The Importance of CAG 003 to the Successful Certification of Sterile Compounding Environments
March 21, 2023 | 1- 2 PM CDT
With the long-anticipated changes to USP General Chapter <797>, one unexpected change was the removal of the reference to CETA Application Guide (CAG) 003. This document, published by the Controlled Environment Testing Association (CETA), is a compilation of all the testing required to certify sterile compounding primary and secondary engineering controls. Without it, certification is done at the discretion of the certification provider and could lack critical tests. Additionally, CAG 003 provides detailed requirements for certification documentation and reporting. This webinar explores why CAG 003 should be used to guide the certification process and reviews the important components of a certification report.
CPE Credit
The complimentary webinar is eligible for Accreditation Council for Pharmacy Education-accredited continuing pharmacy education (CPE) credit. More details regarding the presentation, CPE activity credits, and browser requirements can be found in the CPE Activity Information Guide.
Presenters
Lewis Exner is the director of field operations for Controlled Environment Consulting, overseeing the certification service and training operations. He is a Navy veteran with over 30 years of experience in cleanroom and containment device certification. Mr Exner worked at Micro-Clean (Steris) from 1992 to 2016, where he developed a cleanroom training program along with managing over 35 employees as the certification division manager. He has also been an instructor with the Eagleson Institute since 2003 for the Certification of Pharmaceutical Cleanroom class. Mr Exner is a member of the CETA Board of Directors and is currently a CETA National Board of Testing Registered Certification Professional (CNBT) for sterile compounding facilities.
Abby Roth, founder of Pure Microbiology, has over 18 years of experience in supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Ms Roth served as a United States Pharmacopeia (USP) Compounding Expert Committee member during the 2015-2020 cycle. She is an involved member of CETA, serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Ms Roth has been invited to speak for state boards of pharmacy and for national organizations.