Glossary
Airflow Visualization Study (Smoke Study)
Also writtensmoke test
A study that makes airflow visible, for example with smoke, to confirm that contamination is not carried into critical zones.
Source · EudraLex Volume 4, Annex 1 (2022), §§4.15, 4.30
Details
An airflow visualisation study must demonstrate protection of first air and the exclusion of lower grade air not only at rest but in the dynamic state, simulating operations and interventions. Inspections cite omission of the genuine worst case interventions, failure to retain the video, and no reassessment after equipment changes. Look at the approved protocol, the original video, the intervention scenarios, the conclusions and CAPA, and the rationale for the environmental monitoring locations.
Related sections
Related terms
Source
EudraLex Volume 4, Annex 1 (2022), §§4.15, 4.30GRM Regulatory Glossary
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