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Since August a ZSE 18 HP-PH has been in operation inside a clean room ISO7/GMP at AIMPLAS. With the versatile small extruder from German extrusion expert Leistritz Extrusionstechnik GmbH, the research and development facility is now taking the step towards pharmaceutical applications. “We have more than 30 pilot lines we develop or test various plastics applications with”, says Raquel Llorens, Health Senior Researcher at AIMPLAS. “We want to expand our field of activity in the pharmaceutical (HME) and cosmetics industry, materials for bone and tissue regeneration and medical device developments among others.” AIMPLAS already has a Leistritz ZSE 27 MAXX pilot line, on which research and development in the field of reactive extrusion, recycling and other compounding applications are carried out.
“We are very pleased that AIMPLAS decided for a Leistritz extruder”, says Albrecht Huber, Product Area Manager Life Science & Pharma at Leistritz. “The ZSE 18 HP-PH is the perfect extruder for hot melt extrusion, wet granulation or filament extrusion – exactly the applications important to AIMPLAS. The line can be used for developing formulations as well as for producing small batches.” A decisive factor certainly was the fact that the machine geometry of all ZSE HP-PH extruder sizes (with screw diameters from 12 to 50 mm) are identical. Thus, scale-up from laboratory to production scale is easily accomplished, making customers tests transferable to larger production sizes.
Leistritz is well diversified in the field of pharmaceutical extrusion: Depending on the requirements, the company offers various downstream equipment such as chill roll cooling or the Micro Pelletizer for cutting pellets down to 0.5 mm diameter. The process experts also excel in inline process monitoring with the UvVis technology as PAT instrument (Process Analytical Technology). The AIMPLAS extrusion system, which also includes a side-feeder for conveying material downstream into the melt, is qualified in accordance with the latest GMP guidelines, including the control system.