Industrial Sterilization

The latest information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and more.

Sterilization

Industrial Sterilization for Medical Devices (Jan25)

Jan 21 to Jan 24, 2025

Sterilization

Radiation Sterilization for Medical Devices (Feb25)

Feb 18 to Feb 21, 2025

Sterilization

Navigating ANSI/AAMI ST108:2023 - Guidance for Water Quality (Feb 2025)

Feb 19 to Feb 19, 2025

Sterilization

Ethylene Oxide Sterilization for Medical Devices (Mar25)

Mar 3 to Mar 6, 2025

Sterilization

Industrial Sterilization for Medical Devices (May25)

May 12 to May 15, 2025

Sterilization

Ethylene Oxide Sterilization for Medical Devices (Aug25)

Aug 25 to Aug 28, 2025

Sterilization

Industrial Sterilization for Medical Devices (Sept25)

Sep 22 to Sep 25, 2025

Industrial Sterilization

Industrial Sterilization Foundation

Comprising 8-hours spread out over two days, Foundation Courses combine instructor-led training and hands-on exercises to quickly orient participants to the subject matter covered. Foundation Courses attendees to strike the perfect balance between practical, hands-on training and broader career development!
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Industrial Sterilization

Navigating ANSI/AAMI ST108:2023 - Guidance for Water Quality

This educational training session aims to familiarize participants with the newly established AAMI standard ANSI/AAMI ST108:2023, Water for the processing of medical devices. The training will comprehensively cover the content of the document, enabling end-users to effectively incorporate the recommendations outlined in the new standard.
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Radiation-sterilization-23

Industrial Sterilization

Radiation Sterilization for Medical Devices

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Industrial Sterilization

Industrial Sterilization for Medical Devices

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Industrial Sterilization

Ethylene Oxide Sterilization for Medical Devices

This highly interactive 3.5-day, advanced course assumes that participants 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.
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Faculty

Roberto Zumbado

Roberto Zumbado is the Head of Technical Services for Philips IGTD.  

Roberto is experienced in Medical Devices, Ethylene Oxide, Moist Heat, and radiation sterilization, Control Environment Rooms, Calibrations, Process, Equipment Validation and Laboratory Management. 

Roberto has led the startup and implementation of the first EO in house sterilization site in Costa Rica and lead different sterilization optimization processes for different manufacturing sites. 

He graduated from the University of Costa Rica as a Microbiologist and Chemical Analyst and has a master’s degree in industrial engineering, he also has a certification as Certified Biomedical Auditor and Certified Quality Manager from ASQ. He also has a certification as a Certified Sterilization Specialist on Ethylene Oxide from AAMI. 

Before working with Philips, Roberto worked with companies such as Hologic and Baxter. 

Roberto has published in The American Society of Tropical Medicine and Hygiene and has participated as a speaker in conferences around the world. 

He also teaches Industrial Microbiology at the University of Costa Rica and supports optimization projects for medical device manufacturers as a consultant. 

He is currently member of ASQ, AAMI and EOSA. 

Deborah Havlik

Deborah Havlik has been working as an independent consultant with expertise in microbiology and sterilization for the past four years.  Prior to that, she was the Director of R&D Microbiology for a major pharmaceutical company and was responsible for supporting the development of microbiological test methods and sterilization processes for drug products, biologics and combination products globally. Deborah has industry experience working in medical device, contract sterilization/contract laboratory and pharmaceutical companies. She has developed sterilization processes in ethylene oxide, moist heat, dry heat and radiation and also evaluated novel sterilization technologies. She is active with the Parenteral Drug Association and with AAMI and ISO on multiple working groups developing sterilization standards, and is a member of the USP Small Molecules 1 Expert Committee.  

Kevin O'Hara

Kevin is the Director of Radiation Physics at Sterigenics with corporate responsibility for measurement and calculation of absorbed dose associated with the radiation treatment of product, such as sterilization of healthcare instruments. Kevin holds almost 30 years of experience in radiation physics and radiation dosimetry within a highly technical industry. He is actively involved in numerous industry committees, task forces and working groups. As a Working Group Member, Kevin represents Canada on ISO TC 198 WG2 Radiation Sterilization. He is also a member of the AAMI Sterilization Standards Committee, WG2 – Radiation Sterilization; ASTM Subcommittee E61 Dosimetry for Radiation Processing; and Chair or Co-chair of ISO/ASTM 51707 Estimating Uncertainties, 51275 Radiochromic Film, E2232 Mathematical Methods. Kevin is a Former President/VP, Radiation Process Simulation and Modelling User Group (2002 – 2010). Over his career, Kevin has been published many times.

Expertise: Radiation Sterilization Expert, Radiation Dosimetry, Mathematical Modelling, Hockey

Publications

“A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Industrial Sterilization of Medical Devices and Healthcare Products,” published by Gamma Industry Processing Alliance (GIPA) and International Irradiation Association (iia), 2017

Chapter on Gamma Technology, in “Food Irradiation Research and Technology, Chapter: Dosimetry for Food Processing and Research Applications, IFT Press, Blackwell Publishing, 2nd Edition, 2014

“Evaluation of Tracers and Contrast Agents in Optical Molecular Imaging,” a compilation of numerous publications and the potential impact on Medical Isotopes, 2009.

Biological safety in the context of backward planetary protection and Mars Sample Return: conclusions from the Sterilization Working Group, International Journal of Astrobiology, External Subject Matter Expert (2021)

Samantha Hodge

With more than 15 years of sterility assurance experience in the healthcare technology space, Samantha is a dedicated professional who is passionate about safe, effective, and compliant solutions to industrial sterilization processes.  

