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cooler verification procedures


gshickman

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I don't have such a process, but also would be interested if someone does - seems AABB new std 5.1.8.2.1 is asking for this?

Margaret: If you will post your email address or send me a Private Message here on BBTalk, I will email my cooler validation procedure to you.

Gretchen: I will email my procedure to you this afternoon.

Donna

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Validation of small coolers has to meet the following criteria:

Whatever media is used to cool the contents, we have to prove that it will stay

within certain limits during transport.

Wet Ice in this case is ± 0 ºC as long as the Ice is melting. Just above the bloods freezing point.

Once molten, the temperature will rise.

To validate the cooler, we also need to know, the maximum time it can be in transport.

Better insulation means longer temp. stability.

Another variable is the exposure to ambient temperature.

Now, to validate the cooler.

Insert a documented amount of wet ice in the cooler box.

More Ice, means longer stability.

Insert a calibrated "logger" where the samples are going to be stored.

Place it in a room that mimics the maximum exposure temperature during transport.

Leave it exposed for the maximum time the cooler could be in transport.

Next, take the readings from the logger, to prove, the cooler contents stayed within

the limits.

Document these findings with the coolers operations log, and depending on visual damage

repeat this whenever necessary.

Usually, if no damage to the box is visible, once a year.

Damaged insulation can shorten the temperature stability of the box.

This can be easily checked, by pressing the inner lining of the box, and to see if there is any play

between the lining and the internal foam.

Now, the SOP for transport could be as followed. This could be used for any blood transport.

Blood samples removed from equipment "X" at " Date and Time". Actual temperature can be retrieved

from monitoring system

Blood samples delivered at "Y" at " Date and Time" in box "Z". ( Signature )

Data from logger "A" that was with the transport will be added to transport log file, to prove temp. stability.

I have been testing the Elpro Libero Logger, and this little device could be perfect for the job.

After delivery, it will give you a pdf with the readings or a graph, and this can be filed with the

transport documentation.

Hope, this can be of help.

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Hello Hodag,

Buy...buy...buy... is easy.

They already have coolers, so let people validate what they have, if possible.

And..... even Thermosafes have to be re-validated after 1/2 or 1 year, or in case damaged.

It would be nice, if certain people on this forum would not just try to promote their products.

No offence.

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  • 3 months later...

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