Search results
Results from the WOW.Com Content Network
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]
Because many definitions of standard temperature and pressure differ in temperature significantly from standard laboratory temperatures (e.g. 0 °C vs. ~28 °C), reference is often made to "standard laboratory conditions" (a term deliberately chosen to be different from the term "standard conditions for temperature and pressure", despite its ...
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)
The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. [2] If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF".
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.
Standard sea-level conditions (SSL), [1] also known as sea-level standard (SLS), defines a set of atmospheric conditions for physical calculations. The term "standard sea level " is used to indicate that values of properties are to be taken to be the same as those standard at sea level, and is done to define values for use in general calculations.
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.