In the cleaning validation, we introduce a new equipment to replace a tank in the production process . If the new tank represent a worst case, the cleaning efficiency has to be validated. The problem is how we carry the risk evaluation. How the change of the tank effect the validated state since last validation?
For example, the residual limits of all the equipment will be changed due to the different contact area. For the unchanged equipment, the detect results in last validation are still below the new limits. So in my opinion, we will only to validate the cleaning efficiency of the new tank.
Is it right? Can we carry the validation (3 times) as a concurrent validation in the production?