Continuous Manufacturing. Combined approved technologies swiss made. Prospekt Nr. 655

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1 Continuous Manufacturing Combined approved technologies swiss made Prospekt Nr. 655

2 Continuous Mixing and Granulation The two Swiss companies Gerteis and Gericke present the world s first solution for continuous tablet manufacturing. Therefore the Gerteis compacting and granulating technology is combined with feeding and mixing solutions from Gericke. Both systems are fully developed and have been proven in the market. Approved systems for a reliable production The most important challenge for the pharmaceutical industry is to take the QbD concept and look at its manufacturing processes in lean terms to start to adapt for a more efficient future. Gerteis dry granulation and Gericke continuous mixing process technologies are ideally suited to the new era of efficient solid dose pharmaceutical manufacturing. Combining the continuous Gericke feeding and continuous mixing and Gerteis advanced dry granulation will enable consistent, controlled and stable granulated products to be manufactured. Using the latest PAT techniques constant density can be achieved, leading to consistent granule properties ideal for tableting and capsule filling technologies.

3 Continuous Feeding and Mixing Technology by Gericke Process Control Continuous metering and control of flow rates of API and Exciptients Continuous metering of mixer content and mean mixing time Chemical composition e.g. by on line NIR spectroscopy Gericke continuous mixing systems have a capacity from 5kg/h to 500 kg/h and are used in the pharma industry for: Precise and compact continuous feeding and mixing of API and excipients Minimising risk of segregation Addition of lubricants Wetting of mixtures upstream wet granulation or fluid bed granulation Mixing upstream roller compaction Easy to Clean Gericke feeders and mixers are designed for quick and easy cleaning. All parts with product contact can be removed in short time for cleaning.

4 Continuous Roller Compaction & Dry Granulation by Gerteis Gerteis dry granulation technology is already a continuous technology extensively proven. With the low energy compaction capability it minimises high energy losses likely to generate control and process variability for example caused by temperature variation. Product capacity Mini-Pactor for development, pilot plant, clinical and small scale production: 10 Grams up to 100 kg/h Macro-Pactor for development, pilot plant, clinical and full scale production: 100 Grams up to 400 kg/h Best suited for continuous manufacturing Gerteis advanced roller compaction technology has a number of control parameters that are process critical and that are tightly controlled, defined and stable. By calibrating this control functionality, a long-term stable, consistent and a repeatable process can be achieved. There is also a significant benefit to this tight repeatable control in terms of scale up and rapid process stabilisation essential aspects of continuous manufacturing. This also provides a much greater design space for process developers allowing much improved capability with input raw material variability also providing a wider compression window improving tableting speed, and tablet solubility for example by compressing at lower compression forces.

5 Area of application The versatility of the machines from Gerteis and Gericke allows to process virtually all kinds of powder, even the most difficult ones. And with our ingenious machine design, the cleaning cycles are fast and thorough, enabling you to switch between batches swiftly. A wide range of applications are suitable for this advanced and efficient technology combination. The overall efficiency gains in process and true cost of ownership compared to other technologies offer an interesting opportunity to reduce the cost per tablet, improve tablet quality and substantially improve the pharmaceutical manufacturing efficiency. Pharmaceutics Antibiotics Lactose Natrium bicarbonate Ibuprofen Paracetamol Chemicals Speciality Chemicals Plastics Colouring Detergent powder Foods Vitamins Aromas / Flavours Minerals Animal feeding Spice extract Instant blends

6 Gericke Feeding and Mixing Technologies When space is at a premium, Gericke continuous mixing systems offer the ideal solution. Gericke also provide full recipe management programmes incorporating feeding and flow control for maximum mixing consistency. When the process involves multiple components and frequent product changes, Gericke batch mixing stations are used. About Gericke Gericke supplies conveying, sifting, high-precision feeding and mixing solutions that handle a broad range of ingredients such as pellets, powders, floodable powders and fibreglass for food, chemical, industrial, and pharmaceutical industries. Gericke was founded in 1894 and is managed by Markus Gericke in the 4th generation. Gericke AG Althardstrasse Regensdorf (Switzerland) info@gericke.net T F Gerteis your Dry Granulation Experts Gerteis is a Swiss manufacturer of advanced high quality roller compactor dry granulators who have set the standard with their unique dry granulation technology. Their understanding of the dry granulation process combined with patented roller compaction systems make Gerteis the unrivalled technology leader in the field of dry granulation. About Gerteis With more than 25 years in business, Gerteis Maschinen + Processengineering AG is dedicated to providing world leading technology for dry powder granulation for the pharmaceutical and healthcare industries. The company is privately owned and managed by Paul Gerteis. Gerteis Maschinen + Processengineering AG Stampfstrasse 74 Postfach Jona SG (Switzerland) sales@gerteis.com T F