Glossary
Total Particle (Non-viable) Monitoring
Also writtennon-viable particle monitoringnon-viable monitoringnon-viable particulate monitoringNVP
Measuring total airborne particle concentration continuously or at a defined frequency to watch the state of cleanliness.
Source · EudraLex Volume 4, Annex 1 (2022), §§9.15–9.21
Details
Total particle monitoring quickly picks up the control state of a clean area and transient interventions or equipment degradation, but on its own it does not demonstrate sterility. Inspections cite Grade A critical processing not monitored for its full duration, delayed or disabled alarms, and excursions not linked back to the point in the operation at which they occurred. Check particle counter calibration and sampling locations, continuous data and alarms, the batch timeline, and investigation records.
Related sections
Related terms
Source
EudraLex Volume 4, Annex 1 (2022), §§9.15–9.21GRM Regulatory Glossary
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