BioTrak™ Real-Time Viable Particle Counter

The BioTrak™ Real-Time Viable Particle Counter is an advanced environmental monitoring instrument designed for pharmaceutical aseptic and controlled environments. It enables true isolation of aseptic processes by providing real-time detection of airborne viable particles, while simultaneously performing ISO-compliant total particle counting.

Using biofluorescent particle detection technology, BioTrak operates as an Alternative and Rapid Microbiological Method (ARMM), delivering immediate and reliable viable particle data without the delays associated with traditional culture-based methods. The system offers superior discrimination between viable and inert particles, improving contamination control and environmental understanding.

BioTrak combines viable particle detection, total particle counting, and physical capture of microorganisms through proven gelatin filter technology, allowing subsequent microbial identification when required. It operates at a sample flow rate of 1 CFM (28.3 L/min) and requires only a single isokinetic sampling probe, minimizing intrusion into critical environments.

The instrument can be used as a standalone unit for routine monitoring, investigations, and room release, or integrated into a Facility Monitoring System (FMS) for continuous automated monitoring of aseptic processes. When integrated, BioTrak supports automated data collection, alarm management, and secure data handling, enhancing process control and reducing the need for manual environmental monitoring interventions.

Designed to meet the needs of GMP-regulated pharmaceutical facilities, BioTrak supports high data integrity standards and can operate in Data Integrity Mode in accordance with ALCOA+ principles.

By enabling continuous monitoring, rapid response to environmental excursions, and improved risk assessment, the BioTrak™ Real-Time Viable Particle Counter supports safer pharmaceutical manufacturing, reduced contamination risk, and improved product quality.