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A Continuous process is a process where raw materials are continuously fed into a system at the same time as finished product is continuously removed at the end of the process train. The raw materials are processed in very small quantities, compared to batch processes, and in a controlled manner, which allows the operator to have consistent control over the critical process parameters and therefore the critical product quality attributes.
At GEA, we believe that continuous processing improves the quality of pharmaceutical end products: by focusing on quality during the whole product lifecycle, not just “tested in” quality; and by understanding the capability of your processes, managing sources of variability and decreasing any associated risks.
Our solution for continuous drying and particle processing plants is ConsiGma™, a 6 sigma-inspired manufacturing platform, incorporating different technologies to produce oral solid dosage forms in a continuous, cost-efficient way:
- by collecting more information during R&D phase, in a short time with less product
- by excluding risky, time- and product consuming scale-up exercises
- by introducing online measurement and closed loop control targeting real-time release (6 sigma production)
- by incorporating flexible batch size (JIT production), reducing inventory
- by reducing the energy cost per tablet, reducing environmental impact.
ConsiGma™ Continuous Tablet Coater
After compression, many tablet formulations need a coating to achieve the final product characteristics desired. To complete the ConsiGma™ tableting lines, GEA has developed a coater in line with its continuous manufacturing concept.
ConsiGma™ Continuous Tableting Line
ConsiGma™ offers Continuous oral solid dosage Granulation – Drying & Tablet Compression, all in 1 production line – our blue sky approach from powder to tablet.
Continuous Processing for Pharma R&D
In early research and formulation development, the availability of the active ingredient is often very limited and there is a need for process equipment that is capable of producing only a couple of hundred grams to develop new drug formulas. In response to this need, GEA developed ConsiGma™ 1, the lab-scale version of the ConsiGma™ concept.