The TSI BioTrak® Real-Time Viable Particle Counter has been approved for use in the monitoring of viable particle levels in an aseptic filling line isolator by the US Food & Drug Administration (FDA).

The BioTrak is available in the UK and Ireland from FMS (formerly Validair Monitoring Solutions Ltd).  The approval is a milestone for the adoption of Alternative Rapid Microbial Methods (ARMM) and originates from the federal agency regulator's evaluations at a prominent Danish multinational pharmaceutical manufacturer.

In meetings with Novo Nordisk, the FDA accepted BioFluorescent Particle Counting (BFPC) technology, as deployed in the TSI BioTrak, as a valid and equivalent method for detecting viable particles. BFPC enabled by Laser Induced Fluorescence is at the heart of the BioTrak, which is deployed in a Novo Nordisk filling isolator where multiple BioTrak instruments are used for continuous aseptic monitoring.

The breakthrough was announced by Henrik Louw, Strategy Specialist at Novo Nordisk, while presenting at a recent ISPE pharma conference. In a meeting prior to the conference, the FDA had approved the use of the BioTrak instruments to monitor Novo Nordisk isolators. The news was reported by Mike Dingle, BioTrak Product Specialist at TSI Inc. and a speaker at the ISPE conference.

“This is a milestone moment. It’s great news for the pharmaceutical industry and for us as we support the BioTrak with pharma monitoring applications expertise across the UK and Ireland,” says Deborah Haisman, Commercial Director at FMS (Facility Monitoring Systems Ltd). “Pharma professionals now have a precedent with the FDA announcement accepting the application of BioTrak in a filling isolator. They can now adopt this game-changing instrument, safe in the knowledge that it is approved by a leading regulatory agency,” she points out.

The fact that the acceptance and deployment of BFPC technology has already been anticipated and designed-in by progressive pharma process equipment manufacturers was a related topic covered at the ISPE conference.

Some new fully automated gloveless filling lines are specifically constructed to accommodate the installation of the BioTrak in the expectation that this will become a customer requirement. The use of the BioTrak Real-Time Viable Particle Counter in these applications confers the advantage of continuous monitoring and real-time particle detection, which exceeds new EU GMP Annex 1 guidance, improving viable monitoring data and reducing process risk.