Parker Launches Innovative Automated Solution for PUPSIT Integration

SciLog® NFF+ PF supports businesses in overcoming the challenges associated with implementing PUPSIT in biopharmaceutical manufacturing

Birtley, County Durham, UK, 1st April 2025 – Parker Bioscience Filtration, a division of Parker Hannifin, the global leader in motion and control technologies, announces the launch of SciLog® NFF+ PF. This innovative solution is specifically designed to assist biopharmaceutical manufacturers in seamlessly integrating Pre-Use Post-Sterilization Integrity Testing (PUPSIT) into their filtration processes, ensuring the highest standards of product safety and quality.

The SciLog® NFF+ PF system addresses the complexities of implementing PUPSIT in biopharmaceutical manufacturing environments. This fully automated, multipurpose Normal Flow Filtration (NFF) system features an on-board PUPSIT solution and is designed with a compact footprint, making it ideal for Good Manufacturing Practice (GMP) operating environments.

In response to the updated EU GMP Annex 1 guidelines, PUPSIT—an essential procedure for verifying the integrity of sterilizing filters before use—has become mandatory in most sterilizing filtration applications. This requirement is integral to quality risk management strategies aimed at validating filter integrity prior to its application.

However, the implementation of PUPSIT can introduce increased risks, such as a higher number of connections and elevated operating pressures, which can lead to human error and necessitate additional operator training. Operational errors can result in product waste, potentially affecting supply chains.

To mitigate these challenges, Parker has integrated single-use flow paths, advanced sensing technology, and automation within the SciLog® NFF+ PF system. This design guides operators through the PUPSIT process and overall bioprocessing via an intuitive interface, significantly reducing the risk of human error. Operators can configure fully automated sequences to monitor, adjust, and record pressure and flow rates, optimizing processing times and maximizing filter life and efficiency. The system executes the sterile filtration sequence, with PUPSIT seamlessly integrated as a key step in the process, ensuring filter integrity is validated prior to product filtration.

The SciLog® NFF+ PF system complies with FDA 21 CFR Part 11 and EudraLex Annex 11, ensuring comprehensive batch traceability.

In addition to the SciLog® NFF+ PF, Parker Bioscience Filtration offers technical expertise to support biopharmaceutical manufacturers in implementing effective PUPSIT strategies, working collaboratively to develop tailored solutions that fit within existing site constraints.

David Heaney, Division Strategic Marketing Manager at Parker Bioscience Filtration, stated: “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 minimizes operator intervention, exemplifying Parker Bioscience Filtration’s commitment to addressing industry challenges through our technical knowledge and product development expertise.”

Parker also provides semi-automated (SciLog® NFF+ PS) and manual (SciLog® NFF+ PM) solutions to further support the implementation of PUPSIT.

For more information about SciLog® NFF+ PF and Parker Bioscience Filtration’s solutions, please visit https://ph.parker.com/gb/en/scilog-nff-automated-nff-system-with-pupsit-capabilities 

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Parker’s SciLog® NFF+ PF system. 

About Parker Bioscience
Parker Bioscience Filtration, with its sites in Birtley (UK) Oxnard (US) and Jangangongdan (South Korea) supports customers both locally and globally in improving process control, efficiency and supply chain security throughout their production and packaging processes.

Parker Bioscience Filtration designs, supplies and delivers systems for both upstream and downstream pharmaceutical and biopharmaceutical manufacturing, and provides integrated bioprocessing solutions that speed up development times and increase efficiency and safety to enable reproducible quality.

It has five decades of experience in working with the international food and beverage sector and offers a wide range of filtration solutions that ensure product quality, while maintaining the lowest cost of ownership.

About Parker Hannifin
Parker Hannifin is a Fortune 250 global leader in motion and control technologies. For more than a century, the company has been enabling engineering breakthroughs that lead to a better tomorrow. Learn more at www.parker.com or @parkerhannifin.