Pharmaceutical formulation research and development twin-screw extruder Pharma 11
Thermo Scientific
A tabletop small-scale twin-screw extruder that addresses various challenges in pharmaceutical formulation development, achieving better "formulation performance" and "sustainable production."
The Pharma 11 twin-screw extruder achieves excellent material efficiency and operational efficiency in the extrusion, mixing, and granulation processes. With industry-standard PLCs, it can also be integrated with existing process control systems. Support for 21 CFR Part 11 compliance and options for batch reports/audit trails are also available.
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basic information
■ Excellent Scalability Supports continuous production from approximately 20g of small batch mixing to 2.5 kg/h. External PC monitoring and control via OPC UA, segmented twin-screw design, temperature control at seven locations, up to 280℃, compatible with L/D ratios of 15, 25, and 40. Up to six ports with the option to add venting functionality. Can accommodate up to three feeders for various raw materials, suitable for installation in glove boxes and for sheet/film processing. ■ Excellent Cleanability The top and bottom opening barrel and disassemblable parts allow for thorough cleaning, minimizing contamination from foreign substances and degraded materials. The flat design also makes wiping easy. ■ User-Friendly Design Features an intuitive touch panel for external operation. Equipped with user restrictions and data recording functions. ■ Space-Saving Installation The main unit measures 90 cm in length and weighs 55 kg, making relocation easy. ■ Comprehensive Safety Management GMP compliant. Equipped with emergency stop, torque and pressure monitoring, and a drive stop mechanism when the safety cover is opened. ■ Ensured Scale-Up Dedicated software manages physical energy to the API, supporting data-driven scale-up to larger machines.
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Applications/Examples of results
Hot Melt Extrusion (HME) Implants and Drug Delivery Systems Continuous Manufacturing and Twin-Screw Granulation
Detailed information
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System of Pharma 11 and Chill Roll (cooling flaker for HME) enables continuous production of high-quality amorphous solid dispersions.
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The top and bottom opening barrel, die, screw, frame, and other components of the mixing machine can be disassembled and thoroughly cleaned down to the details, eliminating issues such as foreign material contamination between batches and the inclusion of degraded materials due to heat. The overall flat design without bumps makes cleaning through wiping of surfaces and details easy.
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Pharma 11 and air-cooled conveyor belt, pelletizer system Capable of creating cylindrical pellets with controlled diameter and length.
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![Case Study [Pharmaceutical] Hot Melt Extrusion of Oral Disintegrating Films](https://image.mono.ipros.com/public/catalog/image/01/348/731590/IPROS2703278505574659571.jpeg?w=120&h=170)
![Case Study [Pharmaceuticals]: Continuous Twin-Screw Granulation - Considerations for Process Design, Development, and Scale-Up](https://image.mono.ipros.com/public/catalog/image/01/e9f/731589/IPROS8680156668467617051.jpeg?w=120&h=170)
Company information
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.
