Temperature Mapping at a Pharmaceutical Product Warehouse

Abstract

To sustain pharmaceuticals products with high quality until they arrive to the patients, it is necessary to store them under specified temperature conditions. Warehouses that store these kinds of products use temperature sensors that collects data seven days a week, 24 hours a day, to ensure that an excursion is not happened. Is a requirement of the United States Food and Drug Administration (FDA). To validate those sensors, a temperature mapping must be performed. The temperature mapping is a tool, which involves temperature loggers that are placed strategically, to monitor a controlled enviroment. If a temperature value is not under the established range, it is considered a temperature excursion. In this study, a temperature mapping was executed to determine if there is a temperature excursion on a pharmaceutical product warehouse. After this study, the collected data by the temperature mapping will be used to validate the established sensors. Key Terms ⎯ Quality, Pharmaceutical Products, Temperature Excursion, Temperature Mapping, Validation, Warehouse.