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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.
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 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 ...
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 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.
Aseptic processing is a processing technique wherein commercially thermally sterilized liquid products (typically food or pharmaceutical) are packaged into previously sterilized containers under sterile conditions to produce shelf-stable products that do not need refrigeration. [1] Aseptic processing has almost completely replaced in-container ...
In electrical and safety engineering, hazardous locations (HazLoc, pronounced haz·lōk) are places where fire or explosion hazards may exist. Sources of such hazards include gases, vapors, dust, fibers, and flyings, which are combustible or flammable. Electrical equipment installed in such locations can provide an ignition source, due to ...
t. e. 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.