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AUTUMN 2004 FOSTER WHEELERS PHARMACEUTICALS BUSINESS MAGAZINE

8 NEW TRENDS & BUSINESS DRIVERS 10 SITE MASTER PLANNING 12 SINGAPORE - REALIZING THE VISION
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CONTENTS

PHARMACEUTICALS - BIOTECHNOLOGY - HEALTHCARE

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validation

fitting the pieces

together
Compliance Validation Quality assurance Early integration Documentation Regulatory requirements EU, US FDA and Japan One-stop service

4-5 6-7 8-9 10-11 12-13 14-15

Published by Foster Wheeler Shinfield Park Reading Berkshire RG2 9FW UK www.fwc.com Managing Editors Carolyn Greenhalgh Global Marketing Manager 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 Team

Recent pharma success for Foster Wheeler The benefits of e-Procurement Moving towards science-based technology Site master planning Singapore - realizing the vision New projects in Singapore for MSD and Beacons Smarter, safer and faster for Schering-Plough Achieving HSE excellence Basel brief Sharing experience round the world Foster Wheeler people Thames Valley Life Sciences Network

16-17 18-19 20-21 22-23 24-25 26-27

To talk to us about your validation requirements please contact: fw_pharma@fwc.com

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Foster Wheeler Produced by MMCS

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recent fw success
AWARDED IN THE FIRST HALF OF 2004
Pfizer Site Master Planning Sweden Baxter Plant Expansion Serono Biotechnology Facility Rivopharm Oral Solid Plant Revamp Rivopharm Validation Services Roche Oral Solid Plant Switzerland GlaxoSmithKline Plant Expansion Hungary

Recent success for Foster Wheeler

Elsewhere in Foster Wheeler we have many successes to report
Major wins in Saudi Arabia We have been awarded a program management services contract, including a 12-month FEED, by Saudi Aramco and its partner, Sumitomo Chemical, for development of a large, integrated refining and petrochemical complex at Rabigh, Saudi Arabia. Once implemented, this proposed multi-billion dollar project would be one of the largest integrated complexes ever built. Saudi Basic Industries Corporation has awarded us a program management services contract, including the FEED, for a new multi-billion dollar grassroots petrochemicals facility to be built at Yanbu Industrial City, Saudi Arabia. 3-Year Alliance: Huntsman Petrochemicals We have been selected by Huntsman Petrochemicals as its project design and technical services alliance partner for a period of three years for its Wilton and North Tees sites in the northeast of England. Excellence award from ConocoPhillips Our Teesside, UK, office has won this accolade for its performance on projects executed under our term services agreement at ConocoPhillips Seal Sands Oil terminal in the UK. Czech polypropylene start-up Just over two years after signing the LSTK EPC contract we have successfully started up Chemopetrols new polypropylene plant at Litvinov in the Czech Republic. Early indications are that production will exceed 110% of the design capacity. Major PTA win Our Sriracha office in Thailand has been awarded an EPCm contract for a world-scale purified terephthalic acid plant to be built in Thailand by Indorama Petrochem Ltd. Flagship gas project on-stream We are very proud to announce the successful commissioning of Sasol's gas production facilities at Temane in Mozambique, which have started exporting on-specification gas to South Africa. This is Mozambique's first upstream project. Another LNG terminal win Our Madrid operation, in a joint venture with Soluziona Ingenieria, has been awarded a project management consultancy contract by Regasificacin del Noroeste, S.A. for the new LNG terminal at Mugardos-Ferrol in Spain. Going for gold The Shell Goldeneye onshore gas plant site at St Fergus in Scotland recently achieved one million man-hours worked with no lost time incidents. Milestone for India India has become the fourth Asian country to import LNG with completion of Petronet LNG Ltd.s receiving terminal at Dahej, now fully commissioned and in operation, delivering gas into the national grid network. Shell Alliance Our seven-year-old alliance relationship with Shell UK Oil Products for the provision of basic design, engineering, procurement and construction management services at its Stanlow manufacturing complex, UK, will continue, with the renewal of our alliance contract for a further three years. Clean fuels hat-trick We have been awarded a contract for the detailed engineering, procurement and construction planning for the low-sulphur automotive diesel oil project for Saudi Aramco Mobil Refinery at Yanbu, Saudi Arabia. In Korea, we have been awarded a project management consultancy contract by Hyundai Oilbank for a $200 million clean fuels upgrade project at its refinery at Daesan. We are also currently working on a major clean fuels project for ExxonMobil at its Port Jrme-Gravenchon refinery in Normandy, France.

