Design and Specification of Process Supplies

With our expertise and long-running knowledge of the pharma and life science sector, NIRAS can ensure that production plants and facilities are in full compliance with all regulatory requirements. NIRAS has managed projects for most of the larger life science companies in Denmark.

When pharma and life science companies establish new process supply plants or upgrade or adapt existing facilities, NIRAS maps and challenges the customer’s requirements for capacity, quality, and security of supply. In this way, we ensure optimal facilities that meet both technical requirements while being in full GMP compliance.

Sustainability and the United Nations 17 Sustainable Development Goals are an integral part of NIRAS’ solutions, and we work purposefully to ensure that our customers have the most optimal energy and resource consumption in their facilities. Therefore, an assessment is conducted already in the concept phase of both the direct energy costs and the CO₂ load implied by the different solutions.

NIRAS contributes to a streamlined validation process that either follows the customer's own procedures or NIRAS-developed and tested validation concepts.

With NIRAS’ experiences within GMP, process, function, and mechanical design, we deliver complete and thorough solutions in all types of process supplies for a regulated environment.

NIRAS can assist with:

• Scheduling and capacity calculations
• Determination of quality requirements
• Energy optimisation
• Budgeting and time scheduling
• Supplier contact
• Preparation of requirement specifications for production facilities and distribution systems
• Specification and design of production facilities and distribution systems
• Tender and contracting
• Construction management and supervision
• Qualification and validation
• Factory acceptance test (FAT), site acceptance test (SAT), and commissioning