No. In validating original cleaning procedures, firms need not quantify the level of chemical contamination remaining after manufacturing a product and before cleaning. Firms must, however, ensure that they validate proposed cleaning procedures as for routine use and should not pre-clean or otherwise attempt to make it easier for the procedures being validated to meet their cleaning objectives.
For example, batches significantly smaller than full-scale would not offer sufficient assurance that the cleaning procedure could reliably remove residues to acceptable levels after full-scale production. The material being cleaned should be manufactured at a similar scale and manner as during validation. Also, firms should sample equipment that is stored uncleaned for a longer time than validated to demonstrate that their cleaning procedures are effective.
Once equipment surfaces are cleaned by validated procedures, firms generally are not expected to analytically examine them after each cleaning. (Manual cleaning methods may be an exception to this general rule because of inherent variability in operator compliance and abilities.) However, a residue-monitoring program whose frequency and methods have been determined by risk assessment is recommended.
