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Medication - Sterile Compounding - Secondary Engineering Control (SEC) Testing/Certification Requirements

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.
  • 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 01, 2021

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