Sepax C-Pro | Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti

CT-90.1

Girgin Ltd — Tue, 23 Jan 2018 04:42:40 +0000

Product #29264740

The CT-90.1 kit is integral to our Sepax C-Pro Cell Processing System. It provides a functionally-closed environment and is for single-use only.

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 via a spike or SCD connection
5	Washing Solution Line	Connects the kit to the washing solution
6	Resuspension Solution	Connects the kit to the re-suspension solution
7	1000 mL bag	PVC bag to collect by-product
8	DGM Filter	If applicable, a 0,2µm hydrophilic filter for injecting density gradient medium
9	500 mL final bag	500 mL bag for intermediate and final product
10	Final Line	Connects the kit to the final bag

Kit information

Only for use with compatible Sepax C-Pro equipment.

Shelf life: Two years from the date of manufacture.

Sterilization: Ethylene oxide.

Material: Standard medical grade PVC, PP, POM, PC, ABS, and silicone.

Fluid path: Non-pyrogenic

Compatible equipment

Sepax C-Pro (#29264741)

Protocols: CultureWash C-Pro (#29264736), NeatCell C-Pro (#29264734), Dilution C-Pro(#29264737).

Accessories: Separation Chamber Holder C-Pro (#29270526).

Storage requirements

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

Ordering information

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. ).

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CT-60.1

Girgin Ltd — Tue, 23 Jan 2018 04:41:36 +0000

Product #29264739

The CT-60.1 kit is integral to our Sepax C-Pro Cell Processing System. It provides a functionally-closed environment and is for single-use only.

Components

#	Name	Description
1	220 mL 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 via a spike or SCD connection
5	Washing Solution Line	Connects the kit to the washing solution
6	1000 mL bag	PVC bag to collect by-product
7	Final Line	Connects the kit to the final bag
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 information

Only for use with compatible Sepax C-Pro equipment.

Shelf life: Two years from the date of manufacture.

Sterilization: Ethylene oxide.

Material: Standard medical grade PVC, PP, POM, PC, ABS, and silicone.

Fluid path: Non-pyrogenic

Compatible equipment

Sepax C-Pro (#29264741)

Protocols: CultureWash C-Pro (#29264736), Dilution C-Pro (#29264737).

Storage requirements

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

Ordering information

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. ).

The post CT-60.1 first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

CT-49.1

Girgin Ltd — Tue, 23 Jan 2018 04:40:56 +0000

Product #29264739

The CT-49.1 kit is integral to our Sepax C-Pro Cell Processing System. It provides a functionally-closed environment and is for single-use only.

Components

#	Name	Description
1	220 mL 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	Regulates liquid flow through the kit
5	Initial Line	Connects the kit to the initial bag via a spike or SCD connection
6	500 mL PVC bag	PVC bag to collect by-product
7	Final Line with female luer ports	Allows connection of final bag
8	Final Line extension with spike	Connects the kit to the final bag

Kit information

Only for use with compatible Sepax C-Pro equipment.

Shelf life: Two years from the date of manufacture.

Sterilization: Ethylene oxide.

Material: Standard medical grade PVC, PP, POM, PC, ABS, and silicone.

Fluid path: Non-pyrogenic

Compatible equipment

Sepax C-Pro (#29264741)

Protocols: PeriCell C-Pro (#29264735), Dilution C-Pro (#29264737).

Storage requirements

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

Ordering information

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. ).

The post CT-49.1 first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

PeriCell C-Pro

Girgin Ltd — Tue, 23 Jan 2018 04:39:55 +0000

Product #29264735

Concentrate cells from apheresis product via plasma depletion in combination with the Sepax C-Pro Cell Processing System. Process and initial volume between 100 and 840 mL and select a final volume between 30 and 600 mL.

Key features

Feature
Initial volume	100 to 840 mL
Selectable final volume	30 to 600 mL
Processing time	~ 20 minutes
Average TNC recovery	> 90%

Workflow

Step	Details
1	Prepare a single-use kit with initial product.
2	Install the kit on the .
3	The automatically performs the procedure.
4	Collect concentrated cells from the final product bag.

