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Model Biotrak -Real-Time Viable Particle Counter
FromValidair Group
The BioTrak® Real-Time Viable Particle Counter is one of the most advanced Alternative & Rapid Microbial Method (ARMM) real-time continuous microbial monitoring systems for aseptic manufacturing applications. It is a game-changer in pharmaceutical manufacturing environments that is approved by the FDA and immediately supports compliance with key directives in EU GMP Annex 1 (2022). At the centre of a Contamination Control Strategy, the BioTrak provides real-time counts of total and viable particles to reduce or eliminate aseptic interventions, improve root-cause investigations, and increase process knowledge.
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- FDA-approved as a non-inferior Rapid Microbial Method (RMM)
- Continuous particle counting and environmental monitoring (EM)
- 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 5 for automated continuous environmental monitoring
- Intuitive icon-driven touch screen Graphical User Interface
- Stainless steel enclosure and HEPA filtered exhaust
- 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)
