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GUIDELINES FOR PREPARATION, PACKING AND SHIPPING SPECIMENS


Shipper’s Responsibilities for Preparation of Accompanying Documentation

Use the proper form/s
Fill out the form/s accurately, completely and legibly
Comply with carriers’ requirements for filling out the form/s (handwritten vs. typed)
Sign the form/s (signature must be handwritten)
Modifications and alterations must be signed by the shipper (best practice is to complete a new form if a correction is needed)
The form/s must be printed in color on white paper (e.g. for the Dangerous Goods Declaration Form the left and right diagonal striations must be printed in red)
The form must be completed in English
The shipper must complete three copies. One copy is for the shipper and the remaining two are for the operator



1. CATEGORIZATION OF INFECTIOUS SUBSTANCES

There are four (4) Classes of Dangerous Goods which are relevant to a certified shipper of infectious substances

  a) Class 2: Non-flammable, non-toxic gases
  • Division 2.2 Refrigerated liquid Nitrogen used for refrigeration
  b) Class 3: Flammable liquids (e.g. Ethanol used for preservation)
  c) Class 6: Toxic and Infectious Substances
  • Division 6.1 Toxic substances
  • Division 6.2. Infectious substances(Category A and Category B)
  d) Class 9: Miscellaneous Dangerous Goods (e.g. dry ice)

There are two substance categories which fall under Division 6.2. Infectious Substances

I. Category A, Infectious Substances: is an infectious substance which is transported in a form, that if an exposure occurs, it is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals.

II. Category B: is an infectious substance which does not meet the criteria for inclusion in Category A



2. United Nations (UN) Numbers and Proper Shipping Names


Category A, Infectious Substances

UN 2814, Proper Shipping Name: Infectious Substance, Affecting Humans-assigned to infectious substances meeting the above criteria which cause disease in humans or both in humans and animals

UN 2900, Proper Shipping Name: Infectious Substance, Affecting Animals only - assigned to infectious substances which can cause disease in animals only.

NOTE: Assignment to UN 2814 or UN 2900 shall be based on the known medical history and symptoms of the source human or animal, endemic local conditions, or professional judgement concerning individual circumstances of the source: human or animal.


Category B, Infectious Substances

UN 3373, Proper Shipping Name: Biological Substance


TABLE 1: Examples of Infectious Substances included in Category A

(Reference: Annex 2 WHO Guidance on regulations for the Transport of Infectious Substances 2011-2012)

UN Number and Proper Shipping Name Microorganism
UN 2814 Infectious substance, affecting humans
  • Bacillus anthracis (cultures only)
  • Brucella abortus (cultures only)
  • Brucella melitensis (cultures only)
  • Brucella suis (cultures only)
  • Burkholderia mallei – Pseudomonas mallei – glanders (cultures only)
  • Burkholderia pseudomallei – Pseudomonas pseudomallei (cultures only)
  • Chlamydia psittaci – avian strains (cultures only)
  • Clostridium botulinum (cultures only)
  • Coccidioides immitis (cultures only)
  • Coxiella burnetii (cultures only)
  • Crimean-Congo haemorrhagic fever virus
  • Dengue virus (cultures only)
  • Eastern equine encephalitis virus (cultures only)
  • Escherichia coli, verotoxigenic (cultures only)
  • Ebola virus
  • Flexal virus
  • Francisella tularensis (cultures only)
  • Guanarito virus
  • Hantaan virus
  • Hantaviruses causing haemorrhagic fever with renal syndrome
  • Hendra virus
  • Hepatitis B virus (cultures only)
  • Herpes B virus (cultures only)
  • Human immunodeficiency virus (cultures only)
  • Highly pathogenic avian influenza virus (cultures only)
  • Japanese Encephalitis virus (cultures only)
  • Junin virus
  • Kyasanur Forest disease virus
  • Lassa virus
  • Machupo virus
  • Marburg virus
  • Monkeypox virus
  • Mycobacterium tuberculosis (cultures only)
  • Nipah virus
  • Omsk haemorrhagic fever virus
  • Poliovirus (cultures only)
  • Rabies virus (cultures only)
  • Rickettsia prowazekii (cultures only)
  • Rickettsia rickettsii (cultures only)
  • Rift Valley fever virus (cultures only)
  • Russian spring-summer encephalitis virus (cultures only)
  • Sabia virus
  • Shigella dysenteriae type 1 (cultures only)1
  • Tick-borne encephalitis virus (cultures only)
  • Variola virus
  • Venezuelan equine encephalitis virus (cultures only)
  • West Nile virus (cultures only)
  • Yellow fever virus (cultures only)
  • Yersinia pestis (cultures only)
UN 2900 Infectious substance, affecting animals only
  • African swine fever virus (cultures only)
  • Avian paramyxovirus Type 1 – Velogenic Newcastle disease virus (cultures only)
  • Classical swine fever virus (cultures only)
  • Foot and mouth disease virus (cultures only)
  • Lumpy skin disease virus (cultures only)
  • Mycoplasma mycoides – contagious bovine pleuropneumonia (cultures only)
  • Peste des petits ruminants virus (cultures only)
  • Rinderpest virus (cultures only)
  • Sheep-pox virus (cultures only)
  • Goatpox virus (cultures only)
  • Swine vesicular disease virus (cultures only)
  • Vesicular stomatitis virus (cultures only)


