Medication - Sterile Compounding - Primary Engineering Control (PEC) Testing/Certification Requirements
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.
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
• 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 May 11, 2020
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Chapter:
Medication Compounding MC
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