AptarGroup Seeking Emergency Authorization for Easy Mask Disinfection Process

Aptar, a global leader in drug delivery, consumer product dispensing and active packaging solutions, is seeking U.S. Food and Drug Administration (FDA) 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.
 
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 provide approximately 4 million ActivShield strips per week and is working to expand its production capacity with the intent to deliver 10 million per 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.
 
This 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 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.”
 
Frequently Asked Questions Technology and Process

Why this method of disinfecting and decontaminating masks as opposed to other methods being used today? This unique method of applying chlorine dioxide gas for the decontamination, disinfection and subsequent reuse of N95 masks is effective and easy to use during this current pandemic crisis. In addition to efficiency and efficacy, it is quick to roll out, is amenable to various methods of workflow, and can be deployed in almost any work environment.
 
Does this process degrade the mask material? Third-party data confirms that the ActivSheld solution did not degrade the mask material and has no impact on its performance for up to 10 cycles (10 reuses).
 
How many times can each strip be used? Each strip can only be used once. One strip = one treatment = one use.
 
How does ActivShield work? In this simple disinfection process, a small strip of Aptar’s ActivShield is wet and sealed inside any commonly available one-gallon plastic bag along with the N95 mask. The strip releases a controlled amount of chlorine dioxide inside the bag to decontaminate the mask. The process takes only two hours. Local hospitals can perform this on site where the mask is used.
 
I work a day shift and will return the next day. Is it safe to leave the ActivShield strips in overnight and take them out in the morning before my next shift? Once the two hours of treatment are completed, the mask is ready for use. If the mask is not needed after the two hours of treatment, we recommend storing the mask in a fresh paper bag. The mask can stay in the paper bag until use to help airing of the mask.
 
Do the strips have an expiration date? We recommend using the strips within 12 months of receipt.
 
Testing and Safety
Is chlorine dioxide safe for placing into masks and then placing the mask on your face? 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 the headspace of the bag.
 
How do you know that this is an effective decontamination method? Third-party testing has shown the treatment is sufficient to achieve greater than 99.999 percent reduction in viruses, far exceeding the requirement for disinfection levels. Given the unavailability of the novel Covid-19 strain to test, we have conducted and obtained strong results on comparable, and more difficult to inactivate, viruses. Chlorine dioxide has been widely used for disinfection for decades and there is significant data available. The benefit of our solution is the ease of handling and relatively precise dosing, without the need for the mask to change hands as health care providers can disinfect their own mask.
 
Supply
Are you supplying the mask along with the strips? We are not supplying the masks. We are supplying the vial with the ActivShield strips and instructions. 
 
How much do the strips cost and how many are in each vial? We are in the process of gathering the cost information as there is a considerable amount of testing involved and final pricing is being developed. There are 150 strips in each vial. We are also looking to donate some initial quantities; that plan is also being developed but is not final.
 
How many strips are you able to produce today? We are working to provide approximately 4 million ActivShield strips per week and working to expand our production capacity with the intent to deliver 10 million per week by the end of April. The strips are produced in Auburn, Ala., and we are focusing on capacity expansion serving the U.S. market and we believe that we can make this available to other countries in the very near future.
 
Will you license this to others? We do not plan to license this technology at this time. We are open to strategic partnerships to serve the global health care community fighting the Covid-19 pandemic.
 
Where can I buy the strips? All sales will be coordinated through our commercial teams with relationships with existing governments, hospital groups and hospital distributors. As of now, the strips will not be available for consumers to purchase.
 
Are you evaluating the possibility of donating certain quantities to high COVID-19 incident states to help relieve PPE shortage? We are focused on producing as many ActivShield strips as possible at this time and we will be distributing them to different areas of need. Some of those distributions will be donations in the communities where our employees live and work.
 
What other products can Aptar provide during the pandemic? Aptar is considered an essential business supply chain partner to the food, healthcare and consumer products industries. We are providing dispensing and packaging solutions for hand sanitizers, antibacterial soaps and lotions, actuators for air and surface disinfecting, infant nutrition closures, valves for metered dose inhalers, nasal spray pumps for allergy treatments and life-saving medications, stoppers for medications and vaccines, active packaging for glucose monitoring tests, influenza diagnostics, and other important medications, and many more critical solutions during this time. Aptar is committed to taking all necessary measures to maintain the continuity of business, supplying our customers, consumers and patients with the critical solutions needed during this time, while prioritizing the health and well-being of our people.