Glossary
Critical Zone
Also writtencritical area
The zone in which product and critical surfaces are exposed to the environment during aseptic processing.
Source · EudraLex Volume 4, Annex 1 (2022), §11 Glossary: Critical zone
Details
The critical zone is the most important space because contamination there passes directly to the product, so it requires Grade A conditions and protection of first air. Inspections cite unclear zone boundaries and critical surfaces, and movement of people and materials and interventions that are not reflected in the airflow and monitoring design. Look at the zone drawings, airflow visualisation, the CCS, the intervention risk assessment, and the locations chosen for environmental and personnel monitoring.
Related sections
Related terms
Real inspection findings
See 1 findings whose text contains this termCounted 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: Critical zoneGRM Regulatory Glossary
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