MACO (cleaning acceptance limit)
Maximum Allowable Carryover (MACO) is the equipment-residue limit for a shared-line supplement facility, calculated from the smaller of three criteria: (1) 1/1000th of the lowest therapeutic dose of the previous active, (2) 10 ppm of the previous active in the next product, an...
Maximum Allowable Carryover (MACO) is the equipment-residue limit for a shared-line supplement facility, calculated from the smaller of three criteria: (1) 1/1000th of the lowest therapeutic dose of the previous active, (2) 10 ppm of the previous active in the next product, and (3) a health-based exposure limit (HBEL / PDE) per EMA 2014. The smallest of the three becomes the cleaning swab and rinse acceptance limit.
- EMA HBEL Guideline 2014
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