Biography
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 25 years of experience working in research, laboratory, test design and manufacturing microbiology 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, process design, process controls, sterilization and aseptic processing.
Teaching Interests
Microbiology
Research Interests
Radiation Sterilization Validation
Facility & Environmental Monitoring
Aseptic Processing
Failure Investigations
Medical Devices
Tissue Disinfection, Screening and Processing Techniques
Education
AAMI Certified Industrial Sterilization Specialist: radiation (CISS-RAD), ethylene oxide (CISS-EO), and moist heat (CISS-MH) (2018)
Nelson Laboratories Sterilization Specialists Certification Program: Sterilization Specialist (2007)
American Society for Microbiology: Specialist Microbiologist (2001)
American Society for Microbiology: Registered Microbiologist (1995)
Brigham Young University, Microbiology Major, Chemistry Minor, B.Sc. (1994)
Honors and Awards
American Association of Tissue Banks: Jeanne Mowe Distinguished Service Award
Publications
“Methods of Culturing, Problems Associated with Bacteriostasis, and Radiation Sterilization Options”, Advances in Tissue Banking, Vol. 7, Chapter 7, World Scientific, 2004
“Absorbed Dose Measurement in Low Temperature Samples: Comparative Methods Using Simulated Material”, Radiation Physics and Chemistry, Vol. 71, pp. 351-354, 2004
“Improved Method for Gamma Irradiation of Donor Tissue”, Sterilization of Tissues Using Ionizing Radiations, pp. 105-115, CRC Press, 2005
“Bacterial Inactivation in Tissues”, Sterilization of Tissues Using Ionizing Radiations, pp. 281-286, CRC Press, 2005
“Testing the Tissue and the Environment”, Essentials of Tissue Banking, pp. 167-187, Springer Publishing, 2010
“Microbiological Considerations in Medical Device Industry”, Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, pp. 73-100, Business Horizons, 2011
“Radiation Sterilization Failures – What Can Go Wrong?” Biomedical Instrumentation and Technology, May/June Vol. 45, No.3, pp. 206-208
”Minimizing Material Damage Using Low Temperature Irradiation”, Radiation Physics and Chemistry, Vol. 81, pp. 1254-1258, 2012
“Principles of Process Validation and Equipment Qualification”, Tissue and Cell Processing – An Essential Guide, Blackwell Publishing Ltd, in process, 2012
“Establishing Bioburden Alert and Action Levels”, Medical Device & Diagnostic Industry (MDDI), June 2013, pp. 44-49
“Using Statistics as a Risk Analysis Tool for Selecting an Alternate SAL”, AAMI Industrial Sterilization, Research from the Field, October 2013, pp 94-100
“Irradiation of Advanced Health Care Products – Tissues and Biologics”, Radiation Physics and Chemistry, Vol. 105, 2014
“Updates to the ISO Bioburden Standard, P.S. What Happened to the Microbiologists?”, Contamination Control in Healthcare Product Manufacturing, Vol. 4, Madsen and Moldenhauer, PDA, 2016, pp 33-55
AATB Guidance Document No. 5, Microbiological Process Validation and Surveillance Program, version 2, July 18, 2016, primary author and task force lead
“Disinfection of Human Musculoskeletal Allografts in Tissue Banking: A Systematic Review”, Cell and Tissue Banking, 24 Sep 2016, DOI 10.1007/s10561-016-9584-3
“New FDA Guidance for 510(k) Submission of Orthopedic Medical Implants”, Orthopedic Design and Technology, November/December 2016
“Validation of a Sterilization Dose for Products Manufactured Using a 3D Printer”, from IMRP 2016, Radiation Physics and Chemistry, Vol. 143, 2018
“Five Aspects of the ISO 11737-1:2018; Updates You Need to Know”, Medical Product Outsourcing, online 23 July 2018, print September 2018 (rated Reader’s Choice #4 by MPO for 2018)
“Consider the Most Probable Number Method for Bioburden Testing”, Medical Device & Diagnostic Industry (MDDI), online 22 October 2018
“The Effect of Gamma Irradiation Process Interruption on Microbial Resistance of G. stearothermophilus”, PDA Letter, November/December 2018, pp 36-38 (not credited)
“Quality Control Testing Through the Product Development Lifecycle”, Biotechnology, From Idea to Market, PDA, 2019, pp 609-641
“The Effect of Gamma Irradiation Process Interruption on Microbial Resistance of G. stearothermophilus”, Radiation Physics and Chemistry, 168 (2020)