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 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)

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.