A count alarm limit set at one count for a single sample is not statistically significant but many systems are set for Action alarms on one 5.0 micron particle because of the EU limit.

For non-viable, or airborne particles, these clean rooms must comply with regulatory guidelines. These standards define particle count limits and methodologies for particle cleanliness classification ...

When properly configured, continuous non-viable particle monitoring (NVP) offers helpful information about the variations in the aseptic environment with minute-by-minute updates of count ...

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. Contact TSI ( ...