Samantha started her journey as a contract research technician working on R&D programs for the Vision Care division of Johnson & Johnson.  

Eventually, she transitioned to Medtronic where she has served as a sterility assurance SME in controlled environments, laboratory operations, and terminal sterilization of disposable and reusable medical devices.  

Sam holds a Bachelor of Science in Chemistry with a minor in Mathematics from the University of North Florida as well as a number of certifications which include Registered Microbiology (RM) from the U.S. National Registry of Microbiologist, ISO 9001/ISO 13485 lead auditor certification from Oriel STAT A Matrix, Green Belt certification from Medtronic in Design for Reliability and Manufacturing (DRM) – Design for Six Sigma (DFSS), and CISS in EO and radiation from AAMI ACI.  

She is currently the Senior Director of Sterility Assurance at Medtronic and is set to complete her MBA May 2024 from the College of William & Mary – Raymond A. Mason School of Business.

Gerry A O’Dell

Gerry O’Dell has a master’s degree in microbiology from the University of South Florida. She has been in the health care products industry since 1983 and is owner and President of Gerry O'Dell Consulting for over 25 years. Gerry O'Dell Consulting is a consulting firm that works to assist companies of all sizes and in all phases of business development in the areas of sterilization (all major sterilization modalities and novel sterilization methods), environmental monitoring, laboratory and other related compliance areas for single-use medical devices, reusable medical devices, biologics, and pharmaceuticals.  

Gerry O’Dell has participated in the sterilization standards process for over 35 years and is a member of most of the AAMI sterilization standards related working groups as well as several of the working groups related to reusable medical device processing. She is past co-chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group and the AAMI Industrial Moist Heat Sterilization Working Group. She currently is a member of the U.S. Sub-TAG for ISO/TC 198/WG 1 (ethylene oxide), WG3 (moist heat), and WG8 (microbiological methods).  

Gerry O’Dell was selected as an AAMI Fellow in 2019. She is a Certified Industrial Sterilization Specialist for EO, Radiation, and Moist Heat as well as a Registered Microbiologist with the National Registry of Microbiologists in Consumer Products & Quality Assurance. She was a co-author on “The Application of ISO 11138-7 for Industrial Ethylene Oxide Sterilization Qualification” in the January 11, 2023 issue of the AAMI Array and has authored “Sterilization Validation Principles” in The Medical Device Validation Handbook and “Sterilization by Ethylene Oxide” in Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices. 

Clark Houghtling

Clark Houghtling is the Vice President of Business Development & Technical Affairs for Cosmed Group, Inc. Cosmed was founded in 1981 to sterilize medical devices and spices. The company grew to be among the largest contract sterilization companies in the United States, until it divested its five medical device sterilization locations in 2005 to focus on food safety. The company continues to use various technologies to pasteurize raw agricultural commodities in facilities dedicated to those purposes. The company reentered the medical device sterilization market in 2012 performing contract sterilization, along with selling sterilization equipment (i.e. sterilizers, control systems, scrubbers, and related accessories).

Clark’s varied background includes extensive knowledge in sterilization technologies, related microbiological and chemical testing, business development, plant and quality management, medical device manufacturing, sales, marketing, and regulatory affairs. Prior to this position, Clark worked in various upper management positions for companies including Comet ebeam Technologies, Synergy Health, Stryker Orthopaedics, Microtest Labs, Steris, Mallinckrodt, and Ethox.  He holds a Bachelor of Science degree in Biology from the State University of New York at Geneseo, and attended graduate school in Biology at Niagara University. 

Clark has taught many courses and is a frequent lecturer to many varied groups including the Food and Drug Administration (FDA), the Association for the Advancement of Medical Instrumentation (AAMI) (where he is an AAMI Fellow and serves as an instructor for the Industrial Sterilization for Medical Devices and the Industrial Ethylene Oxide Sterilization for Medical Device courses), the International Society for Pharmaceutical Engineers (ISPE), the Center for Professional Advancement (CPA), and for various companies.  He is a member of the Sterilization Standards Committee at AAMI, the American Society for Microbiology (ASM), and a senior member of the American Society for Quality (ASQ). In addition, he served as Vice President, and as Treasurer, of the Ethylene Oxide Sterilization Association (EOSA), and is a former ASQ Certified Quality Auditor (CQA).  Clark also participated in helping formulate the AAMI Certified Industrial Sterilization Specialist (CISS) program, and was in the first group to achieve the CISS certification in Ethylene Oxide, Radiation, and Moist Heat. 

Martell Winters

 Mr. Winters received a B.S. in microbiology with a minor in chemistry from Brigham Young University.  He has been at Nelson Laboratories for over 25 years testing and consulting regarding radiation sterilization, bioburden/sterility testing, microbiological process validation, allograft tissue and pharmaceutical products.  He is currently a Director of Science for Nelson Laboratories. Mr. Winters serves on many AAMI Sterilization Standards Working Groups and represents the U.S.A. at ISO meetings for microbiological methods, aseptic processing and vaporized hydrogen peroxide sterilization. He is also on the AAMI Sterilization Standards Committee and is the AAMI liaison to the AATB Standards Committee.  In 1995 he received his Registered Microbiologist (RM) certification, and in 2001 his Specialist Microbiologist (SM) certification in consumer products and quality assurance microbiology from the U.S. National Registry of Microbiologists. In 2018 he helped develop the program, and then certified as an AAMI Certified Industrial Sterilization Specialist in radiation (CISS-RAD). 

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