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)