| The purpose of this one-year temperature mapping study was to determine the extreme temperatures and respective durations commercial pharmaceutical products are expected to be exposed to during routine ambient distribution within the continental United States. Extreme temperature conditions may affect the safety and efficacy of pharmaceutical products during distribution. Knowing the value and duration of the extreme temperatures that products are likely to experience in the ambient (uncontrolled) distribution environment allows for improved product degradation testing, optimized thermal package design and scientifically based determination as to when logistical and environmental controls should be used. Before this study, testing was performed using profiles provided by standards organizations. This study was designed to provide company specific data that may be used to design tests, validate, or modify existing test procedures throughout the organization. To achieve this, packages were shipped to selected locations across the United States from the company's Eastern, Southern, and Western Distribution Centers (DCs) during peak summer and winter conditions. The packages were equipped with data logging instrumentation that recorded the temperature and the time-of-day. As a result of this project, the organization now has first hand knowledge of the expected extremes and durations within its United States distribution environment. This information is now in use for study design, logistical decision-making, and proving that appropriate testing has been performed to regulatory bodies. |
