Restoring EN 285 Pure Steam Compliance at the Feedwater, Not the Symptom
A non-condensable gas non-conformance threatened sterilization performance at a GE Healthcare site in Norway. Damgaard Solutions traced it to the feedwater, designed a membrane degassing skid, and qualified the upgrade end to end.
EN 285
Sterilization Standard
<3.5%
Non-Condensable Gas Limit
IQ/OQ/PQ
Full Qualification Delivered
Challenge
A Sterilization Compliance Risk Hiding in the Feedwater
The site could not consistently meet the EN 285 limit for non-condensable gases in pure steam used for sterilization. Elevated air content created a real compliance risk and raised concerns about sterilization performance and process robustness. The cause was not obvious. Treating it downstream at the steam generator would have masked the problem rather than solved it. The real source had to be found and addressed in the upstream water-steam pathway, while keeping the existing utility setup running.
Solution
Root Cause to Qualified Skid, Delivered as One Package
Damgaard Solutions took end-to-end ownership of the issue. From troubleshooting and root cause investigation through bespoke skid design, manufacturing oversight, installation, and full IQ/OQ/PQ qualification. One specialist team, one accountable scope, no multi-vendor handoffs.
1
Systematic root cause investigation
Reviewed piping design, sampled and analyzed feedwater, and assessed the upstream water treatment process to trace the origin of dissolved and entrained gases. The structured diagnostic approach identified the feedwater as the source rather than the steam generator itself.
2
Membrane degasser design at the source
Engineered a skid-mounted membrane degassing system using a microporous polypropylene membrane combined with vacuum to extract dissolved gases from the feedwater while retaining the liquid phase. Solving the problem at the feedwater rather than chasing symptoms in the steam.
3
Integrated control, alarms, and fail-safe interlock
Designed a dedicated control cabinet, vacuum system, alarm handling, and remote start-stop interface to the clean steam generator. Built in a hard interlock so untreated water cannot reach the generator during operation, removing a contamination pathway by design.
4
Manufacturing, installation, and full qualification
Oversaw skid manufacturing and installed the unit upstream of the clean steam generator without disrupting ongoing operations. Executed functionality testing, P&ID verification, arrangement testing, electrical diagram verification, remote start-stop verification, steam quality test supervision, documentation review, protocol execution, and final report.
Results and Impact
Restored steam quality performance to consistently below the EN 285 non-condensable gas limit of 3.5%.
Resolved the compliance risk at the source by upgrading feedwater quality, not by patching downstream symptoms.
Delivered a turnkey upgrade with one accountable specialist team. From diagnosis through IQ/OQ/PQ qualification.
Built in a fail-safe interlock so untreated water cannot reach the clean steam generator during operation.
Steam quality non-conformances are rarely about the steam generator. A system-level view of the entire water-steam pathway, with early feedwater analysis, is what makes them solvable rather than recurring.
Project Facts
At a glance
Client
GE Healthcare
Site
Norway
Service Area
Washing and Sterilization (W+S) / CIP/SIP
Project Type
Utility upgrade
Scope
Troubleshooting through IQ/OQ/PQ qualification
Regulatory Framework
EU GMP, EN 285
Systems Covered
Membrane degasser, clean steam generator feedwater, vacuum system, control and interlock
Outcome
Non-condensable gas levels below the EN 285 3.5% limit
Topics
About the specialist
Kasper led the project end to end. From troubleshooting and feedwater analysis through bespoke skid design, manufacturing oversight, installation, and full IQ/OQ/PQ qualification. The cross-functional expertise across water treatment, clean steam systems, GMP qualification, and control engineering meant GE Healthcare did not need to manage multiple vendors. One accountable specialist, one turnkey outcome.
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