Fallbrook Associate Spotlight: Materials/Sterilization Specialist
Mr. Karl J. Hemmerich, President of Ageless Processing Technology and a Fallbrook Engineering Senior Associate, has over 35 years of experience in medical device product design, development, sterilization and operations. He specializes in sterilization method selection and program development with emphasis on component material selection, process development and sterilization process validation. His experience in product design and process development includes injection molding, RF, ultrasonic and solvent assembly, multivariate process analysis and statistical process control.
In 2004 Medical Device and Diagnostics Industry selected Mr. Hemmerich as one of the 100 Most Notable People in the medical device industry. He holds numerous medical device patents and is a member of American Society of Mechanical Engineers, American Society for Quality Control and the Society of Plastics Engineers. He has written and presented papers on radiation sterilization and materials selection for many corporations, universities and professional organizations, including MDDI, SPE, FDA, HIMA, & ASQC, and his paper on radiation effects on polymers published in Medical Device and Diagnostics magazine remains an industry standard. He has presented short courses in Radiation Sterilization of Medical Polymers and Preventing Plastic Part Failure through the College of Engineering, University of Wisconsin. He is a contributing member of the SWG96/ISO11137 “Radiation Materials Working Group” that developed Technical Information Report # 17 as the guidance for materials selection, qualification/validation test techniques (i.e., accelerated aging), and quality processing methods for all common sterilization methods. Mr. Hemmerich is a member of the Editorial Advisory Board for MDDI magazine where he offers forward looking guidance as well as technical review for state-of-the-art articles prior to publication.
In addition to working with Fallbrook Engineering as a Materials and Sterilization Specialist, Mr. Hemmerich has held various responsible positions in medical product R&D and sterilization operations with Becton-Dickinson, Cutter Laboratories, IVAC Corporation and Steris Isomedix. He holds a Bachelor of Engineering degree from Stevens Institute of Technology, a Masters of Bio-Medical Engineering from the Polytechnic Institute of New York University, and a Masters of Business Administration from Fairleigh Dickinson University.
Click here to read Mr. Hemmerich's article on radiation effects on polymers at MDDI online.