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Technical expertise

We have an impressive track record, safely and successfully delivering projects for facilities covering all aspects of pharmaceutical research, development and manufacture: chemical active pharmaceutical ingredients, bulk biopharmaceuticals, liquid and solid dosage forms, pilot plants, research laboratories, medical devices, consumer health products, and diagnostics.

Regular news headlines underscore the growing importance of vaccine production to meet expanding demands and the threats of global pandemics. Newer recombinant-based technologies promise to enhance or replace traditional production methods, such as egg-based flu vaccine production, while greatly speeding up response and development time-to-market.<br/><br/> Across this spectrum, we provide the process expertise, engineering and CQV experience and project execution capability required to meet new market challenges. We marry facility design with process functionality and project delivery expertise to help our clients ensure their global cGMP regulatory compliance is met.<br/><br/> We offer process solutions for:<br/><br/> <ul> <li>Traditional vaccine production <li>Egg-based vaccine production <li>Live virus vaccine protection <li>Recombinant cell culture based processes <li>Transgenic plant technologies <li>Vaccine purification, formulation and fill/finish <li>Process simulation and optimisation <li>Pathogens containment technology <li>Custom applications</li> </ul>

With manufacturing becoming ever more competitive and profit margins under strain, the cost of manufacturing is increasingly challenging. Efficient product flows, higher production rates, lower cost of utilities, and greater operational up-time are all critical to improving the utilisation of equipment, reducing required capital investment, and driving down the costs.<br/><br/> We provide the engineering design, equipment and facility expertise, full CQV know-how and proven project execution capability to help get our customers’ products to market quickly and cost-effectively. We provide intensive focus on process architecture, ensuring that product, people and material flows are optimised to deliver a cost-effective solution, through a well-coordinated, seamless manufacturing operation, incorporating lean manufacturing concepts and compliance by default. <br/><br/> Our experience will help provide you with a sustainable operation able to meet the challenges of a constantly changing marketplace and ever-evolving regulatory landscape.<br/><br/> We offer oral solid dosage solutions for:<br/><br/> <ul> <li>Granulation <li>Fluid bed drying <li>Powder blending <li>Tableting <li>Blister lines and bottle filling <li>Tablet coating <li>Encapsulation <li>Primary and secondary packaging <li>Containment technology for highly-active ingredients <li>Labelling</li> </ul>

Small molecule, active pharmaceutical ingredients (API) products remain a vital part of global healthcare.<br/><br/> The production of small molecule APIs continues to present many challenges to the pharmaceutical manufacturer and developer. A constantly evolving regulatory landscape, increased competition in the marketplace, and shifting environmental factors forcing process changes are just a few of the challenges that our customers face. High-potency and highly-reactive compounds present special containment challenges for meeting safety and cGMP requirements.<br/><br/> Our extensive expertise encompasses both batch and continuous chemical synthesis. We design and build facilities configured to meet your specific needs for operational flexibility and adaptability and the most stringent safety, regulatory and product quality demands.<br/><br/> We engineer facilities to cover the entire range of containment thresholds including some of the lowest design operating exposure limits in the industry.<br/><br/> We offer process solutions for the API customer:<br/><br/> <ul> <li>Specialty chemical process design <li>Batch/continuous chemical reactor design <li>Recovery and purification operations (distillation, filtration, centrifugation) <li>GMP packaging <li>Environmental control <li>Process safety management and HAZOP studies <li>Containment design for high potency compounds <li>Relief design utilising methods such as DIERS for intrinsically safe equipment and relief system design <li>Process simulation & optimisation <li>Custom applications <li>Solvent recovery</li> </ul>

Our experience includes:<br/><br/> <ul> <li>Batch and fed batch cell culture reactors up to 25,000 litres <li>Perfusion cell culture reactors <li>Fermenter design up to 200,000 litres <li>Single-use applications <li>Engineering of unique mass transfer, heat removal, and mixing strategies <li>Reactor design for extremophiles <li>High biosafety level reactor design</li> </ul> <br/> Our experts work with you to optimise your bioprocess scale-ups and develop a design that minimises system complexity while assuring process reliability. We offer in-depth knowledge and experience in the design, construction and troubleshooting of bioreactor and fermenter systems.<br/><br/> More and more, single-use bioreactors for working volumes of up to 2,000 litres are the design of choice. Our experts helped to pioneer the design of single-use bioreactors and other single-use componentry for the biopharma industry.

