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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.
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 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.
QFD house of quality for enterprise product development processes. The term systems engineering can be traced back to Bell Telephone Laboratories in the 1940s. [1] The need to identify and manipulate the properties of a system as a whole, which in complex engineering projects may greatly differ from the sum of the parts' properties, motivated various industries, especially those developing ...
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.
The V-model is a graphical representation of a systems development lifecycle.It is used to produce rigorous development lifecycle models and project management models. The V-model falls into three broad categories, the German V-Modell, a general testing model, and the US government standard.
The SDR is a technical review conducted to evaluate the manner in which a project's system requirements have been allocated to configuration items, manufacturing considerations, next phase planning, production plans, and the engineering process that produced the allocation. This review is conducted when the system definition is at a point where ...
Manufacturing engineering or production engineering is a branch of professional engineering that shares many common concepts and ideas with other fields of engineering such as mechanical, chemical, electrical, and industrial engineering. Manufacturing engineering requires the ability to plan the practices of manufacturing; to research and to ...