focus 1

focus

8

NEW TRENDS & BUSINESS DRIVERS

10

SITE MASTER PLANNING

12

SINGAPORE - REALIZING THE VISION

FOSTER WHEELER’S PHARMACEUTICALS BUSINESS MAGAZINE

AUTUMN 2004

f.qxd 06/12/2004 09:46 Page 1

focus2 focus 3

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

4-5

6-7

8-9

10-11

12-13

14-15

16-17

18-19

20-21

22-23

24-25

26-27

focus

CONTENTS

Published by Foster WheelerShinfield ParkReadingBerkshire RG2 9FWUKwww.fwc.com

Managing EditorsCarolyn GreenhalghGlobal Marketing ManagerT 0118 913 2494E carolyn_greenhalgh@fwuk.fwc.com

Jacqueline HogartyMarketing ConsultantT 0118 913 2167E jacqueline_hogarty@fwuk.fwc.com

Produced by FW Graphics Team

© Foster Wheeler

Produced by MMCS

validation

fitting

togetherthe pieces

Compliance

Validation

Quality assurance

Early integration

Documentation

Regulatory requirements

EU, US FDA and Japan

One-stop service

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

PHARMACEUTICALS - BIOTECHNOLOGY - HEALTHCARE

f.qxd 06/12/2004 09:49 Page 2

recent fw successAWARDED IN THE FIRST HALF OF 2004

focus4 focus 5

Recent successfor Foster Wheeler

Major wins in Saudi ArabiaWe have been awarded a programmanagement services contract, including a 12-month FEED, by Saudi Aramco and its partner, Sumitomo Chemical, fordevelopment of a large, integrated refiningand petrochemical complex at Rabigh, SaudiArabia. Once implemented, this proposedmulti-billion dollar project would be one of thelargest integrated complexes ever built.

Saudi Basic Industries Corporation hasawarded us a program management servicescontract, including the FEED, for a new multi-billion dollar grassroots petrochemicalsfacility to be built at Yanbu Industrial City,Saudi Arabia.

3-Year Alliance: Huntsman PetrochemicalsWe have been selected by HuntsmanPetrochemicals as its project design andtechnical services alliance partner for aperiod of three years for its Wilton and NorthTees sites in the northeast of England.

Excellence award from ConocoPhillipsOur Teesside, UK, office has won thisaccolade for its performance on projectsexecuted under our term services agreementat ConocoPhillips’ Seal Sands Oil terminal in the UK.

Czech polypropylene start-upJust over two years after signing the LSTKEPC contract we have successfully started upChemopetrol’s new polypropylene plant atLitvinov in the Czech Republic. Earlyindications are that production will exceed110% of the design capacity.

Major PTA winOur Sriracha office in Thailand has beenawarded an EPCm contract for a world-scalepurified terephthalic acid plant to be built inThailand by Indorama Petrochem Ltd.

Flagship gas project on-streamWe are very proud to announce thesuccessful commissioning of Sasol's gasproduction facilities at Temane inMozambique, which have started exportingon-specification gas to South Africa. This isMozambique's first upstream project.

Another LNG terminal winOur Madrid operation, in a joint venture withSoluziona Ingenieria, has been awarded aproject management consultancy contract byRegasificación del Noroeste, S.A. for the newLNG terminal at Mugardos-Ferrol in Spain.

Going for goldThe Shell Goldeneye onshore gas plant siteat St Fergus in Scotland recently achievedone million man-hours worked with no losttime incidents.

Milestone for IndiaIndia has become the fourth Asian country toimport LNG with completion of Petronet LNGLtd.’s receiving terminal at Dahej, now fullycommissioned and in operation, deliveringgas into the national grid network.

Shell AllianceOur 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-trickWe have been awarded a contract for thedetailed engineering, procurement andconstruction planning for the low-sulphurautomotive diesel oil project for SaudiAramco Mobil Refinery at Yanbu, Saudi Arabia.

In Korea, we have been awarded a project management consultancy contractby Hyundai Oilbank for a $200 million cleanfuels upgrade project at its refinery at Daesan.

We are also currently working on a major clean fuels project for ExxonMobil at its Port Jérôme-Gravenchon refinery inNormandy, France.