GlaxoSmithKline Technical Consultancy GlaxoSmithKline Confidential Project GlaxoSmithKline API Plant Merck Sharp & Dohme Infrastructure Development UK Takeda Validation Takeda Secondary Facility Ireland Merck Sharp & Dohme Infrastructure Development France Cordis Validation Services Eli Lilly Validation Services J & J Ortho Validation Services Pfizer Validation Services Schering-Plough Validation Services
Puerto Rico

Bioferma Antibiotic Expansion

Spain

Amersham New Filling Line China GlaxoSmithKline Technical Consultancy Merck Sharp & Dohme Bulk Plant Expansion European Client Secondary Facility Beacons Novel Secondary Plant Singapore

Pfizer Oral Solid Plant

Egypt

Category Key
Secondary General Infrastructure Validation API Biotech

Aventis Clean Room Aventis Secondary Facility DSM New Pilot Plant Novartis Secondary Facility Opocrin Site Master Planning Opocrin Purified Water Unit Opocrin Site Revamps Pfizer Secondary Facility Pfizer Antibiotics Plant Pfizer Veterinary Pharmaceuticals Schering Secondary Facility Revamp Schering-Plough Packaging Facility Upgrade
Italy

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e-procurement
DELIVERING REAL BENEFITS Our Glasgow operation is currently working on a significant expansion at GlaxoSmithKlines (GSK) Dartford manufacturing site. The project, called Valaciclovir Pure Stream E, is adding another process stream for the manufacture of Valaciclovir, an antiviral treatment. The project team is using some of the latest e-Procurement processes and techniques to deliver cost and efficiency benefits.
GSKs tools
GSK has developed a suite of e-Procurement tools which it shares with its selected first tier supply chain partners, for example, main contractors. GSK initially focused on two areas: automating transactional purchasing activities using electronic catalogues and requisitioning, and e-Sourcing. e-Sourcing is the automation of the strategic processes and practices that determine how goods and services are provided. GSKs e-Sourcing system is capable of handling the full cycle of tendering, from initial notification of requirement, through expression of interest, to issue and receipt of tenders, to evaluation, e-Auctions and award. All purchase-related transactions between buyer and supplier/contractor (called suppliers from here on) can be managed and recorded electronically right up to the acceptance/rejection notification of the bid. The e-Sourcing process works in defined stages.

Prequalification
This is the initial stage, with the issue of request for information from potential suppliers. A requirement overview is posted onto the website which describes the project, the bidding process and schedule, along with the project-specific prequalification questionnaire. Prospective suppliers are issued a personal user name and password to allow secure and confidential access to the web site and invited to respond.

Foster Wheelers own global e-Procurement system, being used on this project, has come a long way since its launch in 2000. It already manages: Secrecy agreements Quotation requests, sealed and unsealed quotations with a secure sealed quotation opening facility Purchase orders with electronic signatures Supplier/contractor database Expediting and inspection reports New suppliers/ contractors can also register their details and products and services on our website We are implementing Phase VI, electronic expediting, which will allow suppliers to directly update the latest status of items on order.

The bidding process

Technical design scope, scope of work, drawings and commercial enquiry documents are added to a secure location on the web as a sealed bid e-RFQ (request for quotation) and prequalified suppliers are automatically invited by e-mail to access the web page and participate in the sealed bid event. Whilst the buyer does not have access to electronic sealed bids during the submission stage, it is possible to monitor supplier activity on the tender responses. The messaging/e-mail system allows all suppliers to be instantly notified of changes and additions to the buyer's enquiry package. The high level of transparency and speed of communication allows suppliers to amend their draft bids on the web site right up to the tender deadline. Only when the supplier pushes the red button for submit is the bid finalized and the buyer able to view the tender submission. Upon receipt and evaluation of the tenders, the option to make an immediate award or to proceed to an e-Auction is available. An e-Auction is an innovative procurement technique that uses secure Internet-based technology. It is an effective tool for delivering significant value-formoney gains, offering efficient, open and transparent negotiations as part of a full procurement process, which is beneficial for both suppliers and buyers alike. It is a web-based online event between pre-qualified suppliers competing on a most economically advantageous tender basis as part of a full tendering process. All purchase-related transactions between the buyers and suppliers are managed and recorded electronically up to conclusion. Duncan H Blatch, Sourcing Group Manager for Capital, GSK Procurement

GlaxoSmithKline, Brentford
What is e-Procurement?
e-Procurement is the term used to describe the use of electronic methods at every stage of the purchasing process from identification of requirements through to payment. It can also include the facility to manage contracts. It harnesses electronic tools and Internet technologies to make the procurement process faster and more efficient. Where e-Auctions form part of e-Procurement, they can help promote increased supplier/contractor competition in the market place for the delivery of goods and services. The procurement strategy for this project includes: Use of the Foster Wheeler e-Procurement system to buy the mechanical and E&I equipment from GSK's preferred suppliers. Use of GSK's e-Sourcing system for the competitive selection of the civil, mechanical and E&I construction contractors from GSKs approved pre-qualified contractors. This article focuses on the use of this e-Sourcing system.

