title: Maintaining a frozen shipping environment for Phase I clinical trial distribution.
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 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.
authors.affiliation: Cancer Research UK Formulation Unit, Strathclyde Institute for Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, Scotland, United Kingdom. moira.elliott@strath.ac.uk
authors.forename: M A
authors.initials: MA
authors.lastname: Elliott
authors.forename: G W
authors.initials: GW
authors.lastname: Halbert
mesh_terms: D017321:Clinical Trials, Phase I as Topic; D004356:Drug Storage; D004367:Dry Ice; D005615:Freezing; D011137:Polystyrenes; D014186:Transportation
chemical_list: D004367:Dry Ice; D011137:Polystyrenes