increase manufacturing capacity. That’s exactly the proven technology at the heart of the BioTrak™ Real-Time Viable Particle Counter.

Follow this link Advancing the Adoption of Biofluorescent Particle Counting to go to our BioTrak webpage and visit the Must Read Blog section to read Mike Dingle’s full article.