Some PDI products state “store at room temperature.” What is the definition of room temperature?

August 27, 2018

For our EPA-regulated products, such as Sani-Cloth® and Sani-Prime™ brand products, room temperature is defined as an average temperature of 25◦ C (77◦ F) and within a temperature range of 15◦ C to 30◦ C (59◦ F to 86◦ F). For our FDA-regulated products, such as Prevantics® brand products, “controlled room temperature” indicates a temperature maintained thermostatically that encompasses the usual customary working environment of 20◦ C to 25◦ C (68◦ F to 77◦ F). SOURCE: USP 41-NF 36 General Notices and Requirements (August 1, 2013 First Supplements) Section 10.30.50. “Room Temperature” indicates the temperature prevailing in a working area. Section 10.30.60. Controlled Room Temperature