Aptar seeks USFDA EUA for N95 mask decontamination with ActivShield

ActiveShield can efficiently disinfect N95 masks used by healthcare workers and first responders

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Aptar
N95 mask decontamination with ActivShield by Aptar

Aptar Group, a global leader in drug delivery, consumer product dispensing and active packaging solutions, is seeking USFDA emergency use authorization (EUA) for a solution that allows easy disinfecting of N95 filtering facepiece respirators (N95 mask). The N95 masks are desperately needed by healthcare personnel due to the shortage of disposable masks during the COVID-19 pandemic.

The company states that in this simple disinfecting process, the N95 mask and a small strip of Aptar’s ActivShield 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 N95 mask. The process takes only three 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.

Aptar has submitted its safety and effectiveness data to the FDA for EUA review. The company is working to offer approximately four million ActivShield strips every week. It is working on expanding its production capacity with the intent to deliver ten million every week by the end of April.

“We are extremely encouraged by the promising data generated so far and are eager to deliver this technology to the front line and support the fight against the pandemic,” said John Belfance, president of Aptar CSP Technologies. If the FDA approves the EUA, then ActivShield will immediately become available for this important use. Chlorine dioxide has been widely used as a disinfectant in different industries, including the paper industry, drinking water treatment, food processing, and medical equipment. Aptar’s delivery mechanism uses the disinfecting properties of chlorine dioxide in a controlled, sustained release within a contained volume.”

Aptar claims that this innovative patent-pending technology can efficiently and effectively disinfect N95 masks used by healthcare workers and first responders.

“Aptar’s technology offers a unique, simple, and effective way to help solve the critical problem of PPE shortages we’re currently facing,” said Stephan Tanda, president and chief executive officer of Aptar. “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 facemask, helping to maintain continued proper fit to their face.”

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