NOTE: The table above ((Reference: Annex 2 WHO Guidance on regulations for the Transport of Infectious Substances 2011-2012) is not exhaustive. Infectious substances, including new or emerging pathogens, which do not appear in the table but which meet the same criteria shall be assigned to Category A. In addition, if there is doubt as to whether or not a substance meets the criteria it shall be included in Category A.



PACKAGING AND SHIPPING INSTRUCTIONS

Shippers of infectious substances shall ensure that packages are prepared utilizing the Triple Packaging System. This packaging system is used for the transportation of all infectious substances in such a manner that they reach their destination in good condition and present no hazard to persons or animals during transport.

As the name suggests, there are three layers of containment to protect the substances being shipped –

Primary receptacle containing the specimen must be leak-proof and watertight. It is wrapped/ packaged with sufficient absorbent material to absorb all fluid in case of breakage.
Secondary packaging is a second durable, watertight, leak-proof container/receptacle used to enclose and protect the primary receptacle(s). Several cushioned primary receptacles may all be placed in one secondary packaging ensuring sufficient additional absorbent material is used to absorb all fluid in case of breakage.
Outer packaging involves placing secondary packaging in outer shipping packaging with suitable cushioning material.


I. Shipping Category A Infectious Substances

Infectious substances which fall under Category A can only be transported in packaging which meets the UN Class 6.2 specifications and in accordance with Packaging Instruction (PI) 620. (See PI 620 below)

This ensures stipulated performance criteria are met such as a 9m drop test, puncture test, pressure test and stacking test. The outer packaging must bear the UN specification marking which indicates that the packaging has passed the performance tests to the satisfaction of the competent authority.


TABLE 2: Requirements for Packaging and Shipping Category A Substances

PACKAGING REQUIREMENTS MARKINGS AND LABELS DOCUMENTATION

Primary container is leak-proof

Secondary container is leak-proof

Outer container is rigid

UN specification marking:

  • Pressure tested at 95kPa
  • Drop tested from 9m
  • Puncture tested at 7kg
  • Stacking tested

Shipper must be trained

Markings –

  • Shipper’s name and address

  • Receiver’s name and address

  • Name and telephone of responsible person (who is available 24 hours a day until shipment arrives)

  • Proper Shipping Name and UN Number

  • UN Specification Marking

Labels –

  • Infectious substance label

  • Package orientation label (only used when primary container exceeds 50ml)

Airway Bill

Dangerous Goods

Declaration Form

Must be signed by the shipper

Import/Export permit (as applicable)

CARICOM Invoice


Caribbean Public Health Agency © 2014