Aseptic filling line for biopharmaceuticals
In biopharmaceutical manufacturing, scaling up production while maintaining sterility is crucial. Traditional manual filling methods often fall short in meeting regulatory standards and efficiency requirements, particularly for advanced therapy medicinal products like cell and gene therapies.
Automate aseptic filling with controlled environment
The Crystal® L1 is an advanced aseptic filling line designed by Aseptic Technologies. It integrates a robotic platform with an active Restricted-Access Barrier System (RABS), providing a controlled and sterile environment. This system is ideal for scaling up the production of pharmaceuticals, including biotechnological and medicinal products. The Crystal® L1 is compact and capable of processing up to 500 AT-Closed Vials® per hour, with filling volumes ranging from 0.1 ml to 50 ml. It employs high dosing accuracy and is equipped with single-use materials, minimizing cross-contamination and changeover times. Installed and qualified in one week, it complies with CFR 21 part 11 regulations, making it suitable for cGMP manufacturing and ensuring high-quality production standards.
Benefits
- Scales up production efficiently
- Maintains sterility with RABS
- Processes up to 500 vials per hour
- High dosing accuracy
- Quick installation and qualification