Aseptic vial filling system for gene therapy products
Scaling up manufacturing for cell and gene therapies often requires precise aseptic filling solutions. Common challenges include maintaining sterility, ensuring accurate fill volumes, and minimizing contamination risks, which are critical to adhering to GMP compliance.
Ensure high sterility and precise filling
The Cellana XL1 by Aseptic Technologies is a specialized aseptic filling system designed to handle the precise and sterile filling of gene therapy products, including viral vectors and plasmid DNA. This system utilizes isolator technology to provide high sterility assurance and GMP compliance. Single-use materials minimize the need for batch-to-batch changeover, ensuring efficient and flexible operations. Capable of filling volumes from 0.1 ml to 50 ml at rates up to 700 vials per hour, the Cellana XL1 offers high filling accuracy with 100% in-process weight control (IPC). Additionally, it features a rapid decontamination airlock that completes in under 20 minutes, and it is designed for grade C installation environments. Full compatibility with other isolated modules of the Cellana series further enhances its utility in comprehensive manufacturing workflows.
Benefits
- High sterility assurance with isolator technology
- Versatile vial filling from 0.1 ml to 50 ml
- Up to 700 vials per hour
- Rapid decontamination airlock (< 20 min)
- Compatible with other Cellana modules for integrated workflows