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:
Hospital and Hospital Clinics
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.
Get Extra Help with Books and E-books
Browse our gallery of books and e-books to find trusted prep and readiness resources, practical checklists and toolkits, and resources on specialized health care topics.
Stay Informed with Online Education
Online education is the most convenient and cost-effective way to educate your staff and minimize expenses without the need to leave your organization.
Reach Your Safety Goals with eProducts
Assessing and sustaining compliance with accreditation standards or CMS CoPs can be a challenge, but it doesn’t have to be. Rely on our proven software solutions developed by our team of industry experts.