Medication - Sterile Compounding - Secondary Engineering Control (SEC) Testing/Certification Requirements (USP 797 2008 Version Only)
What testing is required for our Secondary Engineering Controls ?
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.
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.
- Air exchanges per hour of the buffer area
- Pressure differential (between buffer area/ante area; ante area/non-classified area)
- ISO level of the buffer area and ante area
- Viable particle testing surface of the buffer area and ante area
- Viable particle testing air—HEPA filter leak test of HVAC HEPA filter system
- 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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