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  1. VSP Home > OPRP Main > Specimen Shipping Information > General Shipping Guidelines

OPRP - Clinical/Environmental Specimen Shipping Guidelines

    The U. S. Department of Transportation (DOT Hazardous Materials (HazMat) Regulations, 49 CFR 171-180, and the International Air Transport Association (IATA) requires that all persons involved in the packaging and shipping of diagnostic specimens to be familiar with the relevant regulations. To that end, recent changes in the regulations now require that person packaging and shipping these materials receive formal training in the packaging and shipping requirements.

    The shipper - not the transport company - is responsible for the shipment until the package reaches the consignee.

    A diagnostic specimen is defined as any human or animal material being transported for diagnostic or investigational purposes, but excluding live, infected animals.

    Diagnostic specimens are assigned to UN 3373

    Primary packaging requirements

    • Primary receptacle(s) contains the clinical or environmental specimen itself. The receptacle must be watertight to prevent leakage.  Primary receptacles include glass, metal or plastic containers and includes screw-cap tubes, flame-sealed glass ampules or rubber-stoppered glass vials fitted with metal seals. If the primary receptacle has a screw cap, seal it with parafilm, tape, or a similar material. Although glass is allowed as a primary receptacle, the VSP recommends using plastic containers with screw caps as they are less likely to break in transit. Refrain from using urine specimen cups as primary receptacles as they are thin-walled and not designed for transport.
    • Multiple primary receptacles must be wrapped individually to prevent breakage
    • Use enough absorbent material to absorb the entire contents of all primary receptacles in case of leakage or damage
    • When determining the volume of diagnostic specimens being shipped, include the transport media
    • Primary receptacle(s) must not contain more than 500 ml or 500 g.  The entire contents of the primary receptacle is the diagnostic specimen.

    Secondary packaging requirements

    • One or more primary receptacles are placed inside a watertight secondary packaging.
    • Secondary packaging must meet IATA packaging requirements for diagnostic specimens, including 1.2 meter (3.9 feet) drop test procedures.  Since infectious substance packaging surpasses the requirements for diagnostic specimen packaging (see IATA Packing Instruction 602), it can be used, although they generally are more expensive if procured from a vendor.  Infectious substances packaging will have the required specification makings on the packaging.
    • Follow the packaging manufacturer or authorized party's packing instructions included with the secondary packaging.
    • Secondary packaging must be at least 100 mm (4 inches) in the smallest overall external dimension and must be large enough to accomodate the shiiping documents
    • Secondary packaging should also bear a label with the name, address and telephone number of both the shipper and the recipient.

    Outer packaging

    • The outer packaging must be of adequate strength for its capacity, mass and intended use, and must be capable of meeting specific UN performance tests. Packaging that is certified to meet the test standards must bear the UN specification markings
    • When transported by passenger airlines, DOT and IATA limit the quantity per outer package to 50 ml or 50 g. When transported by cargo airlines, IATA limits the quantity per outer package to 4 L or 4 kg. The US Postal Service limits all infectious substance packages to 50 ml.
    • Dry ice, if used, must be placed outside the secondary packaging.  If dry ice is used, the packaging must permit the release of carbon dioxide gas and not allow a build-up of pressure that could rupture the packaging
    • Each package and the air waybill must be marked with the following exact wording:

    UN 3373 DIAGNOSTIC SPECIMEN PACKED IN COMPLIANCE WITH IATA PACKING INSTRUCTION 650

    • Per DOT, IATA and PHS shipping requirements, an itemized list of contents must be enclosed between the secondary packaging and the outer packaging.  Place the document in a sealed, plastic bag to protect it from moisture.  For clinical specimens sent to either CDC labs, the EpiForm should be used as the itemized list.
    • A Shipper's Declaration for Dangerous Goods is NOT required for diagnostic specimens
    • For an example of the labels used in the transportation of diagnostic specimens and infectious substances, see the packing and labels table.