Micom Laboratories offers cold chain qualification laboratory routine and non-routine material testing for a wide range of materials and products.
Whether it is for temperature and humidity cycling, ultraviolet exposure, surface finishes, packaging testing or mechanical properties, our material testing experts will be happy to help you put together a meaningful test protocol that will address your regulatory and technical needs.
Micom Laboratories offers cold chain qualification services to ensure you meet FDA, Health Canada, WHO and any other regulatory requirements in maintaining your product’s label temperature throughout the complete shipping process.
Cold chain qualification test services
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 multiple 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 ±0.005°C. All our thermocouples are high accuracy type T Kaye thermocouples.
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.
Once this is established, you can either try to design your own 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 who 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 pack-out designed and then tested.
Cold chain qualification driving forces Drugs and medications need to be thermally protected in relation to their stability data for the very same reasons that you have stability data. Although this evidence is self supporting, it has been formally recognized by many trade and governmental agencies, namely:
- Health Canada (guide 0069)
- FDA
- PDA (technical bulletin 39)
- World Health Organization
- International Safe Transit Association (ISTA 7D)
More than a single test
With years of specialised technology testing expertise, in-depth experience and absolute commitment to meet your regulatory and technical chalenges, our team of experts does more than simply test your products.
Micom Laboratories strives to deliver material testing services of outstanding value to the pharmaceutical industry.
Micom offers a wide variety of mechanical and physico-chemical material testing according to various standards (ASTM, CGSB, ISTA, ANSI, CSA, Bombardier and others). Our specialists can also provide you with custom material testing services focused on your specific needs.