Airflow Visualization Studies: The Impact Of Annex 1 (2022) On Sterility Assurance

By Luca Calisi, Advisory Specialist, Particle Measuring Systems

Understanding and managing critical air patterns are essential for controlling an environment, particularly in the pharmaceutical industry, where adherence to regulations is paramount. Scientific demonstration forms the foundation of compliance with Good Manufacturing Practice (GMP) regulations, and one of the most effective methods to illustrate air patterns is through airflow visualization studies, commonly known as smoke studies. When unidirectional airflow (UDAF) is employed to reduce the risk of contamination, it is imperative for a company to validate its effectiveness through these studies. Airflow visualization studies have long been a crucial component of the quality by design (QbD) approach for filling lines. However, their importance has been further emphasized in the revised Annex 1 guidelines issued in 2022.

Discover how these studies now play a central role in a company's contamination control strategy, which underscores their significance in ensuring regulatory compliance and maintaining high standards of product quality and safety.