Aseptic small batch filling and closing system
Ensuring the sterility of drug products during small batch production is crucial, especially when dealing with clinical environments or commercial small-batch manufacturing. The challenges include maintaining an aseptic environment, precise dosing, and reliable filling and closing of containers.
Automates filling, closing, and real-time monitoring
The GENiSYS® R, from AST, is an automated aseptic filling and closing system designed to handle small-batch processing of pre-sterilized vials, syringes, and cartridges. It employs advanced robotics to ensure smooth operation and minimal risk of contamination. The system offers versatile filling options, such as peristaltic and rotary piston pumps, and supports various closing methods including vacuum and vent tube options for syringes and crimp or press-fit capping for vials. Integrated with aseptic barrier technologies like RABS or isolators, it maximizes sterility assurance during production. With in-process weight control and real-time monitoring through ASTView, the GENiSYS® R minimizes product waste and maximizes yield. The system’s modular design allows for customization without additional costs, meeting specific application needs.
Benefits
- Ensures precise dosing with up to ±0.5% accuracy
- Reduces contamination risks using robotic technology
- Flexibly processes vials, syringes, and cartridges
- Real-time batch recording and monitoring
- Minimizes waste, maximizing product yield