Airflow within a cleanroom is invisible, but its behaviour is critical to contamination control. The Junray ZR-4001 and ZR-4000 Airflow Pattern Visualizers provide a practical way to make airflow visible by generating fine water fog from easily sourced deionized / ultrapure water that allows operators to observe airflow direction, movement, turbulence and potential recirculation or stagnant areas.

EU GMP Annex 1 Section 4.15 requires airflow patterns in cleanrooms and zones to be visualised to demonstrate that air movement does not present a contamination risk. The section also requires appropriate airflow studies to be performed both at rest and in operation, including simulated interventions where appropriate, with video recordings of airflow patterns retained.

The Junray ZR-4001 and ZR-4000 can be used as the fog-generation component of an appropriately designed airflow visualisation study, helping pharmaceutical manufacturers and cleanroom testing organisations generate visible airflow patterns that can be observed and recorded. The equipment therefore provides a practical tool for supporting airflow visualisation activities associated with GMP qualification and validation.

Practical Tools for Airflow Studies

The ZR-4001 and ZR-4000 do not, by themselves, establish compliance with EU GMP Annex 1 or any other regulatory standard. Rather, they provide the visible water-fog component of an airflow visualisation study. Compliance depends on the complete study methodology, including the defined test conditions, locations, operating states, interventions, observations, video documentation, assessment and associated quality documentation.

When incorporated into an appropriately designed and documented study, the Junray ZR-4001 and ZR-4000 provide a practical and effective way to make otherwise invisible airflow behaviour visible, helping qualified personnel assess whether airflow is behaving as intended within pharmaceutical cleanrooms and other controlled environments.

Supporting Pharmaceutical Manufacturers and Testing Organisations

For pharmaceutical manufacturers, the Junray Airflow Pattern Visualizers can form part of established cleanroom qualification, validation and contamination-control programmes. For NATA testing and validation organisations, the instruments provide a dedicated fog-generation solution that can be incorporated into their established airflow visualisation procedures and customer testing requirements.

The instruments may also be useful in other controlled environments, including biosafety cabinets, laboratories, research facilities and other cleanroom applications where visualisation of airflow behaviour is required.