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§5.2 Alert and action limits
Each classified area has alert and action limits for viable and non-viable monitoring. A result above an alert limit is trended; a result above an action limit starts an investigation the same day.
§5.3 Grade B and aseptic areas
Repeated action-limit excursions in a Grade B area adjacent to aseptic filling require immediate notification of Quality Assurance and an assessment of the impact on sterility assurance before filling continues.