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FOSTER WHEELERS PHARMACEUTICALS BUSINESS MAGAZINE AUTUMN 2005

Right People, Right Expertise

6 LEAN THINKING 14 SPOTLIGHT ON EUROPE 26 SATISFIED CLIENTS

PHARMACEUTICALS - BIOTECHNOLOGY - HEALTHCARE

Delivering quality facilities world-wide

As principal contractor for the fast-track, innovative Teesside facility, Foster Wheeler congratulates Lundbeck on reaching the final of the inaugural Facility of the Year Award
Master Planning Concept Design Basic Design Engineering Construction Commissioning Validation
Global Support: Basel Cork Dublin Istanbul Madrid Milan New Jersey Paris Puerto Rico Reading Shanghai Singapore Tokyo

fw_pharma@fwc.com

www.fwc.com

AU T U M N 2 0 0 5

CONTENTS

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5 6-8 9 10 11

Swiss innovation in high containment Lean thinking in the pharmaceutical industry Continuous processing Britest - Sue Fleet talks about its strengths and successes ISPE - taking the industry forward

12-13 Risk-based approaches - the impact on qualification

Published by Foster Wheeler Shinfield Park Reading Berkshire RG2 9FW UK www.fwc.com Managing Editors Carolyn Greenhalgh Director, Corporate Communications & Global Marketing T 0118 913 2494 E carolyn_greenhalgh@fwuk.fwc.com Jacqueline Hogarty Marketing Consultant T 0118 913 2167 E jacqueline_hogarty@fwuk.fwc.com Produced by FW Graphics Group Foster Wheeler

14-17 Spotlight on Europe 18-19 Global round-up - recent wins 20-21 PAT - transforming pharmaceutical manufacturing 22-27 Project highlights - Ireland, UK, Hungary, Singapore, Turkey 28-29 FW people and events 30 31 Singapore safety accolade Steril - experts in containment

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foreword Our commitment to pharmaceuticals

The pressures faced by the pharmaceutical, biotechnology and healthcare industries require us constantly to innovate, both in terms of the facilities we design and in the way in which we deliver our services.

Having recently been appointed to lead Foster Wheelers Global Engineering and Construction Group, I am delighted to introduce this latest edition of focus. This magazine enables us to communicate directly with our core pharmaceuticals, biotechnology and healthcare customers. In this issue, you can read about some of our current projects and how we are overcoming the engineering and construction challenges posed. What strikes me is the tremendous variety of projects in which we are involved, in terms of size, complexity and location. But these projects all share two key features: our focus on HSE and on quality. Nowhere is this expertise better illustrated than in the project we completed for Lundbeck in the UK; we were delighted that this facility was selected as a finalist in the inaugural Facility of the Year Award. I am also proud to announce that this year Singapores Ministry of Manpower has presented us with our sixth OSH Excellence Award, this time for our performance in completing Schering-Ploughs MPP2 project. We remain the only E&C contractor ever to have received this award.

We continue to invest in our people recruiting, training and developing our teams. The result is a group of skilled technical specialists recognized by the industry as leaders in their fields. They respond by sharing their knowledge and experience with the wider community delivering papers, chairing conferences, organizing seminars, conducting training sessions and participating in the leadership of the organizations that shape our industry. Over the years we have also contributed to key technical developments, such as the installation of fully-automated and isolated large throughput lyophilizer loading and unloading, the application of large-scale simulated moving bed chromatography technology in API manufacture, high containment milling and tabletting, to name but a few. We have also been innovative in the application of our project delivery services, from the widespread use of off-site fabrication and modularization to the application of plug and play techniques. This is a core business for Foster Wheeler and I believe we have the right people with the right skills, attitude and commitment to exceed the expectations of our pharmaceutical clients. Umberto della Sala CEO, Global Engineering and Construction Group

Umberto della Sala

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innovation Swiss innovation

in high containment
Metalor Technologies SA, the Swiss precious metals specialist based at Lake Neuchtel in Switzerland, created its pharmaceuticals business unit in 2003. In 2004, Metalor awarded Foster Wheelers Basel operation the extended conceptual design for a small-scale API facility for highly potent cytostatic products.
This is a highly innovative project with the whole nonaseptic production taking place inside one isolator divided into five chambers (pressure cascading), with an OEL of <0.5 microgram/m3 and a particle count of ISO 5. The main process equipment consists of two 100-litre glass reactors, one stirred vessel for solution preparation, one pressure filter and one tray dryer, with interconnections by hoses or PVDF piping, all with Tri-clamp flanges. Unlike most isolators, which are generally rectangular, this model has a flat T-form so the entire reactor, including legs, could be placed inside. This reduces any sealing requirements to a minimum. The isolator is positioned in the middle of room rather than at the periphery and has windows and gloves fitted at the back, improving view and access to equipment parts. The wall separating the production and technical areas has windows, so that operators can perform checks without leaving the production area, and visitors can see most of the facility without entering. Following the success of the conceptual design, Metalor has awarded Foster Wheeler Basel the basic and detailed design and qualification of this exciting project.
Marco Mascarenhas Manager, Bulk Pharmaceutical Chemicals Foster Wheeler

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IMPROVING PRODUCTION EFFICIENCY

Lean Thinking -

a $US 90 billion opportunity

The potential world-wide annual cost saving from production efficiency improvement in the pharmaceutical industry is suggested to be as high as $US 90 billion - equivalent to developing 80-90 new drugs every year.
This dramatic conclusion of the recent FDA White Paper Innovation and Continuous Improvement in Pharmaceutical Manufacturing contrasts starkly with the mindset in some areas of the pharma industry that manufacturing, and in some cases development, is no longer a core strategic competency.
Huw Thomas Senior Pharmaceutical Engineer

Waste is the Opposite of Value

The multiple tools and methodologies used to apply Lean Thinking are underpinned by a number of core principles. The central theme of Lean Thinking is the elimination of muda (or waste). Taiichi Ohno, creator of the Toyota Production System, originally described seven sources of waste, and four additional sources have since been added to his original list.

When research shows that 90% of manufacturing inefficiencies are locked in during development, then maximizing 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. In discussing modern approaches to manufacturing and quality systems, the FDA White Paper draws heavily on Lean Thinking that has been implemented for many decades in other manufacturing industries. Foster Wheelers Huw Thomas, senior pharmaceutical engineer, presents his opinions based on innovative work carried out at Foster Wheeler and on his experience of using Lean tools in process development and secondary pharmaceutical manufacturing.

