At the 8th CMC-CHINA China Pharmaceutical Industry Expo, held from September 4 to 5, 2026, at the Suzhou International Expo Center, Hartek Technology showcased its HTGD series pharmaceutical-grade twin-screw hot-melt extruder at booth E-B13. The company successfully completed a hot-melt extrusion (HME) process validation of copovidone VA64 with an API (simulated process), producing crystal-clear samples with excellent uniformity and dissolution results.
Hot-Melt Extruder Overview
The HTGD series is a parallel co-rotating twin-screw hot-melt extruder designed specifically for pharmaceutical applications. Its intermeshing screw configuration delivers highly efficient mixing, ensuring excellent drug dispersion and short residence times—critical factors for producing high-quality solid dispersions.
Key Features
Split-Type Barrel: The barrel can be quickly opened for cleaning, eliminating dead zones where material might remain. This design significantly reduces changeover time and supports compliance with strict GMP cleaning requirements.
Modular Screw Design: The screw elements are fully modular, allowing flexible adjustment of the screw assembly to suit different APIs and excipient systems. This adaptability makes the HTGD series suitable for a wide range of formulations, from early-stage R&D to production-scale manufacturing.
Advanced Control System: The equipment is equipped with a Siemens PLC control system, enabling recipe storage and one-click recall. Process parameters are fully traceable and reproducible, ensuring consistent product quality across batches.
GMP-Compliant Construction: Designed in accordance with GMP principles, all components that come into contact with the product are made from food-grade stainless steel, ensuring ease of cleaning and maintenance.
Process Validation Results
In the on-site validation, the HTGD Hot-Melt Extruder series thoroughly blended VA64 with an API-simulated excipient, yielding a uniformly transparent sample with no phase separation or precipitation. These results demonstrated the equipment’s process stability in solid dispersion preparation, as well as its performance in temperature-control accuracy and ease of operation.
About Hartek Technology
Hartek Technology is a national high-tech enterprise holding over 30 national patents and certified to ISO9001 and EU CE standards. Its business spans packaging, agriculture, industry, food, tobacco, healthcare, specialty materials, and new energy electronics, covering eight major sectors.
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