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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 ...
Aseptic processing involves maintaining a sterile environment to prevent the introduction of contaminants during the manufacturing of products, such as sterile injectable medications and sterile medical equipment. This requires stringent control over personnel behavior, equipment sterilization, and the cleanroom environment. [16]
Barrier and Isolator designs are used throughout the industries, from sterile injectable drug filling to cytotoxic sterile drug compounding to electronics manufacturing to orange juice filling. Pharmaceutical industry and pharmacy compounding isolators are used for maintaining sterility of a drug, and that is the focus of this article.
[3] [4] BFS is an advanced aseptic processing technology that is typically used for filling and packaging of certain sterile liquid formulations like liquid ophthalmics, inhalational anesthetics, or lavaging agents, but can also be used for injectables, [1] parenteral medicines, [5] and several other liquid or semiliquid medications, [6] with ...
CSTDs generally follow one of two design concepts, using either a physical barrier or an air-cleaning technology to prevent the escape of hazardous drugs into the work environment. Physical barrier - Blocking the unintended release of drug into the surrounding environment or the intake of environment contaminates into a sterile drug pathway. [8]
The term implies that the design team works in an environment that is "clean" or demonstrably uncontaminated by any knowledge of the proprietary techniques used by the competitor. Typically, a clean-room design is done by having someone examine the system to be reimplemented and having this person write a specification.