Description
Product Details
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, it 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 TSI FMS Software, it can be used for continuous monitoring of aseptic processes to reduce risk by eliminating environmental monitoring (EM) interventions and improve 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, it can also provide value as a standalone instrument. These applications include routine periodic testing, quickly identifying sources of contamination during EM investigations, collecting data to allow for immediate room release, and aiding in the identification and mitigation 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, Data Integrity Mode is designed per the ALCOA+ principles to meet the demanding regulatory requirements of GMP users of TSI portable particle counting instruments.
Features
- 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
- 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
Applications
- Continuous automated monitoring of aseptic environments
- Continuous automated monitoring in support environments
- Improved root cause investigations
- Room release
- Risk reduction
Application Notes
- TSI CC-103 Biotrak Real-Time Viable Particle Counter Discrimination Capability
- TSI CC-104 BioTrak Sample and Collection Efficiency
- TSI CC-105 Biotrak Real-Time Viable Particle Counter Facility Monitoring Systems
- TSI CC-123 Biotrak Real-Time Viable Particle Counter Root Cause Investigation Guidance
- TSI CC-124 Biotrak Real-Time Viable Particle Counter Evaluation Guidance
- TSI CC-129 Improved Viable Particle Discrimination
- TSI CC-130 Interpreting Out-Of-Tolerance Fluorescence Detector Findings
Catalogues
Videos
Overview
Meet the BioTrak Real-Time Viable Particle Counter
Accessories
Software
TSI TPL-S90 TrakPro Lite Secure Download Software
Parts
TSI 7960 Aerotrak High Pressure Diffuser
TSI 700068 Aluminum Isokinetic Probe for 1 CFM Portables
TSI 700215 Aseptic Gelatin Filter Holder
TSI 700070 Basic Filter Scanning Probe 1 CFM
TSI 700127 Cleaning Swabs
TSI 700094 Electronic Filter Scanning Probe 1 CFM
TSI 700123 Filter Holder
TSI 700124 Gelatin Collection Filters for Biotrak
TSI 700119 Purge Zero Count Filter for 1 CFM and 50 LPM Portables
TSI 700069 Stainless Steel Isokinetic Probe for 9310-9510
TSI 700062 Superthane Tubing .375 ID .5 OD 100 Ft
TSI 700097 Temperature-RH Probe with Cable
Power
TSI 700033 Computer Cable USB A to B
TSI 700136 External Battery Pack
TSI 700137 External Battery Pack – Long Life
KENPOWSM2437C1 Power Supply
Adds-on
TSI 700122 Heavy Duty Carrying Case for Biotrak
TSI 700027 Printer Paper (10 Rolls)
TSI 962 Air Velocity and Temperature Articulated Probe
TSI 966 Thermoanemometer Articulated Probe
TSI 960 Air Velocity and Temperature Straight Probe
TSI 964 Air Velocity and Temperature Straight Probe
