Transport of Biological Materials - UCL · Transport of Biological Materials Covering the classification, packaging and labelling of biological materials for transport in the UK and

Transport of Biological Materials

Covering the classification, packaging and labelling of biological materials for transport in the UK and abroad

Dr Joanna MarshallUniversity Biological Safety Adviser

University of Edinburgh

Reference documents and information source

Health and Safety Department website:http://www.safety.ed.ac.uk/resources/Bio/Guidance/Index.html

Various sections, Transport includes- Detailed guidance on transport of biological

materials *essential reading*- Specialist dangerous goods couriers- Suppliers of specialist packaging

Individual workers responsibilitiesThat means YOU!

International agreements for transport of dangerous goods

UN Recommendations/ Model Regulations form basis for international, national, regional and modal regulations

Road ADRRail RIDAir ICAO (IATA)Sea 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

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

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 proper shipping names

• UN 2814INFECTIOUS SUBSTANCE, AFFECTING HUMANS

• UN 2900INFECTIOUS SUBSTANCE, AFFECTING ANIMALS ONLY

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

2005 - 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

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 micro-organism on indicative list

Assign to UN 2814 or UN 2900• Others not controlled

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

Samples from humans or animals

• Minimum Category BAssign 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

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

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 controlledexcept for certain vectors ….

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 reproductionthen classified in

Class 9 - Miscellaneous dangerous goods

Assign to UN 3245 with proper shipping name

GENETICALLY MODIFIED MICRO-ORGANSIMS

Other materials subject to controls

• Genetically modified organisms • Infected live animals• Biological products• Wastes from bio-research

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

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)

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

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 outerEither the primary or secondary must be able to withstand 95kPa pressure differential

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

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

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

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

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

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

Category A

• Mark with UN number and proper shipping name

Either UN 2814 INFECTIOUS SUBSTANCE, AFFECTING HUMANS

OrUN 2900 INFECTIOUS SUBSTANCE, AFFECTING ANIMALS ONLY

Category A

• And following hazard warning label

Category B

• Mark with proper shipping name

Either DIAGNOSTIC SPECIMENS

OrCLINICAL SPECIMENS

Category B

• And following mark

Note no biohazard sign or Class number

Genetically modified micro-organisms (non-infectious)

• Mark with UN number and proper shipping name

UN 3245 GENETICALLY MODIFIED MICRO-ORGANSIMS

Non-infectious GMMs

• And following hazard warning label

Dry ice – transport by road

• Mark with wordsDRY ICE

UN number and hazard warning label is not required

Dry ice – transport by air

• Mark with UN number, proper shipping name and net weight (Kg) of dry ice

UN 1845 DRY ICE ##Kg

Dry ice – transport by air

• And following hazard warning label

Packages containing liquids

• Must display the following Package Orientation label on two opposite sides

Packages for cargo aircraft only

• Must display the following Cargo Aircraft Only label

For example if package over quantity limit for passenger aircraft

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)

Paperwork/documentation

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

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

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

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 websitewww.royalmail.com and search for Safebox– see interactive demo