Elsewhere in Foster Wheeler we havemany successes to report

Merck Sharp & DohmeInfrastructure Development

GlaxoSmithKlineTechnical ConsultancyGlaxoSmithKlineConfidential ProjectGlaxoSmithKlineAPI PlantMerck Sharp & DohmeInfrastructure Development

TakedaValidation TakedaSecondary Facility

PfizerSite Master Planning

BaxterPlant ExpansionSeronoBiotechnology FacilityRivopharmOral Solid Plant RevampRivopharmValidation ServicesRocheOral Solid Plant

AventisClean RoomAventisSecondary FacilityDSMNew Pilot PlantNovartisSecondary FacilityOpocrinSite Master PlanningOpocrinPurified Water UnitOpocrinSite RevampsPfizerSecondary FacilityPfizerAntibiotics PlantPfizerVeterinary PharmaceuticalsScheringSecondary Facility RevampSchering-PloughPackaging Facility Upgrade

BiofermaAntibiotic Expansion

PfizerOral Solid Plant

GlaxoSmithKlinePlant Expansion

AmershamNew Filling Line

GlaxoSmithKlineTechnical ConsultancyMerck Sharp & DohmeBulk Plant ExpansionEuropean ClientSecondary FacilityBeaconsNovel Secondary Plant

CordisValidation ServicesEli LillyValidation ServicesJ & J OrthoValidation ServicesPfizerValidation ServicesSchering-PloughValidation Services

Singapore

China

Hungary

Switzerland

Sweden

UK

Ireland

France

Puerto Rico

Spain

Italy

Egypt

Secondary

General

Infrastructure

Validation

API

Biotech

Category Key

f.qxd 06/12/2004 09:50 Page 4

focus 7focus6

e-procurement DELIVERING REAL BENEFITS

What is e-Procurement?e-Procurement is the term used to describe the use of electronic methods at every stage of thepurchasing process from identification ofrequirements through to payment. It can also include the facility to manage contracts.

It harnesses electronic tools and Internettechnologies to make the procurement processfaster and more efficient. Where e-Auctions form partof e-Procurement, they can help promote increasedsupplier/contractor competition in the market placefor the delivery of goods and services.

The procurement strategy for this project includes:

• Use of the Foster Wheeler e-Procurement systemto buy the mechanical and E&I equipment from GSK's preferred suppliers.

• Use of GSK's e-Sourcing system for thecompetitive selection of the civil, mechanical and E&I construction contractors from GSK’s approvedpre-qualified contractors. This article focuses on the use of this e-Sourcing system.

GSK’s toolsGSK has developed a suite of e-Procurement toolswhich it shares with its selected first tier supply chainpartners, for example, main contractors.

GSK initially focused on two areas: automatingtransactional purchasing activities using electroniccatalogues and requisitioning, and e-Sourcing.

e-Sourcing is the automation of the strategicprocesses and practices that determine how goodsand services are provided. GSK’s e-Sourcingsystem is capable of handling the full cycle oftendering, 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 hereon) can be managed and recorded electronicallyright up to the acceptance/rejection notification of the bid. The e-Sourcing process works indefined stages.

“An e-Auction is an innovative procurement techniquethat uses secure Internet-based technology. It is an effective tool for delivering significant value-for-money gains, offering efficient, open and transparentnegotiations 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 mosteconomically advantageous tender basis as part of a full tendering process. All purchase-relatedtransactions between the buyers and suppliers are managed and recorded electronically up to conclusion.”Duncan H Blatch, Sourcing Group Manager forCapital, GSK Procurement

The resultsThe GSK Valaciclovir Project has benefitedgreatly from the use of the GSK and FosterWheeler e-Procurement systems, which aredelivering cost savings and efficiencyimprovements.

GlaxoSmithKline, Brentford

Our Glasgow operation is currently working on a significant expansion atGlaxoSmithKline’s (GSK) Dartford manufacturing site. The project, calledValaciclovir Pure Stream E, is adding another process stream for themanufacture of Valaciclovir, an antiviral treatment. The project team is usingsome of the latest e-Procurement processes and techniques to deliver costand efficiency benefits.

PrequalificationThis is the initial stage, with the issue of request forinformation from potential suppliers. A requirementoverview is posted onto the website which describesthe project, the bidding process and schedule, along with the project-specific prequalificationquestionnaire. Prospective suppliers are issued a personal user name and password to allow secureand confidential access to the web site and invited to respond.

The bidding processTechnical design scope, scope of work, drawingsand 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 electronicsealed bids during the submission stage, it ispossible to monitor supplier activity on the tenderresponses. The messaging/e-mail system allows allsuppliers to be instantly notified of changes andadditions to the buyer's enquiry package. The highlevel of transparency and speed of communicationallows suppliers to amend their draft bids on the website right up to the tender deadline. Only when thesupplier pushes the ‘red button’ for submit is the bidfinalized and the buyer able to view the tendersubmission. Upon receipt and evaluation of thetenders, the option to make an immediate award orto proceed to an e-Auction is available.

