Sepax C-Pro
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 |