BIOTRAK REAL-TIME VIABLE PARTICLE COUNTER

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. It is a game-changer in pharmaceutical manufacturing environments that is immediately compliant with key directives in the new EU GMP Annex 1 revision. At the centre of a Contamination Control Strategy, the BioTrak provides real-time counts of total and viable particles to reduce aseptic interventions, improve root-cause investigations, and increase process knowledge.

Features and Benefits

• 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

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)