Technical Information

Applications:

The Cryostore bag has received marketing clearance by FDA, and is indicated for freezing of blood components. Click here to open the regulatory information page on the FDA website.

For Bag physical dimensions, please jump to the Catalog page

Configuration:

Each bag:

is made of rugged 100% EVA,
Has an integral label pocket,
Two hermetically-sealed EVA membrane spike ports,
has the donor tube located at the top corner of the bag for easy de-airing,
has a uniquely numbered EVA/PVC Donor tube with four marked segments,
has extension lines which can be SCD connected,
has a Roller clamp on each extension line,
and an integral bag hanger hole.

Packaging:

The bag fluid path is provided sterile and non-pyrogenic. The Cryostore bag is Gamma Sterilized in a Tyvek peel pouch. Usually packed in groups of four per pouch, the Cryostore cryopreservation bag is also available individually packed. See the Catalog page, link at left.

Label Pocket

The label pocket, shown in the photo at the right, allows the insertion of a small label, which can be heat sealed in place with a standard dielectric, RF or impulse sealer. To prevent bursting of the label pouch on re-warming, do not seal the label pouch completely closed.

In addition, the lot number label, which is sealed into the hanger hole, has a self adhesive back, and the user can attach their own label to this. These labels will remain stuck together in liquid nitrogen storage.

Cryostore label pouch cord blood banking

Spike Ports

Two hermetically sealed membrane spike ports are included on each Cryostore blood freezing bag. the solid EVA ports are sealed at the top (blue arrow), to maintain sterility during freezing and thawing. No more rubber stoppers popping off. Twist off the top and access with any standard spike set.

In addition, the port tubes project slightly into the bag to protect the bag walls from accidental puncture with a bag spike. These projections have a longitudinal slit (yellow arrow) that allows them to drain just the same as if the protecting tube was not there.

Instructions for Use

You can download a complete copy of the Instructions for Use in Adobe Acrobat Format by Clicking Here. If you do not have Adobe Acrobat reader, it can be downloaded free at Adobe.com, by clicking the icon below.

Literature References

Physical and thermal properties of blood storage bags: implications for shipping frozen components on dry ice. Hmel, Kennedy Transfusion Vol 42, July 2002 p836-846

Cryopreservation and Freeze-drying Protocols Cryopreservation of Animal and Human Cell Lines, Day, John and McLellan, Mark , Humana Press New Jersey. 1995

High efficiency Recovery of Functional Hematopoietic Progenitor and Stem Cells from Human Cord Blood Cryopreserved for 15 years PNAS Volume 100 No 2 645-650 January 21, 2003

Scaffold Delivered through a Needle Ball, Phillip Nature 13 March 2003

DMSO Cryoprotectant Procedure* Click here for link

DMSO/Pentastarch Cryoprotectant Procedure* Click here for link

*The above procedures were presented at the ISCT 2001 meeting; these sample procedures are for reference only.

OriGen Biomedical Europe
Drottninggatan 13
25221 Helsingborg
Sweden
Tel: +46 46 772 433
Fax: +46 42 146 074

Key list: Blood banking, cord blood storage, cryopreservation,stem cell storage, cord blood freezing, blood component freezing, w