Aptar seeks US FDA emergency use authorisation for mask disinfectant
Consumer product dispensing and active packaging solutions firm Aptar is seeking US FDA Emergency Use Authorisation (EUA) for a product that easily disinfects N95 filtering facepiece respirators (N95 masks).
The N95 masks are "desperately needed" by healthcare personnel due to the shortage of disposable masks during the COVID-19 pandemic, according to Aptar. The company's simple disinfecting process sees the N95 mask and a small strip of its ActivShieldTM placed inside any commonly-available one-gallon plastic bag. The ActivShield strip releases a controlled amount of chlorine dioxide inside the sealed bag to decontaminate the mask. The process only takes three hours until the mask is ready to be worn again, and can be performed on-site in hospitals.
Aptar has submitted its safety and effectiveness data for the FDA to review. It is currently working to provide around 4 million ActivShield strips per week and expand production capacity with the intent to deliver 10 million per week by the end of April.
John Belfance, president of Aptar CSP Technologies, said: "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. If the FDA approves the EUA, then ActivShield will immediately become available for this important use."
Aptar says its patent-pending technology can 'efficiently and effectively' disinfect N95 masks used by healthcare workers and first responders."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's 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 healthcare community. This could enable healthcare workers to retain and disinfect their own face mask, helping to maintain continued proper fit to their face."
The N95 masks are "desperately needed" by healthcare personnel due to the shortage of disposable masks during the COVID-19 pandemic, according to Aptar. The company's simple disinfecting process sees the N95 mask and a small strip of its ActivShieldTM placed inside any commonly-available one-gallon plastic bag. The ActivShield strip releases a controlled amount of chlorine dioxide inside the sealed bag to decontaminate the mask. The process only takes three hours until the mask is ready to be worn again, and can be performed on-site in hospitals.
Aptar has submitted its safety and effectiveness data for the FDA to review. It is currently working to provide around 4 million ActivShield strips per week and expand production capacity with the intent to deliver 10 million per week by the end of April.
John Belfance, president of Aptar CSP Technologies, said: "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. If the FDA approves the EUA, then ActivShield will immediately become available for this important use."
Aptar says its patent-pending technology can 'efficiently and effectively' disinfect N95 masks used by healthcare workers and first responders."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's 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 healthcare community. This could enable healthcare workers to retain and disinfect their own face mask, helping to maintain continued proper fit to their face."
