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.