TABLE IV

Appropriate Personal Protective Equipment for Routine Pharmaceutical Manufacturing (40)

Protective ClothingNon-Sterile Manufacturing AreasSterile Manufacturing Areas
Plant uniform or plant uniform with overalls for high-risk product and environmentYesYes
Hair/beard coveringsYesYes
Safety glassesYesYes
Dedicated shoes or shoe coveringsYesYes
GlovesYes (if in direct product contact)Yes
Face masksYes (if in direct product contact)Yes
Enclosed respiratorsOnly if manufacturing high-potency, toxic drugs or infectious biological agentsOnly if manufacturing high-potency, toxic drugs or infectious biological agents
Sterile clean room uniforms (coveralls), hoods, sleeves, goggles, face masks, and glovesNoYes, if in critical aseptic processing area