Cleaning validation

We have two products in product matrix one is having less LD50 value and another one is having color which difficult to remove then which product to be considered as worst for cleaning validation?
Please suggest…

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First, you will have to calculate the Acceptance criteria for cleaning validation of both the products based on HEBL (Health Based Exposure Limits) as per EU guidelines. Then decide.

There’s no doubt that you will have to consider and calculate your allowance for carryover. I would suggest that you calculate the allowable carryover for both the API the previous and the next as per the MACO calculation. If you get worst case scenario for the one having colour then you are absolutely fine. In any case you will have to develop a method to check the cleaning of colour from your equipment.

In case you are not able to develop a common cleaning method for both the products, then you will have to consider both the products separately for cleaning validation. Because there will be two separate cleaning methods for two products.


I doubt, if you can decide “worst case” here. Both are important for different reasons.

One for health and safety of the patient, the other for aesthetic (company image /patient confidence)!

So please suggest what to do finally…

As informed earlier, please carry out cleaning validation separately for two products. Because you may not have a common cleaning procedure for both the products.

Ok sir thanks

You are always welcome.