We have in-depth knowledge of, and experience in, the design, procurement, installation, start-up, commissioning, qualification and validation of recovery and purification systems for mammalian cell culture, insect cell culture, fermentation, vaccine and transgenic processes. In addition to our process excellence, our facilities design experts are experienced in balancing the proper containment, cleanliness and segregation for purification areas, versus cost, flexibility, reconfigurability.<br/><br/> Our experience includes working with standard and custom process systems. We design and install both modular skid-mounted systems and stick-built systems to meet our clients’ needs. Our designs take all aspects of the manufacturing process into careful consideration including CIP, SIP, cleaning and storage, cGMP operations, sampling, timeline constraints, product changeovers, scalability and maintainability.<br/><br/> Amec Foster Wheeler engineers possess an in-depth practical knowledge in the full breadth of technology, including centrifugation, large-scale chromatography, homogenisation, depth filtration, virus filtration and tangential flow filtration, utilising both disposable and traditional systems.

Amec Foster Wheeler has the engineering experience to create an optimum solution to help get products ‘out the door’. Whether a tablet or a biological parenteral, each filling process requires an experienced approach to integrate a successful production line. We combine the facility expertise with our process and equipment knowledge to ensure complete synergy within the project.<br/><br/> We develop fill / finish solutions for:<br/><br/> <ul> <li>Aseptic liquid filling <li>Lyophilised forms <li>Thermally-sterilised liquid forms <li>Oral solid dosage <li>Oral liquids and topical forms <li>Transdermal products <li>Sterile powder filling <li>Potent compounds <li>Custom applications</li> </ul>

Lyophilisation technology has not changed much over the past 20 years, but the automation associated with loading and unloading has, thus providing new challenges for loading, unloading, cleaning, and containment in the integration of an automated process. <br/><br/> Proper design, construction and factory testing phases can streamline the qualification and operation phases of the equipment once it arrives on site. We have the design, procurement, and qualification experience to work with equipment suppliers in order to minimise the potential risks and obstacles associated with bringing a complicated piece of equipment to a fully automated, operational and validated system.<br/><br/> We do this by developing tight specifications with the equipment suppliers, thoroughly reviewing their documentation and participating in factory testing, ensuring the equipment is not only functional, but meets the requirements established by the owner. We also bring a wealth of experience and solutions during the on-site troubleshooting phase.

Increasingly, pharma companies are looking for ways to achieve flexible, lower cost, manufacturing operations featuring disposables, or single-use components, instead of stainless steel equipment. Amec Foster Wheeler performs an objective process-specific analysis, recommends which of the disposable solutions would best fit your needs, and designs the surrounding plant capable to house and produce by:<br/><br/> <ul> <li>Cell culture/fermentation single-use bioreactors <li>Filtration steps that include disposable equipment for depth filtration, tangential filtration and dead-end filtration <li>Liquid chromatography with disposable, pre-packed columns <li>Product hold utilising disposable bioprocess containers with various mixing options in optional jacketed outer containers <li>Solution prep and hold utilising single-use mixing systems with or without solids/liquid addition ports and bioprocess containers <li>Cold product storage utilising disposables</li> </ul>

