Cleaning validation tools

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

I would like to ask if anybody knows if it is necessary to do cleaning validation of tools used to weigh, and that are in contact with different products.

I think it is not necessary because the quantity of product that could remain in the tools isn’t big enough to affect the next manufacturing.

Thanks in advance.

Georgina

2

Dear Georgina,

we have had questionings during an inspection by our health authorities, because we did not validate the cleaning of the weighing scoops. Our rationale was that even with a gross contamination, visible to the naked eye, there was no risk given the negligible contribution of the scoops to the equipment train surfaces (<1%). The argumentation from the inspectors was that the weighing tools come in contact, not with the formulated product but with the pure API, and therefore pose a higher cross contamination risk. In the end we did not validate the cleanliness but switched over to disposable scoops specifically for the API weighing operations.

Best regards

Alfred

3

Dear Aldred,

Thank you very much for you answer. We have decided to do the same as you. Buy new scoops for every API’s and share the same scoops for the excipients and not validate de cleaning of the tools.

Best regards

Georgina