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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 .
Retrieved 4 April 2018. 1.2.3.3 Definition of Room Temperature: According to the United States Pharmacopeia National Forumlary [ sic] (USP-NF), the definition of room temperature is between 15 and 30 °C in the United States. However, in the EU, the room temperature is defined as being 15 to 25 °C, while in Japan, it is defined being 1 to 30 °C.
An operating temperature is the allowable temperature range of the local ambient environment at which an electrical or mechanical device operates. The device will operate effectively within a specified temperature range which varies based on the device function and application context, and ranges from the minimum operating temperature to the ...
The heat index ( HI) is an index that combines air temperature and relative humidity, in shaded areas, to posit a human-perceived equivalent temperature, as how hot it would feel if the humidity were some other value in the shade. For example, when the temperature is 32 °C (90 °F) with 70% relative humidity, the heat index is 41 °C (106 °F ...
Cleanrooms typically come with a cleanliness level quantified by the number of particles per cubic meter at a predetermined molecule measure. The ambient outdoor air in a typical urban area contains 35,000,000 particles for each cubic meter in the size range 0.5 μm and bigger, equivalent to an ISO 9 certified cleanroom.
Cold chain is a set of rules and procedures that ensure the systematic coordination of activities for ensuring temperature-control of goods while in storage and transit. The objective of a cold chain is to preserve the integrity and quality of goods such as pharmaceutical products or perishable good from production to consumption.
The maximum hot-spot operating temperature is reached by adding the rated ambient temperature of the machine (often 40 °C), a temperature rise, and a 10 °C hot-spot allowance. Electrical machines are usually designed with an average temperature below the rated hot-spot temperature to allow for acceptable life. Insulation does not suddenly fail if the hot-spot temperature is reached, but ...
In industry and commerce, the standard conditions for temperature and pressure are often necessary for expressing the volumes of gases and liquids and related quantities such as the rate of volumetric flow (the volumes of gases vary significantly with temperature and pressure): standard cubic meters per second (Sm 3 /s), and normal cubic meters per second (Nm 3 /s).