Prequalification
For thermal packaging, prequalification means that test evidence already exists for a defined system configuration. This describes the conditions under which the packaging meets its temperature requirements. A specific configuration is therefore prequalified, not an arbitrary combination of similar-looking components.
Which specifications must match?
- Temperature range and demonstrated duration, including the ambient temperature profile used.
- Shipper, cooling elements, number and arrangement, and the required preconditioning.
- Permitted payload, initial state and further limits, such as seasonal variants or planned intermediate storage.
Can the evidence be adopted directly?
Existing data can support your own selection and qualification. The tested conditions are compared with product requirements and the transport process. This does not constitute general regulatory approval. The packaging term must also be distinguished from a separate WHO PQS prequalification. Whether additional testing is needed depends on the specific differences and the user’s quality procedure.
Related terms: Qualification · Packing Instructions
Technical references:
WHO: Qualification of shipping containers
WHO: Cold boxes and vaccine carriers