Considerations for all medicines in transit
It is important to take reasonable steps to make sure that intended storage conditions are maintained when medicines are being transferred from one location to another:
- whilst awaiting collection or despatch
- during transfer from permanent storage to transport vehicles
- in transit
- during delivery and transfer to new storage
Reasonable measures include:
- choosing appropriate transit packaging
- accurate and unambiguous labelling with name and address of intended delivery point and intended storage conditions
- use of specialist logistics provider or other approved provider
- driver instructions as appropriate
- requirement for an audit trail including logistics and times, and temperatures for cold-chain medicines
Exposure to temperatures below 0°C will freeze most medicines and carries a significant risk of causing irreversible damage.
Transporting medicines at 2°C to 8°C
There are three options for transporting refrigerated lines: cool box, refrigerated transport or mini-fridge.
Use cold-chain transit containers and cool packs from a recognised medical supply company. Domestic cool boxes should not be used.
The cool box manufacturer should be able to provide assurance that a stable temperature within the specified range will be maintained for a specified time.
Monitor the temperature
With time and use, cool boxes may no longer be able to maintain this temperature range for extended periods, so temperature monitoring is always required. A calibrated data logger is preferred. If you do not have one of these, use a min / max thermometer. Refer to our article series about temperature monitoring for further information.
Prepare cool packs
Before use, cool packs should be stored in accordance with the manufacturer’s instructions, usually at 2°C to 8°C. In general, ice packs and frozen cool packs should not be used unless the cool box manufacturer’s instructions specifically recommend them. This is because they may create cold spots, and result in the medicines freezing.
Individual manufacturers’ instructions for packing the cool box must be strictly adhered to. It is important to prevent direct contact between the medicine and the cool packs to protect the medicine from risk of damage from excessive cooling. Medicines should be packed carefully to avoid breakage.
Cool boxes should be re-validated according to the manufacturer’s instructions and under simulated conditions of actual use.
It is not necessary to use cool boxes if refrigerated transport is used.
Choose a specialist medicines logistics provider able to provide evidence of temperature control for each delivery.
Electric cool boxes and mini-fridges may also be used.
These run off the vehicle’s power, so validation is essential and must take into account the impact of turning the engine off if there are multiple stops during the journey. This will give assurance that the temperature is maintained until the medicines are delivered.
Transporting frozen medicines
It is unusual to transport frozen medicines.
If this is necessary, is it usually preferable to choose a specialist medicines logistics provider able to provide shipping containers and evidence of temperature control for each delivery.