The e-AuctionFor an e-Auction all design and scopes of works are frozen. The ‘event’ is posted on the web site witha ‘pending’ status. At this stage the bidders havevisibility of their bid ranking and the lowest tenderedprice. Once the e-Auction is opened, bidders maychoose to improve their ranking by submittingrevised bids.

The system allows a high level of transparencyduring the e-Auctions. An in-built messaging facilityallows instant notification of any changes to thepackage and gives the buyer greater visibility of thebidders’ enquiry progress while keeping anelectronic record. Bidders enter responses directlyinto the portal, allowing rapid evaluation and scoringby the software against pre-determined criteria.

Foster Wheeler’s ownglobal e-Procurementsystem, being used onthis project, has come a long way since itslaunch in 2000.

It already manages:

• Secrecy agreements

• Quotation requests,sealed and unsealedquotations 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 implementingPhase VI, electronicexpediting, which willallow suppliers todirectly update thelatest status of itemson order.

f.qxd 06/12/2004 09:53 Page 6

The DriversThis trend has a significant impact onthe organisation and communicationof the basic scientific information and the design methodology.

Reducing costs, maximising utilisationWith manufacturing costs amounting to around 28% of the value of thefinished goods, not including logisticsand 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 whichhandled six products in three trains andfound 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 plantoperation to 40-75%, giving an overall utilization of 34-60%

A similar study of a development pilotplant showed that, due to varyingproduct equipment needs, individualvessel utilization can be as low as 4-5%.Secondary facility utilization can be aslow as 15-20%.

Regulatory pressuresThere is ongoing regulatory pressure for the improvement of product quality;recent FDA initiatives emphasize theneed for a systematic approach,understanding the science and promotion of more innovation andprocess analytical technology (PAT).

At the ISPE Brussels Congress in May2004, the FDA’s Ajaz Hussainchallenged ISPE to provide a morerigorous system and pharmaceuticalengineering approach, arguing thatempirical methods are probablyapproaching their theoretical maximumeffectiveness and new technologies canprovide science-based approaches,using PAT as a model.

Health, Safety & theEnvironmentSocial and regulatory requirements areincreasing to improve facility safety andhealth protection and to reduceenvironmental impact.

Currently, the EU Energy EfficiencyDirective requires a 1-2% improvementper year. Sustaining this level ofimprovement beyond four to five years becomes very difficult without a step-change in technology. Similarly,under the EU Emissions TradingScheme, sites will have to cap carbondioxide emissions. Planned expansionsmay have to achieve significant energysavings. The typical waste from a pharmaceutical process is quoted as25-200 kg per kilo of product. Comparethis to a recently quoted green processof 9 kg per kilo of product.

focus8 focus 9

There is an emerging trend in the design of bulkpharmaceutical and fine chemicals manufacturingfacilities to use technology specifically tailored to theactual chemistry requirements. This is driven by the need to reduce time-to-market, operating costs, capital costs and to meet health, safety andenvironmental requirements.

John NicholsGlobal Technology Director

Foster Wheeler

new trends & business driversIN SCIENCE-BASED TECHNOLOGY DESIGN

Relative Utility Requirements

Continuous Integrated

Continuous Campaign

Batch Campaign

Com

pres

sed

Air

Scru

bber

s

Chille

rs

Nitro

gen

Boile

r

Purif

ied

Wat

er

Proc

ess

Raw

M

ater

ial H

andl

ing

Tota

l Raw

Mat

eria

l Han

dlin

g

Raw

Mat

eria

l/So

lven

t Inv

ento

ry

Solutions in science-based technologydesignFoster Wheeler is already workingwith clients on science-based designswhich address these challenges.

Britest toolsThe Britest ‘tools’ offer a methodologyfor connecting the documentedscientific 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 finalcost, schedule, validation and operationof a facility - another important reasonfor a close connection between chemistand engineer. Our methodologiesencourage this close communicationand, coupled with our systems-basedapproach to design, deliver thesystematic, rigorous approach the FDA is looking for.

Chemistry needsDesigning the technology specifically tomatch the needs of the molecules in achemical transformation can deliver animproved yield, reduce waste, cycletime and impurities.

Continuous processing offers a solution,providing stable, fixed conditions andintensified unit operations. We haverecently completed a review ofapplicable pharmaceutical technologiesto add to our knowledge of continuousprocessing in the refinery, petrochemicaland chemical sector.

Our powerful simulation tools model theprocess and enable quick ‘what if?’reviews of process options, processdebottlenecking, optimisation of utilities,operability, and more.

