EU GMP Annex 1 Airflow Visualization
EU GMP Annex 1 places airflow visualization inside a broader contamination-control strategy. The strongest studies show how the designed airflow protects critical operations under realistic conditions and how adverse patterns are handled.
Evidence within the CCS
The airflow study should connect to facility design, qualification, process simulation, interventions, environmental monitoring and deviation management. It should not be an isolated certification artifact with no relationship to the contamination-control strategy.
Review EudraLex Volume 4 and the current Annex 1 publication.
Representative execution
- Operate equipment in the intended state.
- Include routine and non-routine interventions.
- Show operator positions relative to critical airflow.
- Demonstrate transfer routes and barrier openings.
- Record adverse turbulence, reflux and stagnation.
- Retain raw, labeled video and protocol traceability.
Fogger selection
Use enough output to maintain visibility across the critical route, but not so much that the fog blankets the scene or creates condensation. For large open RABS or suite studies, the higher-output AP Series may be appropriate; for localized critical zones, smaller delivery or carefully controlled output may produce better evidence.
Build a defensible fogger requirement
Send Applied Physics the room, process, utilities, documentation and safety constraints—not just a model number.