Thinking Outside the Box

The requirements for transportation of temperature-sensitive medicinal products are demanding. Numerous packaging solutions have been developed over the years to protect the shipped products, and they all have one thing in common – ambient conditions will affect them in some way. This makes the handling procedures extremely important. Industry guidelines tell us that the implementation of a supply chain for temperature-sensitive products shall ensure repeatability in handling, but how can we measure performance and work on continuous improvements?

WHY TEMPERATURE MATTERS

A large number of medicinal products require storage and transportation under temperaturecontrolled conditions. The reason for this is that temperature variations outside the specified range for the shipped product may result in a degradation of the product efficacy and in the worst case they even become harmful. Clever packaging solutions ranging from reusable containers to insulated single use boxes have been developed to maintain the products at the desired temperature.

The packaging itself is not a guarantee that the product is kept at the desired temperature, as it will also depend on other factors such as the preconditioning of product and handling of equipment. The clear focus on quality within the healthcare industry has long since resulted in requirements for temperature monitoring of the product. Placement of temperature recorders with the shipped products, to allow the shipping conditions to be reviewed, has today become an industry standard even if the utilisation is not formalised in a regulatory format.