title: Maintaining the cold chain shipping environment for Phase I clinical trial distribution.
abstract: The study aimed to demonstrate satisfactory inter-UK transit of cold storage clinical trial material. The product environment had to be maintained between 0 and 8 degrees C throughout transit until delivery. Straightforward, low cost and simplified shipping arrangements were sought that would be appropriate for small-scale Phase I clinical trial activities. A laboratory test defined an optimal three frozen gel pack configuration to maintain refrigerated environmental conditions for dummy product packs in a single type and size of insulated shipper. The internal environment was temperature monitored at 30-min intervals in all tests. Twelve Glasgow to London transits were then studied over 2 years to include all seasonal temperature variations. A configuration using three frozen gel packs and 4 h pre-chill of the transit container maintained the internal environment at 0-8 degrees C for up to 48 h during autumn, winter and spring. A modified four frozen gel pack configuration was suitable for summer transit. Thus cold shipment verification was successfully carried out for a small-scale distribution operation. It was proven that refrigerated shipping conditions could be maintained using a straightforward and cost effective 'passive' type system consisting of frozen gel packs and insulated transit containers.
authors.affiliation: Phase I/II Clinical Trials Committee Cancer Research UK Formulation Unit, Department of Pharmaceutical Sciences, University of Strathclyde, Glasgow, Scotland G1 1XW, UK. eas98110@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; D003080:Cold Temperature; D004349:Drug Packaging; D004356:Drug Storage; D012034:Refrigeration / Q000379:methods*; D012621:Seasons; D013997:Time Factors; D014186:Transportation; D006113:United Kingdom