Cleanroom Disinfection - Essential Elements for Effective Contamination Control

Jim Polarine| Principal Consultant, Technical Services

Jim is a Principal Consultant, Technical Services at STERIS Corporation. He has been with STERIS Corporation for twenty-five years. His current technical focus is microbial control in cleanrooms and other critical environments. Jim is a 2019 PDA Michael S. Korczynski Award recipient and the 2024 PDA Service Appreciation Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. Jim is a frequent international industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control.

He is active on the prestigious PDA’s Scientific Advisory Board (SAB). He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection, Technical Report #88 on Microbial Deviations, and the COVID Points to Consider. Jim teaches industry regulators as well as the pharmaceutical, biotech, ATMP, and medical device industries at the PDA and the University of Tennessee. He currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course. Jim is the current past President for the PDA Missouri Valley Chapter and Vice President of Membership for the IEST. He is the PDA Chapter Council Vice Chairperson and President Elect for the IEST.

Jim graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research manager with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

 

Dan has over two decades of industry experience, including working in research and development for microbiology and clinical affairs. He has also managed a contract testing laboratory. Dan holds a master’s degree in biology and a bachelor’s degree in microbiology.

At STERIS Life Sciences, Dan provides technical expertise to Customers and helps troubleshoot and solve contamination issues. He supports Customers with a variety of critical processes and general understanding of the latest developments in the industry. He frequently presents data and other information at international industry meetings and sponsored events.

Dan is an active member of ASTM International, the Association for the Advancement of Medical Instrumentation (AAMI), the Parenteral Drug Association (PDA), the Association of Official Analytical Collaboration (AOAC) International, the Institute of Environmental Sciences and Technology (IEST) and the Center for Biofilm Engineering (CBE). He previously served as Chairperson of the AOAC International’s Committee on Antimicrobial Efficacy Testing. He is an active participant in ASTM’s E35.15, E55.08 and D37 Committees and a primary member of AAMI Work Group 08.

Throughout his professional experience, Dan has authored numerous industry articles and book chapters in peer-reviewed journals related to disinfection and sterilization.