Product #10045

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.

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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