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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 ...
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.
Industrial autoclaves are used in industrial applications, especially in the manufacturing of composites. Many autoclaves are used to sterilize equipment and supplies by subjecting them to pressurized saturated steam at 121 °C (250 °F) for 30–60 minutes at a gauge pressure of 103 kPa [1] depending on the size of the load and the contents. [2]
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]
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 1953, APV pioneered a steam injection technology, involving direct injection of steam through a specially designed nozzle which raises the product temperature instantly, under brand name Uperiser; milk was packaged in sterile cans. In the 1960s, APV launched the first commercial steam infusion system under the Palarisator brand name. [7] [8]
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.
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.