TRV high-shear inhalation blending

The TRV is a high-shear inhalation blending unit that features a single, bottom-driven impeller drive. It is 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 200g to be processed.

There are a range of bowl capacities up to 60L , 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.

Key Features & Benefits:

• The PharmaConnect^® offers interchangeable bowls that are geometrically scaled to assist with the scale-up of the process. It takes less than 2 minutes to swap the bowls between the process.
• 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 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.