Which is the most appropriate solution for transporting heat-sensitive products in compliance with the cold chain?
There are two ways of transporting fresh or frozen healthcare products at controlled temperatures: refrigerated vehicles or cold chain packaging. Detailed below are 7 determining factors, as a guide to choosing the best solution.
For transporting medicines from the manufacturing laboratory to the storage or distribution site (by truckload) or by groupage transport (by bulk load vehicle), a refrigerated vehicle is used. In this case, the loading and unloading areas must also be refrigerated in order to prevent any interruption to the cold chain.
Preference should be given to insulated packaging solutions, refrigerated by gel packs or dry ice (below –30 °C) in the case of logistics networks involving air transport, or if the platforms and the loading/unloading areas are not refrigerated.
For very low temperatures (below –30 °C), insulated containers refrigerated by dry ice should be used. Products transported at temperatures between +15 and +25 °C also require either cooling boxes with specific facilities or air conditioned vehicles.
The permissible tolerances for the required temperature range can be determining factors in the choice of solution. By utilising the tolerances, it may be possible to opt for a solution with deviations from the specified temperature range – a solution that is simpler and, in turn, less expensive and which may, for example, reduce the dispatch costs.
This parameter has the greatest impact on the cost of temperature controlled transport. If the quantity of the products to be transported from one point to another does not warrant the use of a refrigerated vehicle, cold chain packaging is the best solution.
If a refrigerated vehicle is the preferred choice for transferring pharmaceutical products from the manufacturing laboratory to the storage or distribution site, it is possible to combine sufficient quantities of various heat-sensitive products in one load for several ultimate destinations.
If a temperature profile incorporates open segments (where the temperature cannot be controlled and is determined by the ambient temperature) where the refrigerated vehicle is unable to gain access, the preferred choice is temperature controlled packaging, due to its inbuilt cooling capacity. In such cases it can either be used on its own or in combination with an air conditioned vehicle.
If a temperature profile incorporates hot segments and cold segments (at negative temperature), a combination of an air conditioned vehicle and temperature controlled packaging may be the best solution.
In order to comply with the cold chain, it is essential to qualify the performance characteristics of the resources employed, in accordance with current industrial standards. In France, for example, insulated and temperature controlled packaging solutions are regulated by AFNOR Standard NF S 99-700.
In the absence of any qualification standard for refrigerated vehicles used to transport healthcare products, it is sufficient to obtain approval by the ATP, which regulates processed foodstuffs.
Following qualification, the solution must be validated under actual conditions of use.
Cost is always a determining factor: if two solutions satisfy all the requirements of the specification, the cheaper solution will prevail. The cost of the solution corresponds to the overall logistical cost, which includes the price of the mode of transport or of the container and all the costs incurred by preparation and use (equipment, energy consumption, labour costs, etc.).
The cost of the solution is also dependent on the specified safety level: the safety margin must be evaluated without exaggeration, in order to avoid unnecessary requirements which complicate the solution and increase the cost.
A life cycle analysis (LCA) is conducted in order to compare the environmental impact of each solution. This analysis includes all the systems, all the materials and all the energy involved in the solution, from extraction of the raw materials up to disposal at the end of the life cycle.
Insulated shipping packaging solutions and refrigerated vehicles are not necessarily in competition with each other; instead they are two complementary resources. Each solution is suitable for certain cases and for certain stages in the distribution of medicines. The solution employed must be qualified and it necessitates precautions and the application of best practice in order to ensure its effectiveness.