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"Improving Final Fill Processes and Addressing Annex 1 Requirements"

Taking Final Fill Assemblies to the Next Level with Overmolded Single-use Assemblies

The biopharmaceutical industry is constantly evolving. Progress is accelerated by innovative breakthroughs and the development of new technologies. Manufacturers are always looking for ways to improve the safety, quality and efficiency of their products and processes.

However, with new regulatory requirements, such as Annex 1 of the EU Good Manufacturing Practice (GMP), guidelines often require manufacturers to review their processes. These revisions emphasize the importance of quality risk management and introduce a comprehensive approach to contamination control strategy (CCS). Annex 1 contains specific requirements for single-use systems, addressing their growing role in streamlining manufacturing processes and mitigating co-contamination risks.

As one of the last steps in biopharmaceutical manufacturing, 'Final Fill' is one of the most crucial steps in the process. Minor deviations are unacceptable due to their potential to severely impact patient safety. Therefore, the ultimate goal is efficiency and sterility.

This white paper explores the evolving role of SUS in addressing the critical challenges these processes face, particularly in meeting stringent regulatory requirements. In addition, technological advances, such as Parker's PureTain® Final Fill solutions, will also be illustrated and show how they are reshaping processes, enhancing efficiency, and ensuring sterility, while aligning with regulatory standards.

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