Consigma Turns Powder Into Tablets In 20 Minutes

GEA Pharma Systems has introduced the Consigma Continuous Tableting system. The system satisfies the pharmaceutical industry's demand for continuous production to provide improved quality, flexibility and consistency for pharmaceutical processes. GEA Pharma Systems presented Consigma at the FDA's first Continuous Manufacturing Symposium, held 11 March 2010 in Bethesda, Maryland, US. One Consigma can run 500g in research and development, but can also run clinical trial, launch size, and any production-size batches.

There is no process scale-up, as time is the only relevant factor in a continuous process. This allows manufacturers to dramatically reduce development time to reduce costs and bring products to market much faster. The system is compact (one third the size of a classic granulation line - inclusive of a tablet press) and has a modular construction, allowing it to fit perfectly into any research and development department or existing tablet production room.

There is no need to change the building - just wheel the system in, connect the power and air supply, and after a simple start-up period it is ready to go. Installation time and cost are reduced to a fraction of the current benchmark. It is also possible to avoid high peak-energy periods and run at continuous low energy consumption, helping companies meet their environmental obligations. Consigma is capable of particle design and mimicking any traditional batch granulation process - with a much higher and consistent quality, resulting from its continuous production set-up and risk-based approach to GMP.

The granules generally have a better intra-granular porosity with better compressibility characteristics that help tablet presses run more efficiently at maximum speed, with hardly any weight adjustments required. The full tablet production line consists of the Consigma high shear granulator and dryer, combined with the GEA Courtoy Modul P rotary tablet press. A special in-line blender mixes in the external phase between the systems.

The granulator and dryer section of the Consigma line has three modules: a wet high-shear granulation module, a segmented dryer module and an evaluation module. In the granulation module, dry ingredients are dosed, individually or premixed, in the continuous high-shear granulator. After a dry-mixing section, the granulation liquid is added, so each particle receives the same amount of liquid. The dryer module, based on fluid-bed drying principles, splits the continuous flow of granules in packages of 1.5kg, drying each of them in a separate segment of the dryer, thereby guaranteeing plug-flow. When a segment is dry, it is emptied and transferred to the evaluation module and refilled with a new package of wet granules.

The drying curve of each package is monitored, as a fingerprint of the process, and controlled to maintain a constant end humidity over the whole batch. In the evaluation module, the dried granules can be measured for critical quality attributes such as particle-size distribution, humidity and content uniformity, using specially designed PAT tools. The GEA Courtoy Modul P rotary tablet press is based on the Exchangeable Compression Module (ECM) concept. The ECM is completely isolated from the remainder of the machine, contains all product contact parts and can easily be removed from the press in a contained way. This means that the press remains powder-free and requires no cleaning. The six compression modes available in the Modul P make it the perfect press for this continuous tableting line, allowing easy research and development and perfect production, with dual control for independent weight and hardness control and equal porosity tableting.

The constant dwell time, regardless of throughput, fits perfectly in a continuous line, as it enables the press to change its speed when necessary (for example when a sample is taken in between drying and tableting). With advanced in-line PAT incorporated in the system, GEA Pharma Systems can now provide a full continuous production line. The Consigma Continuous Tableting Line will be on display at: Interphex 2010 - 20-22 April, New York; and Technopharm 2010 - 27-29 April, Nuremberg, Germany.


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