We are discussing the impact of the updated Annex 1 on airflow visualization in cleanrooms. We also cover how to correctly conduct and document smoke studies. The integration of smoke studies into a comprehensive contamination control strategy (CCS) will be a big part. The presentation emphasizes the importance of determining the frequency of these studies to ensure compliance with Good Manufacturing Practices (GMP) and maintaining a contamination-free environment.

What will you learn?

- The role of smoke study in a contamination control strategy (CCS).
- How to document a flow visualization.
- The requirement for proper implementation.
- How to determine the frequency of a flow visualization.