The e-Auction
For an e-Auction all design and scopes of works are frozen. The event is posted on the web site with a pending status. At this stage the bidders have visibility of their bid ranking and the lowest tendered price. Once the e-Auction is opened, bidders may choose to improve their ranking by submitting revised bids. The system allows a high level of transparency during the e-Auctions. An in-built messaging facility allows instant notification of any changes to the package and gives the buyer greater visibility of the bidders enquiry progress while keeping an electronic record. Bidders enter responses directly into the portal, allowing rapid evaluation and scoring by the software against pre-determined criteria.

The results
The GSK Valaciclovir Project has benefited greatly from the use of the GSK and Foster Wheeler e-Procurement systems, which are delivering cost savings and efficiency improvements.

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new trends & business drivers

IN SCIENCE-BASED TECHNOLOGY DESIGN

Relative Utility Requirements

Continuous Integrated

There is an emerging trend in the design of bulk pharmaceutical and fine chemicals manufacturing facilities to use technology specifically tailored to the actual chemistry requirements. This is driven by the need to reduce time-to-market, operating costs, capital costs and to meet health, safety and environmental requirements. The Drivers
This trend has a significant impact on the organisation and communication of the basic scientific information and the design methodology.

Continuous Campaign Batch Campaign

Compressed Air

Scrubbers

Purified Water

Process Raw Material Handling

Total Raw Material Handling

Foster Wheeler is already working with clients on science-based designs which address these challenges.

Regulatory pressures
There is ongoing regulatory pressure for the improvement of product quality; recent FDA initiatives emphasize the need for a systematic approach, understanding the science and promotion of more innovation and process analytical technology (PAT). At the ISPE Brussels Congress in May 2004, the FDAs Ajaz Hussain challenged ISPE to provide a more rigorous system and pharmaceutical engineering approach, arguing that empirical methods are probably approaching their theoretical maximum effectiveness and new technologies can provide science-based approaches, using PAT as a model.

Britest tools
The Britest tools offer a methodology for connecting the documented scientific basis to development of the optimal process option and equipment selection. Foster Wheeler is a working member of Britest, and is already applying these tools on its projects. Process selection will impact the final cost, schedule, validation and operation of a facility - another important reason for a close connection between chemist and engineer. Our methodologies encourage this close communication and, coupled with our systems-based approach to design, deliver the systematic, rigorous approach the FDA is looking for.

Continuous processing & process intensification

Continuous processing can dramatically reduce product lead time and work in progress. For example, a six-step process making each intermediate in sequence in three-month campaigns means potentially 18 months to produce first product compared to a few hours from a continuous process. In addition, the work in progress becomes miniscule compared to the potential 18 months of stock. A Foster Wheeler case study applying continuous processing to the manufacture of a typical ethical product showed the following savings:

PAT
Continuous processing and process intensification may be coupled with PAT to give better control over conditions, improved yield and reduced impurities and a check on the composition, offering better reproducibility. It also enables quick on-line product release, reducing product quarantine and can avoid the need for some process validation. On-line analyzers are used in a similar way to their long-time use in the petrochemical industries where, for example, one of our current projects employs a network of around 500 analysers.

John Nichols Global Technology Director Foster Wheeler

Reducing costs, maximising utilisation

With manufacturing costs amounting to around 28% of the value of the finished goods, not including logistics and distribution, cost reduction is a target area. In one example, switching from a batch reactor to a micro reactor gave a huge yield improvement, from 28% to 85%. We studied a multi-purpose plant which handled six products in three trains and found that:

drying time, being the controlling

period, reduced other plant utilization to 45-70% annual holidays, shutdowns and maintenance reduced available operating weeks to 44 (85%) cleaning and changeover times of 25-60% of annual hours reduced plant operation to 40-75%, giving an overall utilization of 34-60% A similar study of a development pilot plant showed that, due to varying product equipment needs, individual vessel utilization can be as low as 4-5%. Secondary facility utilization can be as low as 15-20%.

Health, Safety & the Environment

Social and regulatory requirements are increasing to improve facility safety and health protection and to reduce environmental impact. Currently, the EU Energy Efficiency Directive requires a 1-2% improvement per year. Sustaining this level of improvement beyond four to five years becomes very difficult without a step-change in technology. Similarly, under the EU Emissions Trading Scheme, sites will have to cap carbon dioxide emissions. Planned expansions may have to achieve significant energy savings. The typical waste from a pharmaceutical process is quoted as 25-200 kg per kilo of product. Compare this to a recently quoted green process of 9 kg per kilo of product.

building volume reduced by over 65% capital cost of facility reduced by

about 60% wastes reduced by over 85% manpower reduced by over 60% In addition, process and solvent inventories were reduced, improving safety. As a process intensification example, compared to batch vessels and manually controlled gravity separation, using centrifugal liquid-liquid contactors gives improved yields and reduces the environmental impact from effluent. Additionally, these technologies reduce the scale-up risk.

