Cold Chain Testing
Cold chain testing 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. Our customer base for this type of testing consists of major pharmaceutical companies throughout North America.
This service, part of our package testing offering, allows us to not only make sure your isothermal packaging will maintain the product’s label temperature but will also properly survive the shipping hazards. This service is also part of our environmental testing offering that deals with thermal and humidity cycling. Our 14 000 square feet laboratory is staffed with highly experienced professionals, lab technicians and state-of-the-art equipment.
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 testing projects 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 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.
For your cold chain testing qualifications, we can measure up to 256 temperature points simultaneously on a continuous basis with accuracy traceable to the 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.
What drives cold chain testing? 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 testing. Although this evidence is self-supporting, it has been formally recognized by many Trade and Governmental agencies namely:
- Health Canada (guide 0069)
- PDA (Technical bulletin 39)
- World Health Organization
Below is a list of key issues to which you need answers when you want to initiate a cold chain project:
Cold Chain Testing 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 a summer temperature profile on their pack-outs. Most of the time the winter and summer pack-outs are different. Few customers also have a spring/fall 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 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. 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.
- Temperature profile
- Test duration
- Number of different pack-outs to be tested
- Number of replicates (usually 3)
- Counts and dimensions
- Number of thermocouples
- Gel conditioning temperature
Cold Chain Testing Qualification Deliverables
Through our 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 calibrations 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.
Micom Laboratories offers testing services to support each of our customer’s needs for cold chain management.
- ISTA certified chambers (#ST2384)
- CGMP adherence
- Testing performed to ASTM D-3103 and other standards/protocols
- Fully programmable chambers
- Temperature ranges: -70°C to +150°C
- Relative humidity control range: 10% to 95%
- Kaye IRTD traceable calibration to National Institute of Standards and Technology (NIST) (±0.005°C)
- Kaye type T, high accuracy thermocouples
- 128 channel data acquisition system
- Videoconferencing capabilities for test witnessing
We also invite you to learn more about our package testing services by consulting our brochure below.