Cell Freeze Cryogenic Storage Containers for HPC’s

Cell Freeze Cryogenic Storage Containers for HPC’s OK’ed in Europe

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CELL-FREEZE® – Cryogenic Storage Container

Charter Medical’s Cell-Freeze® cryogenic storage containers are designed for storage, preservation and transfer of hematopoietic progenitor cells (HPC’s).

Click for Printable Data Sheet

Cell-Freeze® Design offers:

Unique bag film container material remains flexible at ultra low temperatures (-196°C).

Proprietary membrane port design offers thinner walls for increased flexibility andattached cap minimizes membrane exposure during freezing.

Industry standard label pocket design offers ease of use and traceability in labeling

Charter Medical, a part of Lydall (Manchester, CT), received the EU CE Mark for its Cell Freeze cryogenic storage containers for Hematopoietic Progenitor Cells (HPC’s). The devices, which were approved just over a year ago in the U.S., can safely go down to -200° C and handle temperature changes common to stem cell applications. They’re available in sizes from 50 mL to 750 mL.

Features and Benefits

Polyolefin Film – Proprietary EVA blend specifically selected for its low temperature properties while maintaining flexibility and clarity when filled with liquid.

Membrane Port – The attached cap snaps into place to protect the contents and minimizes membrane exposure during use.

Label Pocket – Supports use of computer generated labels. Critical information can be viewed quickly by simply opening the freezing cassette.

Integral Fill Tube – The unique manufacturing method used to secure the fill tube to the container body eliminates the need for pvc interfaces with the liquid nitrogen storage section of the container.

Interface/Connectors – Compatible with sterile connection technology and smart seal technology (Sebra® Model 1100 tube welder). Fits in a variety of freezing cassette systems.

Physical Integrity

The physical integrity of the containers were evaluated for their ability to withstand temperature variations experienced during routine storage of hematopoietic progenitor cell products. All containers passed the physical integrity tests performed, which included the initial pressure test and leak tests and the microbial challenge and dye immersion tests.

Cell Quality

Cell quality was assessed on Cell-Freeze® cryogenic storage containers using diluted HPC with 10% DMSO. All containers met the acceptance requirement for MNC and CD34+ cell recovery of ? 70% relative to cell counts of the sample prior to cryopreservation. The average MNC and CD34+ cell recoveries were 81% and 84%, respectively. All containers met ? 1 CFU acceptance criteria with an average of 78% recovery.

Charter Medical, a unit of Lydall Inc. (Manchester, Connecticut), won FDA 510(k) clearance for the company’s Cell-Freeze cryogenic storage containers. The bags, specifically designed for stem cells transfer and storage, stay flexible to nearly -200° C and can handle the types of temperature changes common in stem cell applications.

Polyolefin Film – Specifically selected for its low temperature properties while maintaining flexibility and clarity when filled with liquid.

Membrane Port – The attached cap snaps into place to protect the contents and minimizes membrane exposure during use.

Attached Label – Supports adherence of computer generated labels and allows manual data entry area. Critical information can be viewed quickly by simply opening the freezing cassette.

Integral Fill Tube – The unique manufacturing method used to secure the fill tube to the container body eliminates the need for pvc interfaces with the liquid nitrogen storage section of the container.

Interface/Connectors – Compatible with sterile connection technology and smart seal technology (Sebra Model 1100 tube welder). Fits in a variety of freezing cassette systems

Source : http://www.chartermedical.com/products-cell-freeze.html

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