Product #10036

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-540.4b kit is designed for processing umbilical cord blood (UCB) in order to concentrate the nucleated cell fraction into a double-compartment CryoSC-Db cryobag.

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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
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-Db 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-540.4b 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-540.4b: Product #10036

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. ).