Continuous extrusion process for pharmaceutical masses

PHARMACEUTICAL TWIN SCREW EXTRUSION Application fields Compounding with co-rotating twin-screws has been successfully applied in the plastics industry for decades. Now, it is a proven system for hot melt extrusion, granulation, lipid extrusion, transdermals and implants. Leistritz was a pioneer when pharmaceutical extrusion started. Today, we are a technology leader in this area. We have extensive knowledge in the areas of process technology, GMP design, plant engineering, and qualification. Hot melt extrusion (HME) Extrusion for transdermal applications Example after chill Roll process Solid...

TWIN SCREW EXTRUDER SETUP Continuous extrusion process Extrusion technology is an accepted method for the continuous processing of pharmaceutical materials, and it often offers significant advantages compared to batch processes. In an extruder a number of processing steps are combined, including feeding, melting, mixing, venting, and discharge. Upstream materials handling and downstream equipment work in conjunction with the extruder to perform the intended manufacturing operation. Here is an example of a typical twin screw extruder setup: multiple solid and liquid dosing units are possible The...

PROCESS KNOW-HOW Understanding the heart of the extruder venting/ discharge The processing unit is the heart of the extruder. The modular barrel and screw design allows for maximum flexibility. They are specifically designed for the formulation being processed. melting/ mixing feeding/ conveying Processing length The processing length (numbers of barrels used) in general depends on the processing task. A typical length for HME is for example 40D. However, some wet granulation or wet extrusion processes only require ₂₀D. Barrel temperature The first barrel is permanently cooled to avoid blockages...

LEISTRITZ ZSE HP-PHTwin screw extruder overview We have been delivering twin screw extruders for the pharmaceutical industry for more than 30 years. The extrusion lines for wet and hot melt extrusion are renowned all over the world for our cutting edge technology. Leistritz offers the appropriate line for each phase in drug research and development, as well as for large scale production. Scale-up The Leistritz family of extruders covers the need for feasibility testing with very small amounts through to volume production with maximum throughputs and utilization. Our laboratory systems are highly...

Easy cleaning and high functionality Design highlights For the highly demanding standards in the pharmaceutical industry, Leistritz presents an extruder series including according auxiliary equipment in GMP design – specially designed for pharmaceutical applications. This machine generation provides everything that meets the GMP requirements of the industry: special fittings, material combinations, surface textures and an increased documentation for qualification. The extrusion lines have an outstandingly detailed design for all components with respect to cleaning, excellent process stability...

LEISTRITZ EXTRUSION LINES Engineering know-how Depending on the formulation and the end product various plant options are available. Here we will introduce the most established ones. Strand pelletizing The main step after the extrusion process is the cooling-off phase; therefore, depending on the formulation different options are possible. The most common method is to use a cooling conveyer belt, where the cooling media is air. Efficient horizontal or vertical water cooling baths are available when the process allows water contact. After the cooling and solidifying of the melt, the strands can...

LEISTRITZ CONTAINMENT SOLUTIONS Engineering know-how As more and more APIs are classified as highly hazardous substances the operators’ safety is a vital issue. This shows the need for new designs of extrusion lines with containment solutions which have already been designed by Leistritz for different kind of OEL levels. split butterfly valve WHY CHOOSE A CONTAINMENT SOLUTION? ↗ ease of operation and full operator safety (without PPE) ↗ no cleaning of the room required ↗ no risk of cross-contamination A P&I is the basis for all further documents and papers with are required in the validation/qualification...

STATE-OF-THE-ART GxP CONTROL SYSTEM GxP conform operating and monitoring With the Leistritz software you can focus on your processes. From controlling a stand-alone extruder to the integration of all components of a whole extrusion line you will need only one software, which grows with its requirements. When designing a twin screw extrusion plant all aspects specific for pharmaceutical applications must be taken into consideration. An extruder unites a high level of mechanical standard components and functions with various customized adaptations. The main objective of Leistritz’ automation and...

The validation of pharma extrusion lines is inevitable in order to constantly produce high-class products. The Leistritz qualification package includes, depending on the specific project, design qualification (DQ). installation qualification (IQ), and operational qualification (OQ). IQ and OQ are typically performed during the factory acceptance test (FAT) and the site acceptance test (SAT). The great advantage: This qualification package simplifies and reduces the validation effort (for the customer) by referring to test results made by Leistritz during IQ and OQ. Overview: engineering and production...

Process Analytical Technology (PAT) A continuous manufacturing method as extrusion is ideal for a quality by design approach. Based on a risk analysis the critical quality attributes can be defined and continuously monitored. In addition to the typical extrusion process parameters like melt temperature, melt pressure, and specific energy consumption, inline monitoring can be applied. TESTING & OPTIMIZING Common technologies are Raman and NIR. Leistritz also provides the possibility to use In-line technologies like UV-Vis measurement. This new method immediately gives you the chance to evaluate...