Requirements and Risks of Sample Transport
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WE PROTECT LIFE’S MOST PRECIOUS CARGO Requirements and Risks of Sample Transport The process of collecting samples and sending them to a laboratory for testing and analysis is an essential part of ensuring the best possible patient outcomes in the process of pharmaceutical drug development through the clinical trials patient process and more generally in the screening, and diagnosis processes of patients in the human and animal healthcare sectors. The majority of human or animal samples are classified as Dangerous Goods for the purposes of packaging and transport. Regulatory background Compliance with Dangerous Goods regulations as set out by The UN Recommendations on the Transport of Dangerous Goods are contained in the UN Model Regulations prepared by the Subcommittee of Experts on the Transport of Dangerous Goods of the United Nations Economic and Social Council (ECOSOC). These recommendations have been adapted by most countries into national regulations, and also form the basis of international agreements such as The IATA DGR, as derived from ICAO T.I’s which govern air transport and the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) . All EU countries have transposed the ADR agreement into national domestic regulations. Outside of the EU countries such as the USA have different regulations albeit all are derived from the UN recommendations. These regulations are necessary to ensure the safety and integrity of the sample and the safety of those handling the sample along the supply chain. As with any supply chain, there are risks and challenges that need to be overcome. In this article we’ll look at: a) What those risks and challenges are b) How we solve those challenges and meet those risks with Intelsius sample transport packaging Requirements The UN recommendations has categorised the shipping of infectious substances into two categories: Category B substances, which is known as UN3373 and is described as: ‘an infectious substance which does not meet the criteria for inclusion in Category A.’ and Category A substances ,which are further split into two further subcategories: UN2814 (affecting humans) and UN2900 (affecting animals only) and is described as: ‘an infectious substance which is carried in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals.’ DGP Intelsius GmbH, Eulerweg 11, 64291 Darmstadt, Deutschland Geschäftsführer: David Walsh, HRB 98763 Darmstadt Bankverbindung: IBAN: DE50 1101 0100 2720 1380 50, BIC: SOBKDEBBXXX (

How compliance is achieved is dependent on whether the dangerous goods are transported via road or air. The European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) and The International Air Transport Association (IATA) are the bodies which have separate and distinct guidelines for the transport of dangerous goods. The guidelines include the quality of packaging used and the labels applied to that packaging. If a substance is classified as belonging to UN3373 (either Category A or B), it must be packed for transport according to guidelines known as Packing...

1. Incorrect labelling Some of the most common mistakes when shipping dangerous goods are with using the right packaging, labelling and documentation. A crucial part of ensuring proper shipping if infectious substances would be to accurately and properly label the samples to ensure that it is handled correctly along the supply chain. We have published our own label compliance guide for those seeking further guidance. 2. Failing to ensure certified packaging It is crucial to ensure that the packaging selected is UN-certified. A good way to ensure your packaging is properly certified is to...

1. Breakages/Leakages If done incorrectly, infectious substances can be extremely harmful to humans. If there is a leakage during transit because incorrect packaging is used or guidelines are incorrectly followed, potentially deadly substances can be exposed to those carrying and handling the products. 2. Temperature fluctuations The environment in which the samples are transported presents another risk, as warmer climates tend to create more fluctuations in temperature both within the packaging system as well as externally. If you’re shipping temperature-sensitive samples, this could harm...

To speak to a member of our team about your sample transport shipping requirements, get in touch at compliance@Intelsius.com. DGP Intelsius GmbH Jens Bichler Business Development Manager Phone: +49 (0) 6151 4936 653 Email: jens.bichler@intelsius.com Web: www.intelsius.de