Supporting across the pharma lifecycle

A complete life cycle service

Our customised approach to problem solving reflects our in-depth understanding of the complexities of producing pharmaceuticals within a highly regulated environment.

Our engineers, architects and designers are experienced in a wide range of processing technologies. They work closely with our facility design, process automation, piping design, pharmaceutical systems and validation groups, efficiently translating customer requirements into optimum manufacturing processes and facility designs in compliance with all applicable CGMPs, codes, regulations and standards. With this approach, we provide sound, cost-conscious engineered solutions.

From the early idea stage, we help define our customers' business cases, evaluate and mitigate risks, challenge current standards and thinking, and develop the right solutions. Through the investment life cycle, we support our customers from initial feasibility and investment advice, to development, project management, execution, validation, start-up and on-going asset support.

Our extensive industry experience includes overseeing refurbishment and maintenance projects for global pharmaceutical manufacturers. Our ability to deliver an umbrella of services under one project management team is the key to adding value in a high-quality, high-precision and extremely competitive manufacturing sector.

This total project management capability extends to the most demanding refurbishment and maintenance needs and includes expertise in fabric maintenance, access support, mechanical, electrical and instrumentation services for bespoke projects, turnarounds and term contracts.

Our services

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• Feasibility studies/concept design
• Site master planning/site selection
• Permitting and EIA
• Basic design
• Project Delivery
• Commissioning and qualification
• Asset support and optimisation
• Facility demolition and decommissioning
• Regulatory compliance

Feasibility studies/concept design

Getting the right start is crucial to maximising the benefits from our customers' planned investments. That’s why customers come to us, because they know we have a commitment to quality and to understanding their business objectives (such as time-to-market and cost effectiveness), so that we can help them find the right solution. We and our customers like to work from the earliest phases of their planned investments, in a collaborative team-focused way, so that we can help to give their project the right start, applying all of our experience, expertise, creativity and innovation.

Our skills in feasibility study/concept design include:

• Process and facility simulation
• Process architecture
  • Facility programming
  • Code analysis
  • cGMP compliance
  • Conceptual design
  • Modularisation
• Master planning
• Process understanding, sizing, optimisation, scale-up
• Technology transfer
• Process and business risk analysis
• HSSE assessment
• Utility / sustainability analysis
• Energy modelling
• Preliminary investment cost estimate, global locations
• Preliminary integrated master schedule
• Funding document preparation

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Site master planning/site selection

As new pharmaceutical sites are developing in markets such as the Middle East, China, India, Brazil and Russia, other facilities are being relocated, rationalised or even closed. Whether you are reassessing your existing assets with a view to increasing operational effectiveness, or planning a new build, Wood has the expertise to develop a strategic master plan specific to your needs.

We consider a wide range of factors including:

• Site location: land cost, supporting infrastructure, natural hazards, accessibility, local workforce, planning regulations
• Site infrastructure: utilities availability, waste handling, emergency back-up
• Environmental concerns: air quality, water usage and quality, site drainage and detention factors as well as the impact on local and regional natural resources
• Governing authority factors: planning authorities, local government, local community, economic incentives
• Analysis of regulatory agencies’ requirements (FDA, EU, Asia, RoW), and facility gap analysis
• Buildings: planning and zoning codes, footprint, topography and soil conditions, sustainability requirements
• Legacy facility integration
• Expandability, flexibility, adaptability
• Site remediation and decontamination

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Permitting and EIA

We apply our in-depth knowledge of applicable legislation around the world to deliver high quality services across a range of planning, permitting and environmental impact assessment (EIA) activities, including:

• Feasibility studies and land use planning appraisals
• Environmental risk assessment
• Site selection investigations
• Regulatory impact assessments
• Environmental statements
• Assessments of environmental effects
• Planning appeals support
• Environmental management systems
• Waste and energy minimisation/recovery studies
• Risk assessments

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Basic design

Wood has a reputation for delivering high quality basic design studies which give robust technical and financial basis to lay the foundation for a successful project. We deliver sound project definition covering process and all technical disciplines as well as a project execution strategy, CQV readiness, a coordinated and integrated master project schedule and an open-book robust investment cost estimate that can be used for project approval within a customer's organisation.

