All-in-One MACO Calculator
- Purpose: This calculator determines the Maximum Allowable Carryover (MACO) for cleaning validation using different approaches: Health Based Exposure Limits (HBEL) i.e. Permitted Daily Exposure (PDE) / Allowable Daily Exposure (ADE) based method, Minimum Therapeutic Dose based method, and 10 ppm Criterion based method. The most stringent (lowest) MACO value is automatically identified as the acceptable limit to ensure patient safety. Regulatory Note: Current regulatory guidance recommends using HBEL (PDE / ADE) for scientifically justified cleaning limits. This calculator is intended for educational, legacy comparison, or preliminary assessment purposes.
- Enter the Previous Product Name for identification purpose.
- Enter the Minimum Therapeutic Daily Dose (TDDmin) of API of the previous product. Ensure correct unit selection (mg/day, µg/day, or g/day). The calculator converts all values internally to mg.
- Enter the PDE / ADE value of API of the previous product. Ensure correct unit selection (mg/day or µg/day). Note: PDE and ADE are effectively synonymous.
- 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, or mg). The calculator automatically converts values internally.
- For the Therapeutic Dose Based Method apply a scientifically justified Safety Factor. If not selected, a default value of 1 is applied. Applicability Note: The Therapeutic Dose Based 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.
- The calculator automatically identifies the Worst-case (Most Stringent) 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.
Disclaimer: The results provided by this calculator are for general informational purposes only.
Users are responsible for verifying all calculations and ensuring suitability for their own formulation, manufacturing, or regulatory needs.
Cakk Magg X Pharmaceutical Services makes no warranties regarding accuracy or applicability and disclaims any liability for use or reliance on the results.
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