Three-Tec AG
ZE5 HMI Hot-Melt Edition
The ZE5 chassis optimized for hot-melt extrusion — PAT-ready probe ports, 21 CFR Part 11 compliance, and ASD-grade process control.
cGMP21 CFR Part 11FDA316L
01 / 04 — OVERVIEW
Built on the same 5 mm twin-screw chassis as the ZE5, the Hot-Melt Edition is configured specifically for pharmaceutical hot-melt extrusion. The barrel integrates 12 mm probe ports at every zone for inline PAT sensors (NIR, Raman, UV-Vis) and inline melt-pressure monitoring. Process PEO, enteric polymers, and amorphous solid dispersions at gram scale — 1.2 cm³ empty volume at L/D 15:1 — with full 21 CFR Part 11 data-integrity compliance. Audit-trail-enabled Siemens PLC records every parameter for regulatory submission.
02 / 04 — FEATURES
Purpose-built for pharmaceutical hot-melt extrusion (HME)
12 mm PAT probe ports at every barrel zone for inline analytics
21 CFR Part 11 compliant — audit trail and electronic signatures
1.2 cm³ empty volume at L/D 15:1 for minimal API waste
ASD-grade process control for amorphous solid dispersions
Compatible with PEO, HPMC-AS, Eudragit, Soluplus, and enteric polymers
316L stainless, tri-clamp, full cleaning validation support
03 / 04 — SPECIFICATIONS
Technical data
GEOMETRY
Screw diameter5 mm
L/D ratio15:1 – 40:1 (modular)
Empty volume (15:1)1.2 cm³
Min. batch size1 g
PAT probe ports12 mm at every zone
DRIVE
Max torque2.5 Nm
Screw speed1–1,000 rpm
Max pressure200 bar
THERMAL
Max temperature230 °C (400 °C optional)
Heating zonesUp to 8 independent zones
CONTROL
PLCSiemens S7-1500
HMISiemens 12" touchscreen
21 CFR Part 11Audit trail, e-signatures
Data loggingIntegrated, CSV export, audit trail
COMPLIANCE
Contact material316L stainless (Ra 0.8 µm)
StandardscGMP, FDA, 21 CFR Part 11
PAT integrationNIR, Raman, UV-Vis compatible
04 / 04 — PAIRS WITH
