No. For cleaning validation, rinse samples alone would not be acceptable; firms should also measure the residue or contaminant on the equipment surface using a direct method (if feasible). One disadvantage of rinse samples is that the rinse solvent may not remove the residue or contaminant. Rinse samples are capable of sampling large surface areas, particularly ones that are difficult to access; therefore, some firms use both swab and rinse samples during the course of their cleaning validation. This is acceptable if the rinse solvent has been demonstrated to dissolve residues of concern and is otherwise suitable for use on the surfaces to be sampled.
For routine equipment cleaning after validation, a residue-monitoring program whose frequency and methods have been determined by risk assessment is recommended to demonstrate that the validated process continues to consistently clean the equipment.
The purpose of cleaning validation is to demonstrate that a particular cleaning process will consistently clean the equipment to a predetermined standard; the sampling and analytical test methods should be scientifically sound and should provide adequate scientific rationale to support the validation.
