AptarGroup, Inc. is seeking U.S. FDA Emergency Use Authorization (EUA) for ActivShield, a solution that quickly and easily disinfects N95 filtering face piece respirators, or masks. Currently health care personnel are facing shortages of disposable masks due to COVID-19 pandemic.
To use, a small strip of ActivShield and the N95 mask are placed in a one-gallon plastic bag. The strip releases a controlled amount of chlorine dioxide inside the sealed bag to decontaminate the N95 mask. The process takes three hours and can be performed on-site at the local hospital or wherever the mask is being used.
Aptar has submitted its safety and effectiveness data to the FDA for EUA review. The company is working to expand its production capacity with the intent to deliver 10 million per week by the end of April. Capacity was previously 4 million.
“Aptar’s technology provides a unique, simple, and effective way to help solve the critical problem of PPE shortages we’re currently facing,” said Stephan Tanda, Aptar President and CEO.
“We are aiming to provide a solution that is not only fast, but it does not require special equipment or training, making it potentially accessible to the wider health care community. This could enable health care workers to retain and disinfect their own facemask, helping to maintain continued proper fit to their face.”