TSI BioTrak Real-Time Bacterial Measurement Device

Truly isolate your aseptic process with the BioTrak™ Real-Time Live Particle Counter (biofluorescent particle detector). An alternative and rapid microbiological method (ARMM) for live air testing combines live particle counting (also known as biofluorescent particle counting, or BFPC) with sample capture capability and ISO-compliant total particle counting to provide a comprehensive solution for pharmaceutical environmental monitoring. Superior discrimination between live and non-live particles ensures reliable live particle data. Time-tested gelatin filter technology efficiently captures sampled microorganisms for subsequent identification.

When integrated with TSI FMS Software, it can be used for continuous monitoring of aseptic processes to reduce risk by eliminating environmental monitoring (EM) interventions and to improve quality through a better understanding of the process. Automatic data collection with 21 CFR Part 11-compliant FMS Software ensures the highest level of data integrity.

Beyond monitoring aseptic processes, it can also provide value as a standalone device. These applications include routine periodic testing, rapid identification of contamination sources during EM investigations, data collection to enable immediate room evacuation, and assisting in the identification and mitigation of risks for advanced risk assessments. Advanced data integrity for standalone applications can be achieved by enabling Data Integrity Mode and using it in conjunction with the included TSI TrakPro™ Lite Secure Software. Data Integrity Mode is designed for TSI portable particle counters to help GMP users meet stringent regulatory requirements in accordance with the ALCOA+ principles.