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CryoMACS ® Freezing Bags

CryoMACS® FREEZING BAGS

CryoMACS® Freezing Bags are designed for freezing and storage down to -196 °C, as well as thawing of human blood components.

Product features:

Each CryoMACS® Freezing Bags consist of a freezing bag and a corresponding overwrap bag that fits into the corresponding storage cassettes.
Both the freezing bag and its corresponding overwrap bag are made of EVA (ethylene vinyl acetate) tubular film.

The freezing bag is equipped with extra long EVA tubing for drawing quality control samples out of heat sealed tube sections. The tubing is provided with luer connectors, roller clamps, and an injection port. The EVA tubing and injection port are DMSO-resistant. Two ports with sealed, twist-off protective caps minimize the risk of nitrogen ingress into these ports.

Each CryoMACS Freezing Bag includes a label pouch and the imprinted lot number.

CryoMACS Freezing Bags are CE-marked medical devices and are marketed in the US and FDA 510 ( K) clearance.

A broad range of CryoMACS Freezing Bags with nominal volumes ranging from 50 to 1000 mL is available and offers flexibility for various applications.

Product	Nominal volume	Recommended fill volume
CryoMACS Freezing Bag 50	50 ml.	10-20 ml.
CryoMACS Freezing Bag 250	250 ml.	30-70 ml.
CryoMACS Freezing Bag 500	500 ml.	55-100 ml.
CryoMACS Freezing Bag 750	750 ml.	80-190 ml.
CryoMACS Freezing Bag 1000	1000 ml.	125-270 ml.

SEPAX SYSTEM

The Sepax cell separation system is a modern cell centrifugation device for fast and automated processing of blood and its components.

Product features:

TraceabilityAS-610:

An important tool which gives the possibility to keep both technical and patient data for each procedure performed with the Sepax system. Data for all procedures can be saved in the Sepax memory card and also be printed.

The traceability features and devices include a thermal printer, a bar code reader, managing software, cables and connector protections.

Applications:

Umbilical Cord Blood Processing:
Biosafe provides three protocols to process umbilical cord blood:

Cabinet construction

Exterior, interior, and door handle(s) made from galvannealed steel with bacteria-resistant powder coating.

Umbilical Cord Blood-HES (UCB-HES): It is based on the sedimentation agent Hydro-Ethyl Starch.
Umbilical Cord Blood processing (UCB)- No Additives: This protocol does not require additives. This separation protocol is ideally suited to UCB banking where storage costs need to be minimized and the use of additives is a concern.
Umbilical Cord Blood-Low Buffy-Coat Volume (UCB-LBC): This protocol produces very small buffy-coat volume.
Umbilical Cord Blood Stem Cell Washing Protocol-Post Thawing (The UCB Washing Protocol): This protocol is designed for automated washing of thawed cord blood units in a closed system. The washed Cells are viable for hours which also allow further processing without time constraints. This washing protocol is recommended when a safe and automated removal of DMSO and hemolysed plasma from thawed UCB products is desired.

Peripheral Blood Processing:

PBSC Volume Reduction: This protocol is designed for reducing volume of peripheral blood stem cell (PBSC) preparations after leukapheresis. The hematopoietic stem cells can then be frozen and stored until future transplantation into a patient. This protocol is recom- mended when optimization of cell concentration and reduction of DMSO toxicity are a concern.
Peripheral Blood Stem Cell Washing: This protocol is designed for automated and safe removal of DMSO and hemolysed plasma from thawed leucapheresis products. The washed cells are viable for hours which also enable further process without time constraints.

Bone Marrow Processing:

Biosafe provides two protocols:

The Generic Volume Reduction Protocol: This protocol is designed for efficient separation of stem cells in a closed system. This protocol is conceived for volume reduction of different blood products and specially adapted for bone marrow applications in transplantation and regenerative medicine applications.
The Density Gradient based Separation Protocol: This protocol is designed for bone marrow or umbilical cord blood processing in regenerative medicine applications. This protocol is recommended when optimization of cell concentration and high depletion of RBC are a concern.