CS-570.1m
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-570.1m kit is designed for routine processing of umbilical cord blood (UCB) in order to concentrate the nucleated cell fraction into single-compartment CryoSC-S cryobags. The components (separation chamber and kit harness) are packed separately and must be connected together by the operator under sterile conditions prior to use.
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 | One automatically controlled rotational valve 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 | Cryobag | CryoSC-S cryobag with 10 to 30 mL storage capacity |
| 7, 8 | Final line | Final line with luer and sampling ports |
The kit remains sterile for 48h in non-controlled environment before processing, under the condition that the connection of the chamber harness is done under laminar flow, and protective caps on input line (spike) and DMSO port (luer) are not removed and are properly closed.
Accessory for component assembly
The Kit connector is used to connect the separation chamber to the kit harness and verifying correct assembly.
The Modular press is used to connect the kit together quicker and easier.
Kit / protocol compatibility matrix
| Kit / protocol | UCB | UCB-HES | FamCord |
| CS-570.4 | x | x | x |
| CS-570.4mb | x | x | x |
| CS-570.1m | x | x | x |
| CS-570.3m | x | 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-570.1m 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.
Packaging
Separation chamber: Five chambers in a Tyvek® sealed blister.
Kit harness: Individually packed in a pouch.
Dimensions of one box with 20 kits: 570 x 370 x 250 mm (22 x 14 x 10 in.), 6 kg (13.23 lb).
Ordering information
CS-570.1m: Product #10045
Minimum order: One pallet containing 28 boxes for a total of 560 kits.
Kit connector: Product #7033
Modular press: Product #7040