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Transportation And Shipment Of Biological Materials

The transportation and shipment of biological materials is subjected to strict regulatory controls. Individuals involved in the transportation and shipment of infectious substances must receive training on the applicable regulations and requirements before shipping such materials.

Biological materials transported by laboratory users within a laboratory or between buildings must be contained in such a way as to prevent release to the environment in case of an accident by following the procedure below:

  • Biological samples must be placed in a primary container or vessel that is a securely closed, leak-proof (or O-ring) tube, vial or ampoule, which is then placed in an unbreakable, lidded, watertight, secondary container.
  • If the outside of the primary container or vessel is suspected of being contaminated, decontaminate prior to placing in secondary container using 10% bleach solution or a disinfectant appropriate for the biological material in use.
  • All biohazards must be labeled with the international biohazard symbol on the outside of the secondary container.
  • When transporting liquids in glass vials/containers, place enough absorbent material, such as paper towels, in the space at the top, bottom, and sides between the primary and secondary containers to absorb the entire contents of the primary container(s) in case of breakage or leakage.
  • The outside of the secondary container must be free of any biohazardous material so that the package can be carried safely between buildings without wearing gloves or lab coats outside.
  • The package must be taken directly to its intended location.
  • If a spill occurs during transport, do not attempt to clean it up without appropriate spill response material and PPE. Keep other people clear of the spill.

Packaging Unregulated Biological Materials

All biological materials must be packaged according to a triple packaging system. The three components of a triple packaging system are:

  • Primary receptacle
  • Leak-proof secondary container
  • Rigid outer container

The primary receptacle holds the biological material and must be leak-proof, and watertight. It is packed in the secondary container in such a way that, under normal conditions of transport, they will not break, be punctured, or leak their contents into the secondary container. If the primary receptacle is fragile, it must be individually wrapped or separated to prevent contact between multiple primary receptacles.

The secondary container is a durable, watertight, leak-proof container that encloses and protects the primary receptacle(s). Several cushioned primary receptacles may be placed in one secondary container. If the primary receptacle contains any liquid, the secondary container must contain enough absorbent material to absorb all of the fluid from the primary receptacle(s) in case of breakage.

The outer container is a rigid and durable container with one side that is at least 10 cm x 10 cm that houses the secondary container. The outer package should be properly marked and labeled. It should be able to withstand outside influences such as physical damage while in transit. An itemized list of package contents must be included between the outer and secondary containers.

Shipping of Biological Materials 

Biological materials are classified as infectious substances (including “biological substances, category B” and “patient specimens”), biological products, genetically modified organisms, or medical/clinical waste for the purposes of shipping. The shipment of certain genetically modified organisms is also regulated.

Infectious substances - Substances which are known or are reasonably expected to contain pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsia, parasites, and fungi) and other agents such as prions, which can cause disease in humans or animals. Infectious substances are separated into the following categories:

Category A - An infectious substance which is transported in a form that, when exposure occurs, is capable of causing permanent disability, life-threatening or fatal disease to humans or animals.

Infectious substances meeting these criteria which cause disease in humans or both in humans and animals must be assigned to UN2814. Those which cause disease in only animals must be assigned to UN2900.

Assignment to UN2814 or UN2900 must be based on the known medical history and symptoms of the source human or animal, endemic local conditions, or professional judgment concerning individual circumstances of the source human or animal.

The proper shipping name for UN2814 is Infectious Substance, Affecting Humans. The proper shipping name for UN2900 is Infectious Substance, Affecting Animals.

Infectious Substances (Category A) Shipping Requirements

  • Triple layer packaging (materials used for transport must be tested to ensure sample won't leak)
  • Absorbent material
  • Itemized contents list
  • Outer package must bear Class 6.2 Infectious Substance diamond label
  • Additional labelling and marking requirements
  • Shipper's Declaration required

Category B - An infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B must be assigned to UN3373

When transported, infectious substances (both Category A & B) are classified as dangerous goods and must be shipped in accordance with international (IATA) regulations.

Infectious Substance, Category B Requirements

  • Triple layer packaging
  • Materials used for transport must be tested to ensure sample won't leak
  • Outer package must bear UN3373 diamond label
  • Outer package and air waybill must bear "Biological Substance, Category B" statement
  • No Shipper's Declaration required; only airway bill

Patient Specimens - Exempt specimens are those collected directly from humans or animals, for which there is a minimal likelihood that pathogens are present. Professional judgment should be used to determine if a substance is exempt. Examples include blood or urine tests for cholesterol levels, blood glucose levels, hormone levels, or prostate-specific antigens (PSA); tests required to monitor organ function such as heart, liver or kidney function for humans or animals with non-infectious diseases, or therapeutic drug monitoring; tests conducted for insurance or employment purposes and are intended to determine the presence of drugs or alcohol; pregnancy tests; biopsies to detect cancer; and antibody detection in humans or animals.

Biological products - products derived from living organisms that are known not to produce viruses, toxins, etc. and are manufactured and distributed in accordance with requirements of national government authorities. These include, but are not limited to, finished or unfinished products such as vaccines. Biological products are not currently regulated for the purposes of shipping.

Dry Ice - In addition to the classifications and rules for potentially infectious materials, shipment of solid carbon dioxide, or dry ice, is regulated as a dangerous good regardless of the hazard classification of any other materials in the package.  Dry ice may cause burns, and if packaged improperly, can result in dangerously high-pressure build-up inside of a sealed contained.  For these reasons, there are specific training, labeling, and packaging requirements for shipments containing dry ice. 

Infectious Substance Shipments with Dry Ice Requirements:

  • Never place dry ice in a sealed container
  • Outer package must be approved to hold dry ice, otherwise use an overpack
  • UN 1845 Dry Ice label, including estimated weight of dry ice
  • Class 9 Miscellaneous Dangerous Goods label

For specific information please see material SDS using ChemWatch.

 

References

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