Enter information for the previous product (residue source) and the next product to be manufactured on the cleaned equipment.
Enter the total shared product-contact surface area of the manufacturing train, or add individual equipment pieces.
Select which limit calculation methods to apply. Adjust safety factors and parameters as needed for your specific application.
The traditional approach: no more than 1/1000th of the minimum therapeutic dose of Product A should appear in the maximum daily dose of Product B.
Residue of Product A must not exceed a defined concentration (default 10 mg/kg) in the next batch of Product B.
Uses the No Observed Adverse Effect Level with uncertainty factors to derive a toxicologically justified limit.
Uses the Health-Based Exposure Limit or Permitted Daily Exposure to set a toxicologically justified cleaning limit per EMA guidelines.
A general limit based on visible residue detection. Typically 4 µg/cm² on stainless steel surfaces (316L SS).
Cleaning validation limits calculated from your input parameters. The controlling limit (most conservative) is highlighted.