Therapeutic Dose Based MACO Calculator
- Purpose: This calculator determines the Maximum Allowable Carryover (MACO) using the therapeutic dose 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.
- Enter the Previous Product Name for identification purpose.
- Enter the Minimum Therapeutic Daily Dose (TDDmin) of API of the previous (worst-case) product. This should be the lowest approved therapeutic daily dose.
- 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.
- Safety Factor: Apply a scientifically justified safety factor. If not selected, a default value of 1 is applied. Applicability Note: The Therapeutic Dose–based MACO method may be used when scientifically justified toxicological data (e.g., PDE / ADE) is unavailable; however, selection and justification of the Safety Factor must be documented based on risk assessment, literature, or internal data to meet regulatory expectations.
- 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.
Safety Factor Value
Detailed calculation will appear here.