Coperion has recently delivered a ZSK 18 MEGAlab twin screw extruder in pharmaceutical design to a renowned international pharma company. This ZSK twin screw extruder with 18 mm diameter screws is part of a total system including two first-class Coperion K-Tron gravimetric loss-in-weight feeders for superior accuracy in API premix and liquid feeding, a cooling belt, and a matching Coperion Pelletizing Technology strand pelletizer.
This high-performance extrusion system is suitable for wet granulation as well as for hot melt extrusion on a lab scale (up to 10 kg/h).
The innovative and versatile, continuous production process of pharmaceutical hot melt extrusion on twin screw extruder has substantially increased in popularity recently due to:
- Solvent-free production of solid dispersions or solids solutions of APIs (also BCS class 2 & 4), thus enhancing their bioavailability
- The short residence time of the products in the temperature-controlled process section, thus considerably reducing the thermal load on the active substances, additives and matrix materials
- The intensive mixing action of the co-rotating twin screws in the process, resulting in improved dispersion of the API
- The exact reproducibility of formulation and product quality
- Encapsulation and taste masking
The process section of the ZSK MEGAlab twin screw extruder is designed as a modular system. It consists of several barrels in which the co-rotating screws operate. The advantage of this modular principle is its maximum flexibility in applying liquids and degassing the melt with vacuum units. The ZSK series for pharmaceutical applications is designed with a constant Do/Di (outer to inner screw diameter) ratio of 1.55 resulting in reliable process scale-up. The self-wiping screws avoid dead spaces and result in a short and narrow residence time distribution in the extrusion process. This leads to increased product consistency. The specific torque of 11.3 Nm/cm3 allows for the maximum throughput to screw speed ratio, resulting in minimized product temperatures and API degradation.
Further advantages of the ZSK 18 MEGAlab are:
- Complete documentation of all process parameters (V-lifecycle) based on URS (User Requirement Specification)
- Manufactured in GMP design, including all parts coming in contact with the product made of stainless steel with minimized surface roughness
- Compact design and therefore low space requirement
- Completely covered process section and controls with easy access for cleaning and maintenance
- Simple handling and quick dismantling using quick release couplings
- Simple to operate PLC and visualization system conforming to 21 CFR Part 11
Since the beginning of pharmaceutical extrusion Coperion has continuously set new standards in the manufacturing of pharmaceutical products with our ZSK twin screw extruders in pharma design. This begins with special applications on a laboratory scale and extends right through to continuous pharmaceutical production systems. Our process engineers benefit from over 30 years of experience with pharmaceutical applications and are able to boost your process development. Interested? Feel free to contact us.