US FDA issues EUA to decontamination system for N95 masks

May 9, 2020 0 By FM

The FDA 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.

Hydrogen peroxide sterilisation is a low-temperature sterilisation process that utilises hydrogen peroxide vapour. The vapour fills the sterilisation chamber, penetrates the device and sterilises 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 will support decontamination of approximately 7,50,000 N95 respirators per day in the US, the agency said.