How Automation Can Facilitate Annex 1 Compliance In Final Filtration

Final filtration brings patient safety, regulatory expectations, and business risk into the same critical process. As Annex 1 places greater focus on pre-use post-sterilization integrity testing (PUPSIT), manufacturers must determine how to implement testing without adding unnecessary complexity or opportunities for human error. Tobias Weitzel and Mehdi Bukami examine key decisions involving operational setup, assembly configurations, automation, and manual intervention. They also review laboratory data on integrity test sensitivity, product hold-up, and filter wetting volume, along with audience insights into current industry practices. A live Q&A explores redundant filtration, vent filter testing, pressure sensor requirements, and the application of Annex 1 beyond the EU.

Get a practical look at how automation can reshape the compliance picture.