Maintaining a frozen shipping environment for Phase I clinical trial distribution

Int J Pharm. 2008 Jan 4;346(1-2):89-92. doi: 10.1016/j.ijpharm.2007.06.008. Epub 2007 Jun 14.

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.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials, Phase I as Topic
  • Drug Storage*
  • Dry Ice
  • Freezing
  • Polystyrenes
  • Transportation*

Substances

  • Dry Ice
  • Polystyrenes