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Choosing a cold chain packaging
solution is not enough to ensure the quality of a heat-sensitive
product: it is necessary to know how to use it effectively. The health of the
patient depends on it.
The temperature of heat-sensitive healthcare products
is subject to very strict and supervised
regulations. This temperature (usually between +2 °C and +8 °C) must be
maintained during storage as well as in transit. The various players in the
medicines distribution network are responsible for the transport and storage of
The consequences of improper use of an insulated or temperature controlled packaging solution become apparent very quickly: a heat-sensitive product stored in a cold room and then exposed to an ambient temperature of +20 °C reaches +8 °C in 3 minutes; if held in the hand of an operator, it reaches +8 °C in 1 minute!
“The eutectic plates should never come into direct contact with heat-sensitive medicines in order to ensure that they don’t freeze. If a heat-sensitive healthcare product freezes, it could – in the best case – render its active ingredients ineffective and – in the worst case – cause the product to become toxic due to chemical changes or microbial contamination.
In its packaging solutions intended for use by healthcare professionals and at the final stage, Sofrigam has incorporated recesses for the gel packs. This form of separation, which prevents direct contact, is integrated into these recesses. This ensures that the user no longer has any doubts about the guarantee that the product will be maintained at the correct temperature.”
“The eutectic gel releases the cold slowly because it is viscous. This gelling agent traps the other main component: water. The cold is diffused by the effect of thermal conductivity. At an ambient temperature of +20 °C, a non-frozen gel pack will maintain the specified temperature for 30 minutes, whereas a frozen gel pack will maintain the temperature for 24 hours.
Qualification of the packaging solutions guarantees that the temperature will be maintained at the correct level as a function of the outside temperature.”
“It is necessary to draw a distinction between a temperature reading at time T and its recorded figure. The recorder generates a log of the temperatures throughout the distribution chain of the medicine. This device indicates that the accumulated tolerances have not exceeded the authorised thresholds. This is the main purpose of traceability from leaving the initial distribution source until delivery of the product to the in-house pharmacy (IHP).”