Cleaning Validation (MACO)

Demonstrating that cleaning between products leaves no more than the maximum allowable carryover, calculated from toxicological or dose-based limits and verified analytically.

How the limit is set

Modern practice derives MACO from a permitted daily exposure based on toxicological data rather than the old 1/1000th-of-dose rule, which matters enormously for cytotoxics and hormones.

Swab and rinse

Swab recovery is established per surface material, because a recovery of 60% on one coupon and 95% on another changes the result. Visual inspection supports but never replaces analytical verification.

Related terms

Containment (OEB/OEL)
Process Validation

Where this applies

Oncology Injectables

Need help applying this?

Stancor Pharma engineers answer specification questions directly. Contact us.