A Direct Path To Annex 1 Compliance With Blow/Fill/Seal Technologies

By Marty Reyes, Weiler Engineering

The 2022 revision of EU GMP Annex 1 has reshaped expectations for sterile drug manufacturing, placing a sharp focus on contamination control, reduced human intervention, and validated sterility assurance. Blow/Fill/Seal (B/F/S) technology from Weiler Engineering aligns naturally with these demands, which offers a closed, automated aseptic process that simplifies compliance. Key features include integrated CIP/SIP cycles, real-time environmental monitoring, and advanced airflow innovations like SuperFlow PMR and Gas Shield™, which maintain Grade A/B conditions during dynamic operations. The system’s design supports cleanability, digital traceability, and seamless integration into site-wide Contamination Control Strategies.

For manufacturers navigating Annex 1 enforcement, B/F/S presents a direct path to regulatory confidence and operational efficiency. Explore how this technology elevates sterility assurance and future-proofs aseptic production.