cooler validations

[lisad]

I validate our blood/blood product shipping containers, both AABB approved boxes and coolers twice a year. I validate them at room temperature and then also perform an extreme validation. During the summer, I don't have a problem finding a warm day. This past winter, when I was doing the extreme validations, we had some unusually warm temps those days. My QA dept. questioned my outside temp of 52F for a winter validation; claiming this was not an extreme validation. I am wondering if anyone else does an extreme validation during the winter and the summer and do you have specific temp ranges that your extreme validations must be performed in. Lisa

[Eoin]

I WOULD CHALLENGE THEM ABOUT THAT, UNLESS YOU ARE IN THE HABIT OF LEAVING STORAGE BOXES WITH BLOOD OUTSIDE IN THE SNOW.

YOU COULD ALWAYS STICK THEM IN A COLD ROOM OR FRIDGE IF THEY FIT AND VALIDATE ThEM THAT WAY.

Cheers

Eoin

[L106]

Lisa -

I think your validation schedule and intent is good. (We follow the same guidelines.) I do agree with your QA dept that an outside temperature of 52F does not fulfill the intent of the validation protocol. You really should have picked a colder day. We do not name a specific temp range requirement, and I now recognize that we should. So I think we should both add specific range for our hot and cold validation procedures.

Yeah, we do need to pick a really cold day, Eoin, because our courier could possible forget our box of blood or platelets in the truck of the vehicle for a period of time. (Hopefully not!)

Donna