0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?

By Sastia Susanti

Sterility testing serves as the definitive decision point in batch disposition, where the stakes include both patient safety and significant financial implications. As the industry transitions from traditional cleanrooms to advanced isolator technology, the debate surrounding airflow velocity and design has intensified, particularly following the implementation of EU GMP Annex 1. While the standard 0.45 m/s airflow velocity is a legacy of open cleanroom environments, its application in closed isolator systems—where the operator is physically partitioned from the process—requires a more nuanced, risk-based evaluation.

The necessity of unidirectional airflow versus turbulent flow should be dictated by the specific contamination risks of the procedure. In closed sterility testing, where product exposure is brief and localized, rigid adherence to cleanroom-derived specifications may add unnecessary complexity. Instead, a strategy grounded in Quality Risk Management ensures that environmental controls are scientifically justified, focusing on validated decontamination and first air principles to maintain the highest levels of sterility assurance.

Read the full article to explore the scientific justification for risk-based airflow design in aseptic processing.