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COOL*SAFE Test results

COOL SAFE_Testergebnisse Thermometer

THE BIGGEST DANGER: FREEZING OF MEDICINE FREEZING CHANGES THE MOLECULAR STRUCTURE OF THE MEDICINE AND MAKES IT UNUSABLE

The biggest danger with medicine cool bags is NOT that your medicine may not stay cold long enough. The biggest danger is that your medicine can freeze.

The word “cool bag” or “cool box” implies, it is a bag or box that “cools”. However, most cool bags freeze the medicine. So, one would actually tend to call most cool bags as “freezing bags”. And this unfortunately also applies to most of the so-called medicine cool bags.

Your medicine must not cool below + 2 ° C and it must never be frozen.

We had the COOL*SAFE medicine cool bags tested by the TÜV with different medicines. The TÜV informed us that one could only write “TÜV-certified”, if there was a special test setting for the underlying TÜV measurements, which the TÜV does not have – and which does not also exist nationwide. There are a few other specifications by the government that would need to be in place for TÜV to “certify” medicine cool bags. These specifications are however not possible for the TÜV to execute.

Thus, it is technically not possible to have a “product certification” of medicine cool bags carried out by the TÜV, so as to warrant one to write “TÜV-certified”. No one can do that.

Nonetheless, TÜV has determined measurements values with our COOL*SAFE cool bags.

And these readings, which are based on the TÜV-measured values, are the foundation of the data that you can find on this website. Since there is no nationwide standard that tells the TÜV how to measure the temperature of medicine in cool bags, so that these readings are reproducible, the TÜV has developed a special methodology to make the readings as accurate as possible and reproducible. These measurements were thus not “evaluated” by the TÜV, but “recorded”.

For this, the TÜV has issued us with a number of TÜV reports. In these reports, it can be seen that the recordings of the measurement results showed that the drug temperature of the measured medicines in the individual cool bags does not fall below + 2° C. Furthermore, the TÜV has recorded the cooling duration on how long the temperature of the measured medicine remains cool between +2° and + 8° C.

With COOL*SAFE, you can remain calm, since your medicine will not be frozen, yet will remain cool for hours.

1. THE SUPERIORITY OF THE COOL*SAFE COOL BAGS: ONLY THEY DELIVER MEASUREMENT RESULTS ABOVE + 2 °C! *

With COOL*SAFE, temperature sensitive medicines that need to be refrigerated and blood remain in the prescribed temperature range! With COOL*SAFE you can transport your cold-chain requiring product in the cold chain, between +2 and + 8° C.

Also drugs that can stay warmer than + 8 °C, e.g. 15 ° C or 25 °C, must by no means get frozen. Such medicines are called “refrigerated” medicines. Of course, these medicines are equally safe with COOL*SAFE.

2. MOST OF THE SO-CALLED "MEDICINE COOL BAGS" FREEZE MEDICINES. FREEZING CAUSES AN IRREVERSIBLE CHANGE IN THE MEDICINE’S MOLECULAR STRUCTURE

The freezing of the medicine already takes place within the first 5 – 10 minutes and can last up to approx. 1 hour.

Also, a medicine will heat up to + 8 °C within the first few minutes, if one gets to transport it without a proper medicine cool bag. A “short way home” for you is too long for your medicine!

You need a secure cool bag that really protects your medicines.

Here, you can read about the changes in the molecular structure of your medicine, and the effects this has on your hea...

3. BEST RESULTS OF THE LENGTH OF THE COOLING DURATION! FINALLY, YOU CAN MAKE YOUR PURCHASES OR GO ON A JOURNEY WITH PEACE OF MIND...

Cooling duration, e.g. for the COOL*SAFE-Basic model:

  • 2° C to 8° C, with an ambient temperature of 20 °C: approx. 17.40 hours
  • 2° C to 8° C, with an ambient temperature of 30 °C: approx. 11.25 hours
  • 2° C to 8° C, with an ambient temperature of 40° C: approx.  .6.20 hours

For the other models, please read the cooling duration for each model (in the product data sheet).

FRIO COOL BAGS ARE ONLY SUITABLE FOR INSULINES THAT ARE CURRENTLY IN USE,

But NOT for the transport of your insulin or other cold chain requiring medicines, which you collect from the pharmacy!

The prescribed temperatures of +2 °C to +8 °C or +2 °C to +15 °C are not achieved with FRIO. (Please pay attention also to the insulin package information leaflet!)

Whenever it is written in the drug’s information leaflet that a drug or insulin needs to be stored at 2 – 8 ° C, it also means it has to be transported within this temperature range.

With COOL*SAFE, you can transport any medicine in the cold chain, between +2 ° to +8 °C. Thus, COOL*SAFE is also the perfect insulin cool bag.

FRIO cool bags are very suitable for those medicines that can be allowed to warm to 20 °C and when the corresponding ambient temperatures are higher than about 25 °C. It’s only from around this temperature that the evaporative effect of the crystals begins and thus the cooling from FRIO. With FRIO, however, the “cooling” temperature itself stays at a high range of over approx. 22 °C.

Conclusion: FRIO is good for those insulin pens, which are currently being used, since they can be allowed to warm to about 28 – 30 °C (as per package leaflet). For all other insulin that have not already started being used, and for all other cold chain medicines, FRIO is not suitable, because the medicines will get too warm.

The cooling effect of the FRIO cool bags is based on the evaporation of water stored in crystals. The contents of the bag often become moist, and this can soften the medicine boxes. We should also keep in mind that blood glucose meters should never be allowed to get moist. Also, blood glucose meters should not get too warm, in order not to give false measurement results.

The COOL*SAFE cool bags and their contents stay dry!

* Comparison of the cool bags available in German pharmacies FRIO expedition, Ardo, Param, Haselmeier, Cool*Safe

* These measurements results are from TÜV Rheinland and were measured with one drug. Of course, the TÜV cannot test the cool bags with all existing medicines, thus deviations in the cooling duration may arise with other drugs.