The R&D project is targeting fugitive ethylene oxide emissions to improve safety in biomedical device supply chains
DANBURY, Conn., Nov. 30, 2022 /PRNewswire/ — Sonata Scientific, a developer of advanced industrial air purification products, has been awarded a Small Business Innovation Research (SBIR) Phase I Grant by the Food and Drug Administration (FDA) entitled: “Reduced EtO emissions to safeguard biomedical supply chains”.
Ethylene oxide (EtO) is used to sterilize more than half of all medical devices, including a vast array of plastic devices that cannot be sterilized by other methods. Awareness of the dangers of EtO has increased steadily, and recently it has been found that fugitive EtO emissions from sterilized medical devices can also play a role in indoor and outdoor air pollution. Since 2019, several medical device facilities have been shut down because of EtO violations.
The FDA SBIR grant will help Sonata Scientific introduce products to reduce ambient levels of EtO along the supply chain. This problem has high visibility at device manufacturers, contract sterilizers, and government agencies as a real danger to the workforce, the community, and the medical device infrastructure.
Bob Henderson, Senior Systems Engineer at Sonata Scientific, said, “While EtO is essential for medical device sterilization, it is detrimental to human health, even at the lower levels present in indoor environments. Current mitigation approaches certainly have their place, particularly at exhaust stacks where inlet concentrations to the scrubber are quite high. But operating at low concentrations is difficult for typical scrubbing systems. Our technology is a perfect fit for addressing EtO emissions in indoor spaces, like employee-occupied warehouses.”
Melissa Petruska, Vice President of Product Development, adds “Our technology platform has the potential to make a positive impact in this market. Initial 3rd party testing demonstrated greater than 99% destruction of EtO at fugitive emission levels using a room-temperature process. This program will help us productize our systems to make a difference in the lives of people in and around sterilization facilities and warehouses.”
This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award R43FD007588, totaling $200,000 with 100 percent funded by FDA. The contents of this press release are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
Sonata Scientific is an early-stage company that is transforming its materials chemistry and systems’ innovations into practical products to improve living and working environments.
Peter Van Buskirk
SOURCE Sonata Scientific