How to Transport Biological Material Internationally
Biological material is frequently transported internationally, being a key part in the growth and development of the pharmaceutical and life science sector. As with all other cross-border freight, biological material is subject to customs formalities.
Transporting biological material is typically for the purpose of scientific research, such as in clinical trials or in the research of infectious diseases.
An example could be a science institute based in Britain, importing blood swabs from Africa to conduct research on a certain type of malaria. It can be human cells from a cancer patient being exported from the UK to a university in the US for scientific testing. There is a growing need for safe, efficient transport.
What is biological material?
Biological material is a broad term that refers to material derived from, or produced by, biological organisms and other living forms. Examples include blood/plasmids, bacteria, viruses, micro-organisms, genetically modified organisms (GMO), toxins of biological origin, seeds, fungi, and antibodies.
How to transport biological material?
When thinking of sending bio material, we need to consider customs, temperature and the routing path.
To find out the customs requirements for your material, you first need to identify what category your material falls under.
This is a necessity as all shipping must meet International Air Transport Association & role (IATA) requirements. IATA is the global regulatory organisation which decides the rules for transporting biological material and other items..
Here are the international IATA categories that need to be adhered to:
- Category A –
-
- “Infectious substances, affecting humans” (UN 2814)
- “Infectious substances, affecting animals” (UN 2900)
- Category B –
- UN 3373, Biological substance
- Genetically modified organisms (GMO) Class 9 –
- UN 3245 Genetically modified microorganisms
- Exempt substances –
- not subject to the regulatory requirements
Cat A material is, as defined by IATA, “an infectious substance, which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals”. Some examples are materials infected by HIV or COVID-19.
Cat B includes infectious substances that do not meet the criteria of category A. In addition to pathogens, this category includes human or animal material such as excreta, secreta, blood, tissue, and body parts transported for research, diagnosis, disease treatment or prevention.
Genetically modified organisms (GMO), or genetically modified microorganisms (GMM), are usually classified as either Cat A or Cat B. However, if there are alterations to the material that are not the result of natural reproduction, they are classified as ‘Miscellaneous Dangerous Goods’.
Exempt substances are specimens in which there is minimal likelihood that pathogens are present and are not subject to other provisions of regulations, provided they are marked with the words “exempt human specimen” or “exempt animal specimen”, and are packaged according to the IATA regulations. This is often overlooked in international shipping; senders are still marking exempt substances as Cat B.
Must-have customs requirements for transporting international material
You should contact clearBorder for advice before packaging and transporting biological material. Cat. A, infectious substances are highly regulated and compliance is crucial to avoid costly delays and penalties.
The table below shows the minimum requirements to be considered for international shipping.
| Shipping Biological material | Cat A | Cat B | Exempt |
| Requirements | |||
| Packaging | |||
| Leakproof packaging | Y | Y | Y |
| Rigid outer packaging | Y | Y | Y |
| Cushioning/Absorbent materials | Y | Y | |
| Package orientation label | Y | ||
| UN Mark | Y | Y | |
| Responsible person label | Y | ||
| Proper shipping name | Y | Y | |
| Exempt specimen label | Y | ||
| Secondary packaging e.g. IATA 620 | Y | Y | |
| Paperwork | |||
| Shipper & Consignee information | Y | Y | Y |
| Customs invoice | Y | Y | Y |
| IATA DG Dec or Multi-Modal | Y | ||
| *Additional documents depending on the country intended for |
Additional documentation and customs formalities may be required depending on the countries you are importing or exporting to. As an example, if you are sending biological material to the US, there is the requirement for an additional document called a Centers for Disease Control and Prevention(CDC) which will need to travel with the shipment, and even more additional documents such as a USDA statement and/or permit depending on what type of biomaterial is transported. You can contact clearBorder consulting. We will provide you with the relevant customs templates and advice to meet the destination country’s requirements.
Proper packaging and labelling are crucial for shipping biological materials, as the transit temperature directly impacts the success of a study. Temperature excursions can render the material unusable, wasting time and investment. For instance, a shipment of blood tubes on dry ice losing its cooling could render the blood expired and redundant for testing. Monitoring devices help ensure temperature compliance, preventing costly issues in pharmaceutical/biological sample deliveries.
Temperature Controlled transit
The table below shows the commonly used temperatures for shipping.
| Temperature | Purpose |
| Ambient | The temperature of the surrounding environment. This can vary depending on the time of year or the geography. With ambient temperature, there is no safeguarding of a temperature range. On occasion, this is used for quick turnaround studies of blood or saliva swabs. It reduces the requirement for temperature control during transit. However, sometimes a fast end-to-end delivery is required to ensure the sample does not expire. |
| Controlled Ambient +15C to +25C | Also known as room temperature, controlled ambient is commonly used in sending high value pharmaceutical drugs and in some studies of biological samples. |
| Refrigerated +2C to +8C | While typically a less used option as of reduced long-term storage capability, refrigerated temperatures are optimal for short-term storage of frequently used biological reagents, such as enzymes and antibodies. |
| Frozen -15C to -25C | This temperature range is utilised for many types of biological samples such as blood, tissue and cells. When material is frozen it preserves the material in such a way that analysis can take place a significant amount of time after the material was made available. |
| Dry Ice -20C to -80C | Dry Ice shipping has much the same benefits of frozen shipping but is utilised more frequently. The ability to replenish dry ice can happen without the constant need for the use of a freeze room or harder to source frozen gel packs. The temperature can be maintained easily though different tranships and whereabouts of the shipment. |
| Deep frozen Dry Ice -60C to -80C | Dry ice shipping and deep frozen dry ice shipping usually average below -70C, but when deep frozen dry ice is requested, more monitoring and regular replenishment should take place to safeguard colder temperatures. |
| Cryogenic -150C to -190C | Cryogenic storage is often deemed the gold standard for long-term storage of biological samples. At these extreme temperatures, all biological activity is suspended and no degradation occurs. Cryogenic freezing is ideal for sensitive samples and specimens. This is often used for transporting types of cells. Liquid nitrogen vapour is used to maintain this temperature range. |
It is best to seek expert advice on finding the right temperature-controlled containers and transport courier/freight forwarder options who accommodate temperature controlled transit and minimise temperature excursions.
There are a range of reasons why you, your organisation, or a staff member might send biological materials. It could be groundbreaking scientific research and can help save lives.
Whatever the case, if you conduct cross-border operations and require some expert, independent advice on gaining the clearances you require, we are here to help.
Here at clearBorder, we offer training to help get your team border-ready. You can take advantage of our expert consultancy services for bespoke advice and practical guidance on ensuring your operations run smoothly, efficiently and profitably, both now and in the future. Just contact us today to speak to a member of our team.