AT-Closed Vial® and Container Closure Integrity during Cryogenic Storage
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L1 Robot Line in RABS
Description
Crystal™ L1 Robot platform enables the scaling-up strategies of biopharmaceutical companies globally. Combined with active Restricted-Access Barrier System (RABS), providing the enclosed controlled environment for aseptic filling process, this robotic filler is typically installed in Grade B.
Crystal™ Robot Line in RABS has a minimal footprint and is able to process up to 500 AT-Closed Vial® per hour.
Features
- For cGMP manufacturing
- Filling from 0,1 ml to 50 ml
- Active laminar airflow
- Reduced footprint
- Up to 500 vials/hour
- High filling accuracy
- Single-use material only
- Aseptic connector for bulk
- Minimum change over
- Installed and qualified in 1 week
- CFR 21 part 11 compliant
Functioning principle
The bulk product container, remaining outside of the filling line, is connected to the operating area with the AT-Port™ System, the aseptic liquid connector. Through mousehole on the left side of the equipment, the nested ready-to-fill AT-Closed Vial®, and other single-use material, are introduced to the critical area, where prepared for operation.
Commanded from the Human Machine Interface (HMI), the aseptic filling line is calibrated to achieve high dosing accuracy.
The high-class cleanroom 6-axis robotic arm then begins the AT-Closed Vial® filling process, consisting of 3 steps: each AT-Closed Vial® is first filled through the stopper with a special non-coring needle, then laser re-sealed and capped by snap-fit. Each operation is performed with a dedicated tool on the robot head.
Once the AT-Nest™ is fully processed, the operator extracts it from the critical area via the exit mousehole.
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