Packaging Regulations For Infectious Samples Transportation
Un compliant packaging regulations - a guideline only
- Hazardous goods have globally recognised symbols and specifications to identify the class of each hazardous goods group.
- Pathology Specimens 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 Specimens are identified specifically under Section 6.2
Categories of Pathology Samples
- Infectious Human and Animal Pathology Specimens (UN2814 and UN2900)
- Biological Specimens, Category B (UN3373)
How to Pack Pathology Samples
No matter what category of pathology specimen is packaged, it must comply with the UN Triple Layer Guidelines as follows:
(one layer of the triple layer system, must be 95kPa validated, be it the initial container, pot/bag or rigid outer.)
- A primary container
- If multiple primary containers, they must not be in direct contact with each other.
- These containers must be placed in a leak-proof and sift proof bag or pot
- There must be sufficient absorbent in the bag so that any leakage is contained within the bag.
- The patient documents must be attached to both the inside of the container and for infectious specimens, on the outside of the rigid outer as well.
- The bag must be placed in a rigid outer which complies with all the labelling required by the regulations 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 Specimen, Category B” printed next to the label.
If the specimens are infectious, an Infectious Label must be placed on the box
The Proper Shipping Name must be printed: either Infectious Specimen Affecting Humans or Infectious Specimen Affecting Animals. If there is doubt about the classification fill in” Infectious Sample Affecting Humans and Animals”.
The UN Number for Infecting Humans: UN 2814
The UN Number for Infecting Animals: UN 2900
The UN Number where there is doubt: UN 2814
Graphics of how the specimens are packed must be printed on the box
Orientation labels to show which way the box must be opened by sample reception
If infectious specimens other than Category B specimens, then the patient documents must also be adhered to the outside of the box.
A Security Sticker should be used to seal the box
If the specimens are classified as Exempt Human or Animal Pathology specimens, 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, but must still be triple layer packaged. However this triple layer system does not have to be UN validated.
The implications of the various categories of infectious substances within section 6 are:
- Infectious Specimens, in the true sense of the word, as in known TB sputum specimens, must be packed in packaging that has passed the most stringent tests under the UN Packaging Certification Process. These tests would also comply with the IATA validations which are required for all pathology specimens transported by air. UN3373 would have to be packed as though infectious if transported by air.
- The Category B Biological Specimens 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 air crash.
- Exempt Human, Animal Samples and GMO seeds, 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 specimens 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 specimens. One layer of the triple layer packaging system, has to be UN validated, be it the initial container, the pot or the rigid outer.
- Be aware that there are volume limitations when packaging pathology specimens 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 specimens, please contact us. We are based in South Africa and we understand limited health resources and have successfully implemented strategies to ensure that funding is not an excuse for non-compliancy.
- Contact: mark@lss.co.za
- Telephones: 082 419 3009(South Africa)