AAMI’s Sterilization suite of courses provide essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and more. Determine how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Attendees will participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.
Sterilization
Industrial Sterilization
Learn about sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design, and product release decisions. Learn how to apply the principles of sterilization and address requirements during product design. Participants will also learn how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Walk through the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes, and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill method
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Ethylene Oxide Sterilization
Training focuses on participants who are experienced in working with an established ethylene oxide sterilization process but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. The combination of a classroom lecture with real-life scenarios helps to illustrate concepts and situational analyses. Faculty will address validation and requalification; validation reports, protocols, and documentation; product adoption; troubleshooting; process changes and process equivalency; product release methods; and optimization of sterilization process.
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Radiation Sterilization for Medical Devices
Develop an understanding of FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance; scientific theory and principles of radiation sterilization; and the 11137 series of radiation sterilization standards. Faculty will address principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices.
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