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Annex 1 Compliance | Pharma 4.0 Ready

with the BioTrak Real-Time Viable Particle Counter

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

TSI offers the BioTrak™ Real-Time Viable Particle Counter [using biofluorescent particle counting (BFPC) technology], for continuous viable air monitoring in aseptic environments that does not pose a risk to the manufacturing process. This biofluorescent particle counter provides you with the ability to achieve improved control over operations and quality through digitization. This is something that traditional microbiological testing used for environmental monitoring cannot.

The BioTrak Real-Time Viable Particle Counter Is the only accepted method to replace active and passive air sampling in Grade A pharmaceutical manufacturing. It ensures: 

  • Compliance — Meets all Annex 1 and data integrity requirements

  • Continuous Manufacturing — No down time for plate changes

  • Process Control — Continuous, real-time results

 Click here to see industry published papers featuring the BioTrak™ Real-Time Viable Particle Counter.

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