Integrating design, construction & validation

Combining the use of engineering databases and early identification of systems with an understanding of the fundamental science delivers integrated design qualification and system and component impact assessment. It also enables semi-automatic production of protocols. The use of Foster Wheelers Fintail database gives control of integrated construction, commissioning and qualification. As described by the ISPE Commissioning & Qualification Baseline guide, a risk-based scientific approach allows the use of engineering and commissioning documents for some systems to support the qualification. We adopt this approach; doing the activities once, and at the right level, can deliver considerable savings and avoid the paper chase.

Chemistry needs
Designing the technology specifically to match the needs of the molecules in a chemical transformation can deliver an improved yield, reduce waste, cycle time and impurities. Continuous processing offers a solution, providing stable, fixed conditions and intensified unit operations. We have recently completed a review of applicable pharmaceutical technologies to add to our knowledge of continuous processing in the refinery, petrochemical and chemical sector. Our powerful simulation tools model the process and enable quick what if? reviews of process options, process debottlenecking, optimisation of utilities, operability, and more.

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Raw Material/ Solvent Inventory

Solutions in sciencebased technology design

Chillers

Nitrogen

Boiler

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site master planning

DELIVERING YOUR VISION

Master Plans for Clients:

Foster Wheeler has successfully completed site master plans for many of the worlds leading pharmaceutical and fine chemical companies, including:
Amersham Health Aventis Elan Eli Lilly GlaxoSmithKline Fournier Pharma Merck Pfizer Rhodia ChiRex Rohm & Haas Sanofi-Synthlabo Schering-Plough Serono Takeda

A site master plan is used to set the overall strategy for future development of a site or building. It is a very important and commercially-sensitive document, used by senior management to develop company assets.
Richard Larkin Principal Consultant, Site Master Planning

Typically a site master plan will record the clients business plan, site vision, proposed site development to meet this vision, and the impact on each department at the site. In this way, the plan encompasses not only typical engineering parameters such as production equipment, utility systems and warehousing, but also site support features such as laboratories, archives, office and canteen areas, site security and parking, environmental systems and planning requirements.

Data collection Concept & analysis development

12 3
Richard explains that the Foster Wheeler methodology ensures a rigorous approach, keeping the client fully involved in the decision-making process and providing high quality reports and presentation material. A key skill in developing a master plan is the ability to identify alternative schemes and then compare them objectively so that the best overall scheme is chosen. This requires a holistic view of all the interconnecting issues on a site, and an excellent relationship with the client.

Foster Wheelers experienced master planning team, supported by our extensive global resource, has a track record of developing site master plans for the world's leading pharmaceutical companies. Over the last five years, principal consultant Richard Larkin, based in Reading, UK, has developed an internationally-recognised methodology for preparing site master plans that follows a simple 1-2-3 approach:

Business Benefits
A well-developed site master plan adds value by:
Demonstrating a sound understanding of the site Meeting an agreed business plan Identifying all potential solutions Incorporating state-of-the-art technical solutions Prioritizing alternatives against agreed criteria Challenging perceived restraints to test validity Meeting regulatory requirements Providing a clear, cost-effective plan that is well researched and simply and effectively presented

Master plan development

For a copy of our site master planning brochure, please contact:

fw_pharma@fwc.com

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A clear vision and well-developed strategy, coupled with drive and commitment from the highest levels of government, is taking Singapore towards its goal of becoming a major player in the global biomedical industry.
From the start, the country has been determined to provide more than just a low cost manufacturing environment, recognizing that Singapore is ideally situated, geographically and demographically, to become a global business and manufacturing centre and distribution hub, as well as a key location for fundamental research and development. The business plan for Singapore recognized that success needed to be founded on more than just fiscal incentives. It also had to encompass education, training, communications, infrastructure - in fact everything from land reclamation to the development of qualified resources to work in the hospitals, research laboratories, manufacturing plants and support facilities that a successful industry would demand. The countrys success to date is only a step on the path towards its ultimate goal, for which it set four objectives.

Build a modern R&D infrastructure

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To underpin the development of a modern R&D infrastructure, a 200,000 m research complex Biopolis - has been created. This houses five government research institutes and has been instrumental in attracting GlaxoSmithKline, Eli Lilly and most recently, Novartis, to make investments in R&D in Singapore. Two US contract research organisations, Covance and Quintiles, have set up clinical trials operations in Singapore, as has Bristol-Myers Squibb.

Integrate operations

Responding to encouragement such as financial incentives, shared resources and clinical trials to vertically integrate operations on the island, a number of companies now formulate and finish as well as manufacture locally and several operate pilot-scale facilities for process and product development.

