All samples must be appropriately packed in compliance with relevant regulations.
Packaging of diagnostic samples
Inadequately packaged samples pose a health and safety risk due to leakage of contents which may contaminate other mail, vehicles, premises, and laboratory reception facilities. There is a legal onus on the sender of diagnostic specimens to ensure that the packaging conforms to legal requirements. Some of the main requirements for packaging and transporting diagnostic specimens are outlined below.
Definition of diagnostic specimens
The rules governing the packaging and transportation of pathological specimens are encompassed in the European Agreement for Transportation of Dangerous Goods (ADR) regulations. Under these regulations, a diagnostic specimen is any “animal material including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment or prevention”. Specimens are classified as Category “A” or “B” depending on the pathogen they either are known to contain, or potentially contain, with much stricter regulations applying to Category “A” material. Fish and shellfish pathogens are considered to be Category “B”. The correct shipping name for Category B is “Biological Material, Category B”, the identification number is “UN 3373” and the material must be packaged in compliance with Packing Instruction 650.
More information on packaging can be view at the following links:
The package labelling must include:
- The UN 3373 hazard diamond and a “Biological Material, Category B” label on the outer package (available from specialist label suppliers).
- The name and address of both the consignor and consignee.
- The name and telephone number of a “Responsible Person” who is familiar with the contents and the hazards it may pose is required either on the waybill if a courier is used, or on the package itself.
ADR Packaging Instruction 650 outlines the packaging requirements for the transportation of diagnostic specimens. This states that the package should include:
- A leak proof primary receptacle that contains:
- no more than 1L or 1kg of specimen including fixative or transport media if being sent by courier, or:
- no more than 50 ml or 50 g if being sent by post.
- A layer of absorbent material sufficient to absorb the entire volume of any liquid contents in the package.
- Secondary packaging that is leak-proof with a maximum volume/weight of:
- 4L/kg for transport by courier or:
- 50 g or 50 ml if sent by post
- An itemized list of contents between the secondary packaging and outer packaging
- Outer packaging e.g. envelope or box that bears the label “Diagnostic Specimen” and the names and contact numbers of both the consignee and addressee.
Packaging is required to be tested to meet defined rigorous tests and all commercially available sample containers are produced to comply with this specification. If commercial packaging is not used then it is the responsibility of the supplier to ensure that the packaging used meets the required specification.
- Multiple primary receptacles may be placed in the secondary packaging but must be wrapped individually.
- Polystyrene containers may crack under the loads normally experienced during transport by post and are not therefore suitable for diagnostic specimens unless placed within a more robust outer container.
- Hypodermic needles should never be included with diagnostic samples.
- Do not place blood tubes directly in an envelope (padded or otherwise) unless protected by a rigid secondary container.
For further details see “Guidelines on transport of infectious substances”
Import licence requirements
Note that an import licence is required for all samples that originate outside Northern Ireland. Please contact us if you require one.