Continuous processing &process intensificationContinuous processing can dramaticallyreduce product lead time and work inprogress. For example, a six-stepprocess making each intermediate insequence in three-month campaignsmeans potentially 18 months to producefirst product compared to a few hoursfrom a continuous process. In addition,the work in progress becomes minisculecompared to the potential 18 months of stock.

A Foster Wheeler case study applyingcontinuous processing to themanufacture of a typical ethical productshowed the following savings:

• 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 solventinventories were reduced, improving safety.

As a process intensification example,compared to batch vessels andmanually controlled gravity separation,using centrifugal liquid-liquid contactorsgives improved yields and reduces theenvironmental impact from effluent.Additionally, these technologies reducethe scale-up risk.

PATContinuous processing and processintensification may be coupled with PATto give better control over conditions,improved yield and reduced impuritiesand a check on the composition,offering better reproducibility. It alsoenables 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.

Integrating design,construction & validationCombining the use of engineeringdatabases and early identification ofsystems with an understanding of thefundamental science delivers integrateddesign qualification and system andcomponent impact assessment.

It also enables semi-automaticproduction of protocols. The use ofFoster Wheeler’s Fintail database givescontrol of integrated construction,commissioning and qualification.

As described by the ISPECommissioning & QualificationBaseline® guide, a risk-based scientificapproach allows the use of engineeringand commissioning documents forsome systems to support thequalification. We adopt this approach;doing the activities once, and at theright level, can deliver considerablesavings and avoid the ‘paper chase’.

f.qxd 06/12/2004 09:54 Page 8

Foster Wheeler’s experienced masterplanning team, supported by our extensiveglobal resource, has a track record ofdeveloping site master plans for the world'sleading pharmaceutical companies. Overthe last five years, principal consultantRichard Larkin, based in Reading, UK, hasdeveloped an internationally-recognisedmethodology for preparing site masterplans that follows a simple 1-2-3 approach:

Richard explains that the Foster Wheelermethodology ensures a rigorous approach,keeping the client fully involved in the decision-making process and providinghigh quality reports and presentationmaterial. A key skill in developing a masterplan is the ability to identify alternativeschemes and then compare themobjectively so that the best overall schemeis chosen. This requires a holistic view ofall the interconnecting issues on a site, and an excellent relationship with the client.

site master planningDELIVERING YOUR VISION

A site master plan is used toset the overall strategy forfuture development of a site orbuilding. It is a very importantand commercially-sensitivedocument, used by seniormanagement to developcompany assets.

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

Foster Wheeler has successfullycompleted site master plans for many of the world’s leading pharmaceutical and fine chemicalcompanies, including:

• Amersham Health• Aventis• Elan• Eli Lilly• GlaxoSmithKline• Fournier Pharma• Merck• Pfizer• Rhodia ChiRex• Rohm & Haas• Sanofi-Synthélabo• Schering-Plough• Serono• Takeda

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

12 3

Master Plansfor Clients:

Business Benefits

Master plandevelopment

Conceptdevelopment

Data collection & analysis

Richard LarkinPrincipal Consultant, Site Master Planning

focus10 focus 11

For a copy of our site master planning brochure,please contact:fw_pharma@fwc.com

f.qxd 06/12/2004 09:56 Page 10

focus12 focus 13

realizing the visionDOING 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.

3

2

4

1

A clear vision and well-developedstrategy, coupled with drive andcommitment from the highest levelsof government, is taking Singaporetowards its goal of becoming a major player in the globalbiomedical industry.

From the start, the country has been determinedto provide more than just a low costmanufacturing environment, recognizing thatSingapore is ideally situated, geographically anddemographically, to become a global businessand manufacturing centre and distribution hub, as well as a key location for fundamental researchand development.

The business plan for Singapore recognized that success needed to be founded on more than just fiscal incentives. It also had toencompass education, training, communications,infrastructure - in fact everything from landreclamation to the development of qualifiedresources to work in the hospitals, researchlaboratories, manufacturing plants and supportfacilities that a successful industry would demand.

The country’s success to date is only a step onthe path towards its ultimate goal, for which it set four objectives.

Attract pharmaceuticalmanufacturing plants

Initial inward investment by several Britishpharmaceutical companies in the early 1980’s saw the establishment of chemical and antibioticAPI manufacture. Since then, investment hasburgeoned: American, European and Asian multi-nationals produce a wide range of chemical and biochemical active substances and final dose forms. Much of this developmenthas 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 government’s fourobjectives but Singapore is also well on the waytowards meeting the other three.

Build a modern R&D infrastructure

To underpin the development of a modern R&Dinfrastructure, a 200,000 m2 research complex -Biopolis - has been created. This houses fivegovernment research institutes and has beeninstrumental in attracting GlaxoSmithKline, Eli Lillyand most recently, Novartis, to make investmentsin R&D in Singapore. Two US contract researchorganisations, Covance and Quintiles, have setup clinical trials operations in Singapore, as hasBristol-Myers Squibb.

