Parker Bioscience Filtration has developed the SciLog NFF+ PF system, which incorporates advanced technologies to enhance compliance with the updated European Union Good Manufacturing Practice (EU GMP) Annex 1 guidelines. These guidelines now mandate the use of Pre-Use Post-Sterilisation Integrity Testing (PUPSIT) for most sterilizing filtration processes. PUPSIT ensures that filters maintain integrity before they are used in the production of biopharmaceutical products. This change poses a significant challenge for manufacturers as it introduces complexities that can impact both operational efficiency and compliance.
Meeting Industry Challenges
To address the emerging complexities resulting from PUPSIT requirements, the SciLog NFF+ PF integrates several innovative features. Biopharmaceutical manufacturing often encounters increased risks related to additional connections, higher operating pressures, and the potential for human error. In response, the system utilizes single-use flow paths, modern sensing technologies, and automated processes. Operators are guided through both PUPSIT and broader bioprocessing steps via an intuitive interface, which considerably mitigates the likelihood of errors. Automation in the SciLog NFF+ PF ensures precise control and monitoring of pressure and flow rates, thereby optimizing processing times and extending the filter’s lifespan and efficiency.
Incorporating PUPSIT into the sterilization sequence ensures that the filter’s integrity is validated before actual product filtration begins. This technological integration complies with stringent regulatory standards, including FDA 21 CFR Part 11 and EudraLex Annex 11 regulations. Comprehensive batch traceability is another significant feature, supporting regulatory compliance and providing critical data visibility.
Technical Expertise and Customized Solutions
Parker Bioscience Filtration goes beyond just providing the SciLog NFF+ PF system by offering extensive technical support to aid manufacturers in implementing effective PUPSIT strategies. Each biopharmaceutical production facility has unique operational constraints, and the expert team at Parker assists in developing tailored approaches that match these specific needs. According to David Heaney, Division Strategic Marketing Manager, the goal is to streamline PUPSIT operations while enhancing overall process control and regulatory adherence. This support not only minimizes operator intervention but also ensures that the new regulatory requirements are met seamlessly.
Additionally, the SciLog NFF+ PF system comes in various configurations to suit different operational needs. Parker offers semi-automated solutions through the SciLog NFF+ PS and manual solutions with the SciLog NFF+ PM options. These variations demonstrate Parker’s commitment to providing versatile and effective filtration technology solutions that accommodate a broad range of biopharmaceutical manufacturing scenarios. Ensuring product quality and regulatory compliance are the cornerstones of these offerings.
Commitment to Advancing Biopharmaceutical Manufacturing
Parker Bioscience Filtration has introduced the SciLog NFF+ PF system, featuring advanced technology designed to meet the updated European Union Good Manufacturing Practice (EU GMP) Annex 1 guidelines. These revised guidelines now require the use of Pre-Use Post-Sterilization Integrity Testing (PUPSIT) for the majority of sterilizing filtration processes. PUPSIT is critical as it ensures that filters are intact and fully functional before being utilized in the production of biopharmaceutical products. Implementing PUPSIT poses a significant challenge for manufacturers as it adds layers of complexity, potentially impacting both operational efficiency and regulatory compliance. However, Parker’s SciLog NFF+ PF system effectively addresses these challenges, providing a reliable solution for manufacturers to meet the stringent requirements. This innovation demonstrates Parker’s commitment to aiding the biopharmaceutical industry in maintaining high standards of quality and compliance.
