Pharma & Biotech

Engineering for execution and qualification

In the pharmaceutical industry, a change during installation carries a double cost: once in execution, and again in qualification. That is why we engineer every solution with on-site execution and final qualification in mind from the initial concept. Close collaboration between design engineers and installation teams minimises on-site modifications, shortens project timelines, and ensures strict compliance with regulatory standards.

What we do:

• Conceptual design (URS, P&ID, spatial layouts)
• Process and functional diagrams
• 3D modelling and BIM coordination
• Detailed engineering, technical specifications, and bills of quantities
• As-built documentation and qualification support
• Project execution strictly aligned with ISPE guidelines and fully compliant with EU GMP and PED

A single partner from initial concept to qualification

A complex project carries as many risks as it has handovers between contractors. We integrate design, procurement, manufacturing, installation, and qualification into a single workflow under one point of technical responsibility. Phases run in parallel, which makes delivery faster and costs predictable.

What we do:

• Comprehensive turnkey project execution (design-build)
• Project management focused on schedule and cost efficiency, and stakeholder coordination
• Technical coordination across design, manufacturing, installation, and qualification
• Change management and regulatory documentation control throughout the entire project lifecycle
• Safe integration of process systems into new or fully operational facilities

Shifting Complexity to a Controlled Environment

An hour of installation work in a cleanroom is significantly more expensive than an hour in a manufacturing facility. That is why we prefabricate and perform Factory Acceptance Testing (FAT) on process and utility skids, modules, and piping systems at our own facilities. The equipment arrives on-site fully tested, accompanied by complete GMP documentation, ready for integration and Site Acceptance Testing (SAT).

What we do:

• Process and utility skids: filtration (TFF, UF/DF), chromatography, bioreactors, WFI/PW, and CIP/SIP systems
• Custom equipment and modules: distillation columns, special vessels, collection tanks, and prefabricated piping modules
• Platforms, frames, and load-bearing structures for safe access and maintenance
• Hygienic surface and joint treatment, alongside full material traceability (EN 10204)

Control from the First Weld to Successful Qualification

In pharmaceutical facilities, piping installations are a critical part of the product pathway, meaning both flawless execution and comprehensive documentation are under strict regulatory scrutiny. In such environments, all installation work from the first weld onward is executed by our own highly trained teams. This allows us to assume full technical responsibility, maintain strict quality control, and ensure complete documentation for rapid and successful system qualification.

What we do:

• Piping systems for clean utilities, process media, and energy
• Installation of prefabricated process units (skids, pumping and metering stations, CIP/SIP units)
• Orbital welding according to the highest industry standards (ISO 3834-2, ASME BPE, AWS D18.2)
• Cleaning, passivation, testing, and final system qualification
• End-to-end testing and commissioning by our in-house experts
• Operations in cleanroom and hazardous (Ex) zones (ATEX 2014/34/EU)
• Documentation and traceability: welding logs, isometrics, and material certificates (EN 10204)

When Time Windows Leave Zero Room for Error

In fully operational pharmaceutical facilities, every intervention poses a risk to existing processes. Overhauls and upgrades demand precise technical preparation and rapid execution. Through a high degree of off-site prefabrication, strict GMP discipline, and the expertise of our in-house teams, we take full responsibility for ensuring your production safely and predictably returns to full operation within the agreed timeframe.

What we do:

• Equipment replacements and system tie-ins / tie-outs
• Retrofitting in fill-finish lines
• Installation of process and utility piping systems
• Existing system upgrades and capacity expansions
• Clean media distribution systems
• Execution during scheduled plant shutdowns and phased operations
• Strictly documented execution with clear segregation of new and existing equipment
• After-sales support: traceable spare parts, preventive maintenance, and periodic inspections—backed by documentation to maintain qualified status

Safe Scale-Up from Laboratory to Industrial Production

During the transition from laboratory development to commercial production, the viability and safety of the entire process must be validated. For R&D departments and pilot plants, we design and manufacture systems that enable reliable scale-up. Because our pilot skids and lines are built to the exact same engineering and manufacturing standards as final industrial systems, we ensure a seamless and predictable transition into regular production under a single point of technical responsibility.

What we do:

• Pilot and laboratory process skids
• Pilot lines to support demanding R&D programs
• Engineering support for process scale-up to commercial production
• Close collaboration with your R&D teams from the initial concept onward