Picture of UK Houses of Parliament

Leading national thinking on politics, government & public policy through Open Access research

Strathprints makes available scholarly Open Access content by researchers in the School of Government & Public Policy, based within the Faculty of Humanities & Social Sciences.

Research here is 1st in Scotland for research intensity and spans a wide range of domains. The Department of Politics demonstrates expertise in understanding parties, elections and public opinion, with additional emphases on political economy, institutions and international relations. This international angle is reflected in the European Policies Research Centre (EPRC) which conducts comparative research on public policy. Meanwhile, the Centre for Energy Policy provides independent expertise on energy, working across multidisciplinary groups to shape policy for a low carbon economy.

Explore the Open Access research of the School of Government & Public Policy. Or explore all of Strathclyde's Open Access research...

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

[img]
Preview
PDF
Int_J_Pharm_346_89_92_2008.pdf
Final Published Version

Download (136kB)| Preview

    Abstract

    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.