Provides real-time counts of total and viable particles in pharmaceutical manufacturing environments to reduce aseptic interventions, improve root-cause investigations, and increase process knowledge.
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
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