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UN COMPLIANT PACKAGING – “The Orange Book” IN A NUTSHELL

Hazardous goods have globally recognised symbols and specifications to identify the class of each hazardous goods group.

Pathology Samples fall under Section 6 and the identifying symbol is a diamond-shaped label: inside the diamond is printed “Infectious Substance” with a “6” printed below within the perimeter of the diamond.

Human and Animal Pathology samples are identified specifically under 6.2

Categories of Pathology Samples

  • Infectious Human and Animal Pathology Samples
  • UN3373 Biological Substance, Category B
  • Exempt Human and Animal Pathology Samples

    How to Pack Pathology Samples

    No matter what category of pathology sample is packaged it must comply to the UN Triple Layer Guidelines as follows:

  • A primary container
  • If tubes, they must be separated.
  • These containers must be placed in a leak-proof bag
  • There must be sufficient absorbent in the bag so that any leakage is contained within the bag.
  • The patient documents must be attached to the outside of the bag and inside the rigid outer.
  • The bag must be placed in a rigid outer.

    The rigid outer must comply with all the labelling required by the “Orange Book” as follows:

  • Consignee and consignor details
  • The contact details of the person who packaged the sample
  • If Category B, then a UN3373 Label and the words “ Biological Sample, Category B” printed next to the label.
  • If the samples are infectious, an Infectious Label must be placed on the box.
  • The Proper Shipping Name must be printed: either Infectious Sample Affecting Humans or Infectious Sample Affecting Animals. If there is doubt about this classification (such as TB) fill in” Infectious Sample Affecting Humans and Animals”.
    The UN Number for Infecting Humans: 2814
    The UN Number for Infecting Animals : 2900
    The UN Number where there is doubt: 2814

  • The description of how the samples is packed must be diagramed on the box
  • Orientation labels must show which way the box must be opened by sample reception
  • If infectious samples other than Exempt or Category B, then the patient documents must also be adhered to the outside of the box.
  • A Security Sticker should be used to seal the box.
  • And most important of all (apart from Exempt Pathology Samples), the box must have the recognised UN certification logo and registration description.

    If the samples are classified as Exempt Human or Animal Pathology samples, for example a person wants to take out life insurance and the insurance company wants blood tests on cholestrol and sugar levels, then the rigid outer must state: Exempt human Substance

    The implications of the various categories of infectious substances within section 6 are:

    Infectious Substances, in the true sense of the word, as in known TB sputum samples, must be packed in packaging that has passed the most stringent tests under the UN Packaging Certification Process.  These tests would also comply to the IATA validations which are required for all pathology samples transported by air.

    The Category B Biological Substances UN3373 which are transported by road, would have to pass less severe testing. Logically, these samples have to survive a road accident compared to an aircrash.

    Exempt Human and Animal Samples, must still be packaged in the triple layer system, but the packaging does not have to be UN validated.

    Footnotes

    The triple layer packaging system applies to all pathology samples which are transported on any public road (no matter how short the distance) and by air.

    Sometimes a Pot is used in place of a pathology bag, as in liquid infectious samples.
    One layer of the triple layer packaging system, has to be UN validated, be it the initial container, the pot or the the rigid outer.

    Be aware that there are volume limitations when packaging pathology samples and they vary according to the infectious level and the mode of transport.

    If you have any queries about how to be cost-effective in transporting your pathology samples, please contact us.
    We are based in South Africa with very limited health resources and have successfully implented strategies to ensure that funding is not an excuse for non-compliancy.

    Contact Sue@lss.co.za or Mark@lss.co.za

    Telephones: 021-7887755 or 082 4193009 (South Africa)

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