All COVID-19 test samples fall under the UN3373 Dangerous Goods Regulations because they may contain pathogens. Sue Fletcher explains how to keep your sample packaging compliant in these more stringent times…
Resistant IATA CE IVD marked 95kPa tested primary packaging for air transport is made from more robust materials and can withstand rigorous sample handling applications
The COVID-19 pandemic has introduced greater awareness and caution on the importance of the regulatory requirements for shipping all types of biological samples from patients, testing centres, clinics and hospitals to laboratories. As a result, lab suppliers have seen an increase in demand for UN3373 compliant sample transport packaging products.
All samples for COVID-19 testing should be packaged and transported in accordance with Category B transportation regulations and labelled ‘Priority 10’. UN3373 packaging must be used for sample transport.”
www.gov.uk, Public Health England Guidance
Laboratory personnel are trained to handle human or animal samples correctly, to keep themselves and others safe. When it comes to sample transport, however, the legislation can be difficult to interpret and costly to implement, both in terms of time and money.
Category A, infectious substances: culture or natural samples, pathogens that are capable of causing permanent disability or life-threatening or fatal disease in humans or animals that were otherwise healthy prior to exposure.
Transport of Category A, Infectious substances is strictly regulated and must only be done in UN-approved packaging.
Category B, biological substances: blood, tissue, excreta and secreta from humans or animals which are not assigned to Category A.
The general guideline from the Health and Safety Executive (HSE) and the WHO is that Category B samples are assigned to UN3373 and must be packaged according to the Dangerous Goods International Air Transport Association’s (IATA) Dangerous Goods Regulation or the European agreement concerning the International Carriage of Dangerous Goods by Road (ADR) Packing Instruction 650 for transport.
Public Health England guidance confirms that all diagnostic samples for COVID-19 are classified as Category B (UN3373), following Packaging Instruction P650.
Category B (UN3373) Packaging Instruction P650
Sample collection and primary packaging for road transport for Category B, biological substances; blood, tissue, excreta and secreta from humans or animals
When samples are being sent as ‘Category B’, the package must include three layers
- Primary receptacle(s) to contain the sample(s) (blood tube/universal container)
- Secondary packaging to enclose the sample(s) and absorbent wrap (eg sealed plastic bag or rigid container)
- Outer packaging (eg cardboard box or mailing envelope)
All UN3373 packaging must meet specific criteria. While the secondary package may include multiple primary receptacles, all primary sample receptacles should be wrapped individually in absorbent material and within a zip-locked bag. This zip-locked bag is not counted as a layer during transport. There must be sufficient absorbent material (special absorbent sheet, blue roll, foam, cotton wool etc.) included in the primary package to absorb all of the sample volume.
Secondary packaging must be waterproof and leak-proof, include absorbent material and ensure individual samples are separate. If being transported by road this layer can be rigid
The primary or secondary packaging must be watertight and leakproof and able to withstand a 95-kPa pressure test. Either the secondary or outer packaging must be rigid and the entire package must withstand a 1.2-m drop test without any damage to the primary container. Additionally, the outer packaging must be the appropriate strength for the weight, size and composition of the inner packages and all packages should display the appropriate symbol: a diamond in a colour, that contrasts clearly with the package background and contains ‘UN3373’ in letters at least 6mm high. This symbol should be accompanied by the correct shipping name, which is “Biological Substance, Category B”.
Multiple individual samples, packaged to the secondary level including absorbent, can be transported in a single large outer rigid transport box. Ideal for collections from GP surgeries and clinics to hospital laboratories.
Outer packaging should be rigid if the secondary packaging is not. Labels and seals must also be UN3373 Biological Substance Category B compliant
Additional stipulations and requirements particularly relate to the IATA. The container, whether primary or secondary, must pass the 95kPa pressure differential test at both -40°C and 55°C. Maximum volume (1L) and weight (1Kg) limits apply to the primary and outer container (4L or 4Kg). The outer packaging must be at least 100mm x 100mm in size, be rigid and contain an itemised list of contents. Lastly, the UN3373 diamond symbol must be at least 50mm along each side of the diamond shape.
DIY doesn’t cut it
Trying to meet these requirements using standard materials or DIY solutions around the lab can be a daunting task and lead to variability within the packaging processes. Trustworthy suppliers offer certified sample containers that are built to specification and manufactured from high density and durable materials along with packaging solutions designed for purpose that will always pass robustness and absorbency tests to ensure compliance.
For further information to include training seminars, posters and a handy Public Health England guide, please visit alphalabs.co.uk and search for UN3373 Compliance Resources.
Author: Sue Fletcher, Alphalabs, alphalabs.co.uk
da Silva RE et al, Globalization of clinical trials: Ethical and regulatory implications, IJCT 3(1): 2016
IATA Dangerous Goods Regulations 57th Edition, Section 3, Classification: PP161,126.96.36.199.3.8