Protective Airflow in Aseptic Manufacturing: Ensuring First Air Integrity

In GMP‑regulated aseptic filling operations, contamination control relies on complementary strategies including protective airflow and barrier systems. Protective airflow delivers High Efficiency Particulate Air (HEPA)‑filtered air directly to critical processing zones, preventing airborne contaminants from reaching exposed product. Barrier systems physically separate personnel from the process and should only permit controlled transfers and have limited interventions, thereby minimizing surface contamination risks¹. The practical implementation and interpretation of protective airflow in relation to ‘First Air’ integrity has long been a subject of discussion within the industry. Recognizing this need, the PHSS formed a dedicated focus group with support from the isolator manufacturer Franz Ziel GmbH to research this topic in depth and develop a harmonized understanding of protective airflow principles in aseptic processing environments.