EU23CEDEC1/SES101 - Air Speed At Working Position. At Working Level?

Air Speed at Working Position. At Working Level?| The new EU GMP Annex 1 “Manufacture of Sterile Medicinal Products” in its final version published on August 25th 2022 requires in paragraph 4.30 “…a homogeneous air speed in a range of 0.36 – 0.54 m/s (guidance value) at the working position…” WHO in January 2023 published their Annex 2 “WHO good manufacturing practices for sterile pharmaceutical products“ and provided a different wording: “…a homogeneous air speed in a range of 0.36–0.54 meters per second (m/s) (guidance value) at the working level…“ This raises the question of “Where to provide which air speed and where to measure and monitor the air velocity?” This presentation initiated by the steering committee of ISPE D/A/CH Community of Practice “Aseptic Processing” wants to show with real data the effect on unidirectional airflow pattern and air velocities at point of fill: working position as well as working level. The data were generated based on CFD simulation with a machine model (vial filling/closing machine) in an open double wall isolator environment. Additionally air velocity measurements and airflow visualization studies were performed with the real model – machine (detailed mock-up) inside real isolator.