The cleaning validation is primarily applicable to the cleaning of process manufacturing equipment in the pharmaceutical industry. It refers to the removal of residues and contaminants, such as detergents, sanitizers, or degradation products resulting from the cleaning process itself.
Cleaning validation is documented evidence with a high degree of assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable standards. The FDA requires this documentation to ensure that no risks are associated with cross contamination of active ingredients, detergents or sanitizers.
Carry-over of product residues should meet defined criteria, for example the most stringent of the following three criteria:
- No more than 0.1% (1/1000th) of the normal therapeutic dose of any product will appear in the maximum daily dose of the following product.
- No more than 10 ppm of any product will appear in another product
- No quantity of residue should be visible on the equipment after cleaning procedures are performed.