Transport Cooler Validation

[Cliff]

Someone asked me for our validation protocol for coolers. I'm attaching our validation results, forms for documenting quarterly QC, and Quarterly QC SOP. The validation was basically done the same as the Quarterly QC. We have 15 coolers and perform QC on 4 each quarter, therefore in addition to the initial validation, each cooler is QC'd once a year. We use FDA temperature criteria for "extension of storage" (1-6C) rather than the temp criteria for transport (1-10 C)as defined in the reference listed after the SOP. Flaked wet ice has the best temperature exchange properties and is better than cubed ice or gel packs. This is due to the increased available surface area on the flakes for heat exchange. I'm also attaching a powerpoint used for training of blood center, OR nursing, and anesthesia personnel. Hope it helps! I've removed headers and footers which contain our facility identity. If you use any of these documents be sure to add your facility ID, adoption/revision date etc.

Related to all the discussion on infrared vs other thermometers, I'll add that our SOP is not very clear on the type of thermometer used. We used a digital thermometer, NIST traceable and sent out each year for calibration. The unit has 2 wire probes on it and can take temperatures in 2 locations at once. The wire probes were placed between the units of blood and the lid closed over the wires. The lid is not opened during the 24 hours of QC testing. During validation however, we simulated OR staff opening and closing the cooler to remove and replace blood.

In the pictures you'll note that there are note cards with various instructions on them.

OK, I can't upload the power point with the pictures and training. So if you want it, e-mail me and I'll send it. <removed by admin>

Thanks Ann. If you wish, you can now upload PowerPoint documents. I removed your email from this post to cut down on your spam.

[redstaff2003]

i am just wondering when running validation for your coolers for how many times that you add wet ice or ice flakes to your coolers? or its the same ice that you use from the start to the end your validation?

tonz m.

[jlemmons]

We add Hemotemps to all of our units that go to surgery in coolers. That way we are sure of the temperature of the blood while it is in surgery. We also validated our coolers to 6 hours but only allow surgery to keep them for 4 hours so as to not have a problem with the requirement for temperature checks. If the surgery is going to go longer, we go to surgery, they bring the cooler out of the room and we move the blood to a new cooler. We have had no problems getting our coolers through AABB and CAP inspections.

[Ann Viernes]

Several of you have asked for my inservice powerpoint for the blue smart shippers. Attached as a pdf since I can't seem to be able to attach ppt.

Also to answer the validation question, we validated the coolers to 24 hours using the same ice, opening and closing the lids to simulate removal of product. If you write your validation to include changing the ice, then in practice you will have to be changing the ice. This may prove difficult if the cooler is in an OR suite at the time of the needed ice change.

Cool Blue Change 11-8-06.pdf

[Alternatives]

Good morning,

Regarding regulatory requirements, you just need to validate one cooler, if they are all the same type (size...etc) and for the same use. If you want to ship outside your hospital, depending your location, i suggest you to validate them during extreme season, winter and summer. At ambiant too if they will be used within your facility. Validation process should be documented and realized 3 times. Calibrated, and traceable data loggers should be used. CFR Part 11 for electronic signature, to make sure graphs and reports are edited by an authorized person.

I also suggest you to revalidate them every year, jsut to meke sure your validation is still good, and your shipment process has not changed.

Regarding gel packs or regular wet ice, it will depend of what your manufacturer will suggest you. But, basically, always use refrigerants conditionned at the temperature you would like to maintain your product. For 15-25 deg C or -10 and below products, you could use some Phase Change Materials that are very efficient. Refrigerated gel, or frozen ones could be used for others range like 2-8, 1-6...etc. Your manufacturer could help you on that, if they prequalified them, they should be able to provide you SOP and a documented method to show you how to load your box.

Hope it will help you,

Have a good day,

Benoît

Edited January 26, 2009 by Alternatives

[redstaff2003]

thank you for the info

we actually run a series of validation of our coolers using cube ice of 1 kg at the end of the validation 24 hours after we observe that temperature go beyond 10c highest of 12 c. i was thinking of running another validation to our cooler (coleman). we actually using our coolers for transport from mobile sites to our blood center.

anyone of you have experience on coleman coolers?