TSI had the great pleasure of participating in the recent interactive workshop hosted by NIBRT (National Institute for Bioprocessing Research and Training), diving deep into the luminous world of Biofluorescent Particle Counting (BFPC) and its use in monitoring fill-finish operations.
What’s BFPC, You Ask?
BFPC is an alternative to traditional growth-based viable air monitoring methods. It is an optical method that looks for the intrinsic autofluorescence of microorganisms to detect viable particles (also known as autofluorescence units or AFU). This provides results in real-time, making it a process control tool that allows for immediate actions to be taken to reduce risk in fill-finish operations.
Talking BFPC and Compliance
Conor Murray, the Irish Subject Matter Expert at ISO/TC 209 (the ISO technical committee responsible for measurement and metrology), started the day by discussing the regulatory landscape for continuous environmental monitoring (EM). Kevin Lomasney from NIBRT followed that up with a summary of the challenges associated with using traditional environmental monitoring methods. I then had the honor of presenting how BFPC can be used to overcome the challenges mentioned, and do it a fully compliant way.
A Tour of NIBRT & the BioTrak™ Real-Time Viable Particle Counter (a BFPC)
Following the discussion, the attendees were able to tour NIBRT’s training facilities and see TSI’s BFPC, the BioTrak Real-Time Viable Particle Counter, in person. If you haven’t heard of NIBRT, you’re missing out. Nestled in Dublin, this is a state-of-the-art facility operated in a realistic GMP simulated, operational manufacturing environment. As for the BioTrak Real Time Viable Particle Counter, it is the only method that has been accepted to replace active and passive air sampling in Grade A.
Why It Matters
Biopharma is booming, and Ireland is at the heart of it. With support from organizations like NIBRT—and a little help from tech like the BioTrak Real-Time Viable Particle Counter—the future is bright (and biofluorescent). TSI is honored to play our part in advancing the modernization of pharmaceutical manufacturing.
Thanks to all the attendees. There high level of engagement is what really made this a great event!
Learn More About the BioTrak™ Real-Time Viable Particle Counter