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Pending FDA approval

One person, one mask, one simple solution for re-use.

The global COVID-19 pandemic has resulted in an acute shortage of Personal Protective Equipment (PPE), specifically N95 or N95 equivalent Respirator masks. Extensive re-use of these single use devices by health care providers is occurring without the ability for decontamination. The CDC recently recognized the decontamination and re-use of N95 or N95 equivalent masks as a crisis capacity strategy.

To help in this fight, Aptar has created a novel molecular delivery system called ActivShield™ to provide individualized decontamination of N95 or N95-equivalent masks.

Aptar Requests U.S. FDA Emergency Use Authorization for N95 or N95-equivalent Filtering Facepiece Respirator Decontamination with ActivShieldTM
AptarGroup, Inc. is seeking U.S. FDA Emergency Use Authorization (EUA) for a solution that allows easy disinfecting of N95 (or N95-equivalent) filtering facepiece respirators. The N95 (or N95-equivalent) masks are desperately needed by Health Care Providers due to the shortage of disposable masks during the COVID-19 pandemic.

Read Press Release | View FAQs | Technology Background

Press Release
FAQs
Technology Background
Resources

Why Use ActivShield™ for Mask Decontamination?

Easy

Decontaminate masks by placing one activated ActivShield™ strip into a one-gallon sealable plastic bag with the contaminated mask for two hours.

Safe

The active ingredient, chlorine dioxide (ClO2), is a commonly used decontaminant in the food and beverage industry. There is no residual odor or residue after treatment.

Effective

ActivShield™ eliminates 99.999% of viruses present including Feline Calicivirus. Mask integrity maintained for up to 10 decontamination cycles.

Personalized

Individuals can manage the decontamination process themselves, which will empower them and allow management to focus on operational issues.

Reusability Data

Third party studies conducted by SGS Laboratories using the NIOSH (National Institute for Occupational Safety and Health) testing process validated after 10 treatments the decontamination process had no degradation effect on the N95 mask.

An independent study by Auburn University also validated that there was no impact on the performance of the N95 mask after 10 uses of ActivShield™ technology (filtration efficiency was >95% compared to control without treatment).

ActivShield™ Effectiveness against Virus on Masks:

Feline Calicivirus (ATCC VR-782) was spot inoculated in four locations on a N95 mask. After treatment a 6 log reduction was observed compared to control.

Easy to Use Individualized Decontamination

  • CSP can quickly scale to be able to supply over 10 million week.
  • This solution can easily be implemented on site.
  • In a sealed 1 gallon plastic bag, the ActivShield™ strip is achieving over 15 ppm of chlorine dioxide with a mask.
  • As soon as the mask is removed from the bag, the ppm (parts per million) level around the mask is not detectable with instrumentation, and zero ClO2 level was detected even with 5x normal dose inside bag with mask.

ActivShieldTM resource center

Technology Background
These slides provide an overview of ActivShield™ technology, including data on the system’s effectiveness, safety, and how it works.

ActivShield™ Fast Facts
This document provides a 30 second overview of ActivShield™ technology..

ActivShieldTM FAQ’s

ActivShield™ N95 Compatible Respirators

Instructions Overview Infographic

ActivShield™ White Paper

How ActivShieldTM works

Learn more about ActivShieldTM

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