CAG Announcement #5 as of March 16, 2022

 CETA CAG-008 Preview

Certification Matrix for Sterile & Nonsterile USP Compounding Facilities

The need to have Sterile Compounding Facilities certified on a semi-annual basis has been dictated by current USP <797> Guidelines.  With the addition of USP <800> & <825>, and the changes in <797>, it became necessary to revise CAG-008 to incorporate these changes.

This Application Guide will serve as the baseline to have a Sterile or Nonsterile Compounding Facility and its Primary Engineering Controls successfully certified in accordance with current ISO, USP, NSF, and IEST standards. The requirements are laid out, test methods specified, acceptance criteria listed, and equipment needed to test described secondary engineering controls.

Applicable for not only certifiers, but all industry professionals, this revised Application Guide provides a table listing room types that may be found during the certification process and lists their required ISO class, ACPH, and Differential Pressure. It eliminates the guesswork pertaining to acceptance criteria that traditionally was agreed to between owners and certifiers.

This guide includes:

  • The nomenclature relating to certifying rooms and their PEC’s

  • Materials and Equipment needed for testing

  • Room Types

  • Required tests

  • Test methods

  • Acceptance Criteria

**PLEASE NOTE: CAG-008 Section 8.5 Dynamic Airflow Smoke Pattern Test for PECs & SECs refers to the NEW CAG-014 for Airflow Visualization Study. CETA anticipates CAG-014 will be published within 45 days**