Formula 3 - MACO using general limit.docx

Calculation of MACO using a general limit as per APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants (APIC, CEFIC, Revision April 2019, updated February 2021

1. MACO[mg]=MAXCONC[
mg
kg
∨ppm]
×MBS
next
[mg]
Where:
MAXCONC: The general limit for maximum allowed concentration of the previous
substance in the next batch.
MBSnext: Minimum batch size of the next product