USP800 Cleanroom Classification Requirements

Now that usp800 has officially rolled out, questions about cleanroom class requirements for maintaining usp800 roll in.

Nonsterile Compounding

• Nonsterile compounding does not require an ISO-classified environment

Note: Nonsterile Hazardous Drugs compounding is to be performed in a C-PEC that provides personnel and environmental protection (i.e., Class I BSC or CVE) Unidirectional airflow within the C-PEC is not required.

Sterile Compounding

• Sterile HD compounding is to be performed in a C-PEC that provides an ISO Class 5 critical area
• The C-PEC shall be placed in an ISO Class 7 buffer area that is physically separated (i.e., a different room from other preparation areas)

Note: Sterile HD compounding shall be performed in a C-PEC that provides an ISO Class 5 critical area and shall be used in conjunction with aseptic practices specified for the appropriate risk levels defined in chapter 797