Provides real-time counts of total and viable particles in pharmaceutical manufacturing environments to reduce aseptic interventions, improve root-cause investigations, and increase process knowledge.
The BioTrak® Real-Time Viable Particle Counter is a biofluorescent particle detector that combines viable particle counting with sample capture capability and total particle counting to offer a complete solution for pharmaceutical environmental monitoring. Its superior discrimination between viable and inert particles delivers reliable viable particle data. Gelatin filter technology efficiently captures sampled microorganisms for subsequent identification.
The BioTrak® Real-Time Viable Particle Counter can be used with TSI FMS Software for continuous monitoring of aseptic processes to reduce risk by eliminating environmental monitoring (EM) interventions and improve quality through better process understanding. It can also be used as a standalone instrument for routine periodic testing, quickly identifying sources of contamination during EM investigations, collecting data to allow for immediate room release, and aiding in the identification and mitigation of risk for improved risk assessments.
The instrument detects airborne viable particles in real-time and fully automates the process with no media or manual processing required. It simultaneously detects both total and viable particles, complies with all requirements of ISO 21501-4, and has a 1 CFM (28.3 L/min) sample flow rate. It only requires a single isokinetic probe at the sample site and has an in-line particle collection filter. The BioTrak® Real-Time Viable Particle Counter can be used as a standalone instrument or fully integrated with FMS for automated continuous monitoring. Its intuitive icon-driven touch screen Graphical User Interface, stainless steel enclosure, and HEPA filtered exhaust make it a valuable tool for pharmaceutical environmental monitoring.