Source: Marchesini Group
GENiSYS® C is a fully featured fill and close platform with a small, cart-based operational footprint designed for the full scope of drug development, from discovery to commercial distribution. A highly flexible aseptic filling and closing machine used for processing vials, syringes and cartridges on a single compact machine, the system is integrated with advanced features to ensure each container is handled with care and consistently produces high quality products. The system is ideal for small-batch aseptic filling applications. With an intuitive user interface, and the ability to process nested ready-to-use or custom vials, syringes and cartridges, the system can be configured to user-specific process requirements. The GENiSYS C is ideal for use in labs and cleanrooms with minimal available space. The system can be fully integrated with a range of barrier systems, including laminar airflow (LAF) hoods, restricted-access barrier bystems (RABS) and aseptic isolators. Other features include: in process control (IPC) for real-time weight feedback and product yield maximization; environmental monitoring for viable, non-viable and particle monitoring; and electronic batch records (EBR) to record critical process information that can be used to create 21 CFR Part 11 compliant batch reports. Pump integration options include peristaltic, rotary piston and time pressure filling. Additionally, barrier system integration is to protect your product and operators during the filling process. — AST Inc./Marchesini Group S.p.A., Bologna – Italy