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The Association for the Advancement of Medical Instrumentation (AAMI) is an organization for advancing the development, and safe and effective use of medical technology founded in 1965 by Robert D. Hall Jr. and Robert J. Allen, President and Vice President respectively of Tech/Reps, Inc. (a medical Instrumentation marketing firm in Needham, Massachusetts).
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 ...
The Healthcare Sterile Processing Association (HSPA), formerly International Association of Health Central Service Material Management (IAHSCMM), [3] is a professional association which represents healthcare Central Service (CS) professionals, and is based in Chicago, Illinois with over 48,000 [4] members worldwide.
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]
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]
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.
The Center for Devices and Radiological Health (CDRH) is one of six product centers of the U.S. Food and Drug Administration (FDA), an agency that is part of the U.S. Department of Health and Human Services (HHS).