Validated isothermal packaging for medicines
As a manufacturer of isothermal packaging, Isovation offers validated isothermal packaging designed to ensure the safe transport of medicines, vaccines and biological products. We rigorously test our packaging to guarantee its compliance and performance, in accordance with NF S99 700 and other international standards (ISTA…).
In the healthcare sector, there are specific temperature intervals: keeping medicines within these intervals ensures compliance with the cold chain.
Why use validated isothermal packaging to transport medicines?
The transport of heat-sensitive products in the healthcare sector must meet constraints in terms of temperature maintenance, regulatory constraints, logistics (mode of transport, transport plan, etc.), and must enable tracking and traceability.
The use of a validated stand-alone packaging satisfies these constraints.
Isothermal packaging is said to be validated when it has been tested under conditions as close as possible to the real thing. The products have been inserted into the packaging, and temperature probes have recorded the temperature of the products throughout transport. This ensured that the product (drug) temperature was maintained within the desired temperature range. If the product temperature has been maintained within the desired range for the duration of the test, the test complies with the specifications, and the isothermal packaging is validated.
A validated isothermal pack, supplied with its validation report, and its method of use: how many cold accumulators, storage conditions before dispatch, quantity of health products to be inserted inside the pack.
Depending on the season, the method of use evolves and leaves no room for doubt: the temperature inside the pack will be maintained within the desired temperature range and the cold chain will be respected.
What are the benefits of validated packaging for the customer?
Validated packaging is the guarantee of receiving a health product that has been transported in compliance with the cold chain. Regardless of the type of transport used, there will be no load breakage, no impact when opening/closing truck doors, and no impact during transfer times for storage, loading and unloading.
Why is Isovation able to validate isothermal packaging?
As a manufacturer of isothermal packaging, our expertise lies not only in mastering the production of such packaging, but also in being able to confirm the performance of our solutions.
Our isothermal solutions are validated according to the NF S99 700 standard, the ISTA-7D standard or according to actual transport plan temperature readings.
Our climatic chambers for testing our solutions are checked annually and meet the requirements of standard NFX 15 140 (Specifications concerning climatic and thermostatic chambers, their characterization and verification).
Our temperature probes are also checked annually against a UKAS-certified measurement chain (European standard).
We manufacture isothermal packaging and are able to determine its performance under different transport conditions: air, road…
Which packaging can be validated by Isovation?
Packaging is said to be validated once we have carried out a real-life test under specific conditions (compliance with NF S99700 or other standards). We can validate any type of packaging. A few hours or several days, refrigerated 2/8°C, ambient 15/25°C, sub-zero temperatures…
There are various standards for validating the performance of isothermal packaging, such as ISTA-7D, NFS99700. However, temperature readings from the actual transport plan remain the best input data for designing isothermal packaging as accurately as possible, since it will be validated according to real data and not theoretical temperature profiles.
Key validation steps
The test protocol
In order to validate a stand-alone isothermal package, it is essential to draw up a test protocol together. This allows you to precisely organize the test procedure, from product preparation to test launch.
It determines every parameter that could influence the test result: probe positioning, package filling rate, number of accumulators, temperature at which products are inserted into the package, type of product tested (medicine, vaccine, biological product, etc.), etc.
No test in a climatic chamber can be carried out without the test protocol being validated by the customer beforehand.
Performing the test
Testing is carried out in-house. The packaging is prototyped in our design office for testing in one of our climatic chambers.
Our climatic chambers are tested annually and meet the requirements of standard NFX 15 140 (Specifications concerning climatic and thermostatic chambers, their characterization and testing).
Our temperature probes are also tested annually using a UKAS-certified measurement chain (European COFRAC standard).
The deliverable, proof of performance
Following each test carried out in our climatic chambers, we draw up and submit a validation report. This lists the conditions under which the tests were carried out, as determined in the test protocol. Details are given of the temperature probes used (probe number / valid verification report) and their location in the packaging.
The validation report establishes what was recorded during the test: compliance with specifications or temperature excursions (duration and maximum/minimum temperatures reached).
Validation reports for all our validated packaging are available on request.