Knowledge / Selection and temperature ranges
Selecting Pharmaceutical Thermal Packaging: Requirements and Evidence
Pharmaceutical thermal packaging must maintain the prescribed temperature range from packing until the goods enter storage at the recipient’s site. Staff must also be able to prepare and pack it correctly using the available equipment. Check requirements and evidence before comparing prices.
Practical guidance
What information does the supplier need, and how can you tell whether its test report matches your shipment?
Loading an insulated shipper with cooling elements. Whether preparation is feasible at the dispatch site belongs in the quotation comparison.
In this guide
- What the GDP Guidelines require of packaging
- Information the supplier needs
- Describe small and large orders in the requirements specification
- Compare durations only under comparable test conditions
- Try the packing process before ordering
- Which prequalification evidence can be used?
- Who releases the packaging for shipping?
What the GDP Guidelines require of packaging
The EU GDP Guidelines require suitable packaging for the transport of medicines. Selection must consider factors including transport duration, expected ambient temperatures and packaging qualification. The description “GDP-compliant box” alone does not show whether these requirements are met for your shipment.
This article concerns medicinal products for human use in a GDP context. For diagnostics, samples and other biotech products, first establish the applicable product and transport requirements.
Information the supplier needs
- Product: permitted temperature range, temperature at packing, dimensions and mass of the smallest and largest loads.
- Transport: dispatch and receiving locations, transport modes, intermediate storage and the longest duration realistically expected.
- Temperatures in transit: available measurement data, summer and winter differences, and transfer points without temperature control.
- Dispatch site: refrigerators and freezers, space for preparing coolant packs, staff and daily shipping volume.
- Procurement: single-use or reusable packaging, delivery quantities, storage space and required documentation.
An enquiry such as “48 hours at +2 to +8 °C” leaves two important questions unanswered: under which ambient temperatures, and with which payload, should the packaging deliver this performance? The particular risks of this range are explained in the article on shipping at +2 to +8 °C.
Describe small and large orders in the requirements specification
Example: A biotech company ships individual reagent containers and full cartons. Both fit in the same shipper. However, the smaller shipment contains less liquid and may sit closer to a cooling element. The test report for the full carton therefore does not automatically apply to the small order.
Describe the smallest and largest intended loads using dimensions, mass and a photograph or diagram. Add initial temperatures and waiting and transfer times. Record missing transport data as an open question; an arbitrary time allowance does not replace obtaining those data.
| Document | What to check |
|---|---|
| Requirements specification with load variants | Are all intended products, quantities and transport lanes described? |
| Test report with configuration and sensor positions | Which requirements does the tested configuration meet? Where are further tests still needed? |
| Packing instructions and preparation specifications | Can staff prepare the coolant packs as prescribed on site and pack the required number of shippers in time? |
Cross-check item numbers and revisions. If the test report specifies a different coolant pack version from the quotation, clarify this difference before ordering.
Compare durations only under comparable test conditions
Two packaging systems may be advertised with the same duration even though one was tested empty and the other loaded with product. Ambient temperatures and sensor positions may also differ. The number of hours alone then does not allow a performance comparison.
Request the temperature histories from all relevant measurement locations. A sensor in the centre, for example, does not show whether a small container at the edge became too cold. Also check the acceptance criteria defined in advance; an average across several sensors can conceal individual limit breaches.
For each quotation, record whether requirements are met, additional testing is needed or suitability has not yet been demonstrated. Include the cost of outstanding tests in the comparison.
Try the packing process before ordering
Have trained staff prepare and load a sample package using the packing instructions. Do the coolant packs fit in the available equipment? Is there enough space to stage the components? Are similar-looking elements confused?
Record packing and waiting times. Then compare the technically suitable quotations in terms of purchasing, freight, preparation and returns. The worked TCO calculation helps bring these costs together per shipment.
Which prequalification evidence can be used?
An existing supplier report can reduce testing effort if its configuration and conditions match the application. Compare minimum load, initial temperatures, duration, ambient temperature profile and coolant pack preparation against your requirements specification, point by point.
Assess each difference and define additional tests where necessary. The article on qualifying thermal packaging explains how this becomes a test plan. Supplier prequalification is neither WHO prequalification nor independent certification.
Who releases the packaging for shipping?
Quality assurance assesses the test evidence and defines how deviations are handled. Logistics confirms that preparation, packing and transport can be performed as intended. Procurement compares quotations that fully describe these requirements.
Document the approved configuration with item numbers and revision. If a coolant pack or shipper is later replaced, assess whether the change affects temperature maintenance before use.
Sources
- EU GDP Guidelines 2013/C 343/01, Chapter 9. Chapter 9: transport, packaging and special storage conditions for medicinal products for human use.
- WHO: Qualification of shipping containers, Supplement 13 (2015). Sections 2.1–2.5: development, qualification and reuse of shipping containers.
Sources checked on 12 September 2026.
Enquire about pharmaceutical thermal packaging from THERMOCON
Send us your temperature range, payload data and planned shipping process. Existing test reports and temperature measurements help narrow down suitable systems.