3P innovation is taking further steps within the cell and gene industry by designing an automated batch cryovial filling platform.
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.
Benefits
• Specially designed to maximise cell yield though use of minimised hold-up volume, intelligent closed loop filling with 100% weight verification and a zero-loss priming sequence.
• Avoids cell damage by automatically filling your batch well within the operating time window for your cryo preservant with a low shear pump system
• Automatic placement into racks to suit your existing controlled rate freezers (CRF) for quick transfer
• Avoid re-validating your process by using your existing preferred vial manufacturer
• Accurate and repeatable filling through use of a co-located high precision peristaltic pumping technology
• Ensure security of your samples with precision control of cap tightening torque
• Protect your product from contamination with the highest standards of hygienic design, including adoption of ‘first air’ principles and minimised vial open time
• Compact footprint to minimise space taken up in your cleanroom.
• cGMP 21CFR11 compliant software
• Available in clean room, BSC or full Isolator configurations
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.