Develop a local start-up industry

The first green shoots appeared in the late 1980s and there now exists a group of companies covering such fields as plant genetics, diagnostics, vaccines and bio-therapeutics.

Managing the permitting process

Attract pharmaceutical manufacturing plants

realizing the vision

DOING BUSINESS IN SINGAPORE

Located at the heart of southeast Asia, Singapore is home to over 6,000 international companies. The total population is around 4.5 million, with a literacy rate of 93%, a labour force of over two million and English as the language of business, administration and technology.

Initial inward investment by several British pharmaceutical companies in the early 1980s saw the establishment of chemical and antibiotic API manufacture. Since then, investment has burgeoned: American, European and Asian multi-nationals produce a wide range of chemical and biochemical active substances and final dose forms. Much of this development has taken place in the Tuas Biomedical Park, an area of around 400 hectares of reclaimed land in the southwest of the island. This meets one of the governments four objectives but Singapore is also well on the way towards meeting the other three.

Planning and building control of new facilities in Singapore is similar to that in the UK, however Singapore is a densely populated island and site development is strictly controlled by the application of plot ratios to ensure optimum land usage. A developer must employ a locally registered architect or engineer who is a Qualified Person to liaise with, and make submissions to, the local authorities. Additionally, structural design calculations must be checked independently by a Singaporean Accredited Checker. The Singapore authorities actively encourage good building design and the use of quality materials, and have implemented various initiatives such as buildability scores to reflect ease of construction and the Productivity Standards Board to control the use of construction materials. The Singapore government was one of the first authorities to introduce electronic submissions for its development control applications. Individual government departments are very helpful in processing applications and pharmaceutical projects can be allocated green lane status to fast-track applications, emphasising the importance of the industry in Singapore.

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new business
IN SINGAPORE

Merck Sharp & Dohme

Our Singapore office has recently won more repeat business with Merck Sharp & Dohme in Singapore.
This reflects our continued successful working relationship with this client and follows our successful handover last year of MSDs new secondary facility in Singapore, on schedule, under budget and with an award-winning safety performance. We will partially fit out rooms within the existing multi-purpose primary production facility which we previously designed and constructed. Existing process and utility services will be altered and extended to support the production of this pharmaceutical product. New equipment will be installed within spare bays of the Factory Building, with miscellaneous installation works in other areas of the building and an existing process area located external to the Factory Building. Because the work will be carried out while the plant is still operating, a strict permit to work system will be necessary. System tie-in works will be executed during pre-planned shutdown operations when operational activities will have ceased or are running at reduced levels.

Beacons Pharmaceuticals Innovative design in Singapore

Beacons Pharmaceuticals has awarded its innovative SPAH1 project, based on a patent-pending design, to Foster Wheeler in Singapore. We are the engineering consultants for this project.
SPAH1 is based on Beacons proprietary Satellite Process Assurance Hub system technology, an infrastructure and operational concept for secondary pharmaceutical manufacturing facilities. SPAH1 is set to enhance Beacons global contract manufacturing capabilities. Beacons Pharmaceuticals is one of Singapores leading generic pharmaceutical manufacturers.

Foster Wheeler in Singapore

Foster Wheeler has operated in Singapore since 1974 and has built an impressive track record in the wider Asia Pacific region.
We have the largest, full service engineering and construction organisation in Singapore and have executed significant projects all over the island, particularly for pharmaceutical majors GlaxoSmithKline, Merck Sharp & Dohme and Schering-Plough. Together with successful projects for BP , ExxonMobil, Shell, Elf, Lonza and Singapore Aromatics Company amongst others, this has given us a thorough understanding of the business and operating environment and has contributed significantly to Singapores current robust economy.

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smarter, safer, faster

SCHERING-PLOUGH

smarter
With key members of the MPP1 team on board on this project, we worked with Schering-Plough to build continuous improvement into every aspect of this new plant. Full advantage has been taken of the rollover benefits and the smart cloning of process building design from MPP1, clearly demonstrated by the reduction in home office manhours by nearly 50%. A remarkable achievement when taken in context with the programme of continuous improvement. We've achieved new levels of documentation quality. Crucial to this was early agreement on requirements, and close collaboration with the clients quality and validation teams, who provided extra checks and balances.

Site Safety
Rob comments:

Site Safety
Rob Holland

Rob Holland is Foster Wheelers project manager at the Singapore Ministry of Manpower OSH Excellence Award-winning Schering-Plough project site at Tuas.

safer At the beginning of this $150 million EPC contract for a newsmart clone multiproduct active pharmaceutical ingredients plant (MPP2) at Tuas, Singapore, Schering-Plough challenged us to beat the world-class safety, cost and schedule performance we achieved for the MPP1 plant.
Safety has really been a way of life on the project. The safety message has become fully embedded in the site culture. This has been evident as soon as you set foot on site, from the exemplary housekeeping to the visible pride the workforce takes in its working environment. The project team achieved a significant safety milestone, reaching three million manhours without a lost time incident - a magnificent achievement. Congratulations to everyone who has contributed to this world-class performance. This has only been made possible by the total commitment of the teams from Foster Wheeler, Schering-Plough and construction contractors.