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Inappropriate Processing: an example Despite the yield loss (muda) of material in the mother liquor, it is often justified to use crystallization to isolate solid intermediate in API manufacturing on the grounds of purifying the stream prior to the next reaction stage. This is an example of a non-value-adding activity which is unavoidable with present technologies or methods. Taking a wider view of waste would mean adopting new technology, such as optimizing the upstream reactor design and operation to minimize the impurity generation, eliminating the need to use crystallization for intermediate purification.

The comparison reveals that assembly of the API molecule is orders of magnitude less complex than automotive assembly, particularly when considering mixed-model production versus multi-product plants. Conversely, automotive assembly is orders of magnitude more efficient in terms of process capability and cost of manufacturing defects. This difference is down to two fundamental factors: The in-depth scientific understanding of the effect on the final product of changes in the manufacturing process. The manufacturing process is designed with minimal possible variability, hence creating minimum variability of the finished product. This inherent design for manufacture is impossible to achieve without the scientific understanding.

Pharma is Different Its Easier than Building Cars!

Some people think that the Lean approach will not work because pharma is different, more complex and more regulated than other industries. Whilst this may be true, even a quick overview of recent regulatory thinking shows that the pharma industry has moved towards the systematic, science-based approach that Lean Thinking requires. The table below compares the manufacturing complexity of API manufacturing with automotive manufacturing.
Measurable Number of components per product Component variation Automotive Assembly >10,000 API Production Line typically <10 (number of reagents and raw materials that create product molecules) None in component but some wrong components (impurities) (each reagent molecule component is identical) Pump

Benefits of Applying Lean Thinking During Development

The use of Lean product development systems has been shown to deliver benefits compared with non-Lean systems: Time to market reduced by 30% or more Product cost reduced by 50% Development hours reduced by 45% Development time reduced by 24% 46% reduction in project team size Three-fold reduction in delayed products Product achieves normal quality eight times faster

Each item has multiple degrees of variation (every specification has an associated tolerance) 6 axis handling required(complex transport and assembly process additional source of variation) Physical assembly required degree of variation

Transport

These benefits can be realized in pharma development by 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. contd over >>

Assembly

Self-assembly (variation in assembly process leads to incorrect assembly) 4-5o(poor manufacturing quality despite low complexity) 20-25% (poor manufacturing quality despite low complexity) Dedicated or <5 for MPP (very poor at multi-product production, significant downtime between products)

Process capability

4-5o(high manufacturing quality for complex operation) 2-8%

Cost of poor quality

Multi-purpose plant

>20,000 options (BMW Mini) (production system handles vast range of products mixed model production)

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leanthinking
IMPROVING PRODUCTION EFFICIENCY Lean API Manufacturing
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. One example is API manufacture, where plants are typically operated on a batch campaign basis. A plant is configured and operated for a single stage of processing, before being cleaned and reconfigured to carry out the next processing stage. All material produced in the first stage campaign is isolated, dried and packed off for storage before being fed back into the plant during the next stage campaign. This mode of operation is anathema to the Lean principle of flow, and locks in vast quantities of waste into the operating cycle. The overall operating cycle of converting raw material into finished products may take many months or even years. Whilst these factors are specific to this plant, data from multiple sources indicates that over 40% of processes are inherently suitable for continuous operation. Achieving the above economic benefits for this proportion of processes represents an enormous economic improvement over current performance.

The Lean Future

The pharmaceutical industry can no longer support the waste that has become locked into the manufacturing sector by the current operating model. As the FDA states, the potential annual cost savings from efficient product development and manufacture outweigh the cost of bringing new products to market. Many other industries have experienced this wake-up call, and many of the companies in these industries have taken on board Lean Thinking and have transformed their businesses to survive in the new economic era. Given the current economic and regulatory pressures, Lean Thinking offers a well-proven model to achieve the order of magnitude improvements in development and manufacturing performance that are now being demanded.

A Lean Case Study

Because API manufacturing is such a massive source of waste, Foster Wheeler carried out a paper case study where a recent multi-stage batch plant of under 10 tonnes per year capacity was re-designed following the Lean principles at every stage. The fundamental Lean Thinking principles used were: 1 Science-based approach: Chemistry assessed for its suitability to convert to continuous operation. 2 Making value flow: Given that the chemistry was inherently suited for continuous operation, the whole process was configured to flow from raw material to finished product in a single, integrated process. 3 Quality from a customers perspective: Delivery of final product in a form suitable for direct formulation without further physical processing such as milling. The summary of the findings of this study are: Throughput: CAPEX: OPEX: Raw material to finished product in <1 day >60% reduction in capital cost Up to 40-fold reduction in utility requirements

Pharma i
This article is adapted from a paper, available on our website, Transforming the Pharma Industry: Lean Thinking Applied To Pharmaceutical Manufacturing presented by Huw Thomas at the 7th World Congress of Chemical Engineering, held in Glasgow in July 2005. A copy of Huws article The Reality of Small Scale Continuous Processing (basis of article published Manufacturing Chemist, April 2005), is also on our website.

Environment Impact: >80% reduction in plant footprint >7-fold reduction in total effluent >100-fold solvent inventory reduction Health and Safety: Elimination of multiple high-containment operator interfaces

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continuousprocessing
INNOVATIVE TUBULAR STATIC MIXER REACTORS

Choosing the right reactor for the job

Foster Wheeler engineers are always keen to analyse new process problems and offer ideas and innovative design solutions. Mark Dickson, one of our specialist pharmaceutical process engineers, reviews some of the work he has done recently to develop tubular static mixers for API manufacture.
Photo courtesy of Sulzer Chemtech

Chemical reactor design is the cornerstone of any process. Britest and process intensification principles aim towards a process reactor that provides ideal kinetic and thermal conditions for the chemistry, which is difficult to achieve in a batch reactor due to the inherent heat and mass transfer limitations. The ability of a continuous reactor to offer more uniform conditions, whilst providing a narrow residence time distribution, improves reaction yield in compact and intensified equipment, with dramatic impact on layout and capital cost. There are numerous reactor options available for continuous processing in the pharmaceutical and fine chemical industries. For example, the highly intensified Marbond and spinning disc reactors offer excellent heat transfer for short residence time reactions, and oscillatory flow reactors have been proven in single and multi-phase systems and for longer residence time reactions with low exotherms. For moderately exothermic reactions, a jacketed static mixer has the advantages of effective heat transfer, excellent approach to plug flow at low velocity, and relatively low pressure drop, making it a low-cost option for lab development as well as full scale production. Foster Wheeler has experience of designing static mixer-based reactors to provide a variety of reaction residence times from 1 to 60 minutes in compact reactors less than 10" in diameter and 1 meter in length. This type of reactor can produce plug flow at very low flow rates. Novel equipment designs also ensure the process fluid is always in contact with a cooled surface, which maintains the reactants at the optimum reaction temperature. We combine knowledge of continuous processing with innovative ideas for modelling heat and mass transfer performance of new reactor designs. In addition, static mixer-based equipment can also be used for multiphase reactions and we can provide innovative engineering solutions in the configuration of reactors for multi-stage synthesis.

