Nov 23, 2012
By PharmTech Editors

Real-Time Viable Particle Counters, like TSI’s BioTrak™ Products, are a new Rapid Microbial Methods (RMM) technique, which has recently been released to the market. These new products are based on the measurement technique of Laser-Induced Fluorescence (LIF). With LIF, essentially, when biological particles are excited by a specific wavelength of light, the emit light at a different, known wavelength. While most LIF based products use similar measurements, there are some considerable differences in products offered on the market.

The BioTrak Real-Time Viable Particle Counter is the only product that measures non-viable particles, just like Portable Particle Counters, and is capable of classifying a cleanroom. This establishes that room meets the specified airborne particulate cleanliness standard, matching previous measurements. The BioTrak Particle Counter also comes with excellent discrimination performance. Some of the early products on the market have had issues with determining viable from non-viable particles. This produces too many “false positives”, and provides uncertainty with customers that the measurement works. To address this issue, TSI has conducted extensive testing and developed algorithms that are proven to provide a much better level of discrimination.

Further, through an evaluation program, you should be able to test the BioTrak against typical sample plates and use that information to properly assess future measurements. Finally, the BioTrak Real-Time Viable Particle Counter comes with a unique built-in sample collection filter that can collect the same particles that were measured. Those samples can then be sent to a lab for more detailed evaluation.