Integrate operations

Responding to encouragement such as financialincentives, shared resources and clinical trials tovertically integrate operations on the island, a number of companies now formulate and finish as well as manufacture locally and severaloperate pilot-scale facilities for process andproduct development.

Develop a local start-up industry

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

Managing the permitting processPlanning 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 controlledby the application of plot ratios to ensureoptimum land usage.

A developer must employ a locally registeredarchitect or engineer who is a Qualified Person toliaise with, and make submissions to, the localauthorities. Additionally, structural designcalculations must be checked independently by a Singaporean Accredited Checker.

The Singapore authorities actively encouragegood building design and the use of qualitymaterials, and have implemented variousinitiatives such as ‘buildability scores’ to reflectease of construction and the ProductivityStandards Board to control the use ofconstruction materials.

The Singapore government was one of the firstauthorities to introduce electronic submissions forits development control applications. Individualgovernment departments are very helpful inprocessing applications and pharmaceuticalprojects can be allocated ‘green lane status’ tofast-track applications, emphasising theimportance of the industry in Singapore.

f.qxd 06/12/2004 09:58 Page 12

Foster Wheeler hasoperated in Singapore

since 1974 and has built an impressive track record in the wider Asia Pacific region.

We have the largest, full service engineeringand construction organisation in Singaporeand have executed significant projects all over the island, particularly forpharmaceutical majors GlaxoSmithKline,Merck Sharp & Dohme and Schering-Plough.

Together with successful projects for BP,ExxonMobil, Shell, Elf, Lonza and Singapore Aromatics Company amongstothers, this has given us a thoroughunderstanding of the business and operatingenvironment and has contributed significantlyto Singapore’s current robust economy.

focus14 focus 15

BeaconsPharmaceuticalsInnovative designin Singapore

Beacons Pharmaceuticals has awarded its innovativeSPAH1 project, based on a patent-pending design, toFoster Wheeler in Singapore.We are the engineeringconsultants for this project.

SPAH1 is based on Beacons’ proprietary SatelliteProcess Assurance Hub system technology, aninfrastructure and operational concept forsecondary pharmaceutical manufacturingfacilities. SPAH1 is set to enhance Beacons’global contract manufacturing capabilities.

Beacons Pharmaceuticals is one of Singapore’sleading generic pharmaceutical manufacturers.

Merck Sharp& Dohme

Our Singapore office hasrecently won more repeatbusiness with Merck Sharp & Dohme in Singapore.

This reflects our continued successful workingrelationship with this client and follows oursuccessful handover last year of MSD’s newsecondary facility in Singapore, on schedule,under budget and with an award-winning safety performance.

We will partially fit out rooms within the existingmulti-purpose primary production facility which we previously designed and constructed.

Existing process and utility services will be alteredand extended to support the production of thispharmaceutical product. New equipment will beinstalled within spare bays of the Factory Building,with miscellaneous installation works in otherareas of the building and an existing process arealocated external to the Factory Building.

Because the work will be carried out while theplant is still operating, a strict permit to worksystem will be necessary. System tie-in works willbe executed during pre-planned shutdownoperations when operational activities will haveceased or are running at reduced levels.

new businessIN SINGAPORE

Foster Wheeler in Singapore

f.qxd 06/12/2004 10:01 Page 14

focus16 focus 17

smarter, safer, fasterSCHERING-PLOUGH

At the beginning of this $150 million

EPC contract for a newësmart cloneí

multiproduct activepharmaceutical

ingredients plant (MPP2)

at Tuas, Singapore, Schering-Plough

challenged us to beatthe world-class safety,

cost and scheduleperformance

we achieved for theMPP1 plant.

smarterWith key members of the MPP1 team on board onthis project, we worked with Schering-Plough tobuild continuous improvement into every aspectof this new plant.

Full advantage has been taken of the rolloverbenefits and the ‘smart cloning’ of processbuilding design from MPP1, clearly demonstratedby the reduction in home office manhours bynearly 50%. A remarkable achievement whentaken in context with the programme ofcontinuous improvement.

We've achieved new levels of documentationquality. Crucial to this was early agreement onrequirements, and close collaboration with theclient’s quality and validation teams, whoprovided extra ‘checks and balances’.

saferSafety has really been a ‘way of life’ on theproject. The safety message has become fullyembedded in the site culture. This has beenevident as soon as you set foot on site, from theexemplary ‘housekeeping’ to the visible pride the workforce takes in its working environment.

