New technique for environmental monitoring in cleanrooms

Published: 2-Apr-2013

BioTrak from TSI offers real-time viable particle counting

Products such as TSI’s BioTrak real-time viable particle counter provide quality assurance professionals with new, valuable information of viable and non-viable airborne particle excursions.

This new technology enhances process understanding and builds knowledge, the company says. Reducing product waste and personnel effort needed to identify and address contamination sources are all potential improvement opportunities.

Viable particles include microbiological constituents that could contaminate product, containers or closures in aseptic manufacturing processes. These are typically monitored using traditional air sampling techniques. Manufactured pharmaceutical product must wait typically 3–5 days for results.

Recent technological advancements, based on optical analysis of individual airborne particles, provide a new method of detecting airborne viable particles in real-time. This technique is referred to as real-time viable particle counting.

The basis of viability detection using Laser Induced Fluorescence (LIF) is the intrinsic fluorescence of microbiological constituents. In simple terms, when laser light is directed at particles, the particles that have certain microbiological properties will fluoresce. The wavelength and intensity can be detected and categorised to determine particle viability. Some early products on the market have had issues with determining viable from non-viable particles, producing too many “false positives”, meaning that customers are uncertain that the measurement works. To address this issue, and to build confidence in the measurement, TSI has conducted extensive testing and developed algorithms that are proven to provide a much better level of discrimination.

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