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New Emergency Use Authorization (EUA) to Decontaminate Respirators

On April 9, 2020, the U.S. Food and Drug Administration granted an emergency use authorization to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide to decontaminate compatible N95 or N95-equivalent respirators.

Hydrogen peroxide sterilization is a low temperature sterilization process that utilizes hydrogen peroxide vapor. The vapor fills the sterilization chamber, penetrates the device and sterilizes exposed surfaces.

The STERIS V-PRO Decontamination Cycle is capable of processing 10 respirators at one time through a process that takes approximately 28 minutes to complete. Each respirator can be processed up to 10 times for single-user reuse.

This EUA is estimated to support decontamination of approximately 750,000 N95 respirators per day in the U.S.

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