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britest
DELIVERING REAL BENEFITS
Q: Do you see further potential in the Britest approach? A: Undoubtedly. Success has served to provide a greater understanding of the opportunities available and point the way to the prospect of transformational change in business performance to much greater levels of economic and environmental sustainability. Britest members believe this is achievable but recognize it will require congruent progress in a number of areas and the involvement of whole supply chains. This ambitious venture requires extensive collaboration and the combination of many different skills and experiences. Q: Do you plan to extend Britests reach? A: Yes, for the reasons I have already described, Britest is extending its networks and activities into the rest of Europe. An early example of this is the IMPULSE (Integrated Multiscale Process Units with Locally Structured Elements) project, funded under the EU Framework VI programme. Britest was heavily involved in the shaping of this project; Britests Jeremy Double leads part of one of the work packages and I currently chair the governing body. As part of the UK Innovation Task Force, Britest is providing input to a draft European Technology Platform for Sustainable Chemistry which is a joint initiative co-sponsored by the European Chemical Industry Council (CEFIC), EuropaBio, and the European Commissions Directorate General Research. The draft has identified reaction and process design as one of three technology sub-platforms. Q: In a nutshell, how would you summarize Britests strengths and successes? A: The strength of Britest is the quality and sustained commitment of the membership and the ongoing delivery of real benefits to all the members. Britest is looking to extend membership to other groupings with similar interests and commitment. Brian Murphy, MD of Robinson Brothers Ltd and chairman of Britest, is also chairman of the Innovation Sub-Group of the recently founded CEFIC European Fine Chemicals Group. He notes that this sub-group is trying to promote greater collaboration amongst its membership across Europe - Britest is an excellent example on which to build.

As an active member of Britest, Foster Wheeler has been able to demonstrate the benefits of applying the Britest tools and methodology in developing processes that offer the potential for dramatic capital and operating cost savings. Here, focus talks to Sue Fleet, CEO of Britest, who describes the background to the formation and growth of the organization.
Sue Fleet CEO, Britest

Q: Sue, how did Britest begin? A: Britest began in 1998 when a group of leading companies in the fine chemical and pharmaceutical fields, together with a team of academics, produced a proposal to develop radical new methodology for manufacturing in these sectors. The task was challenging: to apply fundamental thinking in a novel way. Q: What was the result of this research? A: This research generated a set of innovative techniques and methods, the start of the Britest toolkit, to analyze a process and show where and how major improvements might be possible. Britest Limited was set up as a notfor-profit small company to manage the members interests and to retain intellectual property on behalf of all members. Q: How did you develop and share this Britest toolkit? A: Britest gave technology transfer a strong focus, applying Britest tools and methods to real problems in member companies: testing, revising and extending the techniques, training staff and using highly qualified technology translators and academics. Through these experiences and further research, the Britest toolkit is evolving to become a comprehensive methodology. It encompasses better process chemistry, innovative manufacturing technology, such as new process intensification equipment, new plant concepts and the business case for change - all driven by customer and product requirements. Q: Can you quantify the results? A: Our industrial members have been able to demonstrate capital and operating cost savings well in excess of 50 million and are embedding the Britest tools into their own business processes.

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ispe
TAKING THE INDUSTRY FORWARD ISPEs role at the interface between regulators, manufacturers, equipment suppliers and service providers is well recognized. The societys work at the leading edge of the industry in bringing together interested groups and helping to formulate policy and drive innovation is equally respected. Foster Wheeler sees these efforts as crucial in taking pharmaceutical manufacture into the 21st Century and is committed to supporting ISPE and taking an active role in many aspects of ISPEs work. Baseline Guides
Created in partnership with the US Food and Drug Administration (FDA), the Baseline Pharmaceutical Engineering Guides offer practical answers to the complex, dynamic challenges facing facility designers today. In addition to providing an understanding of products and processes, they also offer an outline of architectural and utility systems needed to meet government requirements. They address GMP and non-GMP regulations and detail facility commissioning and qualification. Foster Wheeler has played a significant role in developing the guides: Maintenance Guide - Pietro Orombelli is joint leader Oral Solid Dosage Guide - Austin Lock is joint leader Dennis Fortune is involved in the layout chapters of both the Oral Solid Dosage and Bulk Pharmaceutical Chemicals Guides, and previously the Sterile Manufacturing Guide John Nichols sits on the Bulk Pharmaceuticals Chemicals Steering Committee Bob Adamson was very much involved with the Commissioning and Qualification Guide

Communities of Practice
ISPEs initiative to form Communities of Practice (CoPs) is now starting to gather momentum, but what are they? CoPs are groups of people who share a concern, a set of problems, or a passion about a topic, and who deepen their knowledge and expertise by interaction. Currently ISPE has CoPs in various stages of incubation on: Active Pharmaceutical Ingredients (API) Biotechnology Clinical Materials Commissioning and Qualification (C&Q) Good Automated Manufacturing Practice (GAMP) Process Analytical Technology (PAT) Process/Product Development Project Management Sterile Products Processing John Nichols represents Foster Wheeler on the overall CoP subcommittee and the steering group of the API CoP , he is also an International Board Director of ISPE. Bob Adamson is committee member on the C&Q CoP . To date all the effort has gone into planning the CoPs, but by November you will see a much wider roll-out of the leading communities.

Education and Training

The ISPE European Education Committees role is to organize and supervize execution of the current and future European program of education seminars and training courses. Again, Foster Wheeler is fully involved, with John Nichols a committee member and past chairman. John also acts as a trainer for ISPE on its Containment Fundamentals training course, and Bob Adamson trains on the C&Q course.

