The Challenge: Modernising a Manual System
At GSK’s Ulverston facility, a manual sterile filtration system was used to transfer product into a Grade C cleanroom. The original system involved a double filtration system and manually operated hoses, leaving the process vulnerable to environmental contamination and inconsistent filter integrity testing.
GSK required a transformation: a fully integrated, automated filtration skid that could perform. They needed:
- Automated integrity testing
- Clean-in-Place (CIP)
- Steam-in-Place (SIP)
- And do it all without breaking the sterile boundary
Only the physical replacement of filter elements would remain manual.
The Project: Collaboration and Complexity
To achieve this, GSK assembled an expert team that included:
- Suncombe (mechanical design and fabrication)
- ITT Engineered Valves (specialist valve technology)
- PM Group (project engineering and commissioning)
- And senior GSK engineering staff
From day one, the collaboration was intensive; detailed P&ID reviews, 3D modelling, weekly meetings, site visits, and multiple design iterations led to a state-of-the-art solution that overcame all technical and regulatory challenges.
The System: Engineering Innovation in Action
The resulting skid was:
- Hard-piped and fully automated
- Equipped with ASME BPE Compliance, ATEX, and GEP
- Equipped with over 70 valves, including multiple monoblock valves
- Capable of dual filtration, with permanent lines to the integrity tester
- Designed for 55 automated sequences, controlled by the plant’s PCS
Cleanroom Integration
The unit was designed to straddle the cleanroom boundary:
- Process connections and filter housings on the clean side
- Valves, instrumentation, and services on the technical side
- Seamless wall integration preserving sterile integrity
Technical Advantages
- Minimised dead-legs and stagnant zones
- Millimetre-tolerance design
- Multiple inlets and outlets, including WFI, Pure Steam, N₂, compressed air
- Reduced equipment footprint in critical spaces
Sustainability Benefits
Beyond sterility and safety, the system offered significant environmental and operational advantages:
- Reduction in processing fluids and utilities
- Lower effluent and waste volumes
- Greater energy efficiency and reduced site-wide resource usage
Global Recognition – Pharma Category Award
The outcome? A filtration solution that:
- Eliminated contamination risks
- Enhanced product quality
- Optimised batch production
- Improved operator safety
- And reduced environmental impact
The collaborative team efforts were recognised at the IChemE Global Awards, where the project won the Pharma Category Award, celebrating excellence, innovation, and impact in the chemical and process industries.
From Suncombe
“Using our 60+ years of experience in hygienic pharmaceutical systems, this project allowed us to push technical boundaries and work as true partners with GSK and their engineering experts. We’re proud that the results not only met but exceeded expectations—and were honoured to see this recognised by IChemE.”
— Steve Overton, Technical Director, Suncombe
Contact Suncombe for for the Future of GMP Filtration Systems
This award-winning project is more than a milestone, it’s a blueprint for the next generation of sterile filtration systems. It demonstrates how careful engineering, cross-functional collaboration, and regulatory focus can deliver measurable value in the most demanding pharmaceutical environments.
At Suncombe, we approach sterile filtration systems with the same precision and regulatory focus that defines our other hygienic processing equipment, including GMP Washers, GMP Process Skids and Systems, and GMP Vessels. Whether you’re modernising a legacy process or designing a new high-containment facility, our award-winning sterile filtration systems provide the equipment needed for critical pharmaceutical and biotech applications.
Speak with our technical specialists today by emailing [email protected] or calling +44 (0) 203 089 0280.
