The Only Accepted Method to Replace Active and Passive Air Sampling in Grade A Pharmaceutical Manufacturing

Traditional environmental monitoring in aseptic environments can create delays, require manual interventions, and limit process visibility. Pharmaceutical manufacturing is rapidly advancing with innovative gloveless isolators and data-driven control with artificial intelligence (AI) becoming the norm. A different monitoring solution is needed – one that is fully automated and can provide environmental data in real-time.

The TSI BioTrak™ Real-Time Viable Particle Counter is the solution for modern aseptic operations. It is a biofluorescent particle counter (BFPC) that delivers real-time continuous viable particle data with no interventions to improve quality and reduce risk and down-time.

The BioTrak BFPC is the only method that has been accepted to replace active and passive air sampling in Grade A. A suite of resources has been developed based on this experience to streamline the adoption of this alternative microbiological method for Grade A environmental monitoring.

Key Benefits for Your Facility

• Annex 1 Compliance Support — Designed to meet the Annex 1 requirements for total particle counting and viable air testing.

• Continuous Manufacturing — Supports uninterrupted operations by eliminating plate changes.

• Real-Time Process Control — Delivers continuous real time results to allow for immediate action.

• Confidence with Implementation — Follow the Implementation Roadmap

• Supported by the Industry — Read Industry-Published Papers featuring BioTrak BFPC 

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