The regulation of pesticide or antimicrobial devices that produce an antimicrobial product or act as the antimicrobial is complex, as regulation of these products in the US can fall under the FDA or EPA. Successfully navigate regulatory requirements and registration of these products with Element’s consultative regulatory and scientific experts.

Examples of these types of devices include, but are not limited to, Ultraviolet (UV), sterilizing, steam, ozone, infrared, and ionizing devices. Antimicrobial Pesticide Devices that work by physical means are regulated by the United States Environmental Protection Agency (EPA) and do not require registration. EPA pesticide regulations do require pesticide device producers to generate efficacy data in support of all claims. For example, UV lights are considered to be an antimicrobial pesticide device, as the antimicrobial is generated and used on site.

Steam cleaning device testing

Virucidal Efficacy of a Steam Cleaning Device for Use on Inanimate Environmental Surfaces – When devices are tested using this method, an aliquot of virus is dried on a carrier surface (2” x 2” ceramic tiles) then exposed to the steam device for the specified exposure time(s) or recommended method of application. Following exposure or application, the virucidal and cytotoxic activities are removed from the virus-test substance mixture, and the mixture is assayed for viral infectivity by an accepted assay method. Appropriate virus, test substance cytotoxicity, and neutralization controls are run concurrently.

Typically, for a device to be considered efficacious, least a 3 log reduction of the virus should be demonstrated.

UV device testing

Evaluation of the Virucidal Activity of a UV Device for Use on Inanimate Environmental Surfaces - When UV devices are tested to this method, a film of virus dried on a glass surface (or other hard, non-porous surface) is exposed to the UV test device for the Sponsor specified exposure time, distance, and wavelength. Following exposure, the carriers are neutralized and assayed viral infectivity by an accepted assay method. Appropriate virus and cytotoxicity controls are run concurrently.

Typically, for a device to be considered efficacious, least a 3 log reduction of the virus should be demonstrated.

Custom pesticide/antimicrobial device testing

In addition to testing antimicrobial pesticide devices to established methods, our team can work with you to develop custom protocols tailored to meet your specific device testing needs. We have worked with many devices including, but not limited to the following:

  • UV devices
  • Steam cleaning/mopping devices
  • Ozone devices
  • Infrared light devices
  • Ionizers
  • Disinfectant generating devices

The Element advantage

The regulations governing antimicrobial pesticide devices is complicated. With more than thirty years of experience supporting the successful registration of a multitude of products, our responsive teams can help you to determine how to generate needed data to comply with regulatory requirements for your antimicrobial pesticide device. Partner with Element for testing to established methods, as well as for customized protocols tailored to meet your specific needs. We can partner with you to develop protocols that can be presented to regulatory agencies for approval in advance of testing to help ensure data acceptance.

For more information about Element’s virucidal antimicrobial pesticide device testing services, contact us today.

Request a quote or speak with one of our antimicrobial experts