Manual: Critical Access Hospital
Chapter: Medication Management MM
Topic: Medication - Sterile Compounding - Primary Engineering Control (PEC) Testing/Certification Requirements (USP 797 2008 Version Only)

What testing is required for our Primary Engineering Controls (Laminar Air Flow Work Bench; Compounding Aseptic Isolator, Biological Safety Cabinets, etc.) ?

Any examples are for illustrative purposes only.
 
The following items are expected to be tested at a minimum with a frequency not to exceed 6 month intervals.  Lack of testing of these items will result in non-compliance with Joint Commission standards: 
  • ISO level of the primary engineering control
  • Viable particle testing surface of the primary engineering control
  • Viable particle testing air within the primary engineering control
  • HEPA filter leak test of the primary engineering control
  • Evidence of remediation/retesting if assessed levels were not in compliance with those listed in USP 797
Last updated on November 05, 2024 with update notes of: Editorial changes only
First Published Date: January 23, 2018