Facility of the Year

Last year, ISPE, in association with Reed Exhibitions and Pharmaceutical Processing magazine, instituted the Facility of the Year Award in order to identify, recognize and promote innovation in the pharmaceutical industry. Clive Mullins serves on the Facility of the Year Award Task Team which oversees the organization of the event.

Pharma i
For other ISPE information see pages 28 and 29

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riskbasedapproaches
THE IMPACT ON QUALIFICATION

Drivers for Change

Recent regulatory developments and industry trends are stimulating an increased focus on the application of scienceand risk-based practices to qualification management. Total validation costs for projects are still reported to be as high as 20% of the total installed cost - industry continues to challenge these costs. The development of the 21st Century Risk-Based Initiative by the US Federal Drug Administration (FDA) has opened the door for industry to work with the regulator and to seek cost reduction strategies that still meet regulatory expectations. Bob Adamson, Foster Wheeler's manager of pharmaceutical compliance, discusses the changes. What is Risk?
Is it risk assessment, or risk management? There are a variety of definitions and two are proposed: Risk management is a systematic process for the identification, assessment, control and communication of risks to life, property or valued objects. Risk assessment is not a single process but a systematic approach to organizing and analyzing scientific knowledge and information that supports a risk decision.

What are the Risks?

Risks in drug development, manufacture and use are inherent in: the drug itself and its known side-effects the delivery systems and method of delivery manufacturing defects; the area in which we, as engineers and designers, can have an impact Risk management can be viewed as a tiered hierarchy of levels of risk methodologies for implementation. The higher levels are driven by principles and involve examining risk by ranking and filtering techniques. Lower down are quantitative methods such as failure modes effects analysis (FMEA), root cause analysis, event tree and fault tree analysis, which involve assessing the likelihood of the event occurring. Sources of risk can be identified and associated with the product and can be examined and related to process activities, identifying critical steps, critical control points and associated parameters which can then be linked directly to activities in the manufacturing process that need to be controlled by the application of good engineering practice and good science. FMEA FMEA is a systematic process for identifying potential design and process failures before they occur, with the intent to eliminate them or minimize the risk associated with them. The technique was used as early as 1949 in a military standard. Many pharmaceutical companies are now using this approach for their computerized systems to determine where to focus their validation resource. It also provides a documented process for recording the decisions and so provides proof of review to offer to regulatory bodies. The GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacture follows a simplified FMEA approach to assign a risk class.

Bob Adamson

Regulatory Expectations
There has been much regulatory activity in the past two or three years that has addressed the topic of risk. At the forefront has been the FDA with its new approach initiatives. These focus on understanding the process, identifying critical steps, improving consistency in regulatory activities, and bringing risk-based strategy into the inspection program. In promoting this program, the FDA has already implemented a number of activities or actions and issued various guidance documents.

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Impact Spectrum The ISPE Commissioning and Qualification Guide introduces the concept of determining whether a system has an impact on product quality, illustrated by the Impact Spectrum. The Guide follows a simple methodology that is familiar to engineers, dividing the facility into systems, assessed against a predetermined set of criteria in order to ascertain any effect on product quality. Further assessments at the component level in the system identify whether the component is critical. Systems are determined to be either direct impact, indirect impact or no impact, with direct impact systems being qualified and indirect or no impact systems executed to good engineering practice.

Risk Areas for a Drug Product

Implications of Risk-Based Approaches

Risks can affect both the enterprise and the project. Risks to GAMP can occur at any stage, even as early as the bid proposal phase, or as late as the commissioning and qualification itself. Typical examples can occur in: Planning - where in the worst case there is none or too little Schedule - inadequate time is allowed for qualification; projects in the industry are often highly schedule-driven with a focus on mechanical completion rather than the actual qualified facility Design - poor specification of qualification requirements at the design stage Regulatory change - failure to plan for changes or unexpected change by the regulators Budgetary - failure to make adequate allowance for qualification expenditure The Commissioning & Qualification Guide addresses some of these issues. It defines the extent of qualification through the impact assessment process, involves QA in the process and defines methodologies in SOPs, change control, protocols, etc. A common example in the design process is the timely delivery and quality of supplier documentation. The new approach to qualification places greater reliance on supporting documentation and avoiding testing repetition. Another example is well-defined user requirements, which form the basis of testing in the latter stages of qualification. Ill-defined user requirements lead to test acceptance criteria that are too often inappropriate for final qualification.

Sources of Risk

Cost and Quality

Frequently, theres a failure to recognize the relationship between cost, quality and schedule. Taking account of the risks to quality and validation at the start of a project allows us to understand the impact of change. We can plan to mitigate or eliminate risk factors; failure to do so results in transfer of risk to the end of the project, where the cost of change and rectification may be an order of magnitude larger.

Right First Time

In summary, we manage risk by understanding products and processes and using the tools available. Regulatory bodies are expecting science-based decisions using risk management approaches and the FDA has fully embraced risk. We need to be right first time - failure to manage risk to quality will lead to increased cost, schedule delays and poor quality.

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Continental

Europe
Driven by innovation, the pharmaceutical industry is one of Europes best performing high-technology growth sectors, its R&D expenditure amounting to 15% of the total R&D investment in Europe. The European Union has recently announced a package of measures aimed at increasing spending on fundamental research, developing relevant skills and enhancing the pharmaceutical industrys competitiveness.

A MAJOR REGION FOR PHARMACEUTICALS Europe represents the second-largest global pharmaceutical market after the US, a major R&D center for the industry and home to 5 of the top 10 global research-based manufacturers. In 2004, the total European market generated revenues of about US$ 163 billion, with growth at around 8% per annum leading to an anticipated level of US$ 260 billion in 2010. Here f ocus features continental Europe; the UK and Ireland will be covered in a future issue.

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Global pharmaceutical market by region 2004

Other Latin America 3.1% 3.8% India/China 4.6% Japan 11.1%

NEW APPOINTMENTS

North America 47.8%

Europe 29.6%
Source: The Economist; IMS Health

The leading research-based pharmaceutical companies

Company Pfizer GlaxoSmithKline Sanofi-Aventis Johnson & Johnson Merck Novartis AstraZeneca Roche Bristol-Myers Squibb Wyeth 2004 Sales($bn) 51.1 32.8 27.4 24.7 23.9 22.9 21.7 17.8 15.6 14.3

Source: The Economist; IMS Health; Thomson Datastream

Particular market growth is evident in generics, responding to constant government pressure to reduce healthcare spending and fuelled by the steady stream of prescription drugs coming off patent. European companies are also expanding in biopharmaceuticals, which currently constitute around 8% of the world drug market but where growth is almost double that of chemically-synthesized products. The recent expansion of the EU has led to significant growth potential in pharmaceuticals. Growth in product sales in the new member states at 16.5% per annum is outstripping the 8% level in the former 15 member states. These new EU countries (especially Poland and Hungary, which have established pharmaceutical industries) are expected to make significant long-term investments in order to improve healthcare infrastructure and match EU regulatory standards.

