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These are specifically designed for non-medical applications. Research autoclaves often use a “jacketless” design where steam is generated directly in the pressure chamber using heating coils (rather than relying on a “steam jacket” and independent steam generator, as is the case in high-throughput medical autoclaves).
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 ...
A cleanroom is a necessity in the manufacturing of semiconductors, rechargeable batteries, pharmaceutical products, and any other field that is highly sensitive to environmental contamination.
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.
ASME BPE (American Society of Mechanical Engineers: Bioprocessing Equipment) is an international Standard developed as an aid for the design and construction of equipment intended for use in the manufacturing of biopharmaceuticals. The standard is approved as an American National Standard by the ASME Board of Pressure Technologies.
Clean-room design (also known as the Chinese wall technique) is the method of copying a design by reverse engineering and then recreating it without infringing any of the copyrights associated with the original design. Clean-room design is useful as a defense against copyright infringement because it relies on
Class I and Class II devices are subject to less stringent regulatory processes than Class III devices. [5] Class I or II devices are focused on registration, manufacturing, and labeling. [5] In general they do not require clinical data. [5] Most class II devices go through a PMN (a 510[k]) clearance. [5]
The engineering design process, also known as the engineering method, is a common series of steps that engineers use in creating functional products and processes. The process is highly iterative – parts of the process often need to be repeated many times before another can be entered – though the part(s) that get iterated and the number of such cycles in any given project may vary.