Description
Truly isolate your aseptic process with the TSI BioTrak® 9510-BD Real-Time Viable Particle Counter (a biofluorescent particle detector). BioTrak combines viable particle counting—also called biofluorescent particle counting (BFPC) — with sample capture capability and ISO-compliant and Annex 1 update-compliant continuous total particle counting to offer a complete solution for pharmaceutical Environmental Monitoring (EM). 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, the BioTrak can be used for continuous monitoring of aseptic processes to reduce or eliminate EM interventions, improve quality, and ensure data integrity. Used as a standalone instrument, it can quickly identify sources of microbial contamination during EM investigations, provide data for immediate room release, and aid in the identification and mitigation of risk.
This particle counter can be placed in Data Integrity Mode for enhanced data integrity. Used in conjunction with TSI TrakPro™ Lite Secure Software, Data Integrity Mode is designed per the ALCOA+ principles to meet the demanding regulatory requirements of GMP users.
The BioTrak uses Laser Induced Fluorescence (LIF) technology to distinguish viable microbial particles from non-viable (inert) particles in real-time, making it an attractive Alternative & Rapid Microbial Method (ARMM).
The LIF identification process is quantitative, continuous and rapid. It physically detects the presence of a viable particle but does not identify its type; that is still the preserve of growth-based methods. The differences between microbial species are too subtle to identify in real-time, which is why the BioTrak also features a collection facility to harvest particles that can then be incubated for identification. This is the qualitative part of the process.
Read our article on the adoption of technology-based Alternative & Rapid Microbial Methods (ARMM) published by Cleanroom Technology Magazine.
Features and Benefits
- Continuous particle counting
- 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
- Instant real-time alerts
- In-line particle collection filter
- Can be used as a standalone instrument
- Can be fully integrated with FMS for automated continuous environmental monitoring
- Intuitive icon-driven touch screen Graphical User Interface
- Stainless steel enclosure and HEPA filtered exhaust
Applications
- Continuous automated monitoring of aseptic environments
- Continuous automated monitoring in support environments
- Continuous particle counting: viable and total particles
- Microbial detection and measurement
- Improved root cause investigations
- Fast isolation and neutralisation of contamination sources
- Rapid room release
- Risk reduction
- EU GMP Annex 1 update compliance (Grade A mandated continuous environmental monitoring)
