A flexible processing system for an economic production of injection solutions, the SVP250 LF, offers seamless transport of the product from the processing machine to the ALF filling machine and can be tracked using a LED visualization.
The SVP250 LF processing system is designed for injection solutions (Small Volume Parenterals, SVPs) with small batches ranging from 15 to 250 liters. The system includes both a preparation and a storage vessel. Depending on the desired volume, these process vessels can be expanded to four each, in a range of different sizes. The preconfigured architecture allows processing modules to be easily and flexibly installed or exchanged, for instance for different temperature-control concepts or the feeding of different media like powders, liquids or gases. Liquid ingredients are automatically dosed by a pump. Since the process vessels are equipped with a gassing module for nitrogen, production can also take place under low-oxygen conditions.
The system features a module for two-stage sterile filtration for aseptic preparation, which is situated between the preparation vessel and storage vessel. It is also equipped with an optional laminar flow hood, which generates a low-turbulence air flow to prevent particles from entering the compounding area. An integrated cleanroom wall completely separates the process vessels from the system’s technical area. Thus, the cleanroom area is compact and easily accessible. Between production batches, an integrated CIP module cleans and sterilizes the system. For applications involving highly potent APIs, a containment flap is used, which also allows aseptic processing.
In addition, data on the machine status or process parameters from both systems can be recorded, stored and visualized, which leads to improved transparency in production and shorter response times. The primary goals are optimal production planning and maximum capacity utilization.
In addition to its suitability for Industry 4.0 applications, the ALF 5000 filling and closing machine delivers a high degree of process reliability and flexibility. In the combi configuration, the machine not only processes ampoules but also injection bottles. It can be equipped with all standard filling systems and four, six, eight, ten or twelve filling heads. A carrying walking beam system can be used for especially gentle handling. Without sacrificing product quality, the ALF 5000 delivers output rates of up to 600 containers per minute.
Per Bosch’s pharmaceuticals line competence, the system can easily be combined with upstream or downstream machines. Customers who order both their preparation and filling machines from Bosch receive a coherent overall concept and several further advantages: during project implementation, Bosch attends to the complete coordination of interfaces between systems, which fosters efficient planning and smooth processes. During the design phase, Bosch can already offer solutions to concerns like cross-contamination and sterile connections, together with uniform documentation and system qualification.
