The Company is developing ethylene oxide control products to improve worker and community safety, and protect biomedical supply chains
DANBURY, Conn., June 20, 2023 /PRNewswire/ — Sonata Scientific, a developer of advanced industrial air purification products, recently demonstrated the destruction and removal of ethylene oxide to levels below 10 parts per billion (ppb) in ambient conditions typical of a medical device sterilization facility.
Ethylene oxide (EtO) is used to sterilize more than half of all medical devices. Fugitive EtO emissions leaking from sterilization facilities pose a major risk to nearby communities. EPA, via its FIFRA authority, proposed dramatically more stringent EtO levels in April. Action levels have been reduced to 10 ppb. Compliance will have significant costs, and medical device supply chains may face interruptions.
The FDA has funded Sonata to develop new products to control fugitive EtO to these low levels in device sterilization facilities. The program is entitled, “Reduced EtO emissions to safeguard biomedical supply chains,” Bob Henderson, Senior Systems Engineer, said “In the first program phase, we achieved greater than 99% destruction and removal efficiency of EtO, reducing EtO to below 10 ppb over a wide range of conditions that are typical of a sterilization facility or warehouse. System performance is high, even with significant CO2 and methane present.”
Melissa Petruska, Vice President of Product Development, added “We are particularly pleased with the system’s performance over wide humidity ranges, from 20% to 80%, confirmed via third-party testing. These results form the foundation for us to deliver products that make a difference in the lives of people in and around sterilization facilities and warehouses.”
About the Grant:
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.
About Sonata Scientific:
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. More information is available on request from Sonata Scientific.
Peter Van Buskirk
SOURCE Sonata Scientific