Cleaning validation - Selection of equipment

[Rambabu_G]

Dear Sir,

I want to know how to select the equipment for cleaning validation in the finished formulations

for example, five equipment are common for the manufacturing of products A, B & C.

If one or two pieces of equipment did not expose to the API operation ( equipment used for inactive materials operation). In this case, shall we consider this equipment as a common equipment surface area?

Regards
Rambabu

[Mdkale (Mayur)]

Yes you have to consider. Because same equipments are used in different batches obuesly it is common surface area. And your concept “equipment used for inactive materials operation” is another matter. While handling of API there is chances of spreading of API material in another equipment (like in granulation area). During sifting,dry mixing etc… and also in cleaning validation we not only valid cleaning of traces API material, we also valid the traces of cleaning agents. I hope you understand my logic.