Transporting biological samples is a critical link in modern medical diagnosis. Even samples classified as non-infectious must be packed and handled correctly to protect specimen integrity and everyone involved in transport.
The legal framework: who sets the rules?
The applicable rules vary with the transport mode, but they pursue the same objective: a safe, documented and leak-free journey.
- ADR regulates the international carriage of dangerous goods by road in Europe.
- IATA defines the requirements applicable to air transport.
- WHO guidance establishes global good practice for biosafety and handling.
The golden rule: the triple-packaging system
For a human or animal specimen where professional assessment indicates a minimal likelihood that pathogens are present, the packaging must prevent leakage and protect the receptacles throughout the journey. The system uses three successive components, each with a clear role.
Classification is not based on the specimen name alone. The shipper must determine, together with qualified medical or laboratory personnel, whether the specimen is exempt, Category B (UN 3373) or Category A. Markings and documents are selected only after this assessment.
- The primary receptacle is the tube, vial or container holding the specimen directly. It must be leakproof; the closure must be fully secured, and multiple fragile receptacles must be separated to prevent contact and breakage.
- Absorbent material is placed inside the secondary packaging around the primary receptacle. For liquids, the gauze, absorbent paper or technical material must be sufficient to absorb the entire volume if breakage or leakage occurs.
- The secondary packaging is a sealable bag or rigid receptacle that is watertight and leakproof. Documents that must not come into contact with the specimen are protected separately from the primary receptacles.
- The outer packaging must have strength appropriate to the weight, volume and journey. At least one surface must measure a minimum of 100 × 100 mm, with enough space for legible shipper and consignee details and the marking required by the classification.
Four checks before closing the box.
The sequence matters: primary receptacle, absorbent material, secondary packaging and outer protection.
Leakproof primary receptacle
The tube or vial contains the specimen directly. Its closure must be fully secured, and multiple fragile receptacles must be separated to prevent contact and breakage.
Sufficient absorbent material
Gauze or absorbent material is placed around the primary receptacle inside the secondary packaging and must be sufficient to absorb the entire liquid volume.
Leakproof secondary packaging
A sealable bag or rigid receptacle forms the second watertight barrier. Documents are kept separate and protected from moisture.
Strong outer packaging
The outer packaging protects the assembly from impacts and provides space for clear contact details and the marking required by the classification.
Absorbent material is not decorative: the quantity must be sufficient to absorb the entire contents of all primary receptacles inside the secondary packaging.
Clear on the box. No contradictory markings.
- ‘Exempt human specimen’ or ‘Exempt animal specimen’, as applicable.
- Full name, address and telephone number for the shipper and consignee.
- No UN 3373 mark when the specimen is classified as exempt.
- Additional markings when dry ice or another regulated refrigerant is used.
Important: the shipper must confirm the specimen classification with the laboratory or qualified medical personnel and verify it against carrier rules and the transport mode.
Correct labelling for non-infectious biological specimens
When professional assessment confirms a minimal likelihood that pathogens are present, the outer packaging is visibly marked ‘Exempt human specimen’ or ‘Exempt animal specimen’, as applicable. Full shipper and consignee details, including an available telephone number, must appear on the package.
The UN 3373 mark does not apply to an exempt specimen. It is reserved for Category B biological substances and brings distinct requirements. Dry ice, liquid nitrogen or another regulated refrigerant requires additional markings and packaging and transport conditions.
Old labels, barcodes and incompatible markings must be removed. The wording must remain visible and legible and must not be covered by tape, film or transport documents.
Temperature, documents and traceability
The required temperature is established with the laboratory and maintained using insulated packaging, cooling elements and monitoring where necessary. Laboratory forms and related documents are protected from moisture, while the route, contacts and critical deadline are confirmed before collection.