The temperature maintained thermostatically that encompasses at the usual and customary working environment of 20 25 68 77 f.
Controlled room temperature.
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Although 100 compliance remains challenging for any given facility the larger protocol may be regarded as constituting a form of clean room which is included in a suite of best practices.
This article provides a brief overview of drug product stability studies and practices with a focus on temperature control during storage and distribution.
The usp controlled room temperature is a series of united states pharmacopeia guidelines for the storage of pharmaceuticals.
And that allows for excursions between 15 and 30 c 59 and 86 f that are experienced in pharmacies hospitals and warehouses.
The relevant omnibus standard is usp 797.
That results in a mean kinetic temperature calculated to be not more than 25 c.
Ulrich c richard poska c and arminda montero c abstract.
Controlled room temperature means a temperature maintained thermostatically that encompasses the usual and customary working environment of 20 to 25 c 68 to 77 f.