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