Short answer: EU GMP Annex 1 expects airflow patterns to be visualized so the organization can demonstrate protection of higher-grade and critical areas, evaluate unidirectional airflow where required, study both at-rest and operational conditions, retain video and use the results in contamination-control decisions.
Decision rule: The deliverable is documented evidence tied to the contamination control strategy—not a ceremonial smoke video.
Map the study to contamination-control risks
Use the contamination control strategy, facility qualification plan and process-risk assessment to identify interfaces, interventions and personnel movements that could carry contamination toward the critical zone. Each identified risk should appear in the protocol and video index.
Test boundaries and interfaces
Airflow visualization is especially important at openings, transfers and interfaces between areas or devices. The study should show whether air moves from a less clean area toward a higher-grade space, whether an open isolator interface experiences ingress and whether equipment or transport devices disturb the intended pattern.
Include operational interventions
Annex 1 explicitly connects visualization with operation. Simulate representative operator actions, component transfers, equipment states and line interventions. If an intervention has multiple positions or speeds, define the condition that represents the process or credible worst case.
Retain and interpret the video
Video retention is not enough by itself. The report should identify what was observed, whether the pattern met the predefined criteria, whether unexpected airflow was found and what corrective action or additional assessment is required. Link observations to the environmental monitoring strategy where relevant.
Procure around repeatability
Regulated studies usually require repeated runs, multiple camera positions and protocol-driven holds. Evaluate run duration, consistent output, refill or recovery time, hose routing and accessories. Repeatability is often more valuable than a single peak-output specification.
Working checklist
- CCS risks mapped to protocol steps
- Grade interfaces and openings identified
- At-rest and operational runs
- Representative interventions
- Video retention and indexing
- Correlation to velocity measurements where required
- Deviation and CAPA process
- Approved final report
What to include in the RFQ
Provide the facility or barrier type, grade interface, airflow direction, pressure relationship, operational interventions, required visual distance and expected total test duration.
Use the GSE technical RFQ to submit the requirement, attachments, destination and required-on-site date.
Connect the study to the contamination-control strategy
The useful purchasing question is not “does this fogger comply with Annex 1?” Equipment alone cannot create compliance. The study must support the site’s contamination-control strategy, approved procedures and risk assessment. The RFQ should therefore state the critical zone, barrier type, interventions, operating state, viewing distance and the evidence the quality unit expects to retain.
For large filling lines, one source may not provide uniform visibility across every station. Plan the study as controlled segments and document overlap between setups. This is usually more defensible than driving fog aggressively from a distant point and allowing the delivery jet to dominate the airflow being observed.
Continue the topic: Cleanroom Airflow Visualization Knowledge Center.
Authoritative references
This guide translates public requirements and technical concepts into purchasing and study-planning questions. The controlling standard, regulation, site procedure and quality approval remain authoritative.
Frequently asked questions
Does Annex 1 expect operational airflow studies?
Yes. The guidance states that airflow pattern studies should be performed at rest and in operation, including simulated operator interventions.
Why is video retention important?
It preserves the visual evidence used for review, comparison, training and investigation.
Should visualization be correlated with velocity measurements?
Where the qualification approach calls for it, the visual evidence should be considered alongside the approved air-speed measurement method.
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