Protocol information

PeriCell C-Pro protocol software is integral to our Sepax C-Pro Cell Processing System. It allows for an automatic, reproducible, and user-independent procedure. Only for use with compatible Sepax C-Pro equipment.

Compatible equipment

Sepax C-Pro (#29264741)

Kits: CT-49.1 (#29264739)

Packaging information

One box for each protocol, including a USB key with the protocol installed and a user installation guide.

The post PeriCell C-Pro first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

NeatCell C-Pro

Girgin Ltd — Tue, 23 Jan 2018 04:39:16 +0000

Product #29264734

Enrich mononuclear cell fractions of apheresis product, bone marrow, and umbilical cord blood via a density gradient medium in combination with the Sepax C-Pro Cell Processing System. Process an initial volume between 30 and 120 mL and select a final volume down to 8 mL.

Key features

Feature
Initial volume	30 to 120 mL
Selectable final volume	8 to 20 mL, or 45 mL
Processing time	~ 1h15 minutes
MNC recovery	> 52%
RBC depletion	> 99%

Workflow

Step	Details
1	Prepare a single-use kit with density gradient medium (via microbial filter), washing solution, and a syringe for collecting the final product (if applicable)
2	Connect initial product to the kit.
3	Install the kit on the Sepax C-Pro.
4	The Sepax C-Pro automatically performs the procedure including: • Priming • Washing
5	Collect purified mononuclear cells from the final product bag or via a syringe.

Protocol information

NeatCell C-Pro protocol software is integral to our Sepax C-Pro Cell Processing System. It allows for an automatic, reproducible, and user-independent procedure. Only for use with compatible Sepax C-Pro equipment.

Compatible equipment

Sepax C-Pro (#29264741)

Kits: CT-90.1 (#29264740)

Packaging information

One box for each protocol, including a USB key with the protocol installed and a user installation guide.

The post NeatCell C-Pro first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

Dilution C-Pro

Girgin Ltd — Tue, 23 Jan 2018 04:38:36 +0000

Product #29264737

Dilute or split cellular products into multiple bags in combination with the Sepax C-Pro Cell Processing System.

Use Dilution C-Pro to:

Further dilute cells after cell washing to prevent aggregation.
Further split final cellular product into several bags.
Dilution of cryo-preserved product prior to transplantation.

Key features

Feature
Dilution volume	220 mL
Bag splits	Up to five
Average TNC recovery	> 90% (splitting) 100% (dilution)
Cell concentration variability	< 10% (splitting)

Workflow

Step	Details
1	Prepare a washing solution.
2	Connect the initial product to a single-use kit.
3	Install the kit on the Sepax C-Pro.
4	The Sepax C-Pro automatically performs the procedure including: • Dilution of final bag • Splitting of initial bag into multiple final bags.

Protocol information

Dilution C-Pro protocol software is integral to our Sepax C-Pro Cell Processing System. It allows for an automatic, reproducible, and user-independent procedure. Only for use with compatible Sepax C-Pro equipment.

Compatible equipment

Sepax C-Pro (#29264741)

Kits: CT-49.1 (#29264739), CT-60.1 (#29264739), CT-90.1 (#29264740)

Packaging information

One box for each protocol, including a USB key with the protocol installed and a user installation guide.

The post Dilution C-Pro first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

CultureWash C-Pro

Girgin Ltd — Tue, 23 Jan 2018 04:37:55 +0000

Product #29264736

Wash, concentrate, and exchange medium of cellular products in combination with the Sepax C-Pro Cell Processing System. Process an initial volume between 30 and 880 mL and select a final volume between 8 and 200 mL.

Key features

Feature
Initial volume	30 to 880 mL*
Selectable final volume	8 to 200 mL**
Average CD34+ recovery	> 80%
Average CD34+ viability	> 95%

*The CT-90.1 kit is only validated for initial volumes up to 220 mL. Higher volumes must be validated by the user.

