Sepax C-Pro

https://cytomed.ae/products/%c2%a7-readycell/

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

 


 

Product Specifications

Description Parametres
Product Division Laboratory Division
Brand Biosafe Cytiva

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Medical Division

Laboratory Division

Industry Business Unit