The latest innovation in rapid microbiology method (RMM) instrument technology is real-time viable detectors, such as TSI’s BioTrak real-time viable particle counter. This technology provides unique benefits for microbial contamination monitoring.
Simply stated, by knowing what is happening when it is happening, Quality Assurance can address excursions immediately, without waiting for the lengthy results from sampling tests.
The BioTrak particle counter has three distinct measurement capabilities, providing maximum awareness of particulate levels present in manufacturing cleanroom environments. It measures total particulate count by incorporating an ISO-21501-4 compliant optical detection engine based on TSI’s field proven AeroTrak airborne particle counters.
Particle viability is determined using TSI’s patented LIF technology developed over the past 20 years in TSI’s biological threat detection products, but optimised for the pharmaceutical application. LIF determines particle viability by monitoring intrinsic fluorescence of cell metabolites associated with cell viability. When excited by 405nm laser light, viability metabolites such as flavins and NADH intrinsically fluoresce, or emit light, that is collected and analysed.
The BioTrak particle counter uses two channels of fluorescence along with particle size in its discrimination of particles to differentiate better between viable particles from non-viable particles. Finally, the exact same optically analysed particles are then collected onto a filter for off-line speciation.
The BioTrak particle counter incorporates all of this capability into a single product operated through an intuitive graphical user interface containing the features found in modern airborne particle counters. These include sample timing, data display, alarming, external data exchange, CFR 21 Part 11 compliant data analysis software, and potential integration with TSI’s FMS facility monitoring software. The BioTrak particle counter’s aerosol performance has been fully characterised by TSI’s aerosol scientists and engineers.
