Calculate acceptance limit in cleaning validation

Hello experts,

I meet a problem while calculating acceptance limit in cleaning validation. Suppose that a manufacturing process uses 4 machine including seiving machine, final mixer, tableting machine and blister packaging machine. Their contact surface are A, B, C and D cm2 respectively.

Now, I need to determine the acceptance limit of API on the final mixer. Should I use the value of B or A+B+C+D?

Thanks for reading my topic.

Nguyen

https://www.gmp-compliance.org/gmp-news/justification-of-limits-for-cleaning-validation-in-themanufacture-of-active-pharmaceutical-ingredients

Thank you but I can’t see what I asked in the article you suggested.

if just for mixer cleaning validation then take only B

This means there will be 4 specs for 1 product (worst-case product)?

4 specs mean?

Sorry. I mean there will be 4 limits (acceptance limit) for only 1 product.

cleaning validation is carried out separately for every equipment.like separate for mixer,separate for sieves and separate for machines etc

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