Transport of Biological Materials

Transcription

1 Transport of Biological Materials Covering the classification, packaging and labelling of biological materials for transport in the UK and abroad Dr Joanna Marshall University Biological Safety Adviser University of Edinburgh

2 Reference documents and information source Health and Safety Department website: Guidance/Index.html Various sections, Transport includes - Detailed guidance on transport of biological materials *essential reading* - Specialist dangerous goods couriers - Suppliers of specialist packaging

3 Individual workers responsibilities That means YOU!

4 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

5 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

6 Air transport Technical Instructions for the Safe Transport of Dangerous Goods by Air ICAO Dangerous Goods Regulations IATA

7 Applicability When transported by road by any means except carriage between one part of the University and another part situated in the immediate vicinity even if carry package yourself When transported by air no exceptions restrictions on how package carried

8 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

9 "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

10 Class 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

11 UN numbers and proper shipping names UN 2814 INFECTIOUS SUBSTANCE, AFFECTING HUMANS UN 2900 INFECTIOUS SUBSTANCE, AFFECTING ANIMALS ONLY

12 UN numbers and proper shipping names UN 3373 DIAGNOSTIC SPECIMENS or CLINICAL SPECIMENS UN 3291 CLINICAL WASTE, UNSPECIFIED, N.O.S., (BIO) MEDICAL WASTE, N.O.S. or REGULATED MEDICAL WASTE

13 revised categorisation scheme Based on risks during transport rather than risks associated with lab work Assign UN number depending on whether Category A or Category B

14 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

15 Category B an infectious substance which does not meet the criteria for inclusion in Category A Assign to UN 3373 except cultures

16 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 micro-organism on indicative list Assign to UN 2814 or UN 2900 Others not controlled

17 Other materials that may contain infectious substances Assign to either Category A or Category B where appropriate Not controlled if material not derived from humans or animals possibility, but low probability, contain pathogens, and concentration at natural levels Examples include foodstuffs, water and environmental samples

18 Samples from humans or animals Minimum Category B Assign to UN 3373 Specific samples Category A on basis of medical history and symptoms endemic local conditions professional judgement on source material individual circumstances Assign to UN 2814 or UN 2900

19 Important note for air transport Some operators apply additional restrictions See Operator Variations eg AF-04 and LH-12 Blood and tissues carried only as UN 2814 or UN 2900

20 Genetically modified micro-organisms (GMMs) If harmful to humans or animals (require CL2 or above for lab work) Assign to UN 2814 or UN 2900 Others not controlled except for certain vectors.

21 Non-infectious GMMs If requires CL 1 for handling but is capable of altering animals, plants or microbiological substances (when in contact with them) in a way not normally the result of natural reproduction then classified in Class 9 - Miscellaneous dangerous goods Assign to UN 3245 with proper shipping name GENETICALLY MODIFIED MICRO-ORGANSIMS

22 Other materials subject to controls Genetically modified organisms Infected live animals Biological products Wastes from bio-research

23 Refrigerated/cooled materials Typically use either wet or dry ice Both may affect packaging Dry ice on Dangerous Goods List UN 1845 CARBON DIOXIDE, SOLID Minimal requirements for road transport Various requirements for air transport Avoid using liquid nitrogen contact UBSA for advice

24 Biological materials NOT classified as "Dangerous Goods" for transport Micro-organisms that are not human or animal pathogens GMMs that can be handled at CL 1 and are not vectors (and plasmids, naked DNA etc) Samples from non- human and non-animal sources, that are either unlikely to contain pathogens or may do so at natural level Blood, tissues or organs collected for blood transfusion, preparation of blood products or for transplant (all in humans)

25 Packaging All use triple layer system For some must use UN type-approved packaging No limits on quantities per package for road transport Quantity limits on packages (and some primarys) for air transport Procedure and type specified in applicable Packing Instruction

26 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

27 UN type-approved packaging Tested against specified criteria by an approved testing laboratory Allocated a unique mark by competent authority, this must be shown on package Mark includes code showing the type(s) of dangerous goods the particular packaging approved for For infectious substances includes code Class 6.2 in mark Valid only if use correctly and as tested

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29 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) Excluding body parts, organs or whole bodies

30 Quantity limits for air transport UN 3245 (non-infectious GMMs) All aircraft 100ml/100g per primary UN 1845 (Dry ice) 200Kg or 2Kg in baggage if with non-dangerous goods

31 Packaging (PI #s for road/air) UN 2814 or UN 2900 (Category A) Packing Instruction 620/602 UN type-approved UN 3373 (Category B) Packing Instruction 650/650

32 Packaging (PI #s for road/air) UN 3245 (non-infectious GMMs) Packing Instruction 904/913 UN 1845 (dry ice) Packing Instruction ---/904 Non dangerous goods - package safely

33 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

34 Labels Delivery address Senders details Emergency contact details name and telephone number And as appropriate UN number and proper shipping name Hazard warning label

35 Category A Mark with UN number and proper shipping name Either Or UN 2814 INFECTIOUS SUBSTANCE, AFFECTING HUMANS UN 2900 INFECTIOUS SUBSTANCE, AFFECTING ANIMALS ONLY

36 Category A And following hazard warning label

37 Category B Mark with proper shipping name Either Or DIAGNOSTIC SPECIMENS CLINICAL SPECIMENS

38 Category B And following mark Note no biohazard sign or Class number

39 Genetically modified micro-organisms (non-infectious) Mark with UN number and proper shipping name UN 3245 GENETICALLY MODIFIED MICRO- ORGANSIMS

40 Non-infectious GMMs And following hazard warning label

41 Dry ice transport by road Mark with words DRY ICE UN number and hazard warning label is not required

42 Dry ice transport by air Mark with UN number, proper shipping name and net weight (Kg) of dry ice UN 1845 DRY ICE ##Kg

43 Dry ice transport by air And following hazard warning label

44 Packages containing liquids Must display the following Package Orientation label on two opposite sides

45 Packages for cargo aircraft only Must display the following Cargo Aircraft Only label For example if package over quantity limit for passenger aircraft

46 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

47 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)

48 Paperwork/documentation Detailed instructions on how to complete the Air Waybill and Shippers Declaration forms are included in Appendix 5 of guidance

49 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

50 Sending dangerous goods by post Must meet both legislative and Post Office requirements Various prohibitions and restrictions HG 4 and certain specified HG 3 pathogens prohibited dry ice prohibited maximum amount of infectious substances restricted to 50g or 50ml only certain persons can send by post cannot send dangerous goods in international service

51 Safebox? Purpose designed packaging produced by Royal Mail for sending Category B materials not suitable for Category A can post in pillar box complete ready to use kit 2.20 each including pre-paid postage Further details on Royal Mail s website and search for Safebox see interactive demo