Martell Winters is a recognized authority and industry leader on Radiation Sterilization, Bioburden, Microbiology, Aseptic Processing, Environmental Control and Tissue Processing and Disinfection. He has over 20 years of experience working in research, laboratory, design and manufacturing functions in the medical device, tissue and pharmaceutical industries. Martell has worked with clients in all areas of the world to speak, train or consult on failure investigations, product design, process controls, sterilization and aseptic processing.
Martell is an active committee member of many working groups with the Association for the Advancement of Medical Instrumentation (AAMI), American Association of Tissue Banks (AATB) and the International Organization for Standardization (ISO). He is currently the AATB liaison to the AAMI Radiation Working Group and he has presented at many AATB meetings, national and international conferences (International Meeting on Radiation Processing, International Atomic Energy Agency) regarding microbiological culturing, bioburden, radiation sterilization, process validation, and sterility assurance levels. Martell has participated in multiple task forces from the AAMI working groups organized to draft new procedures (e.g. VDmax, and aseptic processing of solid medical devices).
He was responsible for development of AAMI Technical Information Report on Radiation Sterilization of Human Tissue-based Products and the TIR on Environmental Monitoring for Terminally Sterilized Medical Devices. He was lead author and editor of AATB Guidance Document #5 on Microbiological Surveillance and Process Validation. He participated with the International Irradiation Association (iiA) in preparing seminars on radiation sterilization of small and large molecules.
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