sterilucent product


Decontamination Solution for Compatible N95 Respirators

Healthcare workers treating patients that have COVID-19 (SARS-CoV-2) require personal protective equipment (PPE) to meet safety requirements. The U.S. Food and Drug Administration has granted Sterilucent, Inc. temporary Emergency Use Authorization (EUA) for the decontamination of compatible N95 respirators using the HC 80TT sterilizer.

Sterilization of N95 Masks

  • Up to 12 respirators may be decontaminated in each 35-minute cycle
  • Each respirator can be reprocessed up to 10 times as long as it is not visibly damaged or soiled
  • Decontamination of the respirator following the procedures outlined in the Instructions for the Healthcare Facilities and Instructions for Healthcare Personnel does not impact the filtration performance or fit of the respirator.

This is a temporary process: Decontamination of the respirators in the HC 80TT is only permissible while the EUA is in effect and there is an insufficient supply of new respirators.

HC 80TT Sterilizer with Cycle Guardian™

The HC 80TT has neither been cleared nor approved for the decontamination of compatible N95 respirators for single-user reuse by healthcare personnel to prevent exposure to SARS-CoV-2 and other pathogenic biological airborne particulates.

The HC 80TT is authorized for the decontamination of compatible N95 respirators only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices during the COVID-19 outbreak, under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.


490048-001 Rev A 8/31/20