Pharma & Biotech
Pharmaceutical
Hot-melt extrusion, amorphous solid dispersions, and taste-masking at true micro scale — from 1 g feasibility batches to clinical-supply quantities.
01 / 05 — OVERVIEW
Pharmaceutical R&D demands exact control over melt temperature, shear, and residence time at the smallest possible batch size. The Three-Tec ZE-series extruders process as little as 1 g of API, reducing material waste during early-stage formulation screening. The ZE5 HMI Hot-Melt Edition adds PAT-ready probe ports, 21 CFR Part 11 data integrity, and ASD-grade thermal control for amorphous solid dispersion development. Gravimetric feeding with the ZD 5 FB i6000 (±0.015 % accuracy) ensures repeatable dosing of low-concentration actives. Downstream pelletizing, film casting, and fiber spinning complete the line for oral solid dosage forms, implants, and transdermal delivery systems.
02 / 05 — CHALLENGES
03 / 05 — WORKFLOW
How it comes together.
Define API loading, polymer carrier, and target dosage form with your formulation scientist
Feed API and excipients via gravimetric ZD 5 FB i6000 feeder (±0.015 %)
Compound on ZE5 HMI (1 g batch) or ZE9/ZE12 for larger runs, with inline PAT monitoring
Shape via strand pelletizer (0.5–10 mm granules), micro film line, or micro fiber line
Collect process data under 21 CFR Part 11 for regulatory submission
04 / 05 — TEST LAB
Run it in our lab first.
Our Piscataway, NJ facility is equipped to run feasibility studies for this application. Ship your material and we’ll process it on validated equipment — onsite observation or video-call available.
Explore the Lab
