CAG Announcement #4 as of 8/04/2021

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-013 Preview

Media-Fill Testing for Sterile Compounding Personnel

Media-fill testing is traditionally overseen by aseptic experts within the sterile compounding organization. However, there are some organizations that are outsourcing the administration of the testing to their certification providers. The growing number of certification professionals designing and administering this critical test made it clear that an application guide on media-fill testing was necessary. This new CETA Application Guide CAG-013 (version 01:2021) was written to provide technical information on media-fill testing with compliance to USP General Chapter Pharmaceutical Compounding – Sterile Preparations.

The new Application Guide provides robust and current guidance for not only certifiers, but all sterile compounding industry professionals, on how to meet the minimum compounding standards for media-fill testing, as well as best practice recommendations.

This guide includes:

  • The nomenclature relating to media-fill testing
  • Media considerations
  • Testing frequency
  • Considerations when designing a media-fill test
  • Documentation needs
  • Sample transportation and laboratory submission
  • Incubation, analysis, data expression and reporting
  • Investigation and remediation of media-fill test failures