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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.
A cleanroom or clean room is an engineered space that maintains a very low concentration of airborne particulates. It is well isolated, well controlled from contamination , and actively cleansed. Such rooms are commonly needed for scientific research and in industrial production for all nanoscale processes, such as semiconductor manufacturing.
NEDU Class 100,000 clean room. Operated by certified technicians, the Class 100,000 Clean Room performs a variety of cleaning and testing tasks: oxygen cleaning of piping, valves, regulators, tanks, and filters, as well as hydrostatic testing up to 10,000 psi (69,000 kPa).
Selection and use of appropriate cleanroom garments [10] Training and monitoring of personnel and activities [10] Installation and use of equipment [10] Requirements for materials used in the cleanroom [10] Maintaining the cleanroom environment in a clean, usable condition conforming to design standards. [10]
Cleanroom suitability describes the suitability of a machine, operating utility, material, etc. for use in a cleanroom, where air cleanliness and other parameters are controlled by way of technical regulations in accordance with ISO 14644. [1]
Filter ceiling grid of a cleanroom for microelectronic (semiconductor) manufacturing with filter fan units installed A fan filter unit ( FFU ) is a type of motorized air filtering equipment. It is used to supply purified air to cleanrooms , laboratories , medical facilities or microenvironments by removing harmful airborne particles from ...
Equipment used in aseptic processing of food and beverages must be sterilized before processing and remain sterile during processing. [1] When designing aseptic processing equipment there are six basic requirements to consider: the equipment must have the capability of being cleaned thoroughly, it must be able to be sterilized with steam, chemicals, or high-temperature water, sterilization ...
ISO 14698-1 was first written in 2003. ISO 14698-1 describes the principles and basic methodology for a formal system to assess and control biocontamination, where cleanroom technology is applied, in order that biocontamination in zones at risk can be monitored in a reproducible way and appropriate control measures can be selected.