In sterile manufacturing, airflow is critical, but you can’t verify what you can’t see. EU GMP Annex 1, section 4.15 requires airflow patterns within cleanrooms and zones to be visualized to demonstrate that air is not moving from lower-grade or less-clean areas into higher-grade areas, or across operators and equipment in a way that could introduce contamination. Where unidirectional airflow is required, visualization studies are expected to demonstrate compliance.
That’s where the Junray ZR-4000 and ZR-4001 Airflow Pattern Visualizers can help. Designed for airflow visualization and smoke-study applications, these systems allow users to make otherwise invisible airflow patterns visible and recordable, helping to investigate:
- Airflow direction and uniformity
- Unidirectional airflow performance
- Turbulence, re circulation and potential dead zones
- The impact of operator interventions and equipment positioning
- Potential airflow ingress between different cleanroom grades
- Visual evidence that can be retained as part of qualification and validation documentation
The value isn’t simply in producing a visible fog pattern. It is about generating clear evidence of how air behaves under relevant conditions, helping teams identify potential contamination risks and make informed decisions about facility design, equipment layout and operating practices. Annex 1 also expects airflow pattern studies to be performed both at rest and in operation, including simulated operator interventions, with video recordings retained.
With the Junray ZR-4000 and ZR-4001, our aim is to give pharmaceutical and other controlled environment industries a practical tool for carrying out these visualization studies and supporting their contamination control strategy. Make airflow visible. Identify risks. Build evidence.
For more information, click HERE email sales@alphascientific.com.au or contact us Australia wide on 1300 025 780.