Acceptance limits for cleaning validation should be pre-determined for chemical and physical residues as well as for microbial contamination (if relevant).

Carryover Limits

These acceptance criteria are usually expressed as limits on the value of the residues or contamination remaining after the cleaning processes have been carried out and are sometimes referred to as “carryover limits”.

Consistent Removal of Residue

The cleaning validation should demonstrate that the cleaning procedure consistently removes residues of the substances previously manufactured down to levels that are acceptable, and that the cleaning procedure itself does not contribute unacceptable levels of residual materials to the equipment.

It should be:

• Practical
• Verifiable
• Achievable
• Scientifically Sound