Statements such as "kills 99.9% of germs" that are often seen on various products are considered antimicrobial claims. If you are making this type of claim, stating your device kills, reduces, mitigates or repels pests, including microorganisms, your product is considered a germicidal device and therefore subject to U.S. regulations. This presentation discusses how to determine which requirements apply to your device, such as differing between medical and non-medical products, and chemical and non-chemical pesticide devices.
Claims involving germicidal devices almost always require testing to support those claims. An overview of the typical germicidal test process is presented and different variables that affect testing are explored. Viral testing will be looked at in depth, using real test examples from Intertek's virology lab to help illustrate how different types of viruses greatly affect the length and complexity of testing. Finally, a look into test results and how to decipher the kill or reduction rate from the number of colony or plaque forming units, and what these terms mean, will be discussed.
- Determine which germicidal claim regulations apply to products marketed in the U.S.
- Understand variables involved in microbial testing for germicidal products
- Learn to interpret your antimicrobial test results
Danielle Melaragno is a chief engineer at Intertek, with technical oversight of microbiological, chemical and sanitation performance and certification programs within the electrical business line. She earned a B.S. in chemistry from Ohio University and began at Intertek 10 years ago doing microbial and sanitation testing. Since then she has developed and implemented many of the test methods within these areas, traveling around the world for projects, training and auditing. She led the transition into a biosafety level 2 lab, developed Intertek's ETL material compliance program and has recently been involved with the virology and aerolization chamber expansions in the Columbus, Ohio, lab, where she currently sits.
Fatai Oladunni is a virology scientist at Intertek, with eight months of testing experience specific to microbial efficacy testing. He earned his Ph.D in virology from the University of Kentucky, where he studied animal herpesviruses. He also has postdoctoral experience from the University of Rochester and Texas Biomedical Research Institute, focusing on human flu and COVID-19 viruses, before joining Intertek.