Parker Bioscience Filtration, a division of Parker Hannifin, a US-based motion and control technologies specialist, has launched the SciLog (trademarked) NFF+ PF.
The SciLog NFF+ PF is a Normal Flow Filtration (NFF) system designed to facilitate the seamless integration of Pre-Use Post-Sterilisation Integrity Testing (PUPSIT) in biopharmaceutical manufacturing.
The SciLog NFF+ PF is a Normal Flow Filtration (NFF) system
The compact and automated system, featuring an on-board PUPSIT solution, is tailored for Good Manufacturing Practice (GMP) environments, ensuring compliance with the updated EU GMP Annex 1 guidelines.
These regulations mandate PUPSIT for most sterilising filtration applications, reinforcing the need for robust quality risk management strategies to verify filter integrity prior to use.
Addressing industry challenges
Implementing PUPSIT is essential but comes with challenges.
These include increased risks due to additional connections, elevated operating pressures, and a higher likelihood of human error.
To mitigate these risks, extra operator training is necessary. If mishandled, these factors can lead to product waste and supply chain disruptions.
To counter these challenges, Parker has integrated single-use flow paths, advanced sensing technology, and automation into the SciLog NFF+ PF system.
The intuitive interface guides operators through both PUPSIT and broader bioprocessing steps, significantly reducing the risk of error
The intuitive interface guides operators through both PUPSIT and broader bioprocessing steps, significantly reducing the risk of error.
The system allows for the configuration of fully automated sequences to monitor, adjust, and record pressure and flow rates—optimising processing times while maximising filter lifespan and efficiency.
With PUPSIT embedded as a key step in the sterile filtration sequence, the SciLog® NFF+ PF ensures filter integrity validation before product filtration.
The system also complies with FDA 21 CFR Part 11 and EudraLex Annex 11, providing comprehensive batch traceability to support regulatory requirements.
Expert support for biopharmaceutical manufacturers
In addition to the SciLog NFF+ PF, Parker Bioscience Filtration offers technical expertise to assist biopharmaceutical manufacturers in developing tailored PUPSIT strategies.
The company collaborates with businesses to implement effective solutions while accommodating existing site constraints.
David Heaney, Division Strategic Marketing Manager at Parker Bioscience Filtration, said: "SciLog NFF+ PF has been designed to streamline the PUPSIT process, delivering reliable integrity testing, enhanced process control, and regulatory compliance while simplifying operations.
This innovative system minimises operator intervention
“This innovative system minimises operator intervention, exemplifying Parker Bioscience Filtration’s commitment to addressing industry challenges through technical knowledge and product development expertise."
Parker also provides semi-automated (SciLog NFF+ PS) and manual (SciLog NFF+ PM) solutions to support the implementation of PUPSIT further, reinforcing its commitment to advancing biopharmaceutical manufacturing through cutting-edge filtration technology.