Central and Eastern European markets are becoming important for both western European and US pharmaceutical companies vying for market share in a more difficult global operating environment. Major pharmaceutical markets in the Czech Republic, Poland and Hungary, followed by the smaller markets of Slovenia, Slovakia and Bulgaria, are expected to see considerable growth over the next decade. The major European locations for research-based manufacturers are Germany, France and Switzerland, with Italy and Spain showing growth potential in the generic sector; Italy in particular, due to its advantageous patent regime. This growth, combined with manufacturers increasing propensity to outsource more complex logistics functions, will stimulate an outsourcing trend. So, the future of the European pharmaceutical industry looks strong, with trends towards an improved R&D environment and increasing levels of manufacture, especially in the east.

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regionalfocus
FOSTER WHEELER IN CEU
BASEL
One of Switzerlands greatest strengths is innovation, with biotechnology and genetic engineering considered emerging growth areas. Foster Wheelers Basel office, in operation since 1997, is well-placed to support this. Its team of technical specialists has the capability and flexibility to provide a complete range of services to our clients, with additional support available from its experts around the world. Switzerland is the sixth largest chemicals and pharmaceuticals exporter in the world, exporting products worth around SFr 49.4bn (US$ 38.9 billion) in 2004. The chemicals and pharmaceuticals industry is the second most important in Switzerland, with a 3.4% share of GDP .

MILAN

In the last few years, Italy has seen the development of a specialized biotechnology sector which has shown rapid and considerable growth, and Foster Wheeler Milan has been part of this exciting new industry. Foster Wheelers Italian operation is a fully integrated engineering and construction contracting organization, capable of undertaking any type or size of project. Since its launch in 1957, it has designed, engineered and constructed more than 700 projects, including many pharmaceutical plants. Steril, our manufacturing division in Milan, provides a complete range of laminar air flow equipment, isolators and turnkey clean rooms designed to protect operating staff and product from contamination.

PARIS

With Frances pharmaceuticals industry and the French government aiming to develop France as a centre for biotechnology, R&D and pharmaceuticals production over the next three years, Foster Wheelers office in Paris will have plenty of opportunities to play a role in this planned development. Operating in France since the early 1930s Foster Wheeler has grown steadily and has extensive experience in the design and construction of pharmaceutical, life sciences and other industrial installations world-wide.

MADRID

A major attraction for the multinational companies is Spains location, which enables good access to a combination of European and Mediterranean countries. The growth of the pharmaceutical market and an improvement in conditions for R&D have led to increased emphasis being placed on Spain by international and national pharmaceutical companies, and it will remain a key region for the pharmaceutical industry in the future. Foster Wheeler established operations in Madrid in 1965, specializing in the design, procurement, construction and management of pharmaceutical, process and industrial plants. In its 40 years of existence, it has executed many projects for multinational and state-owned companies.

ISTANBUL

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Segmentation of Foster Wheelers European pharmaceutical business

R&D 13% API 20%

Scale of Foster Wheelers European pharmaceutical projects

$50-$100m 6% >$100m 6%

Dose Form 38%

Biotech 29%

$10-$50m 23%

<$10m 65%

Foster Wheelers involvement with the delivery of pharmaceutical facilities, measured by projects completed in the last 10 years

The scale of pharmaceutical facilities delivered by Foster Wheeler, measured by projects completed in the last 10 years

projecthighlights
Serono, Switzerland
Biotechnology Plant This conversion of an existing manufacturing facility into a multipurpose biotechnology bulk manufacturing facility houses laboratories, manufacturing suites, warehousing and administration buildings. Foster Wheeler services included project management, project control, procurement, construction management and validation activities.

Merck Mirabel, France

Product Launch Facility This facility is a state-of-the art combination of process and manufacturing technology, never before attempted on such a vast scale, and was designed from the outset to accommodate a later expansion. Foster Wheeler completed both the initial and expansion projects, overcoming significant operational challenges, including fitting new equipment into a live production unit. Project scope included basic design, procurement, construction, qualification and project management, all completed within budget and schedule.

GlaxoSmithKline, Parma, Italy

FDF project Located within an existing production building, this new state-of-the-art multipurpose freeze-dried injectables and sterile liquid vials plant meets the latest cGMP requirements. The new production area is 1,300 m, and our scope included detailed engineering, procurement, subcontracting and expediting services, construction management, FAT/SAT assistance, and validation.

Eli Lilly, France

Roche, Turkey

Gebze manufacturing facility Designed to comply with local and EU cGMP regulations, this project achieved Roches budget, safety, schedule and quality goals. The new fourstorey plant was connected to an existing, extended, warehouse and incorporated packaging equipment relocated from the existing Roche Turkey factory. We completed basic design in our office in Milan and completed procurement, subcontracting, construction management, commissioning, start-up and qualification in our Istanbul operation.

Fill Finish Facility New grassroots facility for the production, formulation, filling and inspection of cartridges of human insulin. The complex includes a two-storey building with area available for future expansion. Foster Wheeler was the general engineering contractor, producing a site master plan and providing preliminary design, detailed engineering, procurement, construction supervision, project control and validation services.

