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^® Biofluorescent Particle Counter (BFPC) was the first method to be accepted for replacing active and passive air sampling in Grade A. It was fully automated, removing the need for interventions, and provided viable results in real-time. This made it an ideal solution for modern aseptic operations. Building off of this success, the BioTrak^® II BFPC delivers the same trusted measurement in a form factor that is more fit for purpose to facilitate the implementation and use for Grade A monitoring. Discover the changes to make the BioTrak II BFPC easier to implement and use >

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