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