Consumer product dispensing and active packaging solutions manufacturer AptarGroup is seeking Emergency Use Authorization (EUA) for a mask disinfecting solution.
It has submitted an application to the German Federal Institute for Drugs and Medical Devices (BfArM).
Aptar’s disinfecting solution is for FFP2 filtering facepiece respirators (FFP2 masks).
It comprises an FFP2mask and a small strip of its ActivShield all packaged in a one-gallon plastic bag. The disinfecting process can be carried out on-site.
According to the company, the mask can be disinfected by placing it, along with ActivShield, inside the sealed plastic bag.
The strip then releases chlorine dioxide to decontaminate the mask, which is ready to use after three hours.
The demand for FFP2 masks is great as healthcare personnel fight the Covid-19 pandemic amidst a global shortage of disposable masks.
The submissions follow after the company applied for FDA’s EUA for N95 filtering facepiece respirators (N95 mask) disinfecting solution.
Aptar president and CEO Stephan Tanda said: “We are proud to continue to support the fight against the Covid-19 pandemic by furthering our efforts to bring this innovative technology to the global health care community.
“We have a long-standing presence in Germany and we will continue to support the communities where we live and work.
“Our technology provides a unique, simple, and effective way to help solve the critical problem of PPE shortages we’re currently facing. We look forward to working with the US FDA and BfArM to bring ActivShield to market and fulfil the ongoing unmet need.”