What air quality must a laminar airflow workbench or other primary engineering control provide for sterile compounding?
- ISO Class 5
- ISO Class 7
- ISO Class 8
- ISO Class 9
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A. ISO Class 5
The direct compounding area inside the hood must be ISO Class 5, the cleanest of the classes used in pharmacy. ISO Class 7 is the requirement for the buffer room around the hood.
Reference: USP <797>: primary engineering controls
In a cleanroom suite used for non-hazardous sterile compounding, what air quality is required in the buffer room where the hood is located?
- ISO Class 5
- ISO Class 7
- ISO Class 8
- ISO Class 9
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B. ISO Class 7
The buffer room must be at least ISO Class 7. ISO Class 5 applies inside the hood itself, and ISO Class 8 is acceptable for an anteroom that opens only into a positive-pressure buffer room.
Reference: USP <797>: secondary engineering controls
How does the room used for sterile compounding of hazardous drugs differ from a room for non-hazardous sterile compounding?
- It is at negative pressure and vented outside
- It is at positive pressure with recirculated air
- It needs no HEPA-filtered air supply at all
- It is kept at a much lower temperature
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A. It is at negative pressure and vented outside
Hazardous drug compounding rooms are kept at negative pressure to adjacent areas and externally vented so contaminated air does not escape into the pharmacy. Positive pressure, used for non-hazardous rooms, would push drug particles outward.
Reference: USP <800>: containment secondary engineering controls