Temperature Mapping Studies
A critical control parameter in the processing, manufacturing, storage and distribution of pharmaceuticals, food and many other products on the market today, is temperature.
More and more, industries are requiring a validation of the temperatures in which environmentally sensitive products are stored. On the one hand, monitoring systems such as an Integrated Monitoring Solutions EDX system can provide real-time, wireless access to environmental conditions, and notifications of temperature excursions. However, ongoing monitoring is not necessarily cost-effective in all situations, nor can it provide the required level of granularity to measure detailed temperature variations within an area.
A cost-effective means to evaluate temperature storage profiles in a variety of locations, as well as to provide a high degree of temperature differentiation in an area, is through the completion of a temperature mapping study. IMS can complete temperature mapping studies in large and small warehouses, walk-in and ‘bar’ refrigerators, tractor trailers and transport containers. If your environmentally sensitive products are stored in a location, we can work with you to map it, and to ensure its stability in relation to the products being stored there.
IMS temperature mapping studies are typically completed over a 10 to 14 day period, using calibrated (N.I.S.T. traceable) and self-contained temperature dataloggers. A report, including the results, recommendations and logger validation certificates are available upon completion of the study.
Temperature mapping results, and the related documentation, are an integral component in supporting quality assurance programs, minimizing product loss through inappropriate storage conditions, meeting legislative and regulatory requirements, and in addressing patient safety issues related to maximum drug potency, as achieved through appropriate drug storage.
For further information about temperature mapping studies, download our PDF or contact IMS.