The Importance of Clean-in-Place Systems to the BioPharmaceutical Industry
Large-scale industrial facilities including pharmaceuticals, biopharmaceuticals, and al...
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.
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 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
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
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
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
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.
“ 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
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. 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.
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