Regulatory authorities such as the UK (MHRA), European (EMEA) and US (FDA) regulatory authorities require the qualification of temperature controlled transport equipment GDP (good distribution practice).
The Official Journal of the European Union has issued Guidelines (7th
March 2013) on:
Distribution Practice of Medicinal Products for Human Use.
Pharmaceutical products require to be conditioned and maintained at temperatures to ensure that they lose none of their potency and efficacy.
Some products, for example-fractionised plasma, are stored frozen and rules sets out in such publications as the European Pharmacopoeia have strict requirements for temperature deviation.
Transportation can be by multiple techniques utilising active and passive temperature control systems.
Such systems include:
|· Insulated mini containers
· Air freight pallet shippers
· Insulated containers with eutectics/dry ice
· Insulated air freight containers with eutectics
· Insulated refrigerated containers
· Insulated refrigerated air freight
· Refrigerated vehicles
In addition, pharmaceutical equipment must follow validation protocols that provide evidence that the equipment is fit for its intended purpose. These provide a high degree of assurance that the carriage criteria will consistently meet requirements.
Within our environmental chambers we can temperature map and thermally validate the equipment within a temperature range between
-20 and +50°C.