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The PMA high shear mixer granulator consists of three machines, offering total flexibility in system design with capacities of 1–1800l. It is the ultimate in versatility, with modular options for blending, high-shear granulating and melt or wet pelletising. The design maximizes product processing and contained handling. Create solutions that meet your needs with user-selected standard process modules, combined with advanced automation and cleaning-in-place (CIP) systems.
GEA supplies advanced solids processing plants for mixing and granulating to the pharmaceutical industry. This includes small capacity systems designed for R&D as well as industrial size plants for batch production of pharmaceutical compounds under cGMP conditions.
Using proven standard components, GEA can supply both simplicity and flexibility in plant design. User selected process options, cleaning equipment, control systems and PAT technologies combine in a system to meet process requirements exactly. This approach ensures that qualification and validation procedures are kept to a minimum.
The formulation of an active compound and other excipients needs to be mixed homogeneously. Low-shear mixing relies on the planetary movement of the mixer arm to achieve homogeneity, while high shear mixing uses a high intensity mixing blade resulting in a homogeneous blend. Which technique is most suitable depends on the subsequent production step.
To form granules out of powders, a granulation liquid and mechanical energy is needed. The formation of pellets can be considered as granulation taken one step further, . For high-shear pelletisation, a special mixing tool is available to optimise the process and maximise the output.
This process uses a rotary atomiser spray to achieve excellent dispersion of binder liquid through the mix, and a special high-speed rotation blade for maximum movement of the product, for more efficient pelletisation. A PTFE container-lining minimises the need for ‘top and tailing’, even with the most cohesive of products. Studies have shown that the PTFE liner, unique to GEA can increase production efficiency by as much as 40%. Alternatively, an extruder may be used, similar to those used for the manufacture of pellets. In a typical set-up, all ingredients are pre-blended in a container after dispensing. Depending on the extruder design the liquid can be added in the extruder or mixed separately to the correct consistency. The material produced by the extruder is now transferred directly into a continuous fluid bed where it is dried to the desired moisture level.
This is an exceptionally fast method of producing pellets in a single step. The active material and binder are mixed in binder form then heated until the binder melts. A single batch is processed typically in just 15-20 minutes, and needs no further drying.
Critically, the process geometry of the PMA-Advanced is identical; modifications to the design have been made solely to benefit the user and owner in terms of ease-of-use, cleanability, process analysis and installation. The space saving PMA-Advanced has a small footprint and unit surface area, and service access is achieved through a GMP cover hinge. By uniting these new benefits with the proven PMA process technology, GEA is providing the logical solution for your granulation needs. You can configure a combination of standardised options into tailor-made plants to meet the requirement for a specific process (as such, granulators of equal capacity may be completely different with respect to design, configuration and physical size).
For full compliance with national, local and internal regulations, GEA offers a range of emission control options including solvent recovery systems, outlet filters and full containment plants. We can supply equipment to meet explosion-proof and pressure shock standards as required.
Extensive safety testing confirms pressure enhancement effects and identifies safe design limits for integrated systems. GEA, in partnership with the FSA, the safety specialist centre in Germany, have completed an extensive test programme with more than 100 test explosions. This research has shown that should an explosion occur during the transfer operation in an integrated system in which a granulator is connected directly to a fluid bed dryer without an explosion isolation valve, the secondary explosion pressures in the granulator can be significantly higher than in the fluid bed. These tests have enabled GEA to gain full EC type approval for a range of pressure shock resistant integrated systems and 16-bar pressure shock resistant high shear granulators.
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