Purpose: This calculator determines the Maximum Allowable Carryover (MACO) using the Health Based Exposure Limits (HBEL) i.e. Permitted Daily Exposure (PDE) / Allowable Daily Exposure (ADE) based method for cleaning validation. The calculated MACO represents the maximum quantity of residue of the previous product that may carry over into the next product while ensuring patient safety. Note: PDE and ADE are effectively synonymous.
Enter the Previous Product Name for identification purpose.
Enter the PDE / ADE value of API of the previous product. Ensure correct unit selection (mg/day or µg/day). The calculator automatically converts all values to mg internally.
Enter the Next Product Name (receiving product).
Enter the Maximum Therapeutic Daily Dose (TDDmax) of the next product. This should represent the highest possible patient exposure.
Enter the Minimum Batch Size (MBS) of the Next Product. Ensure correct unit selection (kg / g / mg). The calculator automatically converts values to mg internally.
Click Calculate to generate the MACO value.
Use Show Detailed Calculation to review step-by-step calculations.
Use Print / Save as PDF to generate a report. Always review the printed report for correctness before use.
