TSI BioTrak Real-Time Viable Particle Counter


  • Particulate size range: 0.5 to 25 µm
  • Simultaneous total and viable particle data in up to six channels
  • Patented laser-induced fluorescence viability detection
  • Integrated particle collection filter for offline speciation analysis
  • Compliance with all ISO 21501-4 requirements
  • Sample flow rate of 1.0 CFM (28.3 L/min)
  • Complete optical particle counter functionality
  • User-friendly icon-driven touch screen graphical user interface
  • Storage and recall of sampling protocols based on recipes
  • Reports for ISO-14644-1, EU GMP Annex 1, and FS209E
  • Storage capacity of 10,000 sample records across 999 locations
  • Outputs via Ethernet and USB
  • Capable of stand-alone operation or integration into a facility monitoring system
  • Displays up to three environmental parameters
  • Encased in a stainless steel enclosure.

TSI BioTrak® Real-Time Viable Particle Counter (a biofluorescent particle detector) allows for the true isolation of your aseptic process. It is an alternative and rapid microbiological method (ARMM) for viable air testing, combining viable particle counting (also known as biofluorescent particle counting or BFPC) with sample capture capability and ISO-compliant total particle counting. As a result, it offers a comprehensive solution for pharmaceutical environmental monitoring. The device ensures superior discrimination between viable and inert particles, providing reliable viable particle data. The gelatin filter technology it employs efficiently captures sampled microorganisms for subsequent identification.

When used in conjunction with TSI FMS Software, it enables continuous monitoring of aseptic processes, reducing risk by eliminating environmental monitoring (EM) interventions and enhancing process understanding to improve overall quality. The 21 CFR Part 11 capable FMS Software facilitates automated data collection, ensuring the highest level of data integrity.

Beyond monitoring aseptic processes, the BioTrak® Real-Time Viable Particle Counter has value as a standalone instrument. It is applicable for routine periodic testing, quickly identifying sources of contamination during EM investigations, collecting data for immediate room release, and aiding in risk identification and mitigation for improved risk assessments. For standalone applications, enhanced data integrity can be achieved by using Data Integrity Mode in conjunction with the included TSI TrakPro™ Lite Secure Software, which is designed based on the ALCOA+ principles to meet the rigorous regulatory requirements of GMP users of TSI portable particle counting instruments.

Various applications can benefit from using this alternative and rapid microbiological method (ARMM) for monitoring, including

  • Continuous automated monitoring of aseptic environments,
  • Continuous automated monitoring in support environments,
  • Improved root cause investigations,
  • Room release,
  • and risk reduction



TSI BioTrak Real-Time Viable Particle Counter (Model 9510-BD)_DpstarGroup