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Annex 1 Compliant | AI Data-Driven Control

with the BioTrak BFPC

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 intervention, and limit process visibility. As pharmaceutical cleanrooms move from reactive monitoring to more predictive, data-driven control with artificial intelligence (AI), real-time environmental data becomes increasingly important for faster decisions and stronger process insight.

The TSI BioTrak™ Real-Time Viable Particle Counter helps you meet these challenges with continuous viable air monitoring powered by biofluorescent particle counting, or BFPC, technology. In Grade A pharmaceutical manufacturing, the BioTrak BFPC delivers the real-time viable particle data that supports digitized environmental monitoring and helps enable the shift from reactive response to more predictive, AI-informed process insight.

As the only accepted method to replace active and passive air sampling in Grade A, the BioTrak BFPC helps streamline operations, support AI-ready, data-driven quality decisions, and lays the foundation for more predictive contamination control.

Key Benefits for Your Facility

  • Annex 1 Compliance Support — Helps you meet Annex 1 and data integrity requirements.

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

  • Real-Time Process Control — Delivers continuous results to help you respond faster.

Explore industry-published papers featuring the BioTrak BFPC here.

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