System Overview

The Sefia Cell Processing System is an automated and functionally-closed technology developed for Cell Processing when manufacturing Cell Therapy products. It consists of the Sefia S-1000 platform, dedicated software protocols, and cell processing kits. Use combinations of these protocols and kits for multiple cell processing steps such as washing, concentration, and final formulation.

 

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Key Features

• Fast processing of large volumes through innovative continuous-flow centrifugation technology.
• Smart process control via an automated, closed, and sensor-controlled system.
• Intuitive user guidance through a responsive interface and user-friendly design.
• Workflow automation via sequential protocols.

Technical Specifications

Feature	Description
Core technology	• Centrifugation technology and a peristaltic pump for continuous flow rates up to 10 L/h. • Four stopcocks for up to eight fluid pathways. • Optical sensors for air bubble and air level detection. • Pressure monitoring sensors. • Electric motor for centrifugation up to 1600 g. • Four bag weight sensors (max. 10 kg per bag). • Peltier modules for temperature control between +4 and +40°C.
Processing capacity	• Initial: 50 mL to >10 L (kit and protocol dependent). • Final: >8 mL
Traceability	• Barcode reader and printer. • Data management with PDF reports and procedural graphs.
User interface	Color touchscreen with an intuitive user graphical interface (GUI).
Software	• Compatible with Sefia protocol software only. • Windows 7 and Bioprocessing Application Software (BPAS).
Connectivity	Five USB slots and two ethernet ports.
Dimensions	W: 74 cm, L: 51 cm, H: 91 cm (29” x 20” x 36”), 45 kg (99 lbs)
Power	1000 W, 100-240 VAC, 50/60 Hz

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Safety and Compliance

The Sefia S-1000 is a laboratory instrument with the CE mark 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. For investigational use only.

 

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Storage Requirements

	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

 

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