CIP/SIP-ready before the walls were finished.
Damgaard Solutions ran layout validation, vendor challenge, and dead-leg redesign for washers, autoclaves, and a single-use isolator at Novo Nordisk Maaloev, aligning the design before installation locked in costly errors under EU GMP Annex 1.
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.
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, and 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.
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.