Rapid MIcrobial Method
The TSI® BioTrak® Real-Time Viable Particle Counter offers best in class features and versatility in the field of real-time airborne viable particle detection and Rapid Microbial Detection Methods (RMM). The BioTrak detects total and viable particle counts in real time and incorporates TSI field proven, patented Laser Induced Fluorescence (LIF) technology to determine particle viability. The instrument detects both culturable organisms as well as viable but nonculturable (VBNC) organisms.
The BioTrak combines real-time viable particle counting, total particulate detection and integrated particle collection functionality into a single portable instrument.
BioTrak® Real-Time Viable Particle Counter
Truly isolate your aseptic process with the BioTrak® Real-Time Viable Particle Counter (a biofluorescent particle detector). An alternative and rapid microbiological method (ARMM) for viable air testing, BioTrak combines viable particle counting—also called biofluorescent particle counting (BFPC)—with sample capture capability and ISO-compliant total particle counting to offer a complete solution for pharmaceutical environmental monitoring. Superior discrimination between viable and inert particles delivers reliable viable particle data. Time-tested gelatin filter technology efficiently captures sampled microorganisms for subsequent identification.
When combined with ParticleSentryᴱᴹ using TSI's FMS Software, BioTrak can be used for continuous monitoring of aseptic processes to reduce risk by eliminating environmental monitoring (EM) interventions and improves quality through better process understanding. Automated data collection with the 21 CFR Part 11 capable FMS Software assures the highest level of data integrity.
Beyond the monitoring of aseptic processes, BioTrak can also provide value as a standalone instrument. These applications include routine periodic testing, quick identification of contamination sources during EM investigations, collection of data to for immediate room release, and to aid in identification of risk for improved risk assessments. Enhanced data integrity can be achieved for standalone applications by placing it in Data Integrity Mode and using it in conjunction with the included TSI TrakPro™ Lite Secure Software.
APPLICATIONS THAT CAN BENEFIT FROM USING THIS ALTERNATIVE AND RAPID MICROBIOLOGIAL METHOD (ARRM) FOR MONITORING INCLUDES:
- Continuous automated monitoring of aseptic environments
- Continuous automated monitoring in support environments
- Root cause investigations
- Room release
- Risk reduction
FEATURES AND BENEFITS
- Detection of airborne viable particles in real-time
- Fully automated process – no media or manual processing
- Simultaneous detection of both total and viable particles
- Complies with all requirements of ISO 21501-4
- 1 CFM (28.3 L/min) sample flow rate
- Only requires a single isokinetic probe at the sample site
- In-line particle collection filter
- Flexibility: BioTrak can be used as a standalone instrument or fully integrated with FMS for automated continuous monitoring
- Intuitive icon driven touch screen Graphical User Interface
- Stainless steel enclosure and HEPA filtered exhaust
