Challenges in Disinfectant Coupon Testing

About the Webinar
This presentation covers current debates in the industry regarding disinfectant coupon testing. PDA Technical Report No. 70 and USP 43 -1072 will be covered in relation to current industry disinfectant efficacy testing. Recent FDA Warning Letters and 483s will be covered that highlight regulator expectations in disinfectant efficacy testing. The current debates on coupon size and coupon testing methodologies will be covered. Data will be presented covering the importance of disinfectant efficacy testing with specific bacterial spores which can be more difficult to kill than ATCC strains. Both sides of the debate on disinfectant validation will be covered in detail with an emphasis on current FDA, MHRA, HPRA, CFDA, ANVISA, ANSM, ANMAT, and FDAHA regulatory expectations and reducing the costs for testing. The recent PDA Technical Report No. 70 recommendations on DET will be discussed.
Mr. Polarine is a senior technical service manager at STERIS Corporation. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST.
Dan Klein currently holds the position of Senior Technical Service Manager at STERIS Corporation and has over 20 years of experience in the antimicrobials industry. He has authored numerous articles and several book chapters in peer reviewed journals including the recent chapter on “Disinfectant Efficacy Testing” in Block’s Disinfection, Sterilization and Preservation. He is also listed as a co-inventor on multiple United States patents. Dan served as the Chairperson of AOAC International's Committee M on Antimicrobial Efficacy Testing.