Application Note

The Importance Of A Good Non-Viable Measurement: Real-Time Viable Particle Counter

A non-viable airborne particle counter is a misnomer. Current airborne particle counting technology such as found in the TSI AEROTRAK™ particle counters, size and count all particles that pass through its viewing volume, it does not matter whether the particle is viable or non-viable. When an airborne particle counter displays 1 particle count at 5 μm it may or may not be viable, the instrument is unable to tell the difference. The great news now is that the BIOTRAK™ Real-Time Viable Particle Counter will be able to tell the difference.

Airborne non-viable particles have been sized and counted using airborne techniques of laser light sources and measuring the scattered light from particles for several decades. The BIOTRAK Particle Counter moves airborne particle counting into the 21st century by using TSI’s patented Laser Induced Fluorescence (LIF) technology to detect viable microbiological particulates in real time. This means end users are immediately notified of the presence of airborne viable particles.

Current FDA Aseptic Processing Guidance 2004 and EU GMP Annex 1:2008 defines non-viable particle count limits and methodologies for particle cleanliness classification and monitoring, directly referencing current ISO 14644-1 and -2 particle air cleanliness standards. The particle counter calibration standard ISO 21501-4 is also linked to these regulatory guidelines as it also references ISO 14644-1. There are currently no guidelines or ISO standards for Classification of viable air cleanliness.

 

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