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fwpharmasuccess
GLOBAL ROUND-UP OF RECENT WINS

Chiron Engineering services Delta Biotech Pilot plant upgrade DSM Engineering services GlaxoSmithKline Facility upgrade OSD containment Novartis Process simulation UK Bristol-Myers Squibb Containment upgrade Ireland Pfizer OSD facility Site master plan
France

J&J Janssen Concept design update Schering-Plough Site master plan Belgium

Confidential Engineering services

USA

Gedeon Richter Site utilities study GlaxoSmithKline R&D facility expansion Sanofi Aventis Clean room Hungary Acraf Angelini Clean room Antibioticos Bulk antibiotics plant Biofer Facility re-qualification Bristol-Myers Squibb Bulk antibiotics plant Site master plan DSM Plant debottlenecking Opocrin Design qualification Bulk plant Pfizer Utilities upgrade Project services Sanofi Aventis R&D facility expansion Schering-Plough Warehouse upgrade Utilities upgrade Teverola Utilities upgrade
Italy

Abbott Validation services Confidential Fill/finish expansion Eli Lilly Validation services Ivax Validation services J&J Cordis Validation services Engineering services J&J McNeill Engineering services Schering-Plough Validation services Engineering services
Puerto Rico

G+P OSD facility Turkey

Category Key
Secondary General Infrastructure Validation API Biotech R&D

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significant wins
Power
Berna Biotech Fill/finish facility Novartis Engineering services Serono Biotech facility expansion Switzerland

Oil & Gas, Power, Refining, Chemicals, Mining & Minerals

Elsewhere in Foster Wheeler we have many successes to report:

New biomass-fuelled power station for SembCorp Utilities, at Wilton, UK Successful inauguration of two power stations for Irelands Electricity Supply Board Biomass-fired bubbling fluidized bed retrofit for Stora Enso Hylte AB in Sweden .... and for Portucel Viana Energia in Portugal Flue gas desulfurization system at American Electric Powers plant in West Virginia, USA

Chemicals and Petrochemicals

Project engineering services contract for JANAs new chemicals facility in Saudi Arabia Project management consultancy services contract for major expansion at Borouges petrochemicals complex in UAE Strategic alliance formed with Methanol Casale to serve the global methanol market
A Bio Pilot plant expansion GlaxoSmithKline Bulk plant upgrade Pilot plant design Singapore

Oil & Gas

Roche OSD facility expansion Indonesia

Leading the JV executing the EPCm contract for a fifth LNG liquefaction train for Woodside in Australia FEED and project management for the major Khurais oilfield development for Saudi Aramco Project management consultancy for GASCOs natural gas liquids project in Abu Dhabi, UAE Engineering services for Chevron Nigerias Escravos gas project Project management services for ONGCs facility to extract petrochemicals feedstock from LNG in India

Refining

Design, engineering and procurement wins for hydrogen plants in Serbia, Russia and Belarus Fuel oil upgrading study for Preem Petroleum AB in Sweden EPC of new delayed coker complex for ENAP in Chile FEED for new coker for BP in Spain

Environmental

Design services for desalination unit in Saudi Arabia for SETE Technical Services Environmental consultancy for Syndial SpA at two of Italys most important sites of national interest EPCm for environmental protection project for Polimeri Europa SpA in Sicily, Italy

Pharma i
See our website for press releases. www.fwc.com

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process analytical technology(pat)

TRANSFORMING PHARMACEUTICAL MANUFACTURING

It is inefficient to run an industrial process in such a way that only a product is produced; a process should be operated so as to produce not only a product but also information on how to improve the product.
US Federal Drug Administration White Paper
Huw Thomas, Foster Wheeler senior pharmaceutical engineer, discusses the FDAs PAT Initiative.

The background
The FDAs PAT Initiative aims to transform pharmaceutical manufacturing by providing the pharmaceutical context to many of the current productivity and quality improvement systems such as Lean Manufacturing and Six Sigma that many other industries have used to revolutionize their manufacturing performance. This systems approach is reflected in the FDA PAT Guidance Document by a desired state, which is a vision of future pharmaceutical development and manufacturing where: product quality and performance are achieved and assured by design of effective and efficient manufacturing processes product specifications are based on mechanistic understanding of how formulation and process factors impact product performance there is an ability to affect continuous improvement and continuous real time assurance of quality

The final point leads to the common misconception that PAT is simply about fitting sensors and analyzers to process plant to generate real-time data in reality the scope of PAT is much wider and deeper than that. The FDA, with ISPE, is moving forward in developing standards for the pharmaceutical industry via ASTM International (originally known as the American Society for Testing and Materials). The first area under development is PAT, via ASTMs E55 committee.

(reprinted, with permission, from E55 PAT Building Blocks presentation, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428).

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What is PAT?
PAT is a system... to enhance understanding to enable design of most efficient, robust, sustainable processes to control the manufacturing process used to meet regulatory requirements for validating and controlling the manufacturing process to identify and explain all critical sources of variation by which variability is reduced and managed by the process by which product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions to give the ability to predict results, reflecting a high degree of process understanding to make continuous improvements from increased understanding

PAT is real-time testing and adjustment, based on a full understanding of how the components affect the final product. It includes chemical, physical, microbiological, mathematical and risk analysis and requires a true understanding of the science and the processes involved. PAT is used to improve processes, using methodologies such as those used by Britest, of which Foster Wheeler is a member. Just as the FDA is drawing inspiration from modern quality management systems developed within other industries, many lessons can be learned from the adaptation of PAT-type systems developed and implemented within other sectors of the process industry.
System Architecture for a Recent Petrochemical Application

How can FW help?

Foster Wheeler has a long history of developing, engineering, installing and commissioning PATtype systems in oil and gas, refining and chemical facilities. The scope of a typical system includes multiple sampler and sensor types, including NIR and UV spectroscopy, on-line chromatography and mass spectrometry; the supporting infrastructure such as sample preparation and transport; the system architecture and data management; and the integration of the PAT systems into the control system, including direct feedback control where required. Many of the pharma PAT application issues have been addressed by other areas of the process industry: time slicing data time stamping data handling quantity of data closing the loop for feed back control validation level of data retained (CFR21 Part 11 does not apply to non-pharmaceutical plants).

In summary
PAT has been demonstrated to have the potential to radically improve the understanding of manufacturing processes. In the words of the FDA White Paper, Is it feasible or prudent to improve the efficiency of processes that are not well understood?

CMMS LIMS DCS AMADAS

Central Maintenance Management System Lab Information Management System Distributed Control System Analyzer Maintenance and Data Acquisition System

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flexiblefacility
MEETING THE CHALLENGE

Takeda
Foster Wheeler, in association with its Irish associate company PM, was awarded the EPC contract for an active pharmaceutical ingredients (API) facility at Grange Castle, Dublin, in December 2002 by Ishikawajima-Harima Heavy Industries Limited (IHI) of Japan. This project, awarded by Takeda Pharma Ireland Ltd to IHI, represents the largest API manufacturing investment to date by Takeda outside Japan. The plant, which has been built on a 20-acre greenfield site, is designed for multipurpose use and initially will produce Takeda's blockbuster type 2 diabetes drug Actos. The high standard of architectural design and landscaping reflects the exacting requirements of South Dublin County Council and the standard

Grange Castle, Ireland

already established by the adjacent Wyeth Biotech facility within Grange Castle Business Park, 10 km west of Dublin. Design and construction was particularly complex: the facility needed to be highly automated to allow minimum operating personnel, and had to permit flexible production operation. To signify compliance with the essential safety requirements of EU Directives, Foster Wheeler has provided Takeda with a CE mark for the completed facility. Construction, which began in January 2003, is now complete. IHI is continuing with qualification and validation activities prior to the final handover of the facility to Takeda.

