AT-Closed Vial® and Container Closure Integrity during Cryogenic Storage
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Cellana XL1
Description
As a result of accumulated expertise and co-engineering within SKAN group, the Cellana XL1 addresses the needs of scaling-up 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.
The adoption of isolator technology and automation for your aseptic fill & finish process is the key for ensuring consistency, high level of sterility assurance, full GMP compliance which can lead to lower cost of ownership over time.
The Cellana XL1 is designed for versatile vial filling utilizing single-use materials to minimize change over from batch to batch. It is also compatible with other isolated modules of the Cellana to complete your manufacturing flow all in an isolator.
- For cGMP manufacturing
- Smooth transition from Crystal® Pure M1
- Filling from 0,1 ml to 50 ml
- Up to 700 vials/hour
- High filling accuracy
- 100% weight IPC
- Rapid decontamination airlock (< 20 min)
- CFR 21 part 11 compliant
- Single-use material only
- For Grade C installation
- Minimal change over
- Aseptic connector for bulk
Functioning principle
The ready-to-fill AT-Closed Vial®, organized in nests, and other consumable materials are introduced into the main chamber via a rapid decontamination airlock, while the bulk product is aseptically connected to the main chamber of the isolator. Such configuration allows the bulk product to be homogenized and cooled.
The robot picks up an individual vial and loads it onto the processing wheel where it will be weighed (empty), filled, laser re-sealed, weighed (filled) and capped. The processed vials are then placed back into the AT-Nest™.