Glossary
Critical Zone
The zone in which product and critical surfaces are exposed to the environment during aseptic processing.
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.
