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
Last updated on May 11, 2020
Manual: Home Care
Chapter: Medication Compounding MC

If no, please comment on how we could improve this response.

If you have additional standards-related questions regarding this topic, please use the Standards Online Submission Form