Safety is fundamental to our business. Our safety track record is a real differentiator and one that we work very hard to maintain. On my project, the safety team is an integral part of the site management team, attends progress meetings with the contractors and holds daily coordination meetings. Our safety teams also train workers, who may be of many different nationalities, speak different languages and have different literacy and skill levels. We find that a rewards-based approach works for us: we dont want a situation where workers hide things from us. The hazard observation scheme records, collates and identifies any developing trends and the safety team then assists in finding ways to eliminate the hazards and educate the workers accordingly. For example, regular rallies are held to promote safety. For a graphic message on safety at height, safety officers have dropped dummies and water melons from a height to simulate the scene of a fatal fall. To stress the importance of protective eyewear, the site has posters with family photos asking: Do you want to see your family again?

faster
We are pleased to announce that the Temporary Occupation Permit was obtained on 9 July 2004 - on target! The outstanding safety record achieved on MPP1 has been maintained on MPP2, with over three million manhours expended without a lost time accident. The benefits of smart-cloning and rollover of key team members: design teams, construction supervision, construction contractors and suppliers, onto the new project have been realized: MPP2 costs are only 70% of MPP1s, with a schedule reduction of over six months! The rollover also contributed to an even higher quality facility, with minimal rework and punchlists.

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award-winning performance
DELIVERING WORLD-CLASS HSE

Success in Singapore
Three more safety accolades
We are proud to announce that our commitment to safety and our safety performance have again been recognised by Singapores Ministry of Manpower (MOM): we have won two more Occupational Safety & Health (OSH) Excellence Awards. These latest OSH Excellence Awards (MOMs highest level of award) bring the companys total to five. Since we remain the only engineering and construction (E&C) company to win a MOM OSH Excellence Award, we believe we can justifiably claim to be the safest E&C company currently working in Singapore. The two OSH Excellence Awards recognize three years of consistent, Gold Award-winning safety performance at two separate pharmaceutical project sites in Singapore for Merck Sharp & Dohme and Schering-Plough. Each of these project sites also won an OSH Excellence Award in 2003. This year we have also won a Gold Award for our safety performance at ExxonMobil's Lubes Plant at Pulau Ayer Chawan. The 2004 Singapore MOM Annual Safety Performance Awards attracted over 335 applications from a wide variety of companies, all based in Singapore. Companies nominated for the MOM Awards undergo a rigorous review of their safety programmes and safety performance during the reporting period.

Safety Eagle Award

Schering-Plough
Achieving safety excellence is always a joint client-Foster Wheeler effort. We have just successfully completed our fourth successive project for Schering-Plough in Singapore and all four projects have achieved a world-class safety performance. The trophy cabinet in the meeting room in the Schering-Plough project office is testament to this co-operation and to the contribution of Schering-Ploughs own teams. Within the cabinet are four Safety Eagles presented by Schering-Plough to its site team over the course of these projects. The Safety Eagle Award recognises individual employees and teams who have demonstrated exemplary commitment and a proactive approach to hazard reduction or regulatory compliance. These awards are presented at the facility level and in 2004, Schering-Plough presented a total of 28 Eagles based on 2003 performance. Rob Holland, project manager, Foster Wheeler.

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swiss strength
DEVELOPING A STRATEGIC LOCATION Our core team of technical specialists, led by Peter Sala, works closely with its neighbours, our Milan and Alsace offices. Having multi-disciplined resources locally, with additional support globally, means our Basel office has the capability and flexibility to provide a complete range of services to our clients, and to provide current advice on the latest available practices, emerging technologies and regulatory compliance.
Many staff have worked previously in pharmaceutical manufacturing or for speciality suppliers, which means they are able to specify or design specialized equipment. Additionally, as all personnel speak German and English, with some French, Spanish and Portuguese, we can offer project execution in many languages! Recent successes include the conceptual design for a new high potency solid dosage form facility for F Hoffmann-La Roche in Switzerland, a feasibility study for the expansion of a multi-national companys biotech facility in Switzerland, and basic design for a new solid dosage form facility, to be constructed in the Far East for a Swiss client.

Capability
Feasibility studies Front-end design Simulation modelling Engineering & procurement Construction Commissioning Qualification/validation cGMP consulting

Clients
Aventis-Behring Baxter Bayer Berna Biotech Boehringer Ingelheim CarboGen Celltrion Cilag (Johnson & Johnson) Fresenius F Hoffmann-La Roche Lonza Merck Sharp & Dohme Novartis Paul Scherrer Institut Pfizer/Pharmacia Sandoz (Azupharma) Sanofi-Synthlabo Serono Valeant (ICN) Werthenstein Chemie (Schering-Plough) Weimer Pharma

Peter Sala, manager of Foster Wheelers Basel office

Since 1997, our Basel office has supported pharmaceuticals manufacturing in Switzerland, Germany and Austria.

