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 (ARMM) 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
- 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
- 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 including but not limited to:
- PDA Journal of Pharmaceutical Science and Technology — the primary source of peer-reviewed scientific and technical papers on topics related to pharmaceutical/biopharmaceutical manufacturing, sterile product production, aseptic processing, pharmaceutical microbiology, quality, packaging science, and other topics relevant to PDA members
- PEMM (Process and Environmental Monitoring Methods) Group — a collaborative group comprised of leading pharma industry experts
- BioPhorum — a business-to-business membership organization consisting of ten phorums leading more than 110 industry-changing initiatives with the help of 7,500 active subject matter experts
- 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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