The Battelle Critical Care Decontamination System (CCDS) has passed both filtration efficiency and fit-related evaluations for its 1860 and 8210 3M respirators, Battelle CCDS reported on Thursday.
“The Battelle CCDS was developed in response to the 2014 Ebola outbreak, at the request of the FDA,” said Battelle president and CEO, and five-time Wash100 Award recipient Lou Von Thaer. “In 2020, after COVID-19 hit the U.S. and caused exactly the kind of PPE shortage this system was designed to address, CCDS was quickly mobilized as a stopgap measure to alleviate the N95 shortage.”
Battelle has successfully passed 3M’s evaluation and multiple decontamination processes on the fit and filtration performance of certain 3M N95s. Battelle CCDS was named an effective respirator decontamination for passing the four components of the test.
3M has evaluated the effect of the Battelle CCDS process on the respirators tested and found that the decontamination process is not expected to have a detrimental impact on respirator filtration or fit for up to 20 cycles.
Battelle also measured the residual hydrogen peroxide content to be below OSHA’s Permissible Exposure Limit (PEL) concentration of 1 parts per million. The company’s system is compliant with the CDC guidance on Decontamination and Reuse of FFRs and has been studying ways to decontaminate filtering facepiece respirators for years.
The FDA confirmed in 2016 that Battelle’s process is safe and effective for decontaminating N95 respirators and a 2020 Duke University study found that “N95 respirators still met performance requirements even after decontamination with hydrogen peroxide vapor in the laboratory setting for over 50 times.”
Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers.
Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries.