A complete range of technologies for R&D.

Batch Processing Solutions: PharmaConnect.

This innovative plug-and-play system provides a unique benefit to the pharmaceutical development industry and enables a diverse range of process modules to be integrated with a single control unit.

Based on GEA’s PMA and Gral granulation technologies, the PharmaConnect can process batch sizes of 25 kg or more, all from a single control system. However, the PharmaConnect is not just limited to granulation; the unique design of the control unit allows any number of process technologies to be operated from the single operator interface, including high-shear granulation, IBC blending and high shear blending.

Typically ranging from 1 to 60 L, standard capacities are available for each set of modules, with each unit being geometrically scalable.

In addition to the typical high-shear granulation process, GEA also supplies PharmaConnect modules for its NICA extrusion and spheronization pelletizing system and for its TRV (Turbo Rapid Variable) high speed blender.

Through-the-Wall or Mobile Control Unit Two versions of the control unit are available: a through-the-wall option and a mobile module. The unit also features a touchscreen user interface, a module drive motor and GEA’s Module Recognition System (MRS), which automatically detects the type and capacity of the connected module, seamlessly displaying an image of the process on-screen and both enabling and defining the correct operational set points and parameters.

PharmaConnect is a truly PAT-compatible, cGMP-compliant, plug-and-play solution for the busy formulation scientist.

6 Batch Processing Solutions — Granulation.

Designed for specific applications, our R&D range covers every aspect of oral solid dosage production: from high shear mixers, fluid bed dryers and single pot systems to extruders and spheronizers, blenders and containment solutions, right through to tablet compression.

Bottom-Driven High Shear Granulation: Offering a wide range of processing capacities, standard module sizes for the bottom-driven PMA are set at 1, 3, 5, 10, 15, 20, 30 and 60 L, with each unit being geometrically scalable. Critically, each of these modules features its own impeller drive motor, maintaining a consistent energy input per unit volume and enabling true scale-up data to be generated, even at the 1 L level, for commercial expansion.

Top-Driven High Shear Granulation: The Gral top-driven granulation system is renowned worldwide for its high quality, robust design and scalability. The UltimaGral comes with a 10 L bowl and can be scaled- up to provide 25 and 75 L capacities, facilitating the move to production-scale equipment. Furthermore, integration with the PharmaConnect control unit provides complete process flexibility.

Extrusion and Spheronization: Designed specifically as a pelletization system for the pharmaceutical industry and able to pelletize small batches (50 g) using the operating principles of larger pilot- scale and production machines, the NICA IPS-5 extruder and spheronizer is the perfect development partner for the PharmaConnect.

IBC Blending Systems: Featuring the unique, removable Blending Prism and designed to handle a complete range of laboratory sized IBCs (3–75 L) using a single process module, NIR technology can also be applied to provide online blend homogeneity detection. The Prism adds low shear mixing to the rotating IBC, adding to the turbulence of the tumbling product and reducing the blend time.

Inhalable Fine Powder Processing: Inhalation is often the preferred drug delivery method for lung diseases, offering a number of advantages for both patients and medical professionals for the administration of vaccines and other biological drugs.

As well as a wide range of high quality homogenization equipment, GEA also offers production-scale mixing, blending, spray drying and micronization solutions for the manufacture of inhalable products (dry powders and suspensions), plus an unparalleled level of expertise in the design and layout of suitable plant: from vessel size dimensions to valves and 3D P&IDs, and from R&D to full-scale production.

The TRV is a high-speed blending unit that features a single, bottom-driven impeller drive. It is particularly suitable for the rapid batch blending of small quantities of APIs and excipients for inhalable products.

The modular design enables batches from as little as 200 g to be processed. And, with a range of bowl capacities up to 60 L — plus standalone systems integrated with isolators — the PharmaConnect system provides the ability to perform 1:10 scale-up procedures that are completely compliant with current regulatory requirements. Integrating GEA’s BUCK® containment valve technologies further enhances the system’s capabilities.

7 Batch Processing Solutions — Granulation.

Batch Processing Solutions: PharmaConnect-PLUS.

GEA has expanded its popular Pharma- Connect system with the introduction of PharmaConnect-PLUS, extending the unit’s high shear granulation capacity to encompass batch sizes of up to 60 kg.

Designed for small-scale granulation and research and development applications, particularly with potent actives, the PharmaConnect-PLUS — based on the established combination of a single control unit with a diverse range of process modules — further benefits from both physical and control integration with GEA’s fluidized bed processors: the MP2-Advanced and MP3- Advanced.

The modular design provides the opportunity to process batches from as little as 5 kg. With the new, increased maximum capacity, one integrated system now provides the ability to perform 1:10 scale-up procedures that are completely compliant with current regulatory requirements.

Both the BUCK® MC valve and the disposable Hicoflex® system can be used to deliver OEB 4 containment levels, facilitating the safe loading of raw materials and the collection of finished granulated product.

The high shear granulator discharges through an integrated wet mill with granules being conveyed directly into a fluid bed processor. After drying, the end product handling system utilizes GEA’s lean phase conveying technology to ensure the rapid, contained transfer of product through the dry mill and into the finished product IBC.

8 Batch Processing Solutions — Granulation.