At Achema, Bosch will run a full line showing all the steps for the production, filling and packaging of medicines for autoimmune diseases administered in syringes.
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 to biopharmaceutical product development and clinical studies, as well as for the first level of industrial production. The fully automated bioreactor with 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.
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.
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.
Depending on the product, sterilizers from the Bosch subsidiary Schoeller-Bleckmann 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.
Bosch’s technologies are on display at Achema in Frankfurt/Main, Germany, from June 15 to 19, hall 3.1, stand C71.