Storage Method

CRYOVIAL  

CRYOBAG

Processing Method

Open System

All CryoCord samples are processed in “closed system” before they are transferred into vials at the very final step in our ISO Class 5 (Class 100) Cleanroom. Therefore, the possibility of contamination is greatly reduced.

“Closed System”

There is still risk of contamination if the samples are processed in normal laboratory. There is no such thing as a “closed system” as additional chemical has to be added during processing and just before freezing. T he EU does not recognize the word “closed system”. The FDA still requires cord blood to be processed in a class 10,000 environment independent on whether they are store in bags or vials.

International Standard

Cryovial is used by numerous cord blood banks and other cellular transplantation . It has a well proven track record in cryogenics. Many cord blood transplantations that have taken place throughout the world were stored in vials.

Used by certain international public cord blood banks where the sole purpose is for haematological transplantation and therefore for convenience sake, they are stored in bags.

The risk of contamination

The risk is lower because all samples are processed in ISO Class 5 ( Class 100) Cleanroom. The risk of contamination is more likely to be related to whether infected cases are stored (especially hepatitis B as reported in medical journal, Lancet ⁵) and unlikely to be due to the type of storage.

Due to the risk of bag leakage. Cracks in bags have been well documented and is usually not detected until the bags are thawed. Some studies have shown a breakage rate of up to 9.6% ⁴. Cross contamination in blood banking has only been reported in cryobag storages in both liquid and vapour nitrogen phases ^5,6.

Risk of Processing Errors

The number of steps involved in processing cord blood is the same as the cryobag system. The only difference is the final step. Instead of transferring the final product into cryobag for storage, we then transferred them into cryovials

We believe that human error, though rare, is definitely not affected by whether your blood is stored in vials or bags.

Long-term cryogenic storage

CryoCord uses shatter-proof polypropylene cryovials which are hermetically sealed and specially designed for long-term storage at low temperatures. ^{1 & 3}

It had been shown that, cryobag is suitable to be used for long-term cryogenic storage. However, it is also well documented that blood bags have a risk of breakage during long-term storage . ¹

There is no evidence that the recovery rate is better for bag compared to vials.

Possibility of multiple usage in the future

Yes

Stored in 5 individual cryovials. Physicians will someday be able to amplify a small number of cells, using cell expansion technology to allow for multiple uses of a single sample. ^{1, 2 & 3}

In some diseases such as heart disease, stroke and spinal cord injury, only one vial is required for such therapeutic use. The other 4 vials will still remain stored for future use.

No

Stored in 1 single bag. The cell expansion bag is connected to the main bag, i.e. there is no way one can expand the cell at a later time period. The whole unit has to be thawed together at the same time.