Drugs against Autoimmune Diseases: Model Line from Bosch Comprises All Process Steps

From formulation to secondary packaging

• New, small-volume fermenter for product development

• Flexible filling and closing processes combined with isolator and new wireless glove testing system

• Comprehensive portfolio for handling, sterilization, inspection and secondary packaging

Frankfurt/Main, Germany — At Achema, Bosch Packaging Technology presents an exemplary line encompassing all process steps for the production, filling and packaging of medicines against autoimmune diseases administered in syringes. Two further model lines depict the therapeutic areas of oncology and diabetes care. "This way we illustrate how Bosch realizes its line competence for concrete therapeutic areas, as well as for different packaging types. Our broad portfolio includes all process steps, for instance for the manufacturing of liquid drugs against autoimmune diseases – from product formulation and sterile filling on laboratory and production scale to sterilization, inspection and secondary packaging," explains Christian Treitel, head of pharma business development at Bosch Packaging Technology.

Compact solutions for product development

Biopharmaceutical production, for instance of monoclonal antibodies or hormones for the treatment of autoimmune diseases, typically requires bioreactors in different scaling ranges. The new stainless steel laboratory fermenter, developed by the Bosch subsidiary Pharmatec, is especially suited for biopharmaceutical product development and clinical studies, as well as for the first level of industrial production. The fully automated bioreactor with completely equipped periphery was developed for batch sizes up to 50 liters. It completes the existing portfolio of larger volume fermentation devices, which handle volumes of 500, 1,000 and 2,000 through to 20,000 liters, depending on the application. Pharmatec offers complete solutions for harvesting and the subsequent downstream processes, as well as for the formulation of the final injection solution. The Bosch machines are complemented through the integration of modules from specialized manufacturers with installation, testing and start-up as complete systems.

Safe filling on both laboratory and production scale

For the filling of injection solutions on a laboratory scale, a laboratory device from the FHM 1000 series is especially suited. The device includes a Human Machine Interface (HMI), a filling and weighing module each, as well as a needle movement for the filling process. The laboratory machine receives the product from the pre-validated, pre-assembled and pre-sterilized single-use filling system PreVAS. Among its key components are bag, tube and filling needles, as well  as the Bosch peristaltic pump. In the version exhibited at Achema, the product bag is situated outside of the isolator, while the filling tubes are compactly and safely guided through the isolator wall via the newly developed multi-tubing port, before being connected to the filling station of the FHM.

Furthermore, the single-use filling system can be flexibly connected to production scale filling and closing machines. Apart from pre-sterilized syringes, the FXS Combi from Bosch for instance also processes nested vials and cartridges. The upstream ATO and ABO tub and bag openers can be used for fully automated opening. The filling station of the FXS Combi with two to five positions enables fast and precise filling with all common filling technologies. As the first machine of this kind, the FXS Combi further features an integrated capping station for vials and cartridges. The flexible and fast format changes for all three packaging types are shown during live demonstrations at Achema. By combining the machine with different barrier systems such as Restricted Access Barrier Systems (RABS) or isolators, operators and products are optimally protected.

Wireless glove testing system

Glove ports make it possible to handle the products inside these barrier systems. With the new wireless glove testing system from Bosch, up to 35 gloves can be reliably tested for integrity at the same time. The test disc is manually applied to the ports from the outside and communicates with the filling machine via WLAN. The fully integrated testing system is controlled via the HMI of the filling machine, thus enabling the integrity testing to be performed in short test cycles. All data is directly recorded in the machine's system architecture, which eliminates the need for a separate laptop. A pump, which is integrated into the test disc, provides for a fully automatic pressure build-up in the glove. The disc enables users to quickly and reliably measure the pressure decay according to glove-specific testing recipes. An exchangeable battery makes sure that no downtimes occur.

Downstream equipment and secondary packaging

Depending on the product, sterilizers from the Bosch subsidiary SchoellerBleckmann Medizintechnik (SBM) provide for sterile containers according to the steam/air mixture process after the medicines have been filled into syringes.

Following sterilization, the filled syringes are inspected for particles and cosmetic defects, for instance on the AIM 8 inspection machine, and subsequently tested for integrity. Further downstream equipment such as the ZPS accumulation system and the RIL rod insertion and labelling system complete the line by further process steps. Different primary packaging types can then be gently packed into folded cartons on the horizontal cartoning machines from Bosch. Modular serialization solutions enable the integration of printing, verification, labeling and IT systems into new and existing lines.

Based in Waiblingen near Stuttgart, Germany, and employing 5,600 associates, the Bosch Packaging Technology division is one of the leading suppliers of process and packaging technology. At over 30 locations in more than 15 countries worldwide, a highly-qualified workforce develops and produces complete solutions for the pharmaceuticals,  food, and confectionery industries. These solutions are complemented by a comprehensive after-sales service portfolio. A global service and sales network provides customers with local points of contact. Additional information is available online at www.boschpackaging.com

The Bosch Group is a leading global supplier of technology and services. The company employs roughly 360,000 associates worldwide (as per April 1, 2015), and generated sales of 48.9 billion euros in 2014, according to preliminary figures.* Its operations are divided into four business sectors: Mobility Solutions, Industrial Technology, Consumer Goods, and Energy and Building Technology. The Bosch Group comprises Robert Bosch GmbH and its roughly 440 subsidiary and regional companies in some 60 countries. Including its sales and service partners, Bosch is represented in roughly 150 countries. This worldwide development, manufacturing, and sales network is the foundation for further growth. In 2014, Bosch applied for some 4,600 patents worldwide. The Bosch Group's strategic objective is to create solutions for a connected life. Bosch improves quality of life worldwide with products and services that are innovative and spark enthusiasm. In short, Bosch creates technology that is "Invented for life."

Additional information is available online at www.bosch.com, www.bosch-press.com, http://twitter.com/BoschPresse

*The preliminary sales figure disclosed for 2014 does not include the former joint ventures BSH Bosch und Siemens Hausgeräte GmbH (now BSH Hausgeräte GmbH) and ZF Lenksysteme GmbH (now Robert Bosch Automotive Steering GmbH), which have since been taken over completely.

Robert Bosch GmbH

Postfach 10 60 50

D-70049 Stuttgart

E-mail Christin.Poenisch@bosch.com

Phone +49 711 811-58502

Fax +49 711 811-58509

Corporate Communications, Brand Management, and Sustainability

Senior Vice President:

Dr. Christoph Zemelka


April 2015

PI 8882 CP

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