PharmaConnect® R&D Processing

PharmaConnect® Technologies

Based on GEA's market-leading granulation technologies and designed for laboratory through to pilot plant scale, the PharmaConnect^® can process batches from 200 g to 25 kg or more, all from a single control unit.

The PharmaConnect^® is not just limited to granulation; its unique design allows any number of process technologies to be operated from the single operator interface, including

• PMA - bottom-driven high shear granulation
• Gral - top-driven high shear granulation
• NICA - extrusion and spheronization
• BUCK^® – IBC blending systems and containment
• TRV – high shear inhalation blending.

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 true PAT-compatible, cGMP-compliant, plug-and-play solution for the busy formulation scientist.

PMA Working Volumes and Batch Sizes

TRV High Shear Blending

For more than 40 years, Turbo Rapid machines have delivered high intensity blending solutions for dry powders. The unique, high speed TRV impeller blades provide the homogeneity and stability that are key factors in the production of inhalable drugs. 

Available with working capacities from 150 g up to 30 kg, the TRV is available as a standalone or PharmaConnect^® options.

Key Features & Benefits

• the PharmaConnect^® offers interchangeable bowls that are geometrically scaled to assist with the scale-up of the process; to swap between the process bowls takes less than 2 minutes
• the TRV system is dedicated to the production of DPI products 
• the impeller surface area is much greater than a conventional high shear granulator, increasing the energy input to the mixing process; the impeller also runs up to a tip speed of 20m/s — twice as fast as a conventional high shear granulator (HSG)
• the increased energy input leads to a very homogenous product, with Relative Standard Deviations of typically less than 2% and often less than 1% (compared with around 4% for a conventional HSG and 8% for a low shear blender)
• the increased energy input encourages the active ingredient to adhere to the lactose carrier; this adherence ensures that the formulated product maintains its composition during storage and throughout the filling operation; if the active ingredient does not adhere to the lactose, then there is a risk of segregation during storage and filling, leading to blisters that are out of specification
• the inhaler device is designed to provide sufficient shear to detach the active ingredient from the lactose carrier, so the micronized active ingredient travel down into the deep lung, whereas the lactose remains in the upper areas
• the energy imparted by the blades helps to break the cohesion of the lactose to ensure that it is free-flowing and therefore allow the active ingredient to mix thoroughly.

Granulation Module

^{A range of standard bowl sizes are available to handle batch quantities of
1-3 L for development scale (the optimal choice for recipe and process development using very small quantities of active material); 5, 10 and 15 L (an intermediate scale for continued product development; and 30 and 60 L for pilot-scale production. However, the modular format of PharmaConnect® allows special modules to be used for customer-specific needs, such as non-standard capacities, different shapes or even different materials such as glass.}

PMA 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.

Gral Top Driven High Shear Granulation

The state-of-the-art Gral top driven granulation system is renowned worldwide for its high quality, robust design and scalability. The Gral module for PharmaConnect® has a bowl size of 60 L. Furthermore, integration with the PharmaConnect^® control unit provides complete process flexibility.