V5 Ultimate
Quality

MACO (cleaning acceptance limit)

TL;DR

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.

Regulatory anchors
  • EMA HBEL Guideline 2014
How V5 handles it
QMS — quality engineered into every action, not bolted on.
Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Related terms
TOC swab vs rinse (cleaning verification)HBEL / PDE in shared supplement facilities
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