The Gericke Formulation Skid GFS is a fully automated continuous manufacturing method for blending excipients and API upstream compaction, available in two versions: Continuous or Mini-Batch-Blending. It combines high precision loss-in-weight feeders with scientifically designed compact blenders and integrated PAT solutions.
Most pharmaceutical granulates and tablets are produced in batches. This is not only the case when preparing the raw material components, but also when mixing the active ingredients with excipients.
After a long period in which the traditional batch process dominated pharmaceutical manufacturing of solids, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recognised the advantages of continuous manufacturing. This removed the regulatory barriers that had in the past hindered the increased use of continuous dosing and mixing processes in the manufacture of pharmaceuticals.
The company Gericke from Regensdorf has developed a Formulation Skid that enables the integration of up to eight differential dosing scales with a mixer. It can be used in full and semi-continuous mode, even with low dosing of highly active ingredients and different throughput rates.
The modular design is also reflected in the automation solution. In addition to the usual requirements of the pharmaceutical industry, a standardised and consistent software structure is required, as well as a high degree of flexibility in terms of integrated refilling equipment and material handling. Furthermore, the lines have an open automation interface to PAT management and advanced process controllers.
So far, the software has been used in several plants, some of them with very different set-ups. The close cooperation with Gericke and continuous product maintenance are the basis for the great success of this groundbreaking solution.
Bernhard Meir
Head of Continuous Manufacturing (OSD)