Int J Pharm 2008 Jan 04;3461-2:89-92. doi: 10.1016/j.ijpharm.2007.06.008.

Maintaining a frozen shipping environment for Phase I clinical trial distribution.

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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 degrees 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 degrees C on average (-10 degrees C maximum) when exposed to external temperatures of up to +20.1 degrees C (mean kinetic temperature). The effect was maintained for at least 52.5h.

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Genes referenced: LOC583082