Sweco has been a trusted partner to the Finnish pharmaceutical industry for more than 20 years. In our projects, we combine local expertise with the extensive experience of the international Sweco Group. Our services cover pharmaceutical manufacturers, medical device companies, and producers of active pharmaceutical ingredients (APIs).
Partner for the Finnish Pharmaceutical Industry – Services for pharmaceuticals and medical devices
Our specialists have extensive experience in regulated manufacturing environments and understand the industry’s stringent regulatory requirements. We help our clients design and deliver facilities and processes that meet the specific needs of the pharmaceutical and medical device sectors.
Projects are carried out in compliance with applicable material and design specifications, GMP requirements, and validation standards. When required, we also address the regulatory expectations of different markets and authorities, including the European Union (EU) and the U.S. Food and Drug Administration (FDA).
Design services for the pharmaceutical industry
Our design services cover structural and building services engineering, as well as plant and process design, including the design of pharmaceutical manufacturing and packaging lines, equipment, and utility systems. We also provide specialist expertise in the design of cleanrooms and production lines for aseptic products.
Cleanroom design
Our structural, electrical, HVAC, and automation engineers specializing in pharmaceutical and medical device facilities design cleanrooms of various cleanliness classifications, together with the associated support areas. Our site supervisors are also experienced in working in controlled cleanroom environments.
Utility systems design
We offer specialist expertise in the design of chemical and utility systems for industrial facilities. Our services include the design of pure steam and clean-in-place (CIP) systems, as well as high-purity water systems, including Water for Injection (WFI) systems.
GMP requirements
Our designers have extensive hands-on experience in the pharmaceutical industry and a thorough understanding of Good Manufacturing Practice (GMP) requirements governing manufacturing, production, and distribution in different regulatory jurisdictions. Particular attention is given to systematic documentation and compliance with applicable regulatory requirements.
Design services
- Process design and process consulting services
- Plant, equipment, and piping design
- Electrical, HVAC, and automation design
- Instrumentation design
- Safety engineering, including ATEX classification and machine safety
- Tank design, including steel structure design
- Utility and chemical systems design
- Design of production lines for active pharmaceutical ingredients (APIs)
- Design of production lines for various dosage forms, including injectable manufacturing lines, wet granulation and fluidized bed granulation lines, and tablet coating lines
- Design of pharmaceutical packaging lines
- Piping design for solvent and mixing vessels
- Process and piping design for dissolution and crystallization reactors
- Design of research and development (R&D) and quality control (QC) laboratories
Services for Active Pharmaceutical Ingredient (API) manufacturing facilities
Sweco provides comprehensive services for API manufacturing facilities, including process, plant, and equipment design, as well as safety engineering. We also have extensive experience in VOC emissions management and the design of steam and condensate systems.
Services for pharmaceutical and medical device manufacturers
We offer comprehensive design and project management services, complemented by specialist expertise in validation, safety engineering, and production line design. Our capabilities also include the design of CIP (Clean-in-Place), PW (Purified Water), WFI (Water for Injection), and pure steam systems.
Project management and construction supervision for industrial projects
Our project management services cover all aspects of project leadership, owner’s engineering, and construction supervision. Industrial projects can be delivered, for example, under an EPCM (Engineering, Procurement, and Construction Management) model, where we are also responsible for overall engineering and design management. An essential part of our project services is continuous monitoring of cost, schedule, and quality, as well as supervision of deliveries and installation activities.
Support services for the pharmaceutical and medical device industries
We support our clients with a broad range of multidisciplinary services, including:
Factory logistics and facility planning
- Factory logistics design
- Factory and laboratory layout design
- Material flow analysis
Risk management
- Expertise in chemical, product, and machine safety, as well as internal logistics and warehouse management
- Risk management for medical devices in accordance with ISO 14971
Process and compliance services
- Process validation and troubleshooting
- Preparation and maintenance of marketing authorization documentation and technical files
- Design of R&D and QC laboratories
- Technology transfer projects for pharmaceutical products, from feasibility studies through implementation
- Sustainability consulting services
Jukka Nykyri
Food & Pharma LeadHannele Eerikäinen
Leading Expert, Pharmaceutical Industry