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The parcels containing heat-sensitive medicines must not be handled in the same way as the other parcels. When the medicines are delivered, identify the insulated packaging solutions with pharmaceutical products that have been transported under temperature-controlled conditions and take charge of them as a matter of priority in order to place them as quickly as possible in a refrigerated cabinet (or in a freezer cabinet in the case of products transported in a frozen condition).
A pharmaceutical product must be stored at a specific temperature – ideally at a constant +5 °C and, if possible, between +2 and +8 °C – without being exposed to any temperature fluctuations. A domestic refrigerator is neither as reliable nor as thermally accurate as a professional refrigerated cabinet. In the event of any partial interruption to its operation, there is no indication as to whether the product has been exposed to a temperature in excess of +8 °C. Professional refrigerated cabinets are accurate to a tolerance of plus or minus 1 °C and they are fitted with alarm systems that immediately indicate any malfunction.
The correct action to take: As a matter of priority, take charge of the insulated containers in which the heat-sensitive pharmaceutical products are packed and store them in a professional refrigerated cabinet.
Contrary to received wisdom, heat-sensitive medicines are not simply affected by heat, they are even more sensitive to cold. Placing a heat-sensitive medicine in direct contact with eutectic plates that have been frozen poses a risk that the medicine itself will be frozen. At best, a frozen medicine is ineffective and, at worst, it can be toxic. The medicine should never be in direct contact with the eutectic plates. Moreover, it should never be supplied in a non-insulated sachet, even if it is cooled by eutectic plates.
An insulated packaging solution without a cold source will not keep the product cool. Only the addition of eutectic plates will ensure that the medicine is stored at a temperature range of between +2 °C and +8 °C.
Best practice: the medicine should be supplied in a suitable temperature-controlled packaging solution, while advising the patient that he/she should return home without delay and place the product in a refrigerator as soon as possible. Always use an insulated shipping packaging with gel packs and never place the medicine in direct contact with eutectic plates.
There is a variety of cold chain packaging solutions on the market. Some of them only maintain medicines at the correct temperature for 5 minutes or more while others are capable of storing them at +5 °C for several hours. A heat-sensitive medicine exposed to a mean temperature of +20 °C will reach the +8 °C threshold in less than 5 minutes. Patients must use suitable and reliable insulated packaging solutions. They must also be made aware of the importance of compliance with the cold chain for healthcare products and they should be instructed in the use of temperature-controlled packaging solutions.
Bailleul, Innovations Manager, Sofrigam