The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Header Artwork

Personal Protective Equipment (PPE) Reprocessing

The COVID-19 pandemic has caused shortages of PPE; as a result, hospitals and healthcare facilities are left with few options but to reuse equipment that was never intended to be reused. Nelson Labs has compiled a test plan to assist innovators trying to validate reprocessing solutions:

Disinfection/Sterilization

Icon of a shield blocking bacteria

Respirators or masks are exposed to a disinfecting or sterilizing process to remove virus and other potential contaminants:

  • Vaporized hydrogen peroxide (VHP) Masks are exposed to a specific cycle in the VHP sterilizer (VPRO 1 VPRO 60)
  • Heat dry-heat disinfection (70°-100°C)
  • Ultraviolet light exposure to UV light at a specific intensity and duration (254-260nm)
  • Chemical spray disinfectants (vs. soaking or wiping which can harm the medium)
  • Radiation exposure to gamma radiation

Functionality Filtration/ Breathability Testing

Icon of a mask

Following a disinfection/sterilization reprocessing cycle, it is necessary to re-evaluate the functional properties of the filter media:

  • Respirators: NaCl, DOP, valve leak, and inhalation/exhalation tests
  • Surgical Masks: Synthetic Blood, BFE, PFE, breathability, Flammability

Biosafety Testing

Icon of 3 people with one wearing a mask

Following a disinfection/sterilization reprocessing cycle it is also necessary to re-evaluate biosafety for the wearer:

  • Cytotoxicity MEM Elution or Agar Overlay
  • Toxicological Risk Assessment

– or –

  • Cytotoxicity MEM or Agar Overlay
  • Irritation In-vivo contact dermatitis
  • Sensitization In-vivo hypersensitivity