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
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
Perfect for
Introducing automation after use of the manual Crystal™ M1 Filling Station, Crystal™ L1 Robot line in RABS supports the scaling-up strategies of novel pharmaceutical and biotech products, including advanced therapy medicinal products (cell and gene therapies).
Relying on the single-use material and the AT-Closed Vial® of various formats, this aseptic filling line provides flexibility in cGMP fill & finish operations, while saving space in the manufacturing site.
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.