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meet us around the world

ITALY, SINGAPORE, BELGIUM AND USA

Associazione Farmaceutici Industria

Interphex 2004, ISPE Brussels & Washington

Interphex Asia 2004
Interphex Asia, held in Singapore in April, showcased a wide variety of equipment, products and services related to the pharmaceutical manufacturing process, with the participation of 105 international exhibiting companies from 14 countries. The exhibition attracted around 2,000 visitors from 30 countries including Singapore, Malaysia, Thailand, Indonesia, India, Australia and the United States. This year, Interphex Asia also incorporated the annual ISPE Singapore conference, featuring industry professionals, including the US Food and Drug Administration and the Australian Therapeutic Goods Administration, covering key issues relating to API, secondary and biotech manufacturing.

ISPE Washington
The first week of June saw Foster Wheeler take its place among the 60 table-top exhibitors displaying a wide range of equipment and services to the conference delegates. The Crystal Gateway Marriott Hotel in Arlington Virginia makes an ideal conference venue, situated as it is within five miles of most of Washingtons best-known sights. Not that many of the exhibitors and delegates had much time to take advantage of the location nor the impressive facilities in, around and under the hotel! The delegates had been drawn by a series of stimulating presentations covering barrier isolation technology, the Maintenance Baseline Guide, 21 CFR Part 11, GAMP 4, PAT and biotechnology. The broad spectrum of attendees provided plenty of opportunity for interchange of ideas and updates on current industry activities.

Come see us at:

7th APIC Conference, Madrid, Spain, 20-22 October John Nichols will present a paper on ISPE Baseline APIs. ISPE Annual Meeting, San Antonio, Texas, US 20-24 October ISPE Annual Seminar, Newcastle, UK 11 November Bob Adamson is presenting a paper on validation. IChemE Seminar Switching from Batch to Continuous Processing 22-23 November Huw Thomas is presenting a paper on the reality of small-scale continuous processing. ISPE Paris Conference, France, 29 November-2 December John Nichols is co-hosting and presenting at the Potent Compounds seminar. David Ainsworth is presenting a case study on FAT for High Containment. Pietro Orombelli is co-chairing and presenting on maintenance at the Baseline conference.

L to R: L Tagliapietra (AFI vice president) with workshop chairmen Giorgio Mari and Emilio Moia, both from Foster Wheeler Steril

Above: Luca Ronchi

There was an excellent response to the workshop Handling of high potency drugs: process and containment organised by Steril, Foster Wheelers manufacturing division in Italy.

The workshop was held at the 44th Annual Symposium held in Rimini, Italy between 19-21 May, in cooperation with AFI, the Italian Pharma Industry Association. Giorgio Mari presented a paper on Modern process plant design and the issue of containment and Emilio Moia talked about An approach to containment: flow control and isolators. Both papers examined issues in high potency powder containment, particularly the concepts of passive containment, a permanent physical barrier between product and operator, negative pressure isolator containment to ensure safety in the event of glove malfunction or accidental door opening, and isolator chamber cleaning systems. Giorgio described the various types of isolator, from simple single chamber to more complex double chamber systems or special connection systems such as external boxes for material ingress/egress. He concluded with a discussion on uses of isolators throughout an entire

production plant, from dispensing operations, through reactor loading and centrifuge unloading, to final product unloading from the filter dryer. Increasingly high levels of containment mean more complex and sophisticated solutions, designed, built and tested by Steril, to meet FAT, SAT, commissioning and IQ/OQ certification and validation. Emilios paper examined the various parameters used to classify products to required containment levels, such as occupational exposure limit, standard risk phrase, dustiness/volatility and exposure predictor band and how to use them to identify the right control approach to product handling. Following the success of the workshop, future events are planned, to include biotechnology and research and development.

ISPE Brussels
Meeting the Challenges of Globalisation in the Life Sciences Industry was the theme of the 2004 ISPE European Congress, held in Brussels in May. Key topics of the congress included global perspectives on the life sciences market, research and development, manufacturing, quality and new technologies, with a focus on the changing global market and harmonisation issues. John Nichols, global technology director, Foster Wheeler, together with Gregor McNab from GSK, led the conference on API manufacturing process equipment, facilities, innovations, and the revised Baseline Guide, while Austin Lock, principal consultant, along with Daniel De Grande of UCB Bioproducts, hosted a workshop on Novel approaches for oral solid dosage forms - the impact and importance of legislation and design.

