Controlled Room Temperature

Temperature

Hello good people of the world! Today’s post is about controlled room temperature, which is of importance for any space holding drug products, including manufacture, storage, and transportation. Storage temperature requirements are closely related to drug stability, so are an important focus of regulatory agencies.

US pharmacopeia has at least two applicable monographs:

Good Storage and Shipping Practices

and

Pharmaceutical Stability

ISPE summarizes the general industry approach nicely in the Good Practice Guide on Cold Chain Management (not free but available here):

“‘Controlled room temperature’ indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.”

How do you control your room temperature space? Leave a comment below and please share this post with whomever you think would benefit.

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