10 ppm Criterion Based MACO Calculator
- Purpose: Calculate Maximum Allowable Carryover (MACO) using the traditional 10 ppm criterion. Regulatory Note: The 10 ppm method is a traditional, non-health-based approach. Current regulatory guidance recommends using health-based exposure limits (PDE / ADE) for scientifically justified cleaning limits. This calculator is intended for educational, legacy comparison, or preliminary assessment purposes.
- Enter the Minimum Batch Size (MBS) of Next Product (kg). Important: Always use the smallest commercial batch size of the next product to represent worst-case conditions as per cleaning validation practice.
- Method Assumption: The formula assumes a fixed maximum allowable concentration of 10 mg of previous product API per kg of next product batch (10 ppm).
- 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.
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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