Recommended PPE for Sterile & Non-Sterile Compounding According to USP-800

CT-International-PFLT-Series-Latex-Gloves,-Natural,-Powder-Free,-Class-10-Cleanroom-Grade

Recommended PPE (Personal Protective Equipment) for Sterile & Non-Sterile Compounding According to USP800

Gloves

  • Tested to American Society for Testing and Materials
    (ASTM) standard D6978 (or successor)
  • Powder-free
  • Inspected for physical defects before use
  • Must be changed:
    • Every 30 minutes
    • When torn, punctured, or contaminated
  • Must be shown to be resist permeability
  • Made of polypropylene or other laminate materials
  • Close in the back
  • Long sleeved
  • Closed cuffs (elastic or knit)
  • No seams or closures that could allow HDs to pass through
  • Changed per manufacturer information for permeation
  • If not manufacturer information, change every 2 -3 hours
  • Change immediately after spill or splash
  • Cannot be worn in other areas

Head, Hair, Shoe, Sleeve Covers

  • Must wear head, hair, beard, shoe covers
  • Shoe covers cannot be worn in other areas
  • Sleeve covers – RECOMMENDED
  • Sterile compounding:
    • Second pair of shoe covers donned before entering buffer room
    • Remove second pair of shoe covers when leaving buffer room

Eye and Respirators

  • Must wear if working outside a C-PEC (spills)
  • Goggles, not safety glasses, are appropriate
  • Face shield with goggles provide protection against a splash versus face shield alone
  • Fit tested NIOSH certified respirator

Source: http://pharmacy.ky.gov/Documents/USP%20800%20Presentation.pdf