Cleanroom Class Requirements for USP800

This cleanroom tip comes from questions about the cleanroom class requirements for meeting and maintaining usp800 compliance.

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

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