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Cold Chain

Cold chain qualification testing services

Micom Laboratories Inc. offers cold chain qualification test services specifically tailored to your needs. Our ISTA certified laboratory is one of the very few truly independent third party laboratories in North America that does cold chain qualification as well as other test services without selling any packaging products. We can execute test protocols for your cold chain qualification needs with our fully programmable walk-in chambers that can hold anything from small parcels up to LD-3 aircraft containers. For smaller pack-outs and long term stability studies we can also use one of our many reach-in units. Using our Agilent VEE-Pro© powered proprietary computer interface we will accurately monitor your payload’s temperature at strategically located positions while it is being cycled through the temperature profiles that simulate foreseeable temperature extremes your product might be exposed to during shipping. We can measure up to 256 temperature points simultaneously on a continuous basis with accuracy traceable to national Standards (NIST). For calibration purposes we use a GE-Kaye IRTD (NIST traceable) with an accuracy of ±0.005oC. All our thermocouples are high accuracy type T Kaye thermocouples.

Cold chain testing

Through our cold chain qualification testing we will demonstrate that your product can stay within its label temperature range using the proposed package when exposed to foreseeable temperature extremes. Our exhaustive test reports contain all the relevant information and technical data necessary to be able to accurately repeat any part of the testing performed to establish your pack-out cold chain qualification. Our reports will also have all of the relevant information for packing the product according to the successful pack-out schemes (packaging, icing, dunnage) including color photographs for each step of the pack-out operation. Our reports will also have all calibration and raw data as well as temperature curves graphically demonstrating your product’s cold chain qualification compliance with its products temperature label under the temperature profile specified.

Cold chain qualification driving forces

What drives the market? Is cold chain qualification a buzz word? The answer is no. Drugs and medications need to be thermally protected in relation to their stability data for the very same reasons that you have to do stability data. Although this evidence is self supporting, if has been formally recognized by many Trade and Governmental agencies namely:

Cold chain qualification is not an issue that will go away. Actually this is quite the opposite.

Cold chain qualification process

Your cold chain qualification process starts with your product’s label temperature and its stability data. You then need to establish what the temperature profiles are that you want your pack-out to be challenged with. These temperature profiles should be typical of the most reasonable worst case conditions your product will encounter during normal distribution. Usually people need to run a winter and temperature profile on their pack-outs which are most of the times different. Few customers also have a spring/fall cold chain qualification pack-out. You also need to bracket the number of doses you want to ship at once; the smallest and the largest number of doses each pack-out design may contain.

Once this is established, you can either try to design your own cold chain qualification pack-out if you feel you have the proper expertise, or you can save yourself lots of headaches and lab costs and hire a consultant that will design your pack-out and help you with your temperature profiles (see cold chain links).

Once you have established your product sensitivity, what your minimum and maximum payloads for each pack-out are and your temperature profiles, you can have your cold chain qualification pack-out designed and then tested.

We would need the following to be able to give you a quote to qualify your pack-out:

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