Cleaning validation (MACO) calculation

sir how can I consider the previous product or the next product in MACO calculation?
please reply

Previous product is the product which is already worst molecule in this equipment train and next product is newly introduced molecule. So in maco calculation consider pde value of worst case molecule and minimum batch size and TDD of newly introduced molecule. And calculate.

Sir has to be spiked swab sample of worst case product in equipment for swab analysis ( MACo calculation)?

Yes…but you may also consider those equipments in shared surface area calculation which will spike with worst case molecules. And also define procedure for spiking.

Recently I has been done cv in my faculty with spiking method …

Tq so much sir for your valuable response especially for cleaning validation :pray:
Sir i have one more question that How much sample will we take of worst product?

This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.