Incorporating their existing fill-finish technology, the aseptic and cGMP compliant platform provides reliable and repeatable liquid filling. The technology is ideally sized to be used in existing isolators, RABS, and bio-safety cabinets and provides 100% fill weight verification together with full 21CFR Part11 compliance via the in-built recipe manager accessed via the HMI.
Key features
- Up to 600 vials per hour output
- Provides de-capping and recapping of vials
- Compact design fits easily into most existing isolators and bio-safety cabinets
- Includes 100% in process weight verification
- Aseptic design and cGMP compliant
- Compatible with most anti-rotate featured cryovials
- Separate HMI can be positioned outside an isolator for easier access
Vials are pre-loaded onto a tray prior to placing on the filling platform. During operation, cryovials are transferred from the tray to the filling module where each vial is de-capped, filled, and subsequently recapped before being transfered back to the tray in its original position. Batch data and processes can be controlled and monitored by the HMI control panel.
The system is designed to handle most standard cryovials. The batch process work off a removable tray to enable safe and easy transport of the cryovials around the clean room. The batch size and cycle time is ideal for cryogenically stored cells allowing plenty of time from setup to filling to storage.