covid-19 compliance guidance

COVID-19 Compliance Guidance

Intelsius has over 20 years of experience helping our customers move infectious materials. As an established business within the Sample Transport Packaging world, we are well placed to help public bodies and healthcare logistics providers react to the ongoing COVID-19 pandemic not just with product but advice and COVID-19 compliance guidance on how to transport vital test samples for analysis effectively.

As a business, we have been through national and international outbreaks before, including BSE in 1998, Avian flu in 2002, and Swine Flu in 2009, and so we know that we will come out of the other side and there’s a lot of hard work to do to get there; not just from us but our suppliers, customers, front line healthcare staff and laboratory workers. We also understand the importance of dynamic supply chains, a diverse product portfolio, and supporting our customer base locally and globally through our different sites and distributors to meet their ever-changing needs. To date, the outbreak of COVID-19 has proven to be one of the bigger challenges that we have faced as a business.

We’re currently seeing a massive rise in demand for two of our product ranges in particular, PathoPak and PathoShield, from health authorities across Europe, Asia, and the USA, with demand expected to rise as testing and screening of populations increases. The product ranges in question are in demand because of their ease of use and compliance. The World Health Organization has advised that COVID-19 samples are classified as UN3373 Biological Substance Category B. Packaging must consist of three components: a primary receptacle, a secondary packaging, and an outer packaging as outlined in packing instruction 650 (PI 650) to transport these materials safely and effectively. Below is an outline of how UK COVID-19 test samples can be packaged safely to comply with the requirements of PI650. Some generalizations encompass the different transport modalities covered by the different regulatory bodies such as IATA and ADR.

Test Samples

As it stands, COVID-19 tests in the UK consist of a nasal swab or secretion sample from the upper respiratory tract, a sputum sample from the lower respiratory tract as well as in some cases, a blood sample of up to 5 ml. Each of these samples is captured in a swab, pot, or tube and held within what is described as primary receptacles.

Primary Receptacles

These primary components contain and segregate the different biological materials required for diagnosis. Therefore, they must be packed into the secondary packaging in such a way that under standard transport conditions, they cannot break, be punctured, or leak their contents. It is also essential to separate these different samples during transport so that the primaries do not damage each other.

Secondary Packaging

Secondary packaging comes in two types, rigid and flexible. Typically, they are in the form of a rigid screw cap bottle or a flexible single-use adhesive sealed bag, which can withstand a pressure differential of 95 kPa. Both component types are safe and compliant ways of transporting samples within complete systems, each with its own set of pros and cons for use. As we are dealing with liquid samples, an absorbent material must be used between the primary and secondary to ensure that any liquid is released during transit is captured and does not compromise the packaging. Additionally, any paperwork related to the enclosed samples must not be packed into the secondary packaging. If you are using a flexible secondary, they will typically have a document pouch attached where the paperwork can be contained. If you use a rigid secondary, you will need to ensure that the paperwork is placed between the secondary and outer packaging.

Outer Packaging

The third layer of packaging is required to protect the primaries and secondary as well as display the required UN3373 diamond (a 50 x 50 mm square with 2 mm line thickness set at 45°), proper shipping name “Biological Substance, Category B,” and any consignor and consignee information. At least one of the packaging surfaces must be 100 x 100 mm also.

Testing

For packaging to fully meet the requirements of PI650, it must be able to pass a 1.2 m drop testing procedure. This testing demonstrates that the complete systems, across various preparation types (such as simulated rainfall and cold conditioning), can withstand a drop of this magnitude without leakage of the primary packaging.

Transporting Category B materials in Category A packaging

This demonstrates compliance with PI650. However, we are aware of some instances where logistics providers and authorities are especially cautious and require samples to be transported in Category A compliant packaging. This means that the complete packaging system must be suitable to transport UN2814 Infectious Substances, Affecting Humans and/or UN2900 Infectious Substances, Affecting Animals; the specific requirements of this are covered in Packing Instruction PI620 and carry a Class 6.2 UN marking.

The requirements of PI620 have some similarities with PI650, with the principles of 3 layers of packaging remaining the same. Still, the minimum size of the outer packaging must be 100 x 100 x 100 mm, and packaging must withstand a greater testing process. A system with cardboard outer packaging is subjected to a testing process which includes; 9m drop test after rain spray conditioning, 9m drop test after preparation at -18°C; Puncture test using a 7kg rod; Stack test on the top of the packaging to simulate 3m high stack of filled product. Packaging that has passed this testing is then issued a test report from the test laboratory and certification from the competent authority.

Furthermore, the US CDC is trying to ensure sample integrity with temperature-controlled packaging, and Intelsius can support this with our BioTherm systems to ensure frozen samples are shipped correctly on dry ice, or refrigerated samples remain with the necessary temperature boundaries of 2-8°C while remaining compliant with PI650 and PI620.

Whatever your requirement regarding moving COVID-19 diagnostic samples, Intelsius will be able to assist with your shipments. Contact your local branch for further information and support.

Alternatively, a range of solutions suitable for the transportation of COVID-19 samples can be purchased online.

Jens Mangelsen
Technical Director

 

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