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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 ...
Such rooms are commonly needed for scientific research and in industrial production for all nanoscale processes, such as semiconductor manufacturing. A cleanroom is designed to keep everything from dust to airborne organisms or vaporised particles away from it, and so from whatever material is being handled inside it.
ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC and the MDR.
A closed system drug transfer device or "CSTD" is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into a system and the escape of hazardous drug or vapor concentrations outside the system. Open versus closed systems are commonly applied in medical devices to maintain the sterility of a fluid pathway.
Research autoclaves display a wide range of designs and sizes, and are frequently tailored to their use and load type. Common variations include either a cylindrical or square pressure chamber, air- or water-cooling systems, and vertically or horizontally opening chamber doors (which may be electrically or manually powered).
BFS-packaged eye drops for single use. Blow-Fill-Seal, also spelled as Blow/Fill/Seal, in this article abbreviated as BFS, is an automated manufacturing process by which plastic containers, such as bottles or ampoules are, in a continuous operation, blow-formed, filled, and sealed.
In the first season of the 2014 TV show Halt and Catch Fire, a key plot point from the second episode is how the fictional Cardiff Electric computer company placed an engineer in a clean room to reverse engineer a BIOS for its PC clone, to provide cover and protection from IBM lawsuits for a previous probably-illegal hacking of the BIOS code others at the company had performed.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.