Packaging in today's healthcare manufacturing environment is more than the traditional bottle in a carton. Our clients’ product investment value is at its peak when the product reaches the packaging operation. Our clients’ reputation is travelling 'down the line' along with the vials, syringes, bottles and cartons. The right packaging equipment, integrated into a complete system, supports the quality of the product all the way to the end-user.<br/><br/>Amec Foster Wheeler has the experience to develop and execute a comprehensive plan for implementation of any kind of packaging line system. We have hands-on experience with the full range of packaging solutions whether it's a semi-automatic highly flexible line or an automated operation incorporating the latest track-and-trace capability.<br/><br/>We offer fill/finish solutions for:<br/><br/> <ul> <li>Cell culture/fermentation single-use bioreactors <li>Filtration steps that include disposable equipment for depth filtration, tangential filtration and dead-end filtration <li>Liquid chromatography with disposable, pre-packed columns <li>Product hold utilising disposable bioprocess containers with various mixing options in optional jacketed outer containers <li>Solution prep and hold utilising single-use mixing systems with or without solids/liquid addition ports and bioprocess containers <li>Cold product storage utilising disposables</li> </ul>

We have a proven track record in the custom design and construction of pre-assembled process modules for the pharma industries, covering the full range of pilot and manufacturing scales of operation. These include individual ‘skidded’ unit operation systems, as well as entire pre-assembled process trains and suites.<br/><br/> Modular fabrication of process and utility systems allows us to separate the fabrication and testing of these systems from the building construction activities, so these activities can be completed in parallel to compress the project schedule.<br/><br/> A modular approach also allows the process to adapt to changes. Purification schemes, for example, may need to adapt to changes that result from increased protein yields in the bioreactor or introduction of new products: a well thought-out modular design can allow for future flexibility to accommodate changes from the present design.<br/><br/> We are experienced in transforming a process design concept into fully operational and tested process modules, ensuring that equipment is delivered on time and meets all customer requirements. Our modular approach also extends to utility systems, such as pumping/cooling/heating skids for WFI and purified water systems.<br/><br/> Our modular system designs include:<br/><br/> <ul> <li>Fermentors and bioreactors <li>CIP / SIP systems <li>Media and buffer prep systems <li>Bio-waste inactivation and neutralisation systems <li>Chromatography systems <li>Filtration and purification systems <li>Custom blending and formulation units <li>High-purity stainless-steel tanks and vessels <li>Compendial water systems</li> </ul>

Evaluation of production facilities can be a challenge, balancing cost, expandability, flexibility, compliance and operability, with key areas of uncertainty in support systems and root utilities. Amec Foster Wheeler has significant experience with simulation, process simulation and optimisation tools. Our goal is to identify constraints/gaps, optimise capacity, and reduce cost while designing for flexibility. This allows us to identify opportunities to increase production while minimising the cost impact.<br/><br/> Our simulation engineers are well-schooled in the delivery of alternative scenarios and ideas for staged implementation, which gives you a truly in-depth evaluation of the alternatives as part of a robust decision-making process.<br/><br/> A focused simulation effort adds visible value at all levels, whether it’s addressing a CFO’s concerns over supply chain issues, supporting the plant manager with anticipated capacity increases and a shortage of high-purity water, or just to evaluate the possible bottlenecks in a unit operation.<br/><br/> An exercise of process optimisation early in the project pays instant dividends, as known and unknown concerns and issues are raised and resolved before the design proceeds too far.<br/><br/> A dedicated Amec Foster Wheeler simulation team, working in partnership with our clients, provides the best recipe for optimisation success.

There is an environmental aspect to just about every project that we execute, whether it’s at the concept, FEED or EPC phase. We work closely with our people, clients, partners, suppliers and contractors to ensure that we work in an environmentally responsible way.<br/><br/> As well as providing a service which integrates the environmental component as part of the overall project, we also apply our environmental expertise in many other ways.<br/><br/> These include addressing the environmental performance of our offices, helping to protect the natural environment, important artefacts or local wildlife around project sites, working with clients to increase energy efficiency or energy integration, providing specialist environmental consultancy or remediation services, or working with our clients on exciting new technology solutions.<br/><br/> Here are just a few examples of our expertise at work:<br/><br/> <ul> <li>We have leading expertise in the increasingly important areas of water management and waste water treatment <li>We work with clients to increase the energy efficiency of their facilities <li>We are at the forefront of the application of continuous processing in the pharma industry <li>We have LEED-accredited professionals and support our clients to achieve LEED certification</li> </ul>

