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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.
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.
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 ...
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 ...
www .usp .org. 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.
Dissolution testing. In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [ 1]
Differential scanning calorimetry ( DSC) is a thermoanalytical technique in which the difference in the amount of heat required to increase the temperature of a sample and reference is measured as a function of temperature. [ 1] Both the sample and reference are maintained at nearly the same temperature throughout the experiment.