Download PDFProduct #10008

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-900.2 kit is designed for isolating multiple cellular products’ components (bone marrow, peripheral blood stem cells, cord blood). A dedicated line allows for small final volume recovery.

Components

#	Name	Description
1	A-200/F 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	Initial Line	Connects the kit to the initial bag; includes a drip chamber (without filter)
5, 6	Washing / Resuspension Solution Line	Connects the kit to the washing / resuspension solution
7	By-product Bag	1000 mL PVC by-product bag to collect waste
8	DGM Filter	If applicable, a 0,2µm hydrophilic filter for injecting density gradient medium
9	Final Bag	500 mL bag for intermediate and final product
10	Final Line	Connects the syringe for final product in case of small final volume. Equipped with luer port and clamp.

Accessory for small final volume option

The separation chamber holder is used for the final steps when the small final volume option applies.

Kit / protocol compatibility matrix

Kit / protocol	CordWash	SmartWash	CultureWash	NeatCell	Dilution	Adipose
CS-600.1	x	x	x	–	x	–
CS-900.2	–	–	x	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, and other materials.

Biocompatibility: ISO 10993-1

Fluid path: Non-pyrogenic

The CS-900.2 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-900.2: Product #10008

Separation chamber holder: Product #6033

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. ).

 Download PDFProduct #10006

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-600.1 kit is designed for processing multiple cellular products (peripheral blood stem cells, cord blood, bone marrow) in order to wash cellular debris, free hemoglobin, and cryoprotectant.

Components

#	Name	Description
1	A-200/B 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	Initial Line	Connects the initial bag extension line via a luer port
5	Washing Solution Line	Connects the kit to the washing solution
6	By-product Bag	1000 mL PVC by-product bag to collect waste
7	Final Line	Connects the kit to the final bags
8	Double Spike Extension Line	Extension line for connecting the initial bag via a double connection
9	Single Spike Extension Line	Extension line for connecting the initial bag via a single connection

Kit / protocol compatibility matrix

Kit / protocol	CordWash	SmartWash	CultureWash	NeatCell	Dilution	Adipose
CS-600.1	x	x	x	–	x	–
CS-900.2	–	–	x	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, and other materials.

Biocompatibility: ISO 10993-1

Fluid path: Non-pyrogenic

The CS-600.1 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-600.1: Product #10006

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. ).

 Download PDFProduct #10039

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-570.4mb kit is designed for routine processing of umbilical cord blood (UCB) in order to concentrate the nucleated cell fraction into a double-compartment CryoSC-Db cryobag. 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-Db cryobag with 25 mL storage capacity
7, 8	Final output line	Connects the kit to the final bag

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 well 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-570.4mb 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-570.4mb: Product #10039

Minimum order: One pallet containing 28 boxes for a total of 560 kits.

Kit connector: Product #7033

Modular press: Product #7040

 Download PDFProduct #10030

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-570.4 is a simplified kit designed for processing umbilical cord blood (UCB) in order to concentrate the nucleated cell fraction into a double-compartment CryoSC-D cryobag.

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-D cryobag with 25 mL storage capacity
7	Female Luer Ports	Allows connection of DMSO extension line
8	Sampling Port	A silicon port for final product sampling

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-570.4 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-570.4: Product #10030

Packaging: Individual blisters sealed with a Tyvek® cover.

Minimum order: Box of 12 kits (dimensions: 57 x 37 x 25 cm, 22.4 x 14.5 x 9.8”).

 Download PDFProduct #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.

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

 Download PDFProduct #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.

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. ).

 Download PDFProduct #10025

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. ).

 Download PDFProduct #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-530.4b kit is designed for processing umbilical cord blood (UCB) in order to concentrate the nucleated cell fraction into a double-compartment CryoSC-Db cryobag.

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	Cryobag	CryoSC-Db cryobag with 25 mL storage capacity
7	By-product Bag	500 mL PVC by-product bag to collect plasma
8	DMSO Extension Line	A line equipped with leur port connections for adding cryoprotectant solution
9	DMSO Vial Spike	Needle with luer port for connecting cryoprotectant solution
10, 11	Final line	Final line with luer and sampling ports

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-530.4b 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-530.4b: 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. ).

 Download PDFProduct #10024

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-530.4 kit is designed for processing umbilical cord blood (UCB) in order to concentrate the nucleated cell fraction into a double-compartment CryoSC-D cryobag.

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	Cryobag	CryoSC-D cryobag with 25 mL storage capacity
7	By-product Bag	500 mL PVC by-product bag to collect plasma
8	DMSO Extension Line	A line equipped with leur port connections for adding cryoprotectant solution
9	DMSO Vial Spike	Needle with luer port for connecting cryoprotectant solution
10, 11	Final line	Final line with luer and sampling ports

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-530.4 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-530.4: Product #10024

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. ).

 Download PDFProduct #10015

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-530.1 kit is designed for processing umbilical cord blood (UCB) in order to concentrate the nucleated cell fraction into a single-compartment CryoSC-S cryobag.

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	Cryobag	CryoSC-S cryobag with 10 to 30 mL storage capacity
7	By-product Bag	500 mL PVC by-product bag to collect plasma
8	DMSO Extension Line	A line equipped with leur port connections for adding cryoprotectant solution
9, 10	Final line	Final line with luer and sampling ports

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-530.1 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-530.1: Product #10015

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. ).