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Heat-sensitive medicines, which are frequently very expensive, need to be transported under conditions of close surveillance in order to safeguard their integrity. How can it be proven that the dispatched products are being transported at the correct temperature? Whose responsibility is this?
Compliance with the cold chain is one of the
fundamental principles of the pharmaceuticals industry with regard to the
transportation of medicines. It safeguards the integrity of vaccines, insulin
and cancer-inhibiting drugs, as well as other heat-sensitive medicines. These
very expensive products (it is by no means rare to see eye drops on sale for
more than 1,000 euros) require forms of packaging, modes of transport and traceability
up to the value. Thus, measures must be taken in order to ensure that the
products are transported under ideal conditions and maintained at the correct
temperature throughout the journey. Traceability of temperatures is one of the
appropriate responses to the secure transportation of medicines under
controlled temperature conditions.
In France, at each link in the chain, the Public
Health Code insists on guarantees regarding the conservation of heat-sensitive
healthcare products. This applies to the manufacturers of medicines, the
wholesale distributors and the pharmacists. Each of them must be able to prove
satisfactory conservation of the product. On arrival, the integrity of the products is verified by checking the documents
relating to traceability of compliance with the cold chain.
More generally, the Good Distribution Practices of Medicinal Products devotes several paragraphs to the responsibility of transporting heat-sensitive medicines, clearly identifying the responsibilities of everyone involved:
Well, does a stand-alone container guarantee strict
maintenance of temperature at +5 °C, comprehensive traceability and proof of the
maintenance of temperature from the time of acceptance of the products?
The iBox is a unique,
semi-active cooling box, specially designed for transporting
pharmaceutical products with a high added-value (clinical trials, orphan
The iBox from Sofrigam, a refrigerated box with a temperature-monitoring system
An intelligent container with on-board electronics, it accurately maintains the temperature, with constant recording of the internal and ambient temperatures to ensure traceability of temperatures throughout the period of transit. This is achieved with the aid of:
An impressive combination of technological and thermal
efficiency, nonetheless the iBox is very easy to use and ensures total control of shipment of pharmaceutical
products via the cold chain.