The industry recognises that CIP and SIP do not begin and end with a CIP system and clean steam distribution. Cleanability and sterility need to be engineered into your process at the start of design to be effective and validatable. If designed correctly, CIP is not a system: it is a methodology that permeates throughout and is integrated into your process.<br/><br/> Time-Action-Chemistry-Temperature principles (TACT) have to be evaluated upfront with specific reference to each product/system so to address cleaning requirements in the design stage and assure efficient cleaning validation.<br/><br/> We have the expertise to implement the optimal CIP/SIP philosophy tailored to a client's process and facility. Our engineers are experts in all facets of CIP/SIP design, from concept through detailed design, automation, installation, start-up, qualification and validation, utilities availability, equipment capacity. Our engineers design CIP systems that cover the spectrum: portable and fixed systems, one tank, two tank, multiple, and even no-tank systems, and centralised CIP systems. We have implemented SIP philosophies to meet your needs, whether the goal is sterilisation, sanitisation, or bioburden reduction.

The lifeblood of every production facility is the critical utilities that feed its operations. The generation, storage, and distribution of critical utilities are just as important to the success of our customers’ facility as the process itself. The optimisation, design, installation, and validation of clean steam, WFI, purified water, and clean compressed gas systems each present complex challenges that we are uniquely positioned to solve.<br/><br/> We have years of experience in every aspect of critical utility design:<br/><br/> <ul> <li>Utility sizing and distribution schematics and simulations <li>P&ID development and purchase specifications <li>Generation and execution of commissioning and qualification protocols <li>Start-up and maintenance support <li>Evaluation and troubleshooting of installed critical systems</li> </ul><br/> We design, build, optimise, and validate all our clients’ critical systems to help ensure their process and product are never jeopardised.

Batch production costs are rising as more sophisticated molecules are demanded by the market. These molecules are expensive but needed in smaller quantities: plants need to have greater manufacturing flexibility and reduced inventory.<br/><br/> Continuous processing can provide the answer and open the road to patient-centred customised healthcare. Amec Foster Wheeler occupies a unique place amongst worldwide design firms in being able to offer real project execution experience in this new technology area. We have people and tools to help our clients realise the opportunities offered by continuous processing.<br/><br/> Our recent experiences show that early involvement in a project by our specialists pays big dividends in the final project investment cost. We have been involved in laboratory R&D studies, consultancy, front-end designs, engineering, procurement, construction management and validation, safely delivering successful projects for our customers.<br/><br/> Our team can deliver the advantages of continuous processing to our customers’ projects, and help them decide what is exactly right for their business by:<br/><br/> <ul> <li>Identifying continuous processing opportunities <li>Helping develop the business case for continuous processing <li>Providing specialist capability to convert batch to continuous processing <li>Sharing experiences in many other industries to maximise synergistic interactions</li> </ul>

When research shows that 90% of manufacturing inefficiencies are locked in during development, then maximising the efficiency of process development is essential to accelerate time to market, rapidly ramp up to production, enhance acceptance of new products and develop a stronger economic position.<br/><br/>We have been at the forefront of the application of the Lean approach to pharma manufacturing, focusing on achieving ‘design for manufacture’, where a lab process can be scaled up to pilot- and full-scale production without the waste-ridden scale-up iterations often currently required at each stage.<br/><br/>Lean thinking can be applied to many areas of pharma development and manufacturing to gain significant benefit. However, some pharmaceutical operating practices are inherently so far removed from the basic Lean principles, that the full benefit of Lean Thinking will only be achieved by radically changing the whole operational practice.

