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European Biopharmaceutical Review

Transportation Tips

 

The biopharmaceutical industry is beset by national and international transportation regulations, particularly with regard to air transport. But these regulations need not be a burden or a hindrance to the drug discovery and clinical trial process. The goal is to tender shipments to the airlines, which will accept them for carriage and transport them rapidly to our consignee. By following some tips on how to comply with the dangerous goods regulations, we can make the process work to our benefit.

TIP 1: IDENTIFY THE COMMODITY CORRECTLY

It all starts with the correct identification and classification of the commodity to be shipped. It is illegal to ship a chemical compound without first determining if it is hazardous or not and, if so, providing a proper shipping name and UN number for the commodity.

As an example, pre-clinical drug or chemical compound samples which contain hazardous components that may be toxic or flammable, must be examined against the criteria for inclusion in one or more UN hazard classes. This process may become complicated if there is more than one hazardous ingredient. Details and instructions can be found in the IATA Dangerous Goods Regulations (DGR), 50th Edition, Sections 3 and 4. Once the classification procedure is completed, a proper shipping name and corresponding UN number is selected from amongst those listed in the Blue Pages of the IATA DGR.

It is often the case in the drug discovery stage that a chemical compound is due to be shipped, for example, to an outside lab for assay, but the hazardous nature of the compound has not yet been determined, and the shipper has reason to suspect the compound qualifies as dangerous goods. One of the more obscure IATA DGR provisions is very useful in classifying and identifying hazardous chemical compounds of a relatively unknown nature. It is Section 3.11: Transport of Samples for Further Testing. This provision allows the shipper to apply subjective criteria, basing the classification and identification less on scientific proof and more on the shipper’s own knowledge or suspicions about the compound. The resultant proper shipping name will have the word ‘sample’ in it, to indicate that the exact nature of the commodity is yet to be determined through laboratory testing.


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Michael Gotz is the Principal of MLG Consulting, specialising in life sciences and dangerous goods transport assistance. He was previously the Director of Dangerous Goods for Quick International Courier, responsible for regulatory compliance and employee, service partner, and customer training. Starting at Flying Tigers Airline, he has been working in the dangerous goods/life sciences transport industry for 24 years. He holds a PhD from the University of California, Berkeley.

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