OIE Standards: Preservation, Packaging and Shipment Nairobi Training 9-11 August 2011 Dr G Thobokwe CVO BVI gthobokwe@bvi.co.bw
Why Samples Samples may be taken from animals or the environment for a variety of purposes, such as -disease diagnosis Is it FMD What serotype Which topotype -disease surveillance Temporal and spatial spread - health certification - monitoring the response to treatment or vaccination Purpose is very important in determining type and number of samples
Preservation Important to preserve samples so they are representative of the condition being investigated and the clinical picture observed Consider mainly Temperature ph E.g FMD virus At ph 6.0 virus is inactivated at 90% per minute At ph 5.0 virus is inactivated at 90% per second
Suitability of Various Storage/Shipment Conditions for Different Specimens Types Storage/Shi pment Conditions -70 C or Dry Ice or Liquid N 2-20 C Swabs or other specimens in VTM for virus isolation SR NR Swabs or other specimens in VTM for PCR SR A Swabs in ethanol for PCR** N/A N/A Blood serum for virus isolation SR NR Blood serum for PCR SR A Blood serum for antibodies detection SR SR + 4 C A* A A A*** A A Room temperatur e NR A A NR A* A* SR: Strongly recommended method; A: Adequate method; NR: Not recommended method; N/A: Not applicable; * For up to 7 days storage; ** Where refrigerator is not available; *** For up to 4 days storage.
PACKAGING and TRANSPORTATION Why Ensure the safe transport of samples to destination Timely transfers Minimizing delays at check-points There are regulations
International agreements for transport of dangerous goods UN Recommendations/ Model Regulations form basis for international, national, regional and modal regulations Road Rail Air Sea ADR RID ICAO (IATA) IMDG
Road transport The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2004 cross references to ADR (& RID) Depending on the material other legislation may also apply, such as The Genetically Modified Organisms (Contained Use) Regulations 2000
Air Transport Technical Instructions for the Safe Transport of Dangerous Goods by Air ICAO Dangerous Goods Regulations IATA
A key point on air transport Dangerous goods must not be carried by passengers as/or in checked baggage carry-on baggage or on their person Dangerous goods must always be transported as separate packages in the hold and must always be declared
"Dangerous Goods" for carriage Criteria defined under 9 UN hazard classes Classify and assign UN number and proper shipping name Each has entry in Dangerous Goods List which indicates limitations packaging labelling special provisions
Class 6.2 - Infectious substances Substances known or reasonably expected to contain pathogens Can cause disease in humans or animals Certain biological materials meet definition stringent requirements for classification, packaging and labelling Consider any other hazardous properties Other biological materials specific requirements to package safely
UN numbers and shipping names Division 6.2 Category A - UN 2814 - Infectious substances, affecting humans-or UN 2900 - Infectious substances, affecting animals, indicative list ofpathogens in manual Category B - UN 3373 -Biological substance, Category B all other pathogens Exempt human specimens or Exempt animal specimens, patient specimens with a minimal likelihood that pathogens are present Other exceptions, e.g. blood for transfusions.
Category A an infectious substance which is carried in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease to humans or animals Refer to indicative list (not exhaustive) Assign to UN 2814 or UN 2900
Category B an infectious substance which does not meet the criteria for inclusion in Category A Assign to UN 3373 except cultures
Cultures, stocks, etc Items containing high concentration or titre of micro-organisms cultured/propagated/amplified/manipulated either deliberately or unintentionally If infectious for humans or animals always Category A irrespective of whether microorganism on indicative list Assign to UN 2814 or UN 2900
Packaging - Triple layer system Leakproof primary receptacle wrapped in sufficient absorbent material to absorb the entire contents Leakproof secondary receptacle Outer packaging (rigid) Enclose paperwork between secondary and outer Either the primary or secondary must be able to withstand 95kPa pressure differential
Material Needed to Send Samples Packaging materials include: Leak-proof primary receptacle Absorbent material Bubble wrap Secondary packaging Fiber-board box/ Cool box (outer packaging) Ice-packs Shipping labels Adhesive material-masking tape.
Step 1 Wrap the primary receptacle (in our case cryovials) with absorbent paper Place the wrapped cryovial in the leak-proof secondary receptacle (e.g. Falcon tube) and close tightly
Step 2 Place the secondary receptacle in a bubble-wrap or protective material which cushions the sample
Step 3 Place these components in a leakproof container and close tightly
Step 4 Place ice-packs inside a cool box (outer packaging) Put the container with the cryovial(s) inside the cool box Container should be placed upright
Step 5 Place specimen identification list in a zip-lock bag This is a crucial step! Specimens must be transported with identifying information Place the Zip lock bag inside the cool box (outer packaging) alongside the secondary container
Step 6 Close the cool box tightly Place shipper and consignee details on outside of the fibrebox or cool box: Name, address and storage requirements Ensure that any other hazard labels and handling labels are properly attached
Quantity limits for air transport UN 2814 & UN 2900 (Category A) Passenger aircraft 50ml/50g Cargo aircraft 4L/4Kg UN 3373 (Category B) All aircraft 4L/4Kg (1L per primary)
Refrigerated/cooled Ensure packaging maintains integrity when ice melts or dissipates Must permit release of gas ALWAYS place dry ice outside secondary Use cold packs or similar for wet ice If Category A must ensure use UN type-approved packaging properly Various options Eg combination packs, overpacks, thermal control units etc
Labels Delivery address Senders details Emergency contact details name and telephone number And as appropriate UN number and proper shipping name Hazard warning label
UN3373 DIAGNOSTIC SPECIMENS UN1845, Class 9 Dry ice Net Quantity 20kg Shipper Consignee UN3373 Responsible person Mr. Son Chong Address. ABC Tel.123456789
Paperwork/documentation - within package Between secondary and outer Must include Senders details Delivery details Emergency contact details Description of the goods UN number and proper shipping name And for UN 2814 or UN 2900 add technical name after proper shipping name itemised list of contents
Paperwork/documentation - accompanying package For road transport dangerous goods declaration form (not required for UN 3373) For air transport Air Waybill Shipper s Declaration for Dangerous Goods (not required for UN 3373)
Example of Documents Docs OIE stds.pdf
Sending dangerous goods by courier Must meet classification, packaging and labelling requirements Give full description of goods to courier in advance Some couriers will not carry dangerous goods or impose additional requirements It is illegal to conceal dangerous goods in any packaging not showing appropriate labels
ALWAYS REMEMBER The prime requirements are the three Ss: Stability, Speed, Safety Ensure: that the sample is stable (temperature, ph) that it is sent by the fastest available route that there is no risk of infectious material escaping
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