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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
Last updated on May 11, 2020
Manual: Critical Access Hospital
Chapter: Medication Management MM

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