Aptar announced that it is seeking FDA emergency use authorization (EUA) for its N95 mask decontamination process with ActivShield.
To disinfect the masks, a small strip of Aptar’s ActivShield is placed alongside an N95 mask inside a one-gallon plastic bag. The strip is designed to release a controlled amount of chlorine dioxide inside the sealed bag to decontaminate the mask in a process that takes three hours before the mask is wearable again. It can be performed on-site at a hospital where the mask is being used.
Crystal Lake, Ill.-based Aptar said it submitted its safety and effectiveness data to the FDA for EUA review and is working on providing approximately four million ActivShield strips per week with the goal of increasing its capacity to 10 million per week by the end of April.
“Aptar’s technology provides a unique, simple, and effective way to help solve the critical problem of PPE shortages we’re currently facing,” Aptar president & CEO Stephan Tanda said in a news release. “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 healthcare community. This could enable healthcare workers to retain and disinfect their own facemask, helping to maintain continued proper fit to their face.”
The FDA has already issued EUA for the Battelle Critical Care Decontamination System, which can decontaminate tens of thousands of respirator masks per day so that health personnel can reuse them.
Battelle’s CCDS can decontaminate up to 80,000 masks per day at full capacity. The system is scalable and can process more pieces of personal protective equipment daily. It uses concentrated, vapor phase hydrogen peroxide and exposes used respirator masks to the validated concentration level for 2.5 hours to decontaminate biological contaminants including the coronavirus, according to the company.