CAG Announcement #9 as of August 23, 2023

CAG-011: Gloved Fingertip Sampling for Sterile Compounding Personnel (Revised 2023) 

This new CETA Application Guide CAG-0011-03:2023 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 <797> Pharmaceutical Compounding – Sterile Preparations. The only change in this version of the CAG is the changes to the relevant text to match the 2022 revisions to USP <797>.

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

View a complete listing of CAGs here!