Continuous Granulation: ConsiGma™
GEA has taken the lead in providing the pharmaceutical industry with new technologies based on the most innovative way of granulating, drying and making tablets using potent APIs. The company has pioneered continuous manufacturing in drug production and was the first supplier to provide and install a complete powder-to-tablet line for customer use.
The pharmaceutical industry is looking at continuous processing to improve production quality in an efficient and cost-effective way and to comply with the increasingly stringent manufacturing acceptance criteria put in place by the regulatory authorities.
The ConsiGma™ continuous high shear granulation and drying system is a multipurpose platform that has been designed to transfer powder into coated tablets in development, pilot, clinical and production volumes in a single compact unit. The system can perform dosing and mixing of raw materials, wet or dry granulation, drying, tableting and quality control, all in one line. By producing granules continuously, batch sizes are determined by how long you run the machine; and, because of ConsiGma™’s innovative design, the amount of waste produced during start-up and shut down is significantly reduced compared with conventional methods. Quality is measured throughout the process and, as such, drastically reduces the cost per tablet.
Typical applications for ConsiGma™ include producing small batches of high added value products, the production/launch of new molecules, reformulations and current non-robust processes, formulations with specific granulation and/or drying issues, site changes or increases in production and more economic and greener production methods. ConsiGma™ offers
- maximal end-product safety using online quality control
- 10 times faster testing in R&D
- 40% saving on labour
- a 60% reduction in manufacturing space compared with industry standards
- 50% energy savings based on reduced installed power and heat recovery
- 0.5–5% yield improvement.
Flexible, Compliant and Energy Efficient
ConsiGma™ was developed in compliance with the FDA’s QbD initiative. It satisfies the industry’s need for reduced risk and higher quality while avoiding lengthy and costly validation and scale-up to bring products to market faster and cheaper. The inherent flexibility enables manufacturers to meet demand, keep expensive cleanroom space to a minimum and reduce inventory costs.
Optionally integrated advanced process control and PAT tools enable monitoring during production, so quality can be designed into products from the start. ConsiGma™ provides maximum output in an energy efficient way, has been tested using more than 100 different formulations and is already being used by several large pharmaceutical companies, and ethical and generic research and manufacturing centres worldwide.