Shipping vaccines and biological medicines chilled
Short answer: most vaccines and biologicals must be transported at 2 to 8 °C, in an EPS box with conditioned gel packs (not directly frozen ice, because that is too cold) and a temperature logger. Some mRNA vaccines require minus 20 °C or even minus 70 °C, usually with dry ice. Always consult the product specification and your responsible person for quality for the exact requirements.
The transport of vaccines and biological medicines is one of the most regulated activities within pharmaceutical logistics. The temperature margins are strict and the consequences of an excursion can be serious.
Standard temperature ranges
- 2 to 8 °C: most vaccines, insulins, biologicals
- 15 to 25 °C: controlled room temperature
- minus 20 °C: some mRNA vaccines
- minus 70 °C: deep freeze for specific vaccines (dry ice required)
Which range applies to your product is stated in the manufacturer's specification. We only give the common categories here.
GDP is a starting point for distribution
The GDP guidelines apply to the distribution of medicines. Important elements:
- Qualified packaging solutions (with test data)
- Continuous temperature monitoring during transport
- Full documentation of transport conditions
- Procedures for temperature deviations
- Validated preparation times for packs
You will find more background in What are GDP guidelines?
The right packaging solution
For shipments at 2 to 8 °C (the most common requirement), we offer:
- EPS boxes with validated insulation value
- Conditioned gel packs, which you do not use straight from the freezer
- Temperature loggers for monitoring during transport
- Insulating base and top layers
Important: pre-conditioning
Conditioned gel packs must be prepared before use. Packs that are too cold can damage vaccines through freezing. How long and at what temperature you condition depends on the type of pack and the configuration. Record the procedure after your own test and always follow it.
Why freezing is just as much a risk as heat
At 2 to 8 °C, people often think of warming up. But many vaccines and biologicals must not freeze. A cooling element that comes straight from the freezer can be far below zero at the spot where the product lies against it. That is why you work with an intermediate layer or with conditioned elements. Our range of PCM packs is made for a fixed target temperature. You can read the difference from ordinary gel packs in rigid cooling element or gel pack.
Setting up a test shipment
- Pack the box as you would in practice, with real filling or a representative dummy.
- Place a logger with the product. For extra insight, you can place a second logger against the wall.
- Send the shipment over the real route, preferably in a warm and in a cold period.
- Read out the data and look at the end point and at the curve.
- Adjust the number of elements or the box if the margin is too small.
You will find more about loggers under data loggers.
Packaging mistakes you can avoid
- Too much empty space: fill it up, so that the air in the box is minimal.
- Cooling elements only at the bottom: heat comes from all sides. Place elements all around.
- Leaving the box open: during packing the preparation is lost. Work in a fixed order and close the box immediately.
- No contingency plan: determine in advance what the recipient does in the event of a deviation.
Season and route: one configuration is rarely enough
A box that works exactly in April may have too little margin in August. Conversely, a shipment in winter may become too cold. Work therefore with a summer and a winter configuration and record from which outside temperature you switch. For shipments abroad, the destination also plays a part. Read more about this in sending medicines safely chilled abroad.
Checklist for the recipient
The recipient also plays a role. Include a short instruction, so that the shipment is handled properly:
- Open the box only at the place where the product will be stored.
- Read out the logger immediately and keep the result.
- Note the moment of receipt and the condition of the packaging.
- Report deviations to the sender straight away.
- Dispose of the empty packaging in line with your waste policy. For EPS, you can read more in disposing of and recycling polystyrene foam.
Documentation
Every shipment comes with:
- Packing and shipping procedure (SOP)
- Temperature log (read out after receipt)
- Proof of shipment and track & trace
- Any deviation report
Frequently asked questions
Can I ship vaccines in an ordinary cool box?
That depends on your requirements and on what you can demonstrate. For pharma shipments, a tested configuration with monitoring is the starting point. Let your responsible person for quality advise you.
What do I do in the event of a temperature deviation?
Follow your own deviation procedure. Set the product aside and assess it according to your quality system before you release it.
Cooled Solutions supplies packaging for pharmaceutical logistics. Also look at cold chain packaging for medicines. Request a quotation via our quotation request for your specific situation.
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Need the right packaging straight away? View our EPS boxes, cooling elements, PCM packs and cold chain packaging for the pharma sector.
