CS-540.4
Sepax kits are integral to our Sepax Cell Separation System. They are supplied sterile for single-use and enable a functionally-closed environment to separate cellular product into its components.
The CS-540.4 kit is designed for processing umbilical cord blood (UCB) in order to concentrate the nucleated cell fraction into a double-compartment CryoSC-D cryobag. Sampling and reagents addition can be performed outside sterile conditions.
Components
| # | Name | Description |
| 1 | Separation Chamber | 220 mL spinning chamber enabling the centrifugation and transfer of processed product |
| 2 | Line Pressure Monitor |
0.2 µm filter that connects to the Sepax pressure sensor |
| 3 | Stopcock Manifold |
Three automatically controlled rotational valves to direct fluid flow |
| 4 | Drip Chamber | 200 μm filter to block blood clots and trap air bubbles |
| 5 | Initial Line | Connects the kit to the initial bag via a spike or SCD connection |
| 6 | By-product Bag | 300 mL PVC by-product bag to collect plasma |
| 7 | DMSO Extension Line | A line equipped with leur port connections for adding cryoprotectant solution |
| 8 | Cryobag | CryoSC-D cryobag with 25 mL storage capacity |
| 9 | Sampling Pillow | For sampling the final product |
| 10 | HES Filter | 0.2µm hydrophilic filter for adding an HES solution |
| 11 | DMSO Filter | 0.2µm hydrophilic filter for adding a cryoprotectant solution |
Kit / protocol compatibility matrix
| Kit / protocol | UCB | UCB-HES |
| CS-530.1 | x | x |
| CS-530.4/.4b | x | x |
| CS-540.4/.4b | x | x |
Environmental conditions and compliance
Store kits in a clean and dry environment without chemical or biological contamination within the following conditions:
| Mode | In operation | Storage and transport |
| Temperature | +7 to +27°C | +4 to +40°C |
| Relative humidity | 30 to 75%, non-condensing | 20 to 75%, non-condensing |
Shelf life: Two years from the date of manufacture.
Sterilization: Ethylene oxide.
Material: Standard medical grade PVC, PP, EVA, and other materials.
Biocompatibility: ISO 10993-1
Fluid path: Non-pyrogenic
The CS-540.4 is CE marked and complies with the applicable requirements of the 93/42/EEC Medical Device Directive. Confirm with your local regulatory authority for compliance with other regulations.
Ordering information
CS-540.4: Product #10025
Packaging: Individual blisters sealed with a Tyvek® cover.
Minimum order: Box of six kits (dimensions: 33 x 35 x 26 cm, 13 x 14 x 10 in. ).