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Chris Whittle (middle), field engineering manager, FW, with CE plate; Les MacCormick (left), field superintendent, FW and Joe Hayes, field superintendent, PM.

Photos courtesy of Chapman Brown Photography

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worldwideprojects
A STORY OF CLIENT SATISFACTION

A big success for a small team

Pictured are Brian Cole, resident site manager, FW (front row fifth from left), and John Morris, general superintendent, FW (front row second from left), surrounded by some of the construction workforce that numbered around 70 at peak.

We recently completed a very successful project for Merck Sharp & Dohme at its active pharmaceutical ingredient facility at Ponders End in North London.
The central key element of the project is a thermal oxidizer, which has been installed to clean any potential process vapors that would otherwise be discharged to atmosphere. Solvents are an essential ingredient of pharmaceutical manufacture and from now on minor vapor traces will be collected and scrubbed clean of solvents before discharge. Firstly, this has been a very safe project, with no safety accidents or incidents at all. Secondly, the quality of finish was excellent and the project was completed below budget. Last, but by no means least, the project was also fun to build, with a strong team spirit and comradeship between the clients team, Foster Wheeler and the subcontractors. This is reflected in the views stated by some of the team members now that the project is complete, that it will feel like leaving friends and family. The plant will guarantee that Merck Sharp & Dohme is well ahead of potential European Union legislation and continues to be a good neighbour in Ponders End. The small Foster Wheeler team, led by Brian Cole, has again successfully demonstrated that Foster Wheeler puts just as much effort into getting a small project right as it does for large projects. This project was linked to a similar facility built at the same time by Foster Wheelers Paris office for the Merck Sharp and Dohme site at La Valle in France.

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GlaxoSmithKline Biologicals, Hungary

ontrack

New vaccine production facility

- on track for completion
GlaxoSmithKline Biologicals new 3,500 m2 grassroots pharmaceutical facility on an existing site at Gdll, in Hungary, comprises a five-storey building, designed for three totally segregated production facilities. It will produce bulk vaccine for shipment to GlaxoSmithKlines secondary facilities. We commenced basic design in mid-October 2003, opened the site in April 2004 and the target is to complete operational qualification by the end of 2005. Detailed design was carried out in our Milan office with the support of a local Hungarian architect. GlaxoSmithKline Biologicals team was integrated into the task force in Milan and is working closely with our team at site. FDA regulatory requirements have resulted in a very extensive validation effort that will peak in the last quarter 2005. This has been a fast-track project with a significant overlap between design, construction, commissioning and validation activities. One of the main challenges is to ensure a safe environment during construction and commissioning and recently we achieved 500,000 accident-free hours worked at site.

Zoran Serbedzija, project manager.

constructionwithoutdust
Pfizer, Singapore
In September 2004, Foster Wheeler's Singapore operation was engaged to manage the construction of increased hydrogenation capacity by Pfizer Asia Pacific at its plant in Singapore, in order to meet anticipated API demand in 2006/2007.
An extension to the existing 42m high organic synthesis building was constructed to contain the additional equipment, along with piping and electrical tie-ins to services and process systems within the existing building and the off-sites area. One of the biggest challenges for the construction team was to carry out the work within the live building without any impact on the operation of the plant. As well as erecting scaffolds, installing piping, electrics, air conditioning and mechanical ventilation facilities in operating process areas, there was a significant amount of demolition work to be carried out - all without creating dust, undue noise or congestion! This fast-track project met the mechanical completion date of September 2005, and met all safety, schedule, cost and quality goals.

Nick Howells, construction manager.

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worldwideprojects
A STORY OF CLIENT SATISFACTION

Colgate-Palmolive
TURKEY

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peopleprofile
MOVERS AND SHAKERS

UK
John Cumming has been promoted to manager of pharmaceutical engineering in our Reading operation. Johns eight years in the pharmaceutical industry includes positions within engineering, proposals and business development functions. John is a chartered engineer with a degree in chemical and bio-process engineering and a masters degree in business administration.

Around the
UK
ISPE Edinburgh

Bob Adamson, manager of validation compliance in our Reading office, has been made treasurer of the UK Southern affiliate of ISPE where previously he has been secretary, chair and a committee member. Bob, who is a chartered engineer and a chartered chemist, has 36 years experience related to the pharmaceutical industry, with over 20 years working for pharmaceutical manufacturers.

world

Overlooked by a historic castle, this years ISPE Spring European meeting was held in Scotlands capital city, Edinburgh. The well-attended conference, Innovations in Oral Solid Dosage Forms, was co-chaired by Austin Lock, principal consultant and leader of Readings secondary pharmaceutical group. One of the key themes of the seminar was continuous secondary processing and associated technologies, and representatives from GlaxoSmithKline, AstraZeneca and Pfizer all gave presentations. In addition, there were a number of presentations on developing technologies and their applications, such as rapidlydissolving tablet technology, foam granulation technology, new atomization methods and electrostatic dry powder deposition for coating. Capsule processing technology was also featured, with presentations from Encap and Ivax. The regulatory view on key issues in OSD processing and the use of continuous processing for OSD production was provided by the Chief Pharmaceutical Inspector from Sweden. Foster Wheeler was among over 30 service providers and equipment vendors who participated in the table-top exhibition over the four days of the event.

SINGAPORE
Mike Brocklebank, manager of pharmaceuticals in our Singapore operation, has been made president of the Singapore affiliate of ISPE. Mike has a PhD from the University of Wales and is a chartered engineer. His 37 years experience in the pharmaceuticals industry has encompassed many varied roles and includes 13 years working with manufacturers.

UK
Iain Calcott, chief process engineer in our Glasgow operation, is one of the steering committee members for the newly-formed ISPE Scotland Region. Existing members may be aligned to the new region and early indications suggest that such numbers could reach 73! The first event will be held at the Heriott Watt University, Edinburgh in January 2006 and the second at Foster Wheelers offices in Glasgow.

