Airflow Visualisation (Smoke Visualisation)
Airflow visualisation is used to observe airflow patterns which can directly affect a product’s sterility.
The results of these studies can be used to develop or expand the filling protocols to ensure compliance with regulatory requirements.
They can also be used as a personnel training tool and as documentation for review by regulatory agencies.
For satisfactory operations in a critical cleanroom environment, a large amount of filtered air is required to remove or dilute contaminants. Airflow visualisation can aid in understanding how air flows in a cleanroom and how it may impact on any potential pollution.
We at Total Clean Air are experts in critical ventilation systems and the checks and repairs they require.
In carrying out airflow visualisation in a wide variety of settings, our specialist technicians have the skills and knowledge to confirm correct airflow and expose problems that need to be corrected.
By providing a complete end-to-end service for the maintenance, testing and verification of your specialist ventilation system, the Total Clean Air team can perform airflow visualisations for your facility to confirm design and performance specifications, help find faults in areas where compromise have been detected and observe the effect of operator interference.
We will digitally record airflow patterns and include an information board with a unique test ID, after dispersing pharmaceutical-grade smoke through custom-made sparge pipes located in suitable positions around your cleanroom.
A black background is applied to walls and floors where necessary to maximise the visibility of the smoke.
During the testing, video footage can be taken and included in your test protocol, and a full test report may be issued including certification, qualitative evaluation and recommendations.
These records are objective evidence used to demonstrate to internal auditors and external regulators the facility’s ability to maintain the proper manufacturing environment.
According to the ISO 14644-3 Annex B7, airflows should be visually verified every 24 months in classified environments of any ISO class.