**CT-90.1 kit required if final volume less than 20 mL

Workflow

Step	Details
1	Prepare a washing solution.
2	Prepare a single-use kit with the initial product.
3	Install the kit on the Sepax C-Pro.
4	The Sepax C-Pro automatically performs the procedure including: • Primary dilution • Osmolarity balancing • Sedimentation and initial product rinsing • Supernatant extraction • Cell resuspension • Cell extraction into a final product bag.

Protocol information

CultureWash C-Pro protocol software is integral to our Sepax C-Pro Cell Processing System. It allows for an automatic, reproducible, and user-independent procedure. Only for use with compatible Sepax C-Pro equipment.

Compatible equipment

Sepax C-Pro (#29264741)

Kits: CT-60.1 (#29264739), CT-90.1 (#29264740)

Packaging information

One box for each protocol, including a USB key with the protocol installed and a user installation guide.

The post CultureWash C-Pro first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.

Sepax C-Pro

Girgin Ltd — Tue, 23 Jan 2018 04:37:07 +0000

Product #29264741

The Sepax C-Pro Cell Processing System is an automated and functionally-closed technology developed for cell processing when manufacturing cell therapy products. It combines exclusively with Sepax C-Pro software protocols and kits to process cellular products. The system allows for versatile combinations of multiple processing steps, including and not limited to enrichment, isolation, washing, concentration, dilution, and splitting.

Specifications

27 x 40 x 46 cm (10.6 x 15.7 x 18.1″)

17 kg (37.5 lbs)

100 – 240 VAC

50/60 Hz

200 VA

Key features

• Functionally-closed and automated

• Compact and mobile

• GAMP compliant system with full traceability

• Intuitive user interface

Technical specifications

Feature	Description
External design	Lightweight housing and one-handed separation chamber pit closure system
Dimensions	W: 27 cm, L: 40 cm, H: 46 cm (10.6” x 14.7”, 18.1”), 16.3 kg (35.9 lbs)
User interface	Color touchscreen display and intuitive graphical user interface (GUI)
Electronics and communications	Windows XP embedded, GMAP, USB, and Ethernet
Data saving capability	32 logfiles, 50 patfiles, and 50 report files (PDF)
Core technology	Electric centrifugation motor and pneumatic circuitry for piston drive
Optical line sensor	• Red/blue transmitted LEDs • Red/blue scatters LEDs
Traceability function	• Barcode reader and printer for multiple code reading capabilities • Procedural data management with PDF report and graph

Safety and compliance

The Sepax C-Pro is manufacturing equipment with the CE mark (Machinery Directive 2006/42/EC) intended for cell therapy manufacturing in good automated manufacturing practice (GAMP) compliant environments. It is compliant with IEC-61010, IEC-61326, and IEC-62304 standards. The Sepax C-Pro is not intended for any therapeutic or diagnostic use in humans. Only for use with Sepax C-Pro software protocols and kits.

Country	Compliance
China	Instrument complies with specific Chinese standard labeling (SJ/T11364-2014) and China ROHS 2 (Order 32- 01 JUL 2016)
USA	Instrument complies with UL 61010-1 :2012-05/R :2015-07 UL 61010-2-020 :2016-12 47 FCC part 15 Subpart B
Canada	Instrument complies with Canadian ICES-001 CAN/CSA-C22.2 NO. 61010-1 :2012
Japan	PSE mark (Electrical safety): Electrical Appliance and Material Safety Law (Denan Law): Not applicable EMC (VCCI Mark (voluntary mark): Not applicable J-MOSS (JIS C 0950 The marking for presence of the specific chemical substances for electrical and electronic equipment): Not applicable here as Sepax C-Pro is not in the scope of JIS C0950 standard

Storage requirements

Only operate the Sepax C-Pro on a flat, stable, horizontal, and clean surface. Use it in an open environment to allow sufficient ventilation. Operate and store it within the following conditions:

	Operation	Storage and transport
Temperature	+7 to +27°C	0 to +50°C
Relative humidity	30 to 75 %, non-condensing	20 to 75 %, non-condensing
Altitude	2000m, 80 kPa	N/A

The post Sepax C-Pro first appeared on Girgin Tıbbi Cihazlar Sanayi İç ve Dış Ticaret Ltd.Şti.