Consigma, the new continuous high shear granulation and drying system from Collette, part of GEA Pharma Systems, is said to be fully capable of particle design as well as reproducing or exceeding the results of traditional batch granulation processes.
Its continuous production set-up and its risk-based approach to GMP claim to result in granules with a generally better intra-granular porosity and improved compressibility characteristics. Optional inline measurement of Critical Quality Attributes fed back to the control system will allow for continuous "real time" quality assurance according to GAMP5.
One Consigma system can run 500g for r&d purposes, but can also run clinical trial, launch size, and any production size batches. A continuous process not only obviates the need for scale-up, but can also reduce significantly development time and cost.
The lightweight, compact modular machine can be easily moved around a plant, making it suitable for use in the r&d lab or an existing tablet production suite.