This white paper aims to clarify the changes in Annex 1, specifically focusing on airflow visualization and cleanroom testing, to help manufacturers understand the technical adjustments and the necessary steps to achieve compliance. By highlighting the differences between the 2008 and 2022 versions, this document will provide manufacturers with a practical guide to implementing the updated requirements and adopting a proactive approach to contamination control.

Next Understanding & Complying with the Updated 21 CFR 820 Quality Management System Regulation for Medical Device Manufacturers