Tuesday, October 17, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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6.1.10Cleaning and Disinfection Validation

Cleaning and disinfection validation should be performed in order to confirm the effectiveness of a cleaning or disinfection procedure. The rationale for selecting limits of carry over of product residues, cleaning agents and microbial contamination should be logically based on the materials involved. The limits should be achievable and verifiable.

Validated analytical methods having sensitivity to detect residues or contaminants should be used. The detection limit for each analytical method should be sufficiently sensitive to detect the established acceptable level of the residue or contaminant.

Normally only cleaning or disinfection procedures for product contact surfaces of the equipment need to be validated. Consideration should be given to noncontact parts. The intervals between use and cleaning or disinfection as well as cleaning or disinfection and reuse should be validated. Cleaning or disinfection intervals and methods should be determined.

For cleaning and disinfection procedures for products and processes which are similar, it is considered acceptable to select a representative range of similar products and processes. A single validation study utilising a ‘worst case’ approach can be carried out which takes account of the critical issues.

Typically three consecutive applications of the cleaning or disinfection procedure should be performed and shown to be successful in order to prove that the method is validated.

‘Test until clean’. is not considered an appropriate alternative to cleaning validation.

Products which simulate the physicochemical properties of the substances to be removed may exceptionally be used instead of the substances themselves, where such substances are either toxic or hazardous.

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