Airflow Visualization Studies: The Impact of Annex 1 (2022) on Sterility Assurance
Understanding critical air patterns and their impacts is paramount to controlling an environment and is a crucial activity in adhering to the relevant regulations. Scientific demonstration is the basis of pharmaceutical GMP regulatory compliance, and the best way to demonstrate air patterns is through airflow visualization studies (also known as smoke studies). If unidirectional airflow (UDAF) is used as a tool for mitigating the risk of contamination, a company must demonstrate its effectiveness through such studies.
