PHARMA 11 TWIN-SCREW EXTRUDER – THERMO

One Platform, Multiple Processes

Pharma 11 can be configured for a wide range of pharmaceutical applications, including:

• Hot-Melt Extrusion (HME)
• Twin-Screw Granulation (TSG)
• Wet Extrusion
• Wet and Melt Granulation
• Orally Disintegrating Films (ODF)
• Transdermal Patches
• Implant Manufacturing

Its flexible configuration allows users to move between different processes without the need for multiple dedicated systems.

Compact Design for Controlled Environments

The compact footprint of Pharma 11 makes it well suited for laboratory environments, including glove box applications where sensitive, potent, or hazardous materials require controlled atmospheric conditions.

The removable touchscreen controller can be positioned outside the glove box, allowing operators to monitor and control process parameters without compromising the controlled environment.

A unique monocoque, fanless design integrates the electronics directly into the unit and eliminates the need for an additional control cabinet. This compact architecture also simplifies cleaning and routine maintenance.

Advanced Hot-Melt Extrusion for Formulation Development

Hot-melt extrusion provides a continuous processing approach for developing solid solutions and solid dispersions, particularly for poorly soluble APIs.

By selecting appropriate excipients and adjusting process conditions, formulation scientists can tailor drug-release characteristics for applications ranging from immediate release to extended-release formulations.

This flexibility makes HME a valuable technology for exploring and optimizing a broad range of pharmaceutical formulations.

Designed for GMP-Oriented Pharmaceutical Processing

Pharma 11 is designed as a GMP-compliant extrusion solution. Product-contact components are manufactured from pharma-grade stainless steel and are supplied with relevant certification.

Comprehensive validation documentation is available, including FAT, SAT, IQ and OQ protocols, supporting equipment qualification and implementation within regulated pharmaceutical manufacturing environments.

21 CFR Part 11-Compatible Software

The control software is designed to support 21 CFR Part 11 compliance and provides an intuitive Windows®-based interface for process control and operation.

The system can be integrated into the customer’s IT environment, while optional features such as Recipe Management, Batch Reports, and Audit Trails provide enhanced process documentation and traceability.

Easy Cleaning and Reduced Cross-Contamination Risk

Pharma 11 is designed with efficient cleaning and changeover in mind. Product-contact components can be easily removed for cleaning and are dishwasher-compatible.

For laboratories working with multiple formulations, optional replacement barrels and screw sets can help reduce cleaning and changeover time while minimizing the risk of cross-contamination.

Optional high-resolution torque monitoring and Process Analytical Technology (PAT) solutions, including FTIR, can also be integrated to provide enhanced process monitoring and development capabilities.

Supporting Scale-Up from Development to Production

Pharma 11 provides a practical bridge between laboratory feasibility studies and larger-scale pharmaceutical manufacturing. Its process-oriented design supports a smooth scale-up pathway to larger Thermo Scientific™ Pharma twin-screw extrusion platforms, helping users transfer process knowledge from development through production.

Customer Benefits

The Thermo Scientific™ Pharma 11 Twin-Screw Extruder combines a compact footprint, advanced software, and a wide range of downstream accessories to provide a flexible solution for hot-melt extrusion (HME) and twin-screw granulation (TSG) applications.

Multifunctional Processing

• 3-in-1 processing platform: Easily converts between hot-melt extrusion (HME), twin-screw granulation (TSG), and wet extrusion.
• Compact design makes the system suitable for R&D laboratories, pilot plants, and small-scale commercial manufacturing.
• Advanced process control enables easy integration of Process Analytical Technology (PAT) tools.
• An industry-standard PLC allows integration with the customer’s process control system through Modbus TCP/IP and OPC UA interfaces.

Cost- and Time-Efficient Development

• Fully scalable across the Thermo Fisher Scientific twin-screw extruder portfolio, supporting a smooth transition from development to production.
• A low minimum feed rate of down to 20 g/h, depending on the material, minimizes raw material consumption during formulation development—particularly valuable when working with high-cost APIs.

User-Friendly Operation

• Highly modular design allows product-contact components to be quickly removed for thorough cleaning and cleaning validation.
• An intuitive, user-friendly interface simplifies equipment operation and process management.
• Online process monitoring can be customized by selecting the required parameters from a predefined list, providing convenient real-time process tracking.

Compact and Space-Saving Design

• A small footprint helps maximize available laboratory space.
• The compact configuration and removable touchscreen make Pharma 11 well suited for glove box and isolator applications, particularly when processing sensitive or hazardous materials.

GMP and Regulatory Compliance

• GMP-compliant design with comprehensive validation documentation, including FAT and SAT protocols.
• Comprehensive process data recording with customizable options for data transfer and reporting.
• Software designed to support 21 CFR Part 11 compliance.

Advanced Software for Optimized Performance

• An intuitive user interface combined with a high-performance PLC enables simple and automated operation.
• Windows-based software supports integration into the customer’s existing IT architecture.
• User management includes Windows password management and password restriction functions.
• Optional Recipe Management, Batch Reports, and Audit Trail functions are available.
• Feeder control is fully integrated into the system.
• Standard HMI languages include English and German, with additional languages available upon request.

Supporting Pharmaceutical Development from R&D to Production

Across the various stages of drug discovery, formulation development, and process development, Thermo Fisher Scientific provides technologies designed to make pharmaceutical development faster, more efficient, and more scalable.

The Thermo Fisher Scientific twin-screw extruder portfolio includes micro-compounders, small-scale extruders, and production-scale systems, providing scalable solutions from early-stage feasibility studies through commercial manufacturing.

Technical Data