1 African Wildlife in a Changing En viro nment Disease Diagnosis and Forensics African Wildlife in a Changing Environment Disease Diagnosis and Forensics 17 November

2 UN-Compliant Packaging for the Transport of Pathology Specimens Agenda Why the Triple Layer System? Does Triple Layer System Work? Why should we use the Triple Layer System? The Cost of using Non-Compliance Packaging Duties of Consignor, Operator and Recipient Summary of Specimen Categories How to pack the pathology Specimens Cold Chain

3 Why use the Triple Layer System? The UN associated organisation, International Civil Aviation Association (ICAO) developed the triple layer packing system, no doubt in response to the problem of specimens arriving at sample reception in shocking condition.

4 Why use the Triple Layer System? (quick intro) The Triple Layer System is designed to ensure: Pathogens in the specimens do not cause harm to anybody during transit; Specimens arrive at the correct destination; Specimens arrive in optimum condition; for Accurate analysis and diagnosis.

5 Does Triple Layer System Work? In 2003, statistical data collected by a group of central laboratories showed the efficacy of packaging compliant with P650 and P620 regulations in assuring that infectious substances are transported without leakage and loss of materials. – 4.92 million primary containers were shipped to any of the world wide regional offices of these central laboratories – 106 Breakages % of the total number were recorded – The leakages that did occur were all contained by the absorbent material – No damage to secondary containers for outer packaging was reported (WH)/CDS/CSR/LYO/ )

6 Why should we use the Triple Layer System? The UN Compliant Triple Layer Packaging System is regulated by both Local and International Regulatory Bodies: International Civil Aviation Association (ICAO) is the United Nations associated organization that develops regulations for the safe transport of dangerous goods by air. International Air Transport Association (IATA) is a trade association made up of airlines and cargo logistics companies. IATA annually publishes a book of regulations which interprets and enhances the ICAO Technical Instructions to reflect industry practices. Each country has their own regulatory bodies and if shipping specimens to other countries, their legislation must be taken into account.

7 Why should we use the Triple Layer System? Legislation references for South Africa: National Road Traffic Act 93 of 1996 & amendments: Chapter V111 – Transportation of Dangerous Goods; SANS 10231:2010 – the Transport of dangerous goods for road vehicles and drivers; WHO/CDS/LYO/ – Transport Planning. SANS (2010) Packaging Instruction P620 (Infectious Specimens) – applies to UN2814 and UN2900; and P650 (Biological Substances) – applies to UN3373 WHO/DCS/LYO/

8 The Cost of using Non-Compliance Packaging In any clinical trial, research study or ongoing collection of specimens for diagnosis, a substantial cost factor is the collection of the specimens: 1.The technicians doing the collection and receiving of the specimens have to be paid; 2.Transport costs to and from the collection site to the central laboratory; 3.The cost of time during which these samples are collected – which may or may not be critical; 4.The cost of the packaging. Seemingly we are willing to pay the “going rate” for items 1 to 3, but when it comes to packaging costs, these are seen as costs that can be kept to a minimum by using any packaging that might be available. The compliant packaging systems, as nice as they are, are deemed to be too expensive

9 The Cost of using Non-Compliance Packaging Compared to what? The specimens have to be incinerated No analysis or diagnosis is possible The cost of repeating steps 1, 2 and 3 (If funds are available for a repeat of the exercise) Time might have been of the essence to contain a suspected outbreak or a clinical trial deadline etc.

10 The Cost of using Non-Compliance Packaging Two important factors to remember are: 1.The transport of pathology specimens is governed by both local authorities and IATA. To ignore this legislation is to break the law and to be liable for paying significant fines 2.Employees have the right to work in a safe environment. Employers are bound, legally, to ensure that the conditions, be they on site or out of the office, are safe for their employees.

11 Duties of Consignor, Operator and Recipient (Specimens arriving at the correct destination) The following section is an abbreviated extract – for full report refer SANS1023:2010 and the National Road Transport Act 93 as amended: Chapter 8 Transportation of Dangerous Goods Duties of Consignor (Shipper or sender) The Consignor makes advance arrangements with the Carrier to ensure: – That the shipment will be accepted for appropriate transport; and – Prepare the necessary documentation, including permits, dispatch and shipping documents The Consignor must advise the Receiver of the transport arrangements. These arrangements must be conveyed to the Receiver well in advance of the expected time of arrival The Operator is provided with a signed Dangers Goods Declaration (DGD) Package the specimens in accordance with packaging instruction P620 and/or P650 (Sans (2010)

