Micronizer cleaning validation

[svrr]

Dear forum members,
I need help on micronizer cleaning validation...[our facility is multi product facility]

1.How batch size has to be considered?
2.Which equipments surface area has to be considered for establishing the swab limits? Either total chain of equipments or only micronizer followed by shifter.
3.Is it correct for following two type of limits for the same product, i.e, for micronizer followed by shifter one specification limit and other chain of equipments another specification limit, because we did not require micronized material every time.
4.Concurrent validation is acceptable for micronization?

[ramyaraj725]

Dear SVR...
By answering your previous question (theoretical yield calculation), I understand that you are working in API company. So this question also related to API, I think.
Generally, in API, "input quantity of KSM" can be considered as batch size. In cleaning validation, you have to consider the entire contact surface of the product chain. You can use two MACO limits based on complexity of equipment design. Process the product through the entire chain, including micronized and sifter, for the validation batches. Then, no question of concurrent validation for micronized.

Regards
Veerraju