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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 ...
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.
"closed" in terms of microbiological contamination. This definition deals purely with introducing micro-organisms into a sterile product, and there is no consideration of the sterile product coming out of the vial contaminating the environment. [11]
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.
Microorganisms growing on an agar plate. Sterilization (British English: sterilisation) refers to any process that removes, kills, or deactivates all forms of life (particularly microorganisms such as fungi, bacteria, spores, and unicellular eukaryotic organisms) and other biological agents (such as prions or viruses) present in fluid or on a specific surface or object. [1]
Sterile dental instruments from hospital central supply (barcoded label indicating sterilization date, expiry date and contents). The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization ...
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 ] (about double atmospheric pressure) depending on ...
So SAL is used to express the probability of the survival. For example, medical device manufacturers design their sterilization processes for an extremely low SAL, such as 10 −6, which is a 1 in 1,000,000 chance of a non-sterile unit. SAL also describes the killing efficacy of a sterilization process.
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