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PRODUCTS

SynGenX®-1000 System

For processing umbilical cord blood

  • 1- X1000 fam
  • 2- X1000 fam
  • 3- X1000 fam
  • 4- X1000 fam
  • 5- X1000 fam
  • 6- X1000 fam
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SynGenX®-1000 System
SynGenX®-1000 Disposable Cartridge
SynGenX®-1000 Control Module
SynGenX®-1000 Docking Station
CryoPRO™-2 Cryopreservation/Storage Bag Set


SynGenX®-1000 Platform

The SynGenX®-1000 Platform is a cord blood cell processing system intended for processing umbilical cord blood in combination with a specific and compatible single-use separation kit supplied by SynGen Inc. Designed to be used with a programmable bench-top centrifuge, the SynGenX®-1000 System processes up to 4 cord blood units in 35 minutes. The System’s firmware and SynGen® DataTrak software download a performance report for each run to a host personal computer for cGMP-compliance.

The SynGenX-1000 System is available for sale in the U.S. and EU/EEA.

 

Key Features:

  • Advanced Technology for Cell Separation and Cryopreservation
  • High CD34, MNC and TNC Recovery and Post Thaw Viability
  • Critical Process Control with Electronic Records
  • Easy to Use for Both Small and Large Scale Operations


The Components of the System:

  • SynGenX®-1000 Disposable Cartridge
  • SynGenX®-1000 Control Module
  • SynGenX®-1000 Docking Station
  • CryoPRO™-2 Cryopreservation/Storage Bag Set
  • SynGen® DataTrak Software

lg_disposableThe SynGenX®-1000 Disposable Cartridge

The SynGenX-1000 Disposable Cartridge processes one unit of cord blood with a volume between 40 and 220 mL. The Disposable Cartridge has three discrete compartments for separation of the cord blood into buffy coat, red blood cells and plasma. The buffy coat compartment has a volume to 20 mL.

 

 

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SynGenX®-1000 Control Module

The SynGenX®-1000 Control Module monitors the acceleration and deceleration of the centrifuge to direct the depletion of red blood cells and harvest of the buffy coat in the Disposable Cartridge.

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SynGenX®-1000 Docking Station

The SynGenX®-1000 Control Module monitors the acceleration and deceleration of the centrifuge to direct the depletion of red blood cells and harvest of the buffy coat in the Disposable Cartridge.

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CryoPRO™-2 Cryopreservation/Storage Bag Set

See CryoPRO2 Bag Sets page.

 

 

 

1-LoginSynGen® DataTrak Software

The SynGen® DataTrak software is installed on the host’s personal computer and is the user interface for the SynGenX-1000 System. The software allows the operator of the SynGenX-1000 System to use a bar code reader, to track and record equipment serial numbers and disposable lot numbers.

 

 

 

 

35 - Control Module Processing Report

Control Module Processing Report

The software downloads performance data from the Control Module, including:

  1. Timing and duration of the centrifuge accelerations and decelerations.
  2. Opening and closing of the red blood cell and buffy coat transfer tubing.
  3. Documentation of the successful completion of the processing cycle.

 

 

 

 

How It Works

The SynGenX®-1000 System is designed for safe, rapid, automated isolation and harvest of buffy coat (some red cells, and nearly all nucleated cells and platelets, topped up with plasma to a final volume of 20 mL) from a unit of collected cord blood.

 

X1000_DCCM_Std_Front-1A_V0214 2 units

Cord blood is transferred via the input tubing through a 150 micron filter into the SynGenX®-1000 Disposable Cartridge. The Disposable Cartridge is latched into the SynGenX®-1000 Control Module and placed in the centrifuge with other cartridges or appropriate counterweights for balance.

 

SynGenX-in-Centrifuge-Bucket_v021During centrifugation, the blood is separated into three fractions: red blood cells, buffy coat, and plasma. The cartridge, features an internal cone, the bottom narrow portion of which is monitored by four (4), vertically aligned, infrared sensor-pairs that can detect cell fraction interfaces that appear in the bottom narrow portion as a result of the red cell depletion phase of the centrifugation process. These sensors provide the information that allows the precise isolation and harvest of the buffy coat during processing.

 

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  1. Transferred cord blood from the collection bag to the central conical chamber of the disposable cartridge.
  2. During centrifugation, the blood stratifies into layers based on the density of the cellular components within the cord blood.  The red blood cells move to the bottom of the stratification cone.  The buffy coat (including granulocytes, lymphocytes, monocytes and hematopoietic stem cell and progenitor cells and platelets rest on the red blood cells and the plasma sits on top.
  3. Interface detected by the sensors, the control module directs the red blood cells into the red cell depletion compartment.
  4. Interface detected by the sensors, the control module directs the buffy coat to the harvest compartment and tops it up with plasma to a final volume of 20 mL.

 

The SynGenX-1000 Control Module automatically directs the separation of the three fractions in the Disposable Cartridge while they are spinning in the centrifuge. It does so by using an internal microprocessor, four optical sensors to detect the interface between the red blood cells and buffy coat, and accelerometers to monitor the centrifuge speed and to open and close the tubing in the Disposable Cartridge, directing the red blood cells and buffy coat to their respective compartments.

 

 

Pinching mechanism of the SynGenX®-1000 Disposable Cartridge

 

Modular cam rotation of the SynGenX®-1000 Control Module

 

X1000_DSCM_Std_Front-01_v0514The Control Module also gathers and stores information during each centrifuge run, which provides a cGMP compliant report of the process, when downloaded by the SynGen® DataTrak Software while it is seated in the docking station.

Results

The SynGen X®-1000 System for processing cord blood provides:

  • Advanced technology for cell separation and cryopreservation
  • High CD34, TNC , MNC recovery and post-thaw viability
  • Critical process control with electronic records
  • Easy to use for both small and large scale operations

This system gives you:

  • Cord blood processing ranges  of 40 mL to 220 mL
  • A fast, automated, and sterile environment
  • The option of using a sedimentation agent, such as HES, for red blood cell depletion