Mike Dingle, TSI Senior Product Specialist for Controlled Environments, participated in an interactive workshop hosted by NIBRT (National Institute for Bioprocessing Research and Training) on 7^th May in Dublin. He reports that the day wasn’t just about Guinness and green fields – it was about green lights for the future of biopharma, with the event diving deep into the luminous world of Biofluorescent Particle Counting (BFPC) and its use in monitoring fill-finish operations.

What is BFPC?

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) and FMS Ireland’s BioTrak™ Technical Specialist, 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. Mike Dingle then had the honour of presenting how BFPC can be used to overcome the challenges mentioned, and do it in 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, says Mike. Nestled in Dublin, it 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 organisations like NIBRT – and a little help from technology like the BioTrak Real-Time Viable Particle Counter – the future is bright (and biofluorescent). Mike is honoured to have played a part in advancing the modernisation of pharmaceutical manufacturing.

Thanks to all the attendees. Their high level of engagement made it a great event!