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Controlled room temperature.
This article provides a brief overview of drug product stability studies and practices with a focus on temperature control during storage and distribution.
Excursions between 15 and 30 59 and 86 f that are experienced in pharmacies hospitals and warehouses and during shipping are allowed.
Ulrich c richard poska c and arminda montero c abstract.
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.
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.
Designed to meet precise temperature and humidity requirements for storage of foods blood products tissue samples and more a temperature controlled room may complete your foodservice or scientific operation.
The temperature maintained thermostatically that encompasses at the usual and customary working environment of 20 25 68 77 f.
The relevant omnibus standard is usp 797.
Usp controlled room temperature range expansion desmond g hunt a chris chandler b david a.