Cleaning Validation approach

While performing the cleaning validation is it required to evaluate the cleaning method all the times by Swab, Rinse and Visual?

The reason why the above question came is:

we are having a kilo lab facility where we can able to manufacture the material with low volume (where regulatory filing is also possible/happened from this facility). The facility consist of small glass vessel where in some cases it is not possible to perform swab sampling.

In such cases can we go by Rinse and visual? (by avoiding swab)

Also it will be helpful if there is any regulatory reference for this.


Regards / Raghu

Dear raghu,

which is your issue with sampling by rinsing? It is a perfectly acceptable sampling method, and to my point of view, it renders better results than swab sampling. Classical regulatory references are the GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES (
) which states “There are two general types of sampling that have been found acceptable. The most desirable is the direct method of sampling the surface of the equipment. Another method is the use of rinse solutions”, and the PIC/S document PI-006-2, (

), which states on page 21: “There are two methods of sampling that are considered to be acceptable, direct surface sampling (swab method) and indirect sampling (use of rinse solutions). A combination of the two methods is generally the most desirable, particularly in circumstances where accessibility of equipment parts can mitigate against direct surface sampling”.

Your concerns with sampling by rinsing probably come from a statement from the FDA, that rinse sampling (that is the sampling of the last rinsewater, not sampling by rinsing with an appropriate solvent!) is not acceptable because if the target analyte is water insoluble, it will not be drawn into the rinsewater and remain in the equipment, leading to a false conclusion of equipment cleanliness. The above links are self explaining!

Best regards


Thanks Alfred.

The reply exactly answers my query.

Regards / Raghu