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The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; [1] the relevant omnibus standard is USP 797. [2] [3] Although 100% compliance remains challenging for any given facility, [4] the larger protocol may be regarded as constituting a form of clean room [5] which is included in a suite of best practices.
For instance, for the shipping and storage of pharmaceuticals, the United States Pharmacopeia-National Formulary (USP-NF) defines controlled room temperature as between 20 and 25 °C (68 and 77 °F), with excursions between 15 and 30 °C (59 and 86 °F) allowed, provided the mean kinetic temperature does not exceed 25 °C (77 °F). [17]
Mean kinetic temperature (MKT) is a simplified way of expressing the overall effect of temperature fluctuations during storage or transit of perishable goods. The MKT is used to predict the overall effect of temperature fluctuations on perishable goods. It has more recently been applied to the pharmaceutical industry.
The United States Pharmacopeia (USP) is a pharmacopeia (compendium of drug information) for the United States published annually by the over 200-year old United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself.
The refrigerator should maintain a temperature between 2° and 8 °C (36° and 46 °F). Freezers should maintain a temperature between -50° and -15 °C (-58° and +5 °F). [14] Thermometers are useful to monitor the temperature by placing at the storage unit's central location, adjacent to the vaccines.
In United States Pharmacopeia (USP) General Chapter <711> Dissolution, there are four dissolution apparatuses standardized and specified. [6] They are: USP Dissolution Apparatus 1 – Basket (37 °C ± 0.5 °C ) USP Dissolution Apparatus 2 – Paddle (37 °C ± 0.5 °C) USP Dissolution Apparatus 3 – Reciprocating Cylinder (37 °C ± 0.5 °C)
An ultra low temperature (ULT) freezer is a refrigerator that stores contents at −80 to −86 °C (−112 to −123 °F). [1] An ultra low temperature freezer is commonly referred to as a "minus 80 freezer" or a "negative 80 freezer", referring to the most common temperature standard. [2] ULT freezers come in upright and chest freezer formats.
Since 1982, STP has been defined as a temperature of 273.15 K (0 °C, 32 °F) and an absolute pressure of exactly 1 bar (100 kPa, 10 5 Pa). NIST uses a temperature of 20 °C (293.15 K, 68 °F) and an absolute pressure of 1 atm (14.696 psi, 101.325 kPa). [3] This standard is also called normal temperature and pressure (abbreviated as NTP).