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Safeguarding the supply chain for medicines: what are the problems facing laboratories?

23 June 2015

Find out more about the problems confronting pharmaceutical laboratories in safeguarding the cold chain for medicines, from their manufacture until they are consumed by the patient. Annick Demouy, Quality Assurance Pharmacist at Laboratoires Stradis, tells us about the 4 main problems.

1- The route is long and littered with pitfalls.

Control of the cold chain is essential, from the initial utilisation of raw materials, progressing through the manufacturing operations and packaging and culminating in the transport and storage phases. The supply chain for medicines transported via the cold chain is long and each stage is important in its own right. It is the cumulative effect of temperature deviations that can result in the potential deterioration of a medicine.

2- Choosing the most suitable materials and equipment is not easy.

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Insulated shipping packaging solution with cold source or refrigerated transport, which is the better option?How to choose a refrigerated cabinet for the pharmacy? How to evaluate the cold storage capacity of an insulated enclosure issued to the patient in order to safeguard the final link in the chain? How to simulate the circuitous route taken by a chilled medicine inside a hospital? It is necessary to be well-informed, trained and competent in order to choose the best solution in every situation involving the storage and transport of heat-sensitive medicines.

3- Problems arise in transit and during temporary storage.

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Maintaining the cold chain is under complete control at the pharmaceutical manufacturer’s site: identification of special conditions, compliance with procedures training of personnel, qualification of equipment, temperature monitoring, risk assessment,installation of high-performance alarms, backup solutions in the event of an incident and more. Nothing is left to chance. Yet the problems are more likely to be identified while the medicines are in transit or in temporary storage. It is there that a series of temperature deviations, of variable duration, can occur. The total number of deviations can be just as prejudicialas a cold temperature peak of less than 2 °C. And these temperature deviations are deceptive, since it is not always easy to trace them and measure them.

4- The action to be taken in the event of temperature deviations is demanding.

It is very difficult to assess the impact on a healthcare product of a single deviation or series of deviations in temperature. The challenge facing pharmaceutical laboratories is to expand their knowledge base relating to medicines and to conduct additional stability trials, sometimes exceeding the boundaries of statutory requirements. It is also necessary to select haulage contractors and suppliers with great care. These efforts can incur significant costs and should be reflected in every aspect of medication and transport. What is the point of controlling the cold chain at source if it is disrupted downstream, on an airport apron, on the loading bay of a logistics platform, on a hospital trolley, in the glove compartment of a car or in the patient’s shopping basket when he leaves the pharmacy? 

Faced with these challenges, what is to be done? Examine the vast choice of qualified temperature controlled packaging solutions for transport via the cold chain, attend training courses in control of the cold chain, etc.

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