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USP 800 Minimum PPE Requirements For Sterile Compounding

Here’s a quick list of PPE (Personal Protective Equipment) Requirements for USP 800

  1. Gloves – must be powder-free and free of defects and comply with ASTM D6978.
  2. Gowns – must be disposable, have long sleeves, resist permeability to HD’s, elastic or knit cuff, closed seams, must close in the back.
  3. Eye protection goggles – must always be worn, although, as of October 2019, USP guidance is unclear for personnel working in C-PEC’s.
  4. Face shield – worn in combination with goggles.
  5. Respiratory protection – Fit tested NIOSH approved N95 mask is required.
    Niosh Approved N95 Mask

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  6. If unpacking HD containers that are not made of plastic an elastomeric half-mask with a multi-gas cartridge should be worn.

    Elastomeric Half Mask


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  7. Head, hair, shoe, beard, and sleeve covers – are required and 2 pairs of shoe covers must be worn when compounding HD’s. Second pair must be worn before entry into C-SEC.

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