Designed for a broad array of 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. We believe that by continually stretching the boundaries of pharmaceutical processing, we can help our customers to enhance the health and well-being of millions of people all over the world.
Always looking to improve the research, development and scale-up process for oral solid dosage forms, we’re currently working on a compaction data acquisition and analysis system (CDAAS). Comprising mechanical components (feeders, hoppers and tooling), electrical elements and a software package, the CDAAS makes it possible to do formulation development work on a production-scale machine using minute amounts of product.
With this new kit, just 50 g of product is enough to proceed with the fundamental characterization of the compression process on a commercial-scale rotary tablet press. Test sequences can be generated with multiple runs to optimize the press parameters. Loaded into the MC5 control system as a single recipe, the machine will modify the variable parameters for each run according to the recipe-defined values and produce a specific number of tablets.
So, with very little product, several tests can be done before producing a clinical batch with a well-defined set of parameters. Plus, as clinical, pilot or commercial-scale batches can be produced on the same machine under equivalent conditions, there are no scale-up issues and often expensive and lengthy equivalence studies can be avoided.
At the heart of GEA’s small-scale, batch-based R&D portfolio approach is PharmaConnect™, which allows a number of diverse process modules from GEA companies to be docked to one control unit. Based on the company’s market-leading PMA™ and Gral™ 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.
Continuous R&D: Direct Compression
Making its ACHEMA debut, the ConsiGma® Continuous Dosing and Blending (CDB1) system has been developed with process understanding and scale-up in mind. Designed to match the unit operations of a ConsiGma®CDC50 continuous direct compression unit, the CDB1 has been created to accelerate formulation optimization and reduce the use of high value APIs. PAT-compatible and offering flow capacities of 0.5–50 kg hour — depending on the blender size and product characteristics — the system also supports DoE work and RTD measurements.
The data derived from the CDB1 can be used to support regulatory submissions so that customers can get products to market faster. A number of other solutions to improve the processing of small- or pilot-scale amounts of developmental products will also be on display. Plus, don't miss our future-thinking conference presentation on “Continuous Processing and Industry 4.0.”
Furthermore, on 12 June at 11:00, we’ll be holding a joint press conference with other key suppliers to the pharmaceutical sector to announce a number of industry collaborations that will help to facilitate the uptake of continuous manufacturing technology in the drug production sector.
We look forward to welcoming you to Stand F46 in Hall 4.0 and showing you how GEA is making science work.