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Medication - Sterile Compounding - Primary Engineering Control (PEC) Testing/Certification Requirements

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
Manual: Critical Access Hospital
Chapter: Medication Management MM
First published date: January 23, 2018 This Standards FAQ was first published on this date.
This page was last updated on November 29, 2021 with update notes of: Editorial changes only Types of changes and an explanation of change type: Editorial changes only: Format changes only. No changes to content. | Review only, FAQ is current: Periodic review completed, no changes to content. | Reflects new or updated requirements: Changes represent new or revised requirements.
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