The project team achieved a significant safetymilestone, reaching three million manhourswithout a lost time incident - a magnificentachievement. Congratulations to everyone whohas contributed to this world-class performance.

This has only been made possible by the totalcommitment of the teams from Foster Wheeler,Schering-Plough and construction contractors.

fasterWe 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 overthree million manhours expended without a losttime accident.

The benefits of ‘smart-cloning’ and rollover of key team members: design teams, constructionsupervision, construction contractors andsuppliers, onto the new project have beenrealized: MPP2 costs are only 70% of MPP1’s,with a schedule reduction of over six months!

The rollover also contributed to an even higher quality facility, with minimal rework and punchlists.

SiteSafetyRob Holland is Foster Wheeler’s projectmanager at the Singapore Ministry ofManpower OSH Excellence Award-winning Schering-Plough project site at Tuas.

Rob comments:

“Safety is fundamental to our business. Our safety track record is a real differentiator and onethat we work very hard to maintain. On my project, the safety team is an integral part of the sitemanagement team, attends progress meetingswith the contractors and holds daily coordination meetings.

“Our safety teams also train workers, who may be of many different nationalities, speak differentlanguages and have different literacy and skilllevels. We find that a rewards-based approachworks for us: we don’t want a situation whereworkers hide things from us.”

The hazard observation scheme records, collates and identifies any developing trends and the safety team then assists in finding waysto eliminate the hazards and educate the workers accordingly.

For example, regular rallies are held to promotesafety. For a graphic message on safety at height,safety officers have dropped dummies and water melons from a height to simulate thescene 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?”

SiteSafetyRob Holland

f.qxd 06/12/2004 10:02 Page 16

Safety Eagle AwardSchering-Plough

Achieving safety excellence is always a joint client-Foster Wheelereffort. We have just successfully completed our fourth successiveproject for Schering-Plough in Singapore and all four projects haveachieved a world-class safety performance.

The ‘trophy cabinet’ in the meeting room in the Schering-Ploughproject office is testament to this co-operation and to thecontribution of Schering-Plough’s own teams. Within the cabinet are four Safety Eagles presented by Schering-Plough to its siteteam over the course of these projects.

“The Safety Eagle Award recognises individual employees and teamswho have demonstrated exemplary commitment and a proactiveapproach to hazard reduction or regulatory compliance. These awardsare 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.

focus18 focus 19

award-winning performanceDELIVERING WORLD-CLASS HSE

Success in SingaporeThree more safety accoladesWe are proud to announce that ourcommitment to safety and our safetyperformance have again been recognised bySingapore’s Ministry of Manpower (MOM): we have won two more Occupational Safety & Health (OSH) Excellence Awards.

These latest OSH Excellence Awards (MOM’shighest level of award) bring the company’s totalto five. Since we remain the only engineering andconstruction (E&C) company to win a MOM OSHExcellence Award, we believe we can justifiablyclaim to be the safest E&C company currentlyworking in Singapore.

The two OSH Excellence Awards recognize three years of consistent, Gold Award-winningsafety performance at two separatepharmaceutical 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 oursafety performance at ExxonMobil's Lubes Plantat Pulau Ayer Chawan. The 2004 Singapore MOMAnnual Safety Performance Awards attracted over335 applications from a wide variety ofcompanies, all based in Singapore. Companiesnominated for the MOM Awards undergo a rigorous review of their safety programmes andsafety performance during the reporting period.

f.qxd 06/12/2004 10:06 Page 18

focus20 focus 21

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 thecapability and flexibility to provide a complete range of services to ourclients, and to provide current advice on the latest availablepractices, emerging technologies and regulatory compliance.

Many staff have worked previously inpharmaceutical manufacturing or for specialitysuppliers, which means they are able to specify or design specialized equipment. Additionally, as all personnel speak German and English, withsome French, Spanish and Portuguese, we canoffer 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 inSwitzerland, a feasibility study for the expansion of a multi-national company’s biotech facility inSwitzerland, and basic design for a new soliddosage form facility, to be constructed in the Far East for a Swiss client.

swiss strengthDEVELOPING A STRATEGIC LOCATION

Since 1997,

our Basel office

has supported

pharmaceuticals

manufacturing

in Switzerland,

Germany

and Austria.

Peter Sala,manager of Foster Wheeler’sBasel office

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-Synthélabo

• Serono

• Valeant (ICN)

• Werthenstein Chemie (Schering-Plough)

• Weimer Pharma

f.qxd 06/12/2004 10:08 Page 20

ISPE WashingtonThe first week of June saw Foster Wheelertake its place among the 60 table-topexhibitors displaying a wide range of equipment and services to the conference delegates.

