Pharmacy Courses

Rinse Sampling Procedure for Cleaning Validation

Rinse sampling is a technique for ensuring cleaning validation. Sampling and testing of rinse samples for residual active ingredient is a commonly adopted method to evaluate cleanliness. This is a fairly convenient method in many cases and requires control over the solvent used for rinsing, the contact time and the mixing involved. 


The solvent used should be selected based on the solubility of the active ingredient and should either simulate a subsequent batch of product or at least provide adequate solubility.


Rinse sampling does not employ mechanical action on the surface and the sample is collected as a final rinse or rinse applied specifically for collecting a validation sample. A disadvantage of rinse samples is that the residue or contaminant may not be soluble or may be physically occluded in the equipment. An analogy that can be used is the "dirty pot." In the evaluation of cleaning of a dirty pot, particularly with dried out residue, one does not look at the rinse water to see that it is clean; one looks at the pot.


Read also: Swab Sampling Procedure for Cleaning Validation