CIP/SIP-Ready Before the Walls Were Finished
Layout validation, vendor challenge, and dead-leg redesign inside a new sterile facility still under construction. Equipment specified and design aligned before installation locked in the wrong decisions.
ANNEX 1
GMP Framework
W+S
CIP/SIP Specialist
EU
Delivery Region
Challenge
Specifying Critical Equipment Inside a Moving Layout
A new sterile production facility at Måløv was being built while critical process equipment. Washers, autoclaves, and isolator systems. Was being specified in parallel. Room boundaries were still shifting, vendor solutions had not been pressure-tested against real operational needs, and the technical documentation made it difficult to spot where the design did not match how the facility would actually run. Inside one single-use isolator system, non-drainable piping sections created hold-up volumes that would have compromised effective flushing and contamination control. Left unresolved, each of these issues would have been significantly more expensive to fix after installation.
Solution
Hands-On Design Validation Before Procurement Commitments Were Made
Damgaard Solutions was engaged to review the design from a practical, equipment- and operations-focused perspective. Ensuring the final setup would work for the people using and servicing it, not only on paper.
1
On-site layout validation through physical marking
Made layout constraints tangible by physically marking equipment footprints and service zones on the floor, allowing the full project team to see space requirements, access routes, operator flows, and service envelopes before installation committed any of them.
2
Early design challenge sessions
Challenged layouts systematically using grounded questions: where will the equipment fit, how will operators move safely, and can service technicians access critical components without workarounds? Each answer shaped decisions while they were still low-cost to change.
3
Vendor dialogue and package alignment
Identified specific mismatches between user and service needs and vendor standard packages, and drove the required design adjustments. Worked directly with builders and installation stakeholders to ensure building adaptations. Walls, penetrations, utility routes. Supported installation, service access, and future modifications.
4
Routing redesign to address dead legs
Identified non-drainable sections in the single-use isolator piping, supported redesign with a fabrication partner, and aligned the solution so implementation and subsequent acceptance testing would be achievable without late surprises.
Results and Impact
Avoided costly late changes to walls, penetrations, and utility routing by identifying conflicts at layout stage.
Secured better operator and service access around critical equipment before installation locked the layout in.
Improved cleanability and contamination-control robustness by removing dead legs from the isolator piping.
Reduced commissioning and qualification risk by aligning the design with practical use and testability from the outset.
Every problem identified was solved while it could still be addressed with lines on the floor and design adjustments. Not expensive changes, deviations, and delays after handover.
Project Facts
At a glance
Client
Novo Nordisk
Site
Måløv, Denmark
Project Duration
2023–2024
Service Area
Washing and Sterilization (W+S) / CIP/SIP
Scope
Layout validation through design qualification
Regulatory Framework
EU GMP ANNEX 1
Systems Covered
Washers, autoclaves, CIP/SIP, single-use isolator systems
Outcome
Design aligned before procurement commitments
Topics
About the specialist
Peter Mastrup is a Senior Engineer at Damgaard Solutions with 25 years of hands-on experience with washers, autoclaves, and CIP/SIP systems in pharmaceutical environments. He is known for identifying layout, accessibility, and design issues long before they appear as deviations. And for making sure clients end up with solutions that can be operated, maintained, and validated in practice, not just on paper.
To discuss projects like this one, visit our specialists page →
Link copied to clipboard