Airflow Visualization: The Most Misunderstood & Underappreciated Cleanroom Test
Airflow Visualization (Smoke Studies): The Most Misunderstood and Underappreciated Cleanroom Test
Airflow Visualization studies (AKA Smoke Studies) are used to evaluate air patterns in medical product cleanrooms and barrier systems (RABS, Isolators, pass-throughs and airlocks) that support aseptically produced, terminally sterilized and low bioburden product manufacturing.) These studies should be considered as more than a definitive pass/fail test. The criticality of adequate airflows in medicinal product manufacturing demand additional scrutiny that goes beyond the testing outlined in international cleanroom standard ISO 14644-3:2019.