CAG Announcement #3 as of 3/01/2021

The Controlled Environment Testing Association (CETA) is pleased to announce the revision of the following CETA Application Guides (CAGs). Please visit Application Guides (CAGS) at for further details. Members have free access to all CAGs. Login to download your copy. Would you like to join CETA?


Gloved Fingertip Sampling for Sterile Compounding Personnel

This new CETA Application Guide CAG-0011 (version 01:2021) includes gloved fingertip sampling, which was originally presented in CETA CAG-009-2011v3 (January 31, 2012). CAG-011 provides technical information on gloved fingertip sampling 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 gloved fingertip sampling, as well as best practice recommendations.

This guide includes:

  • The nomenclature relating to gloved fingertip sampling
  • Media considerations
  • Testing frequency for initial and ongoing gloved fingertip sampling
  • The process for collecting gloved fingertip samples
  • Restricted access barrier systems (RABS) considerations
  • Documentation needs
  • Sample transportation and laboratory submission
  • Incubation, analysis, data expression and reporting
  • Investigation and remediation of exceeded action levels