Process Scale-up

Short Description:

QbD/DoE-based scale-up from lab to pilot to commercial lines. We define design space and control strategy so that disintegration/dissolution, content uniformity, thickness/size, mouthfeel, and stability remain within specs after scale-up.

Product Video Sample Diagram Performance & Features Work station details Technical Parameters

Isomorphic mapping of CPPs across lines to avoid re-development.
Robust window via DoE and edge-of-failure stress tests.
In-line controls for thickness/areal weight/tension/web guiding to minimize intra/inter-batch variance.
Data-driven SPC & Cpk monitoring with trend alerts.
Parallel confirmations (where justified) to shorten time-to-market.

Material/formulation equivalence: solids, viscosity/rheology, dispersion stability; water/hydroalcoholic evaporation and EX-proof controls.
Casting & drying: die/slot gap, coating speed, zoned drying temp/airflow/dew point; stress release and roll-to-roll tension map.
Converting: tool steel/die base, fiducials/registration, web guiding, tolerance & burr control.
Packaging fit: WVTR/OTR match, moisture equilibrium, coding & seal strength.
Statistics & docs: scale-up plan, DoE report, Cpk stabilization, deviation/change logs, batch record abstracts.

Category	Target/Range	Notes
Scale-up factor	Lab→Pilot ×5–10; Pilot→Comm ×3–10	Depends on width & drying
Viscosity (25 °C, mPa·s)	500–5,000 @ 10–100 s⁻¹	For uniform coating
Thickness tolerance (µm)	±5 (target)	Sampling ≤50 m or ≤10 min
Areal dose (mg/cm²)	RSD ≤3%	Weight–thickness cross-cal
Web tension (N)	30–120	Cpk ≥1.33
Web wander (mm)	≤±0.5	Edge/vision guiding
Die-cut tolerance (mm)	±0.2 (target)	Burr ≤0.05 mm
Yield (%)	≥92–97	After ramp-up
OEE (%)	≥70–85	Product-dependent
Drying temp (°C)	40–60	Zoned w/ dew-point ctrl

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