Temperature-controlled transport: 2-8 °C, 15-25 °C, the cold chain and why measuring beats promising

For medicines, the manufacturer sets the storage condition on the basis of stability studies, and the European guidelines prescribe which statements may appear on the pack for it. If a product remains stable at 25 °C and 60 percent humidity and at 40 °C and 75 percent, there are no special storage conditions; if it was only tested at 25 °C, the pack says 'Do not store above 25 °C'; if it belongs in the refrigerator, 'Store in a refrigerator (2 °C - 8 °C)'. The statement 'Store and transport refrigerated' is meant for exceptional cases. Terms such as room temperature or ambient are not allowed, because they state no limit. The GDP guidelines then require transport to stay within that limit, and give no figures themselves.

For laboratory specimens the condition comes from the examining laboratory, per test; the Dutch RIVM, for example, gives a condition per specimen type in its submission information. Anyone who says 'refrigerated' or 'room temperature' without a source has therefore not yet agreed a condition.

The cold chain is the series of links, from producer via wholesaler and transport to the recipient, in which a refrigerated product stays within its condition without interruption. The IGJ understands cold chain to mean products that must be stored at 2 to 8 °C or below -20 °C. Transport is the most vulnerable link: it is the only step in which the product leaves the controlled environment, in a car, in a car park, at a reception desk.

A cold chain is therefore not the same as refrigerated transport. It is a controlled chain with a condition that is fixed and demonstrated, not a cool box. A shipment can have a controlled condition without one universal limit applying: a medicine labelled 'Do not store above 25 °C' does not travel in a refrigerator, but it does travel within a limit the manufacturer has set, and a product without a storage condition is, according to the regulator, still kept within room temperature and monitored. Conversely, 'refrigerated' without a label or instruction is not yet a condition. The limit always comes from the product: from the manufacturer via the label, or from the laboratory per test.

The GDP guidelines therefore ask for qualified equipment for temperature-sensitive products (thermal packaging, conditioned containers or vehicles), cooling elements that do not touch the product, and staff who know how an insulated box is assembled per season. According to the IGJ, short domestic rides do not always have to be conditioned; that follows from a risk assessment of duration, outside temperature, packaging and the limits on the label.

The guidelines describe transport as moving medicines between two locations without storing them for unnecessarily long. A ride is therefore one link, and that link itself consists of parts, each of which can break the chain. How temperature is measured and recorded on the way is explained in temperature logging in medical transport; how medicines move through the whole chain in medicine transport.

• Packaging: chosen for the product, the volume, the expected outside temperature and the duration of the ride; cooling elements do not touch the product.
• Monitoring: a risk assessment of the route determines where temperature control is needed and whether measuring at pickup and delivery suffices or a logger travels along.
• Handover: every handover is a moment at which the chain can break, from the loading dock to the front desk; delivery is made to the addressee at the address on the delivery note.
• Deviation: if the temperature moves outside the condition, this is reported to the distributor and the recipient and investigated; the owner of the product decides on usability.

Agreeing a condition is one thing; showing that it was met is the second. The guidelines require measuring equipment to be calibrated at least once a year, and temperature information to be given to the customer on request. The IGJ accepts risk-based monitoring with spot checks, but outliers must be investigated and reported.

A measurement at pickup and at delivery shows the start and the end of the ride; a data logger shows the course. European standards exist for the equipment: EN 12830 for temperature recorders and EN 13486 for the periodic verification of recorders and thermometers. Those standards cover the instrument, not the ride. A measurement that was not taken belongs in the file as 'not recorded', not as 'in order'. How measuring, logging, calibrating and validating relate to one another is explained in temperature logging in medical transport.

If the temperature moves outside the condition, the guidelines require the deviation to be reported to the distributor and the recipient and investigated. The decision whether the product is still usable lies with the owner of the product, not with the carrier, who supplies the facts. What exactly should happen and what is recorded is explained in temperature excursion during transport. How UrgentX transports refrigerated and conditioned shipments, with measurement at pickup and delivery, is described under refrigerated medical transport.