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Cleaning Validation Glossary

Maximum Acceptable Carryover (MACO)

Highest tolerated transfer

PDA TR29 states that the maximum allowable carryover (MACO) is the total amount of a target residue allowed in a batch of the next manufactured product. The equation to solve for MACO is Acceptable Residue Limit in the next product (ARL) multiplied by the Minimum Batch Size of the next product (MBS). ISPE CV Life Guide defines MACO as the carryover concentration or mass of carryover of contaminates allowed in the next manufactured batch from a patient safety standpoint.

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