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Efficacy of cleaning procedures is typically evaluated:
– At the end of the manufacturing or product changeover (cleaning after batch)
– At the end of a manufacturing campaign (production of subsequent batches)
– After a period of dirty state (Dirty Holding Time, DHT)
– After a period of storage in clean state (Clean Holding Time, CHT)
– After maintenance
Periodically, after a pre-established period, on the basis of a proper risk-assessment aimed to keep the risk of cleaning failure under control
There are also some cases in which cleaning procedures require a re-validation:
When one is establishing initial qualification of cleaning method and equipment.
– If there are some major changes in a cleaning procedure are being adopted.
– If there is a major change in the master formula.
– If the cleaning agent is changed.
