Aseptic small / medium batch filling and closing system
In clinical and commercial pharmaceutical manufacturing, maintaining stringent cGMP requirements for cleanliness and sterility is crucial, particularly when processing medium-sized batches of injectable drug products. This necessitates a highly adaptable and reliable fill-finish system that ensures product integrity.
Automate aseptic filling and closing processes
The ASEPTiCell® by AST is an advanced aseptic fill-finish system designed to handle small and medium-sized batches. Featuring reliable robotics, the system facilitates a full changeover in as little as 30 minutes, boosting production efficiency. It can process ready-to-use vials, syringes, and cartridges with various filling accuracies up to ±0.5% using peristaltic and rotary piston dispensing options. The ASEPTiCell® integrates key features such as environmental monitoring, in-process fill weight control, and electronic batch record reporting. Additionally, it supports multiple aseptic barrier options, such as Restricted Access Barrier System (RABS) or isolators with in-situ bio-decontamination using hydrogen peroxide, to ensure maximum sterility. This system is compact yet versatile, fitting various modular configurations to meet specific application requirements without the cost of extensive customization.
Benefits
- Flexible modular design tailored to specific application requirements
- Fast changeover between batches, minimizing production downtime
- Multiple aseptic barrier options for enhanced sterility
- Integrated robotic system for consistent, hands-free operation
- Compact footprint suitable for cleanroom setups