No Method of Detection for Cleaning Validation

Hi everyone,

I’ve run into some difficulty with a cleaning validation where we cannot determine a method of detection for the API.

On calculation of our limits, the most stringent criteria is that no more than 10ppm of the product will appear in the next product. However all the limits are well below a quantitative limit of detection for both swab samples and rinse waters.

We have done spiking studies with a 10ppm solution of the product and cannot visually detect it on stainless steel.

What can we do in this case where we have no method of detecting if the product/active has been successfully removed after cleaning??

Any help would be much appreciated.


The most simple approach would be to use as much disposable product contact equipment as possible – replace piping with tubing, use bags instead of tanks, etc…
You might also try increasing your sample volume and/or surface area to bring the limits into a range that is detectable.

This is always happens in Quality control.

simply choose HPLC or GC method (UV Method is not suitable in this case).

Injection volume must be increased in the method to get the peak.

Bujji kanchi.