In automatic filling and closing of ready-to-use syringes and cartridges, the trend is towards ever smaller batches. A new filling and closing machine in which a Stäubli Stericlean robot operates in an aseptic environment provides the necessary degree of flexibility.
The aseptic filling and closing of vials, syringes and cartridges in small batches calls for highly flexible automation solutions. One innovation, made possible by a Stäubli Stericlean TX2 series robot, is a small-batch filling and closing machine that meets even the most demanding requirements in terms of safety, efficiency and flexibility.
There is a clear trend towards ever smaller batches, which is why flexibility plays such an important role in production. At the same time, there can be no compromise in terms of quality, efficiency and aseptic processing. Robot-based Advanced Aseptic Processing (AAP) systems offer the perfect solution, as exemplified by the GENiSYS® R aseptic small-batch filling and closing machine from Automated Systems of Tacoma (AST).
GENiSYS R automates the aseptic filling and closing of ready-to-use vials, syringes and cartridges in strict compliance with cGMP guidelines. The machine is designed for use with RABS (Restricted Access Barrier System) and isolator barrier technologies.
An integral part of this highly modular system is a Stäubli Stericlean robot, either TX2-40 or TX2-60 depending on the configuration. The six-axis robot performs critical steps in every phase of the aseptic process, including bag and tub opening, filling, stoppering, sealing/closing and reject handling. If certain tasks along the production line need to be performed manually, the system can easily accommodate this need while ensuring operator safety and product sterility.
The system is optimized for filling small batches, with an emphasis on dosing precision and high throughput. The Stäubli Stericlean six-axis robot used in the system facilitates 100% in-process control (IPC).
The combination of modular design and advanced robotics allows GENiSYS R to fulfill different process requirements without complex customization. With the intuitive ASTView® human-machine interface, operators can easily generate formulas for specific formats and pharmaceutical products, and program the robot and pump settings accordingly.
The system’s modular design also offers flexibility with regard to the desired degree of automation: Bags and containers can be opened manually, semi-automatically or fully automatically, while filling and closing of the vials is fully automated throughout.
The robots are as dynamic as possible and as gentle as necessary in all handling processes. Particulate emissions are reduced to a minimum. The smooth, jerk-free movements of the six-axis robots ensure that the integrity of the process is maintained at all times and that unplanned manual interventions that could compromise the aseptic environment are eliminated.
The use of Stäubli robots in aseptic environments contributes significantly to the GENiSYS R’s high flexibility. They enable precise filling and closing of ready-to-use, pre-sterilized vials, syringes and cartridges. Without the unique Stericlean robots, such rapid changeovers between formulas and formats would simply not be possible when processing small batches.