Ensuring the fast, safe and reliable transport of clinical specimens and vaccines around the world is more important than ever. Unfortunately, differences in infectious substance classifications, packaging requirements and other shipping regulations between countries create significant supply-chain challenges — particularly when it comes to sourcing approved packaging for shipping COVID-19 samples in Southeast Asia.
Consistent regulations for these shipments are critical. Without controls, test samples could be ruined or generate false readings, and vaccines could spoil. That’s why pharmaceutical companies and laboratories take numerous steps to ensure every shipment, regardless of origin or destination, is kept within a specific temperature range and arrives in a certain condition.
Packaging is a key component in achieving this goal. For this reason, organizations shipping these substances want to use the same tested and approved packaging, with specific dimensions, performance expectation and insulation properties, anywhere in the world. But the emphasis on proper packaging isn’t just from individual organizations — it also comes from government authorities and regulatory bodies.
Samples of pathogenic viruses and other infectious substances are classified as “dangerous goods,” and therefore highly regulated. Category A substances (e.g. Ebola) are considered immediately life-threatening and governed by far more restrictive regulations than Category B (e.g. flu), which is not generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans.
Due to the high-risk nature, all shipments containing deadly Category A infectious substances require UN-certified packaging that has passed strenuous performance tests, including temperature control, water spray temperature conditioning, steel spike penetration, and 9-meter (30-foot) drop. Category B packages must be “capable” of a water spray temperature conditioned 1.2-meter (3.9-foot) drop. Under these global testing requirements, organizations should be able to get consistent, performance-tested packaging anywhere in the world.
Despite being certified by the UN and tested to a standard that adheres to the shipping regulations in all countries, Category A packaging must also still be tested and certified by each country’s competent authority. While meeting this requirement is generally easy in most parts of the world, it became a significant challenge in Southeast Asia during the COVID-19 pandemic since labs in that region were not equipped to test infectious substance packaging according to UN standards. As a result, the country’s competent authorities could not certify Category A packaging to move COVID-19 samples in the region.
This presented a significant challenge for pharmaceutical companies and central laboratories to use consistent and approved packaging globally, but with no way to source locally. Organizations had to work with local manufacturers to have access to the necessary testing capabilities or ship copious amounts of certified boxes into the region — both of which can be extremely expensive and significantly slow down testing.
The global awareness of the importance and critical nature of shipping infectious substances and vaccines has never been higher. The COVID-19 pandemic has spotlighted regulatory and supply-chain challenges in transporting these substances around the world. New viruses and strains will continue to emerge, so it’s important to use what we’ve learned to address these global supply-chain gaps to ensure we won’t face these same challenges in the future.
Jay Johnson is senior manager of Labelmaster Services at Labelmaster.
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