Aptar Submits Application for Emergency Use Authorization to the German Regulatory Agency BfArM for ActivShield™ FFP2 Decontamination System
AptarGroup, Inc. is seeking Emergency Use Authorization (EUA) from the German Federal Institute for Drugs and Medical Devices (BfArM) for a solution that allows for easy disinfecting of FFP2 ltering facepiece respirators (FFP2 masks). The FFP2 masks are desperately needed by healthcare personnel due to the global shortage of disposable masks during the COVID-19 pandemic. In this simple disinfecting process, the FFP2 mask and a small strip of Aptar’s ActivShield™ technology are placed inside any commonly available one-gallon plastic bag. The strip releases a controlled amount of chlorine dioxide inside the sealed bag to decontaminate the FFP2 mask. The process takes only two hours until the mask is ready to wear again. It can be performed on-site at the local hospital where the mask is being used. The EUA submission in Germany is part of Aptar’s strategy to expand global access to FFP2 respirators allowing for the decontamination and reuse of masks for ten cycles. This innovative patent pending technology can eciently and eectively disinfect FFP2 masks used by healthcare workers and first responders.