12 Duties of Consignor, Operator and Recipient (Specimens arriving at the correct destination) Duties of the Operator (Carrier) Shall be registered as a dangerous goods operator with the relevant gov. department Ensure that the driver of the vehicle is in possession of a PrDP-D Licence (Professional Driving Permit- Dangerous Goods) There is a Spill Kit in the vehicle Ensure that the specimens are packed in accordance with packing instruction P620 and/orP650 (Sans (2001) Ensure that all the transport documents are available for transport with the specimens

13 Duties of Consignor, Operator and Recipient (Specimens arriving at the correct destination) Duties of the Consignee (Receiver, Recipient) Confirms the advance arrangements that have been made by the Sender Confirms that there will be no delay in the delivery of the package to its destination Advises Consignor of receipt of the pathology specimens

14 Summary of Specimen Categories Category A (UN2814) – An infectious substance that is transported in a form that is capable of causing permanent disability, life-threatening or fatal disease to humans (UN2814) or animals (UN2900) when exposure to it occurs. A list of these pathogens and cultures considered to be category A can be found in SANS (2010) – packaging instruction P620. (if there is doubt as to whether the specimen is harmful to humans or animals – use Category A (UN2814) Category B (UN3373) – called Biological Substance Category B. This is the term given to specimens that do not meet the criteria for inclusion in Category A. Specimens in this category do not cause permanent disability, life-threatening or fatal diseases to humans or animals when exposure to it occurs. Refer to SANS (2010) Packaging Instruction P650. Exempt Human Specimens: Patient specimens for which there is minimal likelihood that pathogens are present. Examples are: Blood for cholesterol levels or hormone levels. The triple layer packaging system still applies, but is not regulated.

15 Summary of Specimen Categories The Triple Layer Packaging System Explained: The Triple layer packaging system must be used when specimens are transported by road – no matter how short the distance – or by air No matter what category of pathology specimen is packaged, it must comply with the UN Triple Layer Packaging Guidelines as follows: Components of the Triple Layer Packaging System: Leak-proof primary; Leak-proof secondary; Outer Package (Rigid Outer) of adequate strength for its capacity and printed in accordance with UN Guidelines; and Absorbent Material – pouches or strips –sufficient so that if there is breakage there is not leakage.

16 How to pack the Pathology Specimens One layer of the triple layer system must always be 95kPa validated, be it the initial container pot/bag or rigid outer Primary Container; If tubes, they must be separated; These containers must be placed in a leak-proof and “sif” proof bag/pot; There must be sufficient absorbent material in the pot/bag so that leakage is contained within the pot/bag; The patient documents must be attached to the outside of the pot/bag and inside the rigid outer. If infectious specimens, the patient documents must also be attached to the outside of the rigid outer; and

17 How to pack the Pathology Specimens The pot/bag must be placed in a rigid outer which complies with all the labelling required by the UN Guidelines: – Consignee and Consignor details; – The contact details of the person who packaged the specimens; – If Category B, then a UN3373 Label: Biological Substance, 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 specimens affecting humans (2814) or Infectious specimens affecting animals (2900) If there is doubt, use 2814; – Graphics of how the specimens are packed must be printed on the box; – Orientation graphics to show which way the box must be opened; – If infectious specimens, then the patient documents must also be adhered to the outside of the box; – A security sticker is to be used to secure the box.

18 How to pack the Pathology Specimens Bag is the 95kPa layer

19 How to pack the Pathology Specimens Pot is the 95kPa layer

20 How to pack the Pathology Specimens Pot is the 95kPa layer

21 How to pack the Pathology Specimens

22 How to pack the Pathology Specimens

23 Cold Chain (specimens arriving in optimum condition) UN Validated Rigid Outer Temperature Validated

24 Cold Chain (specimens arriving in optimum condition) Although temperature control does not fall under the ambit of the Triple Layer Packaging System, it is an important factor in ensuring that specimens arrive at their destination in optimum condition. The rigid outer is the first option to consider: Re-usable transport box: – UN Validation No.: 4H1U/Class 6.2/ ZA/LSS/CT1483 – UN Validation Description: Certified and approved as a 95kpa container within the LSS 650 and 620 compliant packaging system – Temperature Validation: 2˚c - 8˚c

25 Cold Chain (specimens arriving in optimum condition) LSS Thermo Box – Dry ice shipper 96 hrs

26 Cold Chain (specimens arriving in optimum condition) The use of Cooling Agents Ambient Gel Wrap – room temperature Ice Bricks (2-8 degrees c) Dry-ice (-70 degrees c)

27 Cold Chain (specimens arriving in optimum condition) Medical Design Excellence Award

28 Handbook to keep in the Lab: UN Compliant Triple Layer Packaging Systems Summary of how to pack Pathology Specimens (4 pages) Introducing: NanoCool – A Cool Revolution (limited number of copies)

29 THANK YOU