New USP <800> Placement Requirements

USP <800> CACI Placement

Old Requirement

New USP <800> Requirement

Room Type

Unspecified

C-SCA (Category 1 CSPs)
ISO 7 Buffer Room (Category 2 and 3 CSPs)

Room Externally Vented

Not Required

Required

Negative Pressure Room

Not Required

Required (0.01-0.03" w.g.)*

Air Changes Per Hour (Minimum)

Not Required
Not Required

12 (C-SCA)
30 (Cleanroom Suite)

CACI Externally Vented

Preferred

Required