Compliant UN3373 Dangerous Goods Regulations sample packaging for COVID-19
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.”
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.
Sample classification
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
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.
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