TSI BioTrak® Real-time Viable Particle Counter 9510-BD

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.

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

Improved root cause investigations

Room release

Risk reduction

Features and Benefits:

Particulate size range: 0.5 to 25 μm

Up to six channels of simultaneous total and viable particle data

Patented Laser Induced Fluorescence viability detection

Integrated particle collection filter for off line speciation analysis

Complies with all requirements of ISO 21501-4

1.0 CFM (28.3 L/min) sample flow rate

Full optical particle counter functionality

Intuitive icon driven touch screen Graphical User Interface

Recipe based storage and recall of sampling protocols

Reports for ISO-14644-1, EU GMP Annex 1, and FS209E

10,000 sample record storage, 999 locations

Ethernet and USB outputs

Stand-alone operation or integrate into a facility monitoring system (FMS)

Displays up to three environmental parameters

Stainless steel enclosure and HEPA filtered exhaust