FACILITY MONITORING AND THE BIOTRAK™ REAL-TIME VIABLE PARTICLE COUNTER

Sep 09, 2014
By PharmTech Editors

FACILITY MONITORING AND THE BIOTRAK™ REAL-TIME VIABLE PARTICLE COUNTER

How do you know the critical processing environment is in control? Traditionally, a facility monitoring system like TSI’s FMS software with Remote Particle Counters detects change and adverse trends in airborne particulates in real-time. Critical process parameters such as differential pressure, temperature and humidity are also monitored. Detecting change, adverse trends and enabling a real time response is aligned with the risk reduction principles of ICH Q9 Quality Risk Management (QRM). Until now, the only environmental parameter that could not be measured in real-time and arguably the most important is airborne microbiological contamination.

TSI’s BioTrak® Real-Time Viable Particle Counter challenges this reality.  Now it is possible to detect airborne microbiological contamination during critical processing in real-time. And, the instrument easily integrates into a facility monitoring system, enabling a real-time response to airborne viable particle excursions.

BioTrak Particle Counter first counts airborne particles compliant to ISO 21501-4 at a 28.3 lpm sample flow rate. It then analyzes each particle for viability providing a real-time count. Finally, it collects all optically analyzed particles on a collection filter for laboratory-based speciation. BioTrak – the real-time viable particle counter that delivers airborne viable particle count data you can trust, moving you towards real-time quality assurance and process control.

About TSI Incorporated
TSI Incorporated serves a global market by investigating, identifying and solving measurement problems. As an industry leader in the design and production of precision instruments, TSI partners with research institutions and customers around the world to set the standard for measurements relating to aerosol science, air flow, health and safety, indoor air quality, fluid dynamics and biohazard detection.

Further information on BioTrak visit: www.tsi.com/biotrak-9510

or E-Mail: tsi.emea@tsi.com