Adoption of isolator technologies and automation is key for ensured consistency, highest sterility assurance, full GMP compliance of the aseptic fill & finish, as well as lowering its total cost of ownership.
The Cellana L1 Robot Line is an isolated fill & finish line able to process up to 500 vials per hour and can be installed in lower-class cleanroom environment, thanks to the integrated H2O2 decontamination system.
This isolated robotic aseptic fill & finish line is a result of accumulated expertise and co-engineering within the SKAN group.
Features
For cGMP manufacturing
Smooth transition from Crystal® Pure M1
Filling from 0,1 ml to 50 ml
High filling accuracy
Rapid decontamination airlock (< 20 min)
CFR 21 part 11 compliant
Single-use material only
For Grade C installation
Minimum change over
Fast decontaminations cycles
Aseptic connector for bulk
Perfect for
Fully equivalent transition from manual Crystal® Pure M1, Cellana L1 Robot line addresses the needs of scaling-up of the aseptic filling of novel pharmaceutical and biotech products, including cell and gene therapy products, their intermediate products, as viral vectors, plasmid DNA, cell banks.
It is designed for versatile vial filling, providing easy change over batch to batch with single-use product path and between the AT-Closed Vial® formats, and can be connected with other isolated modules of Cellana, completing the manufacturing flow in isolator.
The Cellana L1 Robot Line contains the AT-Closed Vial® process within the modular isolator by SKAN.