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Cleaning Validation:

Common product contacting surface

Acceptable residue limits

Change Control

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MACO (maximum acceptable carry over) will automatically be calculated as soon as

are available. The most critical limit is highlighted

Both values are given at the end of the table.
As carryover during a manufacturing campaign of the same product or changing from smaller dosage to larger dosage is not a problem, the corresponding column is marked with a grey background.

To establish all combinations of previous and next product the spreadsheet will automatically combine the results of all “previous” calculations for the 1/1000 dose criterion

and the 10 ppm criterion

and finally the most critical of both criteria

In the hypothetical example given Risperidone followed by Repaglinide is the most critical product sequence allowing for a 0,000254 mg carryover on 25cm2. This is caused by a potential use of Risperidone in Alzheimer desease with a small dose of 0.25mg dose and a maximum Repaglinide dosage of 16mg/day.4

The values given in the table above will automatically be inserted in the calculations, but may be adjusted in the „EquipmentTrain&Simulation”- sheet if a theoretical worst case situation does not seem appropriate.