Our process engineers, project managers, planners, and CQV specialists are fully experienced in applying modular concepts to respond to a project’s schedule-driven needs with:<br/><br/> <ul> <li>Parallel construction efforts with regards to civil structural construction of the building <li>Decreased field commissioning and qualification time <li>Combining subject-matter experts with skilled labour availability <li>Higher respect of safety and quality goals and standards <li>Confirmed footprint <li>Standardised design</li> </ul><br/> Amec Foster Wheeler can ensure that the process equipment is fit for purpose within the facility space constraints in a 3D design environment. Our engineers possess a knowledge of the biopharmaceutical equipment supply chain and can tailor any project and program to meet the cost and schedule demands of our customers’ projects.

Wherever significant amounts of organic solvents are used for a pharmaceutical process, it is important not only to focus on the safety aspects, but on the minimisation of the environmental implications and the associated costs.<br/><br/> Disposal by incineration, previously the only strategy adopted by pharmaceutical firms on the basis of claimed cross-contamination concerns, can no longer be considered the default approach.<br/><br/> Taking advantage of technological competencies based on our deep knowledge of state-of-the-art commercial simulation tools (e.g. Aspen HYSIS®, Invensys PRO/II®), we can provide our clients with reliable engineered alternative solutions, based, for example, on batch distillation technology.<br/><br/> This allows comparative analysis of different approaches, aimed at achieving cost-effective and environmentally friendly installations, while meeting quality and regulatory expectations.<br/><br/> We deliver benefits for our clients, including:<br/><br/> <ul> <li>Use of sophisticated tools with in-depth hands-on knowledge and competence <li>Improved plant sustainability and safe-guarded public image <li>Reduced facility running costs <li>Provision of physical parameters to validate and control solvent quality</li> </ul>

Lab design covers a wide variety of typologies depending on the activities to be designed for, from drugs discovery and development, to final drugs testing before release to market, from process development to troubleshooting support to manufacturing, with substantially different needs in terms of flexibility and GMP compliance.<br/><br/> Therefore, it is crucial to understand each lab’s requirements and to identify final users’ activities and needs, in order to design labs that are fit for purpose.<br/><br/> Amec Foster Wheeler can provide process and engineering experience as well as execution capability to help our customers develop flexible and lean labs, fully compliant with applicable GLP/GMP requirements and HSE aspects.<br/><br/> We develop effective solutions for different labs types:<br/><br/> <ul> <li>Quality control, including microbiology, analytical, vaccine potency testing, bioassay <li>R&D, including bench scale and pilot scale plants, in-vivo and in-vitro clinical trials testing <li>Manufacturing science and technology, including process transfer, troubleshooting and process optimisation</li> </ul>

Optimisation of plant availability and focus on the life cycle cost through RAM studies have become key drivers when designing new facilities.<br/><br/> Amec Foster Wheeler can apply these RAM studies to pharmaceutical processes, with the main purpose of identifying the main contributors to the forced downtime, loss of valuable product or safety critical equipment, allowing to identify at an early project phase if re-design is required or if different mitigation actions should be considered to increase the availability/safety of the system.<br/><br/> Analyses are performed on the entire pharmaceutical facilities, including the process units, the clean utilities and the black utilities.<br/><br/> We can perform different type of analysis depending on needs: Reliability block diagram development and RAM analysis, failure effect analysis and equipment criticality analysis.

Amec Foster Wheeler has in-depth experience and expertise in the use of building information modelling (BIM) and 3D modelling, for the complete success of a project.<br/><br/> BIM is a process, not an application. It is based around models used for the planning, design, construction and management of building and infrastructure projects faster, more economically and with less environmental impact. BIM models are different from CAD drawings that may be 2D or even 3D. BIM models are made up of intelligent objects that can stay updated throughout the design, no matter who is working on it. The key word in BIM is Information. <br/><br/> Designing and building a pharmaceutical plant is a very challenging task. Creating a virtual 3D model from the very beginning is essential to respect the schedule, the cost of the project and to facilitate client review, including final users and operators.<br/><br/> Amec Foster Wheeler can model every system in the building: REVIT is used for architectural and pharma finishing, TEKLA for structural design, and Smart 3D or E3D/PDMS for all the engineering disciplines. We have tools and experience to prevent and solve interferences during design phases, thus to avoid clashes during construction.

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