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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 ...
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. By comparison, an ISO 14644 -1 level 1 certified cleanroom permits no particles in that size range, and just 12 particles for each cubic meter of 0.3 μm and smaller.
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.
Externally, the upper limit of the human body’s thermoneutral zone—the ambient temperature range in which the body can effectively maintain its temperature and equilibrium—likely falls ...
Operating temperature. 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 ...
USP 800 ( Hazardous Drugs—Handling in Healthcare Settings) is a guideline created by the United States Pharmacopeia Convention (USP), as one of their General Chapters through which the USP "sets quality standards for medicines, dietary supplements and food ingredients". USP 800 provides guidance about the handling of hazardous drugs (HDs) in ...
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 ...
A combustible material is a material that can burn (i.e., sustain a flame) in air under certain conditions. A material is flammable if it ignites easily at ambient temperatures. In other words, a combustible material ignites with some effort and a flammable material catches fire immediately on exposure to flame.