MACO value

MACO (Maximum Allowable Carryover) refers to the maximum acceptable transfer of product A into the subsequently manufactured product B via shared production facilities. It defines the upper limit for product or active ingredient residues after cleaning and serves as an acceptance criterion in cleaning validation to ensure patient safety and product safety.

The calculation of the MACO value can be based on various approaches, for example on dose- or toxicology-based criteria. A frequently used dose-based scheme is as follows:

MACO= ADI⋅ M_Batch,B/ Dosis_A

• ADI (Acceptable Daily Intake) or ADE (Acceptable Daily Exposure) is the acceptable limit for health.
• MBatch,B is the batch size of the subsequent product B.
• DoseA is the maximum daily dose of product A. 

In practice, the MACO value is translated into surface or concentration limits (e.g. mg of active ingredient per m² of equipment surface or per litre of rinsing solution), which are checked by wipe or rinse samples in the cleaning validation. 

For manufacturers of powder mixers such as amixon®, this means that the systems must be designed in such a way that they are easily accessible and cleanable. This ensures that the specified MACO limits can be reliably achieved during operation and that cross-contamination between different products can be safely avoided.