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Pharmaceutical Manufacturing Pharma Series Twin-Screw Extruder

A twin-screw extruder suitable for scale-up from formulation research and development, pilot production, and commercial production.

You can find it useful in the following cases: - You want to manufacture solid dispersions using HME. - You want to perform continuous granulation. - You want to manufacture solid dispersions under ideal production conditions. - You need a feeding system to smoothly deliver difficult-to-add additives. - You want to optimize the usage of expensive and rare APIs (active pharmaceutical ingredients). - You want to keep a record of the kneading state while continuously kneading. - You want to optimize kneading conditions by changing the order and timing of material addition. - You want to knead various forms of materials such as powders and pellets. - You want to remove gases and water vapor generated during kneading. - You want to reduce the effort required for cleaning. - To prevent contamination, it is necessary to thoroughly clean the details of the extruder's barrel and screw. - You want to confirm what changes are occurring in the materials during kneading. - You want to continuously pelletize the kneaded materials as they are. - You want to rationally scale up to a larger extruder to gradually increase production volume. - You also want to apply it to veterinary pharmaceuticals.

[Must-see!] An on-demand webinar is now available on the utilization of extruders (such as in the production of plant-based meat, HME formulations, continuous granulation, and battery material development)!

basic information

■ GMP Compliance Materials suitable for hygiene management are used in the contact areas of APIs (Active Pharmaceutical Ingredients). Medical-grade high-hardness stainless steel is used in the contact areas of materials. Elimination of painted parts. Preparation of necessary documents for regulatory compliance (IQ, OQ). ■ Security and Safety It is possible to limit the operating range of equipment according to the operator's level. User access is restricted through password settings. An emergency stop button is equipped on the front of the device. Monitoring of abnormal torque and pressure. ■ Rational Scale-Up Theoretical scale-up is possible based on data obtained from the small extruder Pharma 11. ■ Integration with Process Analytical Technology Raman or near-infrared probes are installed in the die section where the mixed material is extruded, allowing for quality verification through spectral analysis.

Price range

Delivery Time

Model number/Brand name

Thermo Scientific

Applications/Examples of results

Manufacturing of amorphous solid dispersions using hot melt extrusion (HME) Switching between HME and dry/wet granulation with a single machine

Detailed information

Related Videos

Line up(2)

Model number overview
Pharma 16 Dual-Axis Screw Extruder Barrel diameter 16mm, HME: 0.5 to 5 kg/h, granulation: 1 to 15 kg/h (depending on materials and formulation)
Pharma 24 Dual-Screw Extruder Barrel diameter 24mm, HME: 2–20 kg/h, granulation: 4–60 kg/h (depending on materials and formulation)

Solutions for Melt Mixing for Formulations and Their Analysis

TECHNICAL

Case Study: Mechanisms of Process Parameters for Successful Scale-Up of the Hot Melt Extrusion (HME) Process in Pharmaceuticals

APPLICATION_NOTE

Case Study [Pharmaceutical] Hot Melt Extrusion of Oral Disintegrating Films

APPLICATION_NOTE

Case Study [Pharmaceuticals]: Continuous Twin-Screw Granulation - Considerations for Process Design, Development, and Scale-Up

APPLICATION_NOTE

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Distributors

Thermo Fisher Scientific K.K., the Japanese subsidiary of Thermo Fisher Scientific Incorporated, is a sales company for comprehensive system analysis instruments, bio-related equipment, and research reagents. In Japan, it has bases in Yokohama, Tokyo, Osaka, Fukuoka, and Nagoya, handling various analytical instruments including mass spectrometers, various bio-related equipment, measuring instruments, medical devices, lab software, and research reagents.