BioTrak Real-Time Viable Particle Counter

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. Learn more > 

Applications that can benefit from using this alternative and rapid microbiologial method (ARMM) for monitoring includes:

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

Meeting Requirements for EU GMP Annex 1 — 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
• 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

Learn More 

• Video — Meet the BioTrak
   
• Application notes   
  • Improved Viable Particle Discrimination (CC-129)
  • Interpreting OOT Fluorescence Detector Findings (CC-130)
  • Root Cause Investigation Guidance (CC-123)
  • Evaluation Guidance (CC-124)
  • Facility Monitoring Systems (CC-105)
     
• ​White papers
  • Fundamentals of Real-Time Viable Particle Monitoring: How Does It Work
  • Real-Time Viable Particle Detection for Definitive Root Cause Investigation
  • ​BioTrak Real-Time Viable Particle Counter Continous Environment Monitoring in Fill-Finish: Return on Investment
     
• Major industry publication features
  • Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
    Source: PDA Journal of Pharmaceutical Science and Technology
  • A Discussion on Bio-fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
    Source: PDA Journal of Pharmaceutical Science and Technology
  • Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing
    Source: PDA Journal of Pharmaceutical Science and Technology
  • Practical Applications of Bio-Fluorescent Particle Counting in Environmental Monitoring Investigations.
    Source: PDA Journal of Pharmaceutical Science and Technology
  • Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes
    Source: PDA Journal of Pharmaceutical Science and Technology.
  • Real-Time Viable Particle Monitoring: How Does It Work? How Can It Help?
    Source: Pharmaceutical Online
  • A Clear Path to Implementing Alternative and Rapid Microbiological Methods. 
    Source: BioPhorum
     
• On Demand Webinars
  • BioTrak Updates — Fulfilling the Needs of the Industry to Meet Annex 1 Compliance & Pharma 4.0 Implementation
  • Implementing Real-time Viable Particle Counting for Aseptic Manufacturing
  • Fundamentals of Laser Induced Fluorescence for Real-Time Viable Particle Counting 

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