Pls suggest,
If common blend batch size is 135 kg at Granulation stage. And we will be taken this CB in three different strength (25/50/100 mg) as 45 kg / 6 lakh + 45 kg / 3 lakh + 45 kg / 1.5 lakh from compression stage. So in cleaning validation which batch size is considering for MACO calculation ?
The largest is critical.
During the MACO calculation, consider maximum batch size of the product.
Maximum batch size has more API content, if your cleaning procedure is capable of removing the previous product content to acceptable level (in general 10 PPM Criteria) then it ultimately removes the low content of API also.
So for MACO calculation, maximum batch size is the worst case.
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