The Crystal Gateway Marriott Hotel in Arlington Virginia makes an ideal conferencevenue, situated as it is within five miles ofmost of Washington’s best-known sights. Not that many of the exhibitors and delegateshad much time to take advantage of thelocation nor the impressive facilities in, around and under the hotel!

The delegates had been drawn by a series of stimulating presentations covering barrierisolation technology, the MaintenanceBaseline® Guide, 21 CFR Part 11, GAMP 4,PAT and biotechnology. The broad spectrumof attendees provided plenty of opportunity for interchange of ideas and updates oncurrent industry activities.

ISPE BerlinISPE North CarolinaAttendees at these two conferences alsovisited Foster Wheeler’s table-top exhibition.

Interphex Asia 2004Interphex Asia, held in Singapore in April,showcased a wide variety of equipment, products and services related to thepharmaceutical manufacturing process, with the participation of 105 international exhibitingcompanies from 14 countries. The exhibitionattracted around 2,000 visitors from 30 countriesincluding Singapore, Malaysia, Thailand,Indonesia, India, Australia and the United States.

This year, Interphex Asia also incorporated theannual ISPE Singapore conference, featuringindustry professionals, including the US Food and Drug Administration and the AustralianTherapeutic Goods Administration, covering key issues relating to API, secondary and biotech manufacturing.

ISPE Brussels Meeting the Challenges of Globalisation in the LifeSciences Industry was the theme of the 2004 ISPEEuropean Congress, held in Brussels in May.

Key topics of the congress included globalperspectives on the life sciences market, researchand development, manufacturing, quality and new technologies, with a focus on the changing globalmarket and harmonisation issues.

John Nichols, global technology director,Foster Wheeler, together with Gregor McNab fromGSK, led the conference on API manufacturingprocess equipment, facilities, innovations, and therevised Baseline® Guide, while Austin Lock,principal consultant, along with Daniel De Grandeof UCB Bioproducts, hosted a workshop on Novelapproaches for oral solid dosage forms - theimpact and importance of legislation and design.

focus22 focus 23

meet us around the worldITALY, SINGAPORE, BELGIUM AND USA

Interphex 2004,ISPE Brussels & Washington

Associazione Farmaceutici Industria

The workshop was held at the 44th AnnualSymposium held in Rimini, Italy between 19-21 May, in cooperation with AFI, the Italian Pharma Industry Association.

Giorgio Mari presented a paper on Modernprocess plant design and the issue of containmentand Emilio Moia talked about An approach tocontainment: flow control and isolators. Bothpapers examined issues in high potency powdercontainment, particularly the concepts of passivecontainment, a permanent physical barrierbetween product and operator, negative pressureisolator containment to ensure safety in the eventof glove malfunction or accidental door opening,and isolator chamber cleaning systems.

Giorgio described the various types of isolator,from simple single chamber to more complexdouble chamber systems or special connectionsystems such as external boxes for materialingress/egress. He concluded with a discussionon 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 meanmore complex and sophisticated solutions,designed, built and tested by Steril, to meet FAT,SAT, commissioning and IQ/OQ certification and validation.

Emilio’s paper examined the various parametersused to classify products to required containmentlevels, such as occupational exposure limit,standard risk phrase, dustiness/volatility andexposure predictor band and how to use them to identify the right control approach to product handling.

Following the success of the workshop, futureevents are planned, to include biotechnology and research and development.

There was anexcellent response

to the workshopHandling of high

potency drugs:process and

containmentorganised by Steril,

Foster Wheeler’smanufacturing

division in Italy.

Come see us at:7th APIC Conference, Madrid, Spain, 20-22 OctoberJohn Nichols will presenta paper on ISPEBaseline® APIs.

ISPE Annual Meeting, San Antonio, Texas, US20-24 October

ISPE Annual Seminar, Newcastle, UK11 NovemberBob Adamson ispresenting a paper on validation.

IChemE SeminarSwitching from Batch to ContinuousProcessing22-23 NovemberHuw Thomas ispresenting a paper on thereality of small-scalecontinuous processing.

ISPE Paris Conference, France, 29 November-2 DecemberJohn Nichols is co-hosting and presentingat the Potent Compoundsseminar. David Ainsworthis presenting a case studyon FAT for HighContainment. PietroOrombelli is co-chairingand presenting onmaintenance at theBaseline® conference.

L to R: L Tagliapietra (AFI vicepresident) with workshop chairmenGiorgio Mari and Emilio Moia, bothfrom Foster Wheeler Steril

Above: Luca Ronchi

f.qxd 06/12/2004 10:09 Page 22

focus 25

fw peoplePLAYING A KEY ROLE

Mike Brocklebank, managerof pharmaceuticals in ourSingapore execution centre,plays an active role insupporting local education,especially the NationalUniversity of Singapore and Singapore Polytechnic.

