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Oregon News: Temperature Controls
Published in the February 2008 Oregon State Board of Pharmacy Newsletter
The Board’s inspectors continue to encounter interesting situations during their on-site pharmacy inspections. One of the routine checks on the inspectors’ lists is the refrigerator/freezer or other controlled temperature environments. In reviewing the temperature log with a pharmacist, the inspector noted that the daily temperatures were logged impeccably without a single miss. However, a number of the temperatures logged were outside the accepted range for the contents of the unit. The Board wants to remind all pharmacists of the importance of actually monitoring the storage environment and not just writing down numbers.
Some United States Pharmacopeia (USP) monographs contain specific directions for stating the temperature at which articles should be stored, for example, when stability data indicate that storage at a lower or higher temperature produces undesirable results. These directions apply generally, but not where the label on an article specifies different storage conditions on the basis of studies for that particular formulation. The following are storage conditions as defined in the General Notices section of the USP XXII-NF XVII.
Freezer: A place in which the temperature is maintained themostatically between -20ºC and -10ºC (-4ºF and 14ºF).
Cold: Any temperature not exceeding 8ºC (46ºF). A refrigerator is a “cold” place in which the temperature is maintained thermostatically between 2ºC and 8ºC (36ºF and 46ºF).
Cool: Any temperature between 8ºC and 15ºC (46ºF and 59ºF). An article that requires cool storage may be stored in a refrigerator unless otherwise specified by its individual USP monograph.
Room Temperature: The temperature prevailing in a working area.
Controlled Room Temperature: A temperature maintained thermostatically that encompasses the usual and customary working environment of 20ºC to 25ºC (68ºF to77ºF) that allows for brief deviations between 15ºC and 30ºC (59ºF and 86ºF) that are experienced in pharmacies, hospitals, and warehouses.
Warm: Any temperature between 30ºC and 40ºC (86ºF and 104ºF).
Excessive Heat: Any temperature above 40ºC (104ºF).
Protection from Freezing: Where, in addition to the risk of breakage of the container, freezing subjects an article to loss of strength or potency, or to destructive alterations of its characteristics, the container label bears an appropriate instruction to protect the article from freezing.
Dry Place: A place that does not exceed 40% relative humidity at controlled room temperature (or the equivalent water vapor pressure at other temperatures). The determination may be made by direct measurement at the dry place or may be based upon reported climatic conditions.
