Datasheet | February 19, 2025

Aseptic Filling Qualification Solutions

Source: Cytiva
Cytiva SA25 aseptic filling workcell

Cytiva presents a pioneering suite of solutions designed to streamline the qualification of aseptic filling equipment, addressing the often complex and costly nature of this process. With an emphasis on efficiency, their dedicated project management team guides clients through each phase, ensuring adherence to timelines and project readiness. Key features of their offering include a comprehensive documentation package, critical testing protocols such as Factory Release Tests (FRT), Factory Acceptance Tests (FAT), and Installation Qualification (IQ), alongside on-site technical support for Operational Qualification (OQ).

Clients can choose between Standard and Premium documentation packages, the latter offering advanced protocols for process and performance qualification, including airflow control and VPHP decontamination. Cytiva’s integrated qualification approach minimizes redundancy by leveraging previous test results, ensuring a thorough evaluation of critical design elements throughout the qualification journey. Training is a cornerstone of their service, encompassing both basic and advanced operator training to equip users with essential and specialized skills. The structured support extends to a detailed project roadmap and risk management strategies, ensuring timely delivery and compliance.

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