Formula 1 - APIC general MACO calculation.docx

Calculation of MACO 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]=
HBEL
previous[
mg
day]
×MBS
next
[mg]×PF
TDD
next
[
mg
day
]×SF
Where:
MACO: Maximum Allowable Carryover
HBEL (PDE/ADE): Health-Based Exposure Limit for the previous substance
MBSnext: Minimum batch size of the next product
PF: Purging Factor (default = 1; adjust based on process evidence)
TDDnext: Maximum Therapeutic Daily Dose for the next product
SF: Safety Factor (default = 1, unless specific patient hazards apply; assign by
toxicologist)