Cytiva Aseptic Filling Workcells And Annex 1

Aseptic filling processes are critical for ensuring drug product safety, and recent updates to EU GMP Annex 1 have raised the bar for contamination control. Robotic, gloveless isolator technology like the SA25 workcell offers a transformative approach by eliminating human intervention—the primary contamination risk. This system integrates automated material handling, nested container formats, and validated vapor-phase hydrogen peroxide decontamination to maintain ISO 5/Grade A conditions throughout production. It simplifies operations by removing indirect contact parts, reducing particle generation, and streamlining container closure in a single step. Designed for small-batch manufacturing, the SA25 supports clinical and commercial production while meeting stringent regulatory requirements.

Access the full FAQ to learn how this innovation aligns with Annex 1 principles, including “first air” compliance and continuous monitoring, to deliver a robust contamination control strategy.