PharmaConnect™ R&D Processing

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.

• 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.

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.

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™.

The NICA™ IPS5 operates exclusively as a process module on the GEA PharmaConnect™ platform, combining the NICA™ E100 basket extruder with the NICA™ S250 spheronizer.