CAG Announcement #2 as of 9/23/2020

The Controlled Environment Testing Association (CETA) is pleased to announce the revision of the following CETA Application Guides (CAGs). Please visit for further details.

CETA CAG-009 Preview

Viable Environmental Monitoring for Sterile Compounding Facilities

This CETA Application Guide revision CAG-009 (version 02:2020) builds on the technical information presented in the original CETA CAG-009-2011v3 (January 31, 2012) that provided technical information on viable environmental sampling for compliance with USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations.

The completely rewritten Application Guide provides robust and updated guidance for not only certifiers, but all sterile compounding industry professionals, on how to meet the minimum compounding standards for environmental monitoring, as well as best practice recommendations. Information on garbing competency and gloved fingertip sampling will be in a new CAG, CAG-011.

This guide includes:

  • The nomenclature relating to viable environmental monitoring
  • Viable air sampler and media considerations
  • Guidance on standard operating procedures (SOPs) and developing a sampling plan
  • The process for collecting viable air and surface samples
  • Restricted access barrier systems (RABS) considerations
  • Documentation needs
  • Sample transportation and laboratory submission
  • Incubation, analysis, data expression and reporting
  • Trending and investigation and remediation of exceeded action or alert levels

CAG-004 and CAG-007 were released in September 2019 and have received a minor revision. The Section 5 Introduction has moved to Section 1. No other changes were made, please feel free to download this update.


Biological Decontamination and Disinfection of Accessible Surfaces in Biosafety Cabinets


Exhaust System Requirements of Class II Biosafety Cabinets