ISPE Berlin ISPE North Carolina

Attendees at these two conferences also visited Foster Wheelers table-top exhibition.

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NEW APPOINTMENTS

Italy

fw people
PLAYING A KEY ROLE
Stefano Cattaneo
Mike Brocklebank, manager of pharmaceuticals in our Singapore execution centre, plays an active role in supporting local education, especially the National University of Singapore and Singapore Polytechnic.
Mike has acted as an IChemE industrial assessor on the accreditation panel for the chemical engineering departments at both establishments. Additionally, he has advised the polytechnic on the course content of its specialist diploma in pharmaceutical technology, which is supported by ISPE. He is currently chairman of the advisory panel on chemical and pharmaceutical engineering and a committee member of the Chemical and Life Sciences School advisory committee. Mike says: Education in Singapore is world-class, and great efforts are being made to provide life sciences training to support this key growth sector. I am pleased to have the opportunity to contribute to these efforts. is the new business development manager for the Italian pharmaceutical sector and is based at Foster Wheeler Steril pharmaceutical division in Milan. Stefano joined Steril in 2000 and has also held the positions of HVAC engineer and proposal engineer. Stefano is an active member of AFI and also the Biotech Committee of the American Chamber of Commerce in Italy. You may have met him at the 44th AFI Symposium in May!

Luca Defendenti

is the new head of validation at Steril. Lucas ten years in validation include the key positions of QA engineer, validation leader and automated system administrator in pharmaceutical companies. His in-depth experience includes building validation strategies, co-ordinating validation activities for leading companies in full compliance with cGMP and cGAMP , and obtaining FDA and major world agency approvals.

has been appointed manager of automation and electrical at Steril, bringing to the role fifteen years of experience in the design and commissioning of large and complex instrument and control systems. Since 1999, he has worked as discipline head with responsibility for technical design choices and resource management. Gianpaolo is an active member of several professional associations including ISA, ISPE and ANIPLA.

Gianpaolo Orlandi

UK

France

Gary McMinn, our US-based regional sales vice president, has been appointed to the Advisory Board for the Department of Chemical & Biochemical Engineering at Rutgers University, the State University of New Jersey.

The Advisory Board includes major pharmaceutical companies such as Merck, Johnson & Johnson, Bristol-Myers Squibb and Amgen. Its objective is to help ensure future industry needs are met, by planning and approving course modifications, fostering relations between students and industry and reviewing graduate research.

Victoria Westgarth
has been appointed business development director for Foster Wheeler in the UK. Victoria joined Foster Wheeler as a graduate trainee in 1980 and her career to date includes business winning, project management and project execution. Victoria brings to her new role an understanding of complex interface issues, and ideas and experience from a number of different industry sectors.

Les James
has recently been appointed divisional director, pharmaceutical and nuclear operations. Based in Reading, Les is currently developing business plans to implement Foster Wheeler's global pharmaceutical business strategy for the UK, USA and Puerto Rico. Previously, Les has managed a number of major pharmaceutical projects, most recently for Merck Sharp & Dohme in Singapore.

Pierre Grus
has recently taken up a new position as pharmaceuticals sales manager in our Paris office, where he will use his excellent knowledge of the French pharmaceuticals market. Pierre joined Foster Wheeler in 2002 as pharmaceuticals project manager and previously worked for Assystem and Pharmaplan where he was in charge of sales and development activities.

STOP PRESS!
Congratulations to John Nichols, our global technology director for pharmaceuticals, who has been appointed to the ISPE International Board of Directors for the 2004-2006 term. John is a very active member of ISPE. He chairs the European Education Committee, is a member of the Knowledge Management Task Team,is European Technical Advisor, and was voted Member of The Year 2003.

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thames valley
LIFE SCIENCES NETWORK

Foster Wheeler is an active member of the Thames Valley Life Sciences Network (TVLSN), the only networking organisation dedicated to serving life science professionals in the Thames Valley, southern England. It was founded in response to demand from regional businesses for improved networking opportunities across the thriving life sciences sector.
The Network attracts members from the biotechnology, pharmaceutical, food, agricultural and environmental industries plus academics and clinicians, and provides a forum for regular meetings and the discussion and exchange of ideas. This is achieved in part through a programme of networking evenings which, for the remainder of 2004, includes; Current Development in Life Sciences in the Thames Valley, .and wheres the money coming from? and Negotiating the 3PsPatent, Intellectual Property and Protection. Members also benefit from exclusive e-networking opportunities via the on-line TVLSN membership database. In addition, TVLSN offers free business mentoring to all members. Mentoring sessions, held regularly throughout the year, give members a confidential session with a panel of experts, comprising legal and accountancy professionals, business advisors and life scientists, aimed at signposting clients towards a structured solution to their problems, however large or small. For membership enquiries and details of future events please visit www.tvlsn.org

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