Transferring a laboratory formula to production scale
R&D6 min read

From laboratory to production: critical steps in formulation scale-up

A successful laboratory sample is an important milestone, but it is not yet a commercial process. Mixing, heat transfer, timing and equipment effects must be reassessed as scale increases.

UNIENBIOWORKS

Define critical process parameters

The impact of addition order, mixing speed, time, temperature and resting periods on product quality should be understood. These parameters cannot simply be multiplied; they require verification on the intended equipment.

Manage raw-material and equipment variability

Materials with the same name can have different physical properties. Supplier specifications, particle characteristics, density and equipment operating principles can all change the result.

Turn pilot learning into records

Pilot work creates evidence for yield, loss, filling behaviour and control results. Recording deviations and decisions makes the next production run more predictable.