Whether planning a grassroots facility, a major upgrade or expansion, or a small ‘maintenance-type’ investment, we help customers shape or re-shape projects to get the green light to proceed with investment, utilising value engineering exercises, developing phased investment plans, optimising the investment, while using innovative and creative solutions to meet project objectives.

Wood provides experienced design solutions including:

• RAMS
• Process and GMP risk analysis
• Constructability
• HSSE studies

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Project delivery

We provide a complete engineering, procurement and construction management service for our customers. Our detailed design capabilities include specialist pharma and biopharma architectural, mechanical, electrical, automation, process and piping expertise, supported by state-of-the-art tools.

As well as working with our customers on the design of their facilities right from the concept design phase, through basic design and detailed design, we have global procurement capability and experience to develop and implement optimal contracting and purchasing strategies. Our strategies address the appropriate allocation of risk to manage project costs and time as well as contractors and suppliers. We use our knowledge base and experience to approach project delivery systematically. We align the contracting strategy with our clients’ needs and the attributes of a project.

Our approach is to identify appropriate actions to address issues such as:

• Advance purchasing of long-lead bulk materials
• Long-lead equipment
• Workload of local suppliers and contractors
• Site access constraints/temporary facilities and construction contractors’ lay-down areas
• All required insurances

We have an in-depth understanding of the pharmaceutical / biotech sector of the construction market. We rely on solid management, a thorough understanding of the project scope and the ability to procure the best subcontractors and suppliers while managing to achieve successful outcomes within our clients’ cost objectives. We focus on construction early in the design phase and continue with the management of all construction activities to ensure the project is executed successfully.

Our operations management support expertise ensures that in-depth and critical activities related to a large capital project with regard to validation, maintenance and operations are not overlooked or left until it’s too late. The validation and operations start-up phase of projects have the same, if not increased, level of requirements with regard to schedule activities and logic, resources, and deliverables as does the EPCM execution phase.

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Commissioning and qualification

We are recognised industry experts in validation, with teams of experienced validation and regulatory specialists providing the full spectrum of commissioning, qualification, and validation services. In fact, we co-authored the ISPE Commissioning and Qualification Guideline. We can offer our expertise as a standalone service, or as an integral part of our full EPCMV project delivery.

From conceptual design through handover, our validation team works closely with engineering, manufacturing, procurement and construction to ensure that quality is designed into the project, that user requirements are achieved in the design, that regulatory concerns are addressed, and that commissioning and qualification needs are clearly communicated to the entire project team.

At Wood we follow the life-cycle approach to commissioning, qualification, and validation (CQV). This defines the requirements for design, procurement, pre-delivery inspection, factory acceptance testing, installation, commissioning, and qualification (or verification) during the earliest project phases.

We offer the following CQV services:

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Asset support and optimisation

We provide comprehensive and cost-efficient solutions to meet our customers' on-going maintenance management needs. Our engineers and technicians provide expertise and experience for our customers' maintenance projects. We have extensive experience as employees of owner organisations and as service suppliers performing maintenance services for facilities, equipment and systems in the regulated pharmaceutical and biotech manufacturing facilities.

We can support the development, implementation and operation of computerised maintenance management systems, work with our customers to maximise inventory dollars by stockroom optimisation and inventory management, and our experienced maintenance supervisors and engineers provide maintenance training, planning and troubleshooting services.

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Facility demolition and decommissioning

Wood can offer facility demolition and decommissioning, as well as site decontamination. Our experience spans industry and geographies enabling us to leverage lessons learned and bring innovation to each of our projects. We have the flexibility to meet customer requirements and to operate at the programme, project or task level, and can provide a full turnkey service including site disposal and redevelopment to maximise value from the asset. Coupling this expertise with our excellent HSSE performance, resource capabilities and knowledge of industrial site operations, we are the ideal partner for end-of-life pharmaceutical facility projects.

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Regulatory compliance

At every part of the product life cycle, from R&D through manufacturing, distribution and marketing of products, pharmaceutical companies must adhere to regulations from local, national and international authorities. We keep regulatory compliance firmly in our minds from the earliest phases of projects, from developing the conceptual design, applying the right codes and standards, managing the information required to demonstrate regulatory compliance, material selection, quality control and factory acceptance testing amongst many other factors.

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