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Dose setting methods Method 1 or Method 2, ANSI/AAMI/ISO 11137, which take into account distribution and radiation resistance of product bioburden, and to a limited extent, the end use of the product, andDose substantiation methods, VDmax methods, which entail experimentation designed to qualify predetermined gamma dosages as a sterilization dose 1,2,3. Requirement for demonstration of continued effectiveness through periodic testing to verify that the established irradiation sterilization dose remains appropriate for product sterilization. Table 1 summarizes additional similarities and differences of the various methods. Although it illustrates the main attributes of different methods, please refer to the actual ANSI/AAMI/ISO standards or AAMI TIR for comprehensive information. Collectively, these methods provide users with a degree of flexibility in application of standards to qualify an irradiation process, in recognition that products are not all manufactured and commercialized under uniform circumstances. Users are afforded latitude to make pragmatic decisions, provided that they observe technical correctness in several key areas:Frequency of audit testing performed periodically to support continued use of the established sterilization dose. Although AAMI TIR33:2005 and ANSI/AAMI/ISO 11137 standards were initially developed with a focus on the medical device industry, they also apply to bioprocess systems and components. The remainder of this guide is therefore founded on these industry standards. GLOSSARYAseptic: Technically, free from disease producing microorganisms. In bioprocess applications, it refers to an operation performed in a controlled environment or with purpose designed connectors to prevent contamination through introduction of microorganisms may be sterile or microbially controlled. Bioburden: Population of viable microorganisms on a product.
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He also received the Society's Melville Medal in 1989 and 1998, for his publications in the Society's Transactions. Okiishi was born in Honolulu, Hawaii and graduated from Roosevelt High School in that city. From 1965 to 1967 Okiishi was in the United States military, where he worked with NASA and also did research on river flows in South Vietnam. He joined the Iowa State University faculty in 1967. Okiishi would be Associate dean of engineering at Iowa State for a time He served as Mechanical Engineering Department chair from 1990 to 1995. He also served as interim vice president of research and development at Iowa State. He was editor of the Journal of Turbomachinery from 1993 to 2003. Okiishi is married to the former Rae Wiemers, a native of Brockton, Massachusetts. He is a Latter day Saint. Among other positions in The Church of Jesus Christ of Latter day Saints Okiishi has served as a bishop, counselor in a stake presidency and stake patriarch. In the fall of 2013 he and his wife began serving as temple president and matron over the Winter Quarters Nebraska Temple.
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VLC media player commonly known as just VLC is a free and open source portable cross platform media player software. Faculty and Staff: VLC media player is available on Regent computers via Software Center. For personal machines, please visit here. Students: VLC media player is available on Regent computers via Software Center. For personal machines, please visit here. Regent University has partnered with Zoom to give Faculty and Staff access to world class video conferencing.