Guide To Shipping Biological Materials
Guide To Shipping Biological Materials
Guide To Shipping Biological Materials
Introduction
This manual is to aid in the shipment of biological materials from NC State University in
compliance with the US Department of Transportation (DOT) and the International Air
Transporters Association (IATA). This manual does not include agricultural and foreign
customs restrictions.
Carrying biological materials on ones person onto an aircraft is prohibited. All biological
materials must be properly packaged and checked as luggage or transported via a courier.
The steps to properly ship biological materials include:
Classification
Packaging
Labeling
Documentation
Anyone participating in any one of the previous steps must be trained and certified
according to DOT and IATA regulations. Training can be scheduled at the
Environmental Health and Safety Center by calling 515-2895.
Biological materials fall into the following categories:
Infectious substances
o Category A infectious substances
o Category B infectious substances
Diagnostic specimens
Biological products
Genetically modified organisms and micro-organisms
Unregulated biological materials
Infectious substance shipping regulations do not apply if the biological material to be
shipped cannot cause disease. Substances that have a low probability of containing
infectious substances such as water samples or food are not subject to these requirements.
Infectious Substances
Infectious substances are those substances known to contain, or reasonably expected to
contain pathogens. Pathogens are defined as microorganisms or recombinant
microorganisms that are known or reasonably expected to cause infectious disease in
humans or animals. However, they are not subject to the provisions of shipping if they
are unlikely to cause human or animal disease. Infectious substances are subject to the
regulations only if they are capable of spreading disease when exposure to them occurs.
UN 3373 label
Class 9 label, including UN 1845, and net weight if packaged with dry ice
Diagnostic Specimens
Any human or animal material including, but not limited to, excreta, secreta,
blood and its components, tissue and tissue fluids, being transported for
diagnostic or investigational purposed, but excluding live infected animals
Diagnostic specimens must be assigned to UN3373 unless the source patient or
animal has or may have a serious human or animal disease which can be readily
transmitted form one individual to another, directly or indirectly and for which
effective treatment and preventable measures are not usually available in which
case they must be assigned to UN2814 or UN 2900.
Packaging
Diagnostic and clinical specimens must be tripled packaged and compliant with IATA
Packing Instruction 650 detailed in Figure 2. The maximum quantity for a primary
receptacle is 500 ml or 500g and outer packaging must not contain more than 4 L or 4 kg.
Labeling
The outer container of all diagnostic/clinical specimen packages must display the
following on two opposite sides:
Senders name and address
Recipients name and address
The words Biological Substance, Category B
UN 3373 label
Class 9 label, including UN 1845, and net weight if packaged with dry ice
Biological Products
These are products derived from living organisms, that are manufactured and distributed
in accordance with the requirements of national governmental authorities which may
have special licensing requirements, and are used either for prevention, treatment or
diagnosis of disease in human or animals, or for development, experimental or
investigational purposed related thereto. They include, but are not limited to, finished or
unfinished products such as vaccines and diagnostic products.
Biological products transported for final packaging, distribution, or uses by medical
professionals are not subject to shipping regulations. Biological products that do not
meet these requirements must be assigned to UN 2814, UN 2900, or UN 3373 as
appropriate.
Figure 1
U
N
7. Name and number of the person responsible for the shipment must appear on the
package
8. Minimum dimension 100mm
9. See IATA 5.0 p418/419 for the complete document
Packing Instruction 650
Figure 2
Labeling
Below are examples of labels required on biological material packages.
Shipping Papers
A Shippers Declaration for Dangerous Goods must be completed when shipping a
Category A infectious substance or a Genetically Modified Organism or Micro-organism
assigned to UN 3245. A declaration is not required for shipments in which dry ice is the
only hazardous material. A declaration is not required for Category B infectious
substances or diagnostic/clinical specimens assigned to UN 3373. All shippers
declarations must be in English, typed, and printed in color with red hatchings bordering
the document. Three copies must be presented to the courier with a fourth copy retained
by the shipper for at least 375 days. All shippers declarations must conform to the
following format:
L
M
Shipment Type
Proper Shipping
Name
Category A infectious
Infectious substance,
substance, affecting humans affecting humans
and possibly animals
(technical name)
Category A infectious
substance, affecting only
animals (not humans)
Category B infectious
substance
Diagnostic Specimens
Dry Ice
Infectious substance,
affecting animals
(technical name)
Biological Substance,
Category B
Biological Substance,
Category B
Dry Ice
Non-infectious, transducing
genetically modified
Genetically modified
organism or micro-organism micro-organisms
UN Number
UN 2814
6.2
602
50 ml or 50 g
4 L or 4 kg
Un 2900
6.2
602
50 ml or 50 g
4 L or 4 kg
Un 3373
6.2
650
4 L or 4 kg
4 L or 4 kg
Un 3373
Un 1845
6.2
9
650
904
4 L or 4 kg
200 kg
4 L or 4 kg
200 kg
UN 3245
913
No limit
No limit
III
10
YES
Air Waybill
The Air Waybill contains the following information in the Nature and Quantity
of Dangerous Goods.
1. The words Carbon dioxide, solid or Dry ice
2. The Class number 9
3. The UN number UN 1845The number of packages of dry ice
4. The net quantity of dry ice in kilograms
Note: The packing group III and packing instructions 904 are optional upon
the particular air waybill being used.
Quantity
5. The quantity of the dry ice per package is 200kg or less
Packages and Overpacks
6. Outer packaging is UN approved and has corresponding signage
7. Packages are free from damage and in proper condition for carriage
8. The packaging conforms to packing instruction 904 and the package is
vented to permit the release of gas.
Markings
9. The words Carbon dioxide, solid or Dry ice
10. The UN number UN 1845
11. Full name and address of the shipper and consignee
12. The net quantity of dry ice within each package
Labels
13. Class 9 label affixed
14. Irrelevant marks and labels removed
11
NO