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If we wish to do low risk sterile compounding in a table top ISO Class 5 isolation unit, what garb does the person doing the compounding need to wear?
Compounding under Immediate Use provisions does not require special personnel cleansing and garb. However, compounding of any Risk-Level category products (including Low-Risk Level CSPs with 12-Hour or Less BUD) does require special personnel cleansing and garb.
Briefly, procedures to be followed include:
- Before entering the buffer area or segregated compounding area, remove personal outer garments; cosmetics; hand, wrist, and other visible jewelry or piercings that can interfere with the fit of gloves and sleeves; artificial nails or nail extenders.
- In the following order, don dedicated shoes or shoe covers; head and facial hair covers; face masks/eye shields.
- Perform hand cleansing (e.g., soap and water).
- Don non-shedding gown with sleeves that fit snuggly around the wrists and enclosed at the neck.
- Don buffer area (or segregated compounding area)
- Perform aseptic hand cleansing using alcohol-based scrub with persistent activity.
- Don sterile gloves.
With regard to the "table top ISO Class 5 isolation unit", it is important to verify, via viable and nonviable environmental air sampling testing, that the unit performs as designed and that the resulting levels of contamination be within acceptable limits as stipulated in USP <797> .