Tubing Sets – perfect connections from bag to bag
CellGenix offers multiple tubing adapter sets which can be used with VueLife® Cell Culture Bags and KryoSure® Cryopreservation Bags. They are also compatible with other systems and can be connected to sterile docking devices.
The tubing sets are made from the highest quality USP Class VI material. Sterile transfers can be performed in a laminar flow hood by attaching the tubing to the luer fitting of the VueLife® Cell Culture Bags or KryoSure® Cryopreservation Bags. Another option is to use a sterile docking device, which eliminates the need to make connections in the laminar flow hood.
We offer the following to assist you with your regulatory approval process:
- Comprehensive documentation (e.g. Technical and Regulatory Information Overview (RIO)
- cGMP declaration and cGMP and compliance to 21CFR8201 on Certificates of Conformance
- Separate Certificate of Sterilization for each lot
- Change notifications prior to relevant changes
Customized solutions can be provided to meet special compliance needs.
Please contact our Regulatory Support Team for all your regulatory requests & questions:
121CFR820: Quality System Regulations for Medical Devices of the Code of Federal Regulations of the United States