COVID-19 Compliance Guidance
Intelsius has over 20 years’ experience of helping our customers moving infectious materials, and 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 effectively transport vital test samples for analysis.
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 both 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 huge rise in demand for two of our product ranges in particular, PathoPak and PathoShield, from health authorities across Europe, Asia and USA with demand expected to rise as testing and screening of populations increases. The product ranges in question are so 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. To transport these materials safely and effectively packaging must consist of three components: a primary receptacle, a secondary packaging and an outer packaging as outlined in packing instruction 650 (PI 650). Below is an outline of how UK COVID-19 test samples can be packaged safely to comply with the requirements of PI650. There are some generalisations to encompass the different transport modalities covered by the different regulatory bodies such as IATA and ADR.
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 are described as primary receptacles.
These primary components are used to contain and segregate the different biological materials required for diagnosis. 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 important to separate these different samples during transport so that the primaries do not damage each other.
Secondary packaging comes in two types, rigid or 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 their 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 if any liquid is released during transit it is captured and does not compromise the packaging. 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 are using a rigid secondary you will need to ensure that the paperwork is placed between the secondary and 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 surfaces of the packaging must be 100 x 100 mm also.
For packaging to fully meet the requirements of PI650 it must be able to pass a 1.2 m drop testing procedure. This testing is to demonstrate that the complete systems, across a variety of preparation types (such as simulated rainfall and cold conditioning) are capable of withstanding a drop of this magnitude without leakage of the primary packaging.
Transporting Category B materials in Category A packaging
Where this demonstrates the compliance with PI650 we are aware of some instances of where logistics providers and authorities are being especially cautious and requiring 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 but 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 which has passed this testing is then issued a test report from the test laboratory along with 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 whilst remaining compliant with PI650 and PI620.
Whatever your requirement with regards to 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.