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
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 05, 2024
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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