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news.GEA Pharma Systems has introduced ConsiGma continuous tableting system to satisfy the pharmaceutical industry’s demand for continuous production and improve quality, flexibility and consistency of pharmaceutical processes.
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The system is compact (1/3 of a classic granulation line inclusive of a Tablet Press) and has a modular construction allowing it to fit perfectly into any R&D department or existing tablet production room.
GEA Pharma said that ConsiGma is capable of doing 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 have generally a better intra-granular porosity with better compressibility characteristics that help tablet presses run more efficiently at maximum speed with hardly any weight adjustments being 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 1.5 kg, drying each of them in a separate segment of the dryer thereby guaranteeing plug-flow. When each 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 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 easlily be removed from the press in a contained way. This means that the press itself remains powder-free and requires no cleaning.
The 6 compression modes available in the Modul P make it the perfect press for this continuous tableting line, allowing easy R&D 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, because it enables the press to change its speed when necessary.
With advanced in-line PAT incorporated in the system GEA Pharma Systems can provide a FULL continuous production line. One advanced process control system steers the whole line, including feedback and feedforward loops based on actual process values derived from o.a. GEA’s patented LighthouseProbe avoiding window fouling with an ingenious inline cleaning and recalibration system.