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Maintaining a frozen shipping environment for Phase I clinical trial distribution

Elliott, Moira and Halbert, G.W. (2008) Maintaining a frozen shipping environment for Phase I clinical trial distribution. International Journal of Pharmaceutics, 346 (1-2). pp. 89-92. ISSN 0378-5173

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The need for stringent temperature control provides significant challenges to pharmaceutical distributors operating in all sectors of the industry. Products with a frozen storage label requirement can be significantly problematic. This study aimed to provide evidence of robust and reproducible frozen shipment arrangements to be operated by a Phase I clinical trial unit. Dry ice was used to achieve a deep frozen internal parcel environment and was tested in a laboratory setting using ultra low temperature loggers within dummy product packs within the test parcels. The laboratory dry ice packing configuration was then repeatedly tested in real time transits using a Glasgow to London delivery schedule. An internal temperature specification was set to not exceed −10 °C during the transport. During each delivery, external temperature monitoring measured the temperature stress experienced by the box in transit. Results demonstrated the ability of the chosen system to not exceed −13.6 °C on average (−10 °C maximum) when exposed to external temperatures of up to +20.1 °C (mean kinetic temperature). The effect was maintained for at least 52.5 h.