Glossary
First Air
Filtered air that has not been interrupted by people or objects before it reaches exposed product or product contact surfaces.
Source · EudraLex Volume 4, Annex 1 (2022), §11 Glossary: First Air
Details
First air protects exposed product directly in the Grade A critical zone, so hands, tools, and containers must not come between the HEPA face and the critical point. Inspections cite cases where an operator's hands or an item blocked the airflow and this was not reflected in the airflow visualisation study or in the procedures. Check the airflow visualisation video, the aseptic technique SOP, the intervention list, and operator training and observation records.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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An operator placed components within the ISO (b)(4) work area that had the potential to block the movement of first air to critical in-process operations.
FDA · FDA Warning Letter · 2025-11-25 -
An operator blocked first air by placing their gloved hands directly over open sterile containers.
FDA · FDA Warning Letter · 2023-08-08 -
An operator placed components and equipment within the ISO 5 work area that had the potential to block the movement of first air to critical in-process operations.
FDA · FDA Warning Letter · 2023-05-30
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EudraLex Volume 4, Annex 1 (2022), §11 Glossary: First AirGRM Regulatory Glossary
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