ITALY
In Milan, project manager Pietro Orombelli is vice president of ISPE's Italian chapter. Pietro joined Foster Wheeler's Steril pharmaceutical division in 2000. He has a postgraduate degree in pharmaceutical engineering and has spent the last 12 years working exclusively on projects for the pharmaceutical Industry. Pietro is co-leader of the ISPE Maintenance Baseline group.

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exhibitions&conferences
incident exercise was held at the nearby Pentagon! Nonetheless, inside the meeting venue, the focus was clear. Our table top display was prominent amongst those of more than 50 equipment suppliers and service providers. Clive Mullins and John Nichols, global technology director, participated in a meeting of the Facility of the Year Task Team. The main aim of this meeting was to gather feedback and lessons learned from the success of the inaugural event and apply them to the plans for 2006 and 2007.

Interphex 2005
The Interphex Conference and Exhibition at the Jacob Javits Center in New York City was the venue for the presentation of the inaugural Facility of the Year Award, sponsored by ISPE, Reed Exhibitions and Pharmaceutical Processing magazine. Foster Wheeler was delighted that Lundbeck had been selected as one of the five finalists for this award, in recognition of the innovative nature of its new API manufacturing facility at Seal Sands in the UK. Foster Wheeler was the principal contractor on this project, which delivered technical as well as project execution creativity. The Lundbeck team at the award ceremony was supported by Steve Davies, CEO of Foster Wheelers UK operating unit, Clive Mullins, FW global business line leader for pharmaceuticals and Tom King, FW project manager for the Seal Sands project. The presentation to the winner preceded a charismatic presentation by Rudi Giuliani, former Mayor of New York City. All agreed that this, together with the industry recognition that being a finalist represents, made the event very special.

45th AFI Symposium

Sun, sea and the beautiful Augusto's Arch were the backdrop to the 45th AFI Symposium, held in Rimini in July. Foster Wheeler and its pharmaceutical equipment manufacturing division, Steril, shared one of over 100 stands, representing both our pharmaceutical engineering and construction division in Corsico and our manufacturing division in Mazzo di Rho. A particularly well-received feature of the stand was the discussion area, staffed by Dr Emilio Moia, manufacturing division director, and Dr Stefano Cattaneo, business development manager. Enthusiastic discussions on engineering, manufacturing, research, technical issues concerning the design, construction and validation of API production departments, and use of isolators, were amongst many subjects covered. This important event attracted over 700 pharmaceutical specialists, including key representatives from the Italian pharmaceutical industry.

World Congress of Chemical Engineering

Molecules to Money was one of the themes at the 7th World Congress of Chemical Engineering, held by the Institute of Chemical Engineers in Glasgow in July. The venue was the magnificent Scottish Exhibition and Conference Centre on the banks of the River Clyde. John Nichols was theme leader and describes the thinking behind Molecules to Money; Chemical engineering drives economic development and is fundamental to wealth creation. This theme addressed the generation of new opportunities through product and/or process innovation, discussed the techno-economic analysis, business decision-making, the role of entrepreneurship in chemical engineering, and the strategies and methodologies for technical innovation.

Come and meet us at...

IMechE, Refurbishment of Pharmaceutical Buildings 9 November 2005, London, UK. ISPE Annual Meeting 6-10 November 2005, Arizona, USA. ISPE UK Annual Awards Dinner and Seminar 17 November 2005, Stratford-upon-Avon, UK. ISPE Milan Conferences 28 Nov-1 Dec 2005, Milan, Italy. ISPE Tampa Conferences 20-24 February 2006, Florida, USA. ISPE Copenhagen Conferences 24-27 April 2006, Copenhagen, Denmark.

ISPE Washington
Foster Wheeler was involved in a number of activities at the ISPE Washington conferences held at the Crystal Gateway in Arlington, Virginia, USA. Washington in June offers many distractions and this year was no exception as the sun shone, the temperature soared and a major

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MOMsafetyawards
OUTSTANDING SAFETY PERFORMANCE

We have again won prestigious safety excellence awards from Singapores Ministry of Manpower (MOM) for outstanding safety performance in Singapore during 2004.
Firstly, we won an Occupational Safety & Health (OSH) Excellence Award for our performance on the Schering-Plough pharmaceutical projects. To qualify for this award, we had to achieve Gold Award standard at the Schering-Plough site for at least three consecutive years. In fact, this is our sixth OSH Excellence Award since the safety award scheme was introduced by MOM in 1999. We are the only engineering and construction contractor in Singapore to have achieved this. We also won a Gold Award for the Merck Sharp & Dohme Simvastatin project and a Silver Award for the ExxonMobil Feed Logistic Improvement Project. We are very pleased to receive these latest awards, which bring our MOM awards tally to an impressive total of 23: 6 OSH Excellence Awards, 8 Gold Awards, 8 Silver Awards and 1 Merit Award. Our world-class safety performance in Singapore has again been recognized independently, by the Singaporean Government, and everyone involved at these sites can be justifiably proud of his or her achievements. Franco Anselmi CEO, Foster Wheeler Asia Pacific.

Nick Howells (right), FW construction manager, receiving a Singapore Ministry of Manpower OSH Excellence Award for the Schering-Plough pharmaceutical project from Dr Ng Eng Hen, Singapores minister for manpower and second minister for defence.

In the UK, Foster Wheeler has also been awarded the prestigious Royal Society for the Prevention of Accidents (RoSPA) Presidents Award for the third year in a row. The Presidents Award is only presented to those companies that have attained a minimum of 10 consecutive RoSPA Gold Awards.

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Foster Wheelers pharmaceutical equipment manufacturing division

Sterils comprehensive range of products includes vertical and horizontal laminar air flow (LAF) benches, biosafety cabinets and isolators for powder containment.
A continuous research and development programme maintains Sterils equipment at the forefront of LAF and containment technology. In addition, Steril also designs and installs complete clean rooms ranging from class ISO5 to ISO9 and can provide cost-effective solutions to problems such as air purity, sterility, cross-contamination and pressure balance.

e-mail: sterilmfg_info@fwceu.com www.steril.it

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Technical consultancy Feasibility studies Concept design Site selection Site master-planning Permitting Environmental consultancy Process simulation Basic design Detailed engineering Project management Procurement Construction management Commissioning Validation Plant operation Maintenance Site remediation

the right people with a can do attitude and the commitment to deliver

PHARMACEUTICALS - BIOTECHNOLOGY - HEALTHCARE

fw_pharma@fwc.com www.fwc.com