Gary McMinn, our US-based regional sales vice president, has beenappointed to the AdvisoryBoard for the Departmentof Chemical & BiochemicalEngineering at RutgersUniversity, the StateUniversity of New Jersey.

Stefano Cattaneo is the new business developmentmanager for the Italian pharmaceuticalsector and is based at Foster WheelerSteril pharmaceutical division in Milan.Stefano joined Steril in 2000 and hasalso held the positions of HVAC engineerand proposal engineer. Stefano is anactive member of AFI and also theBiotech Committee of the AmericanChamber 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.Luca’s ten years in validation include the key positions of QA engineer,validation leader and automated system administrator in pharmaceuticalcompanies. His in-depth experienceincludes building validation strategies,co-ordinating validation activities for leading companies in full compliancewith cGMP and cGAMP, and obtainingFDA and major world agency approvals.

Gianpaolo Orlandi has been appointed manager ofautomation and electrical at Steril,bringing to the role fifteen years ofexperience in the design andcommissioning of large and complexinstrument and control systems. Since1999, he has worked as discipline headwith responsibility for technical designchoices and resource management.Gianpaolo is an active member ofseveral professional associationsincluding ISA, ISPE and ANIPLA.

Italy

Victoria Westgarthhas been appointed businessdevelopment director for FosterWheeler in the UK. Victoria joined Foster Wheeler as a graduate trainee in 1980 and her career to dateincludes business winning, projectmanagement and project execution.Victoria brings to her new role anunderstanding of complex interfaceissues, and ideas and experience from a number of different industry sectors.

Les Jameshas recently been appointed divisionaldirector, pharmaceutical and nuclearoperations. Based in Reading, Les iscurrently developing business plans toimplement Foster Wheeler's globalpharmaceutical business strategy for theUK, USA and Puerto Rico. Previously,Les has managed a number of majorpharmaceutical projects, most recentlyfor Merck Sharp & Dohme in Singapore.

Pierre Gérushas recently taken up a new position aspharmaceuticals sales manager in ourParis office, where he will use hisexcellent knowledge of the Frenchpharmaceuticals market. Pierre joinedFoster Wheeler in 2002 aspharmaceuticals project manager andpreviously worked for Assystem andPharmaplan where he was in charge ofsales and development activities.

UK France

NEW APPOINTMENTS

Congratulations to John Nichols, our global technology director forpharmaceuticals, who has been appointed to the ISPE International Board ofDirectors for the 2004-2006 term.

John is a very active member of ISPE. He chairs the European EducationCommittee, is a member of the Knowledge Management Task Team,is EuropeanTechnical Advisor, and was voted Member of The Year 2003.

STOP PRESS!

focus24

The Advisory Board includes major pharmaceuticalcompanies such as Merck, Johnson & Johnson,Bristol-Myers Squibb and Amgen.

Its objective is to help ensure future industry needsare met, by planning and approving coursemodifications, fostering relations between studentsand industry and reviewing graduate research.

Mike has acted as an IChemE industrial assessor onthe accreditation panel for the chemical engineeringdepartments at both establishments. Additionally, he has advised the polytechnic on the coursecontent of its specialist diploma in pharmaceuticaltechnology, which is supported by ISPE.

He is currently chairman of the advisory panel onchemical and pharmaceutical engineering and a committee member of the Chemical and LifeSciences School advisory committee.

Mike says: “Education in Singapore is world-class,and great efforts are being made to provide lifesciences training to support this key growth sector. I am pleased to have the opportunity to contribute to these efforts.”

f.qxd 06/12/2004 10:09 Page 24

focus 27focus26

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.

thames valleyLIFE SCIENCES NETWORK

The Network attractsmembers from thebiotechnology,pharmaceutical, food,agricultural andenvironmental industriesplus academics andclinicians, and provides a forum for regularmeetings and thediscussion andexchange of ideas. This is achieved in partthrough a programme of networking eveningswhich, for the remainder

of 2004, includes; Current Development in LifeSciences in the Thames Valley, ….and where’sthe money coming from? and Negotiating the3P’s…Patent, Intellectual Property and Protection.Members also benefit from exclusive e-networkingopportunities via the on-line TVLSN membershipdatabase.

In addition, TVLSN offers free business mentoringto all members. Mentoring sessions, heldregularly throughout the year, give members a confidential session with a panel of experts,comprising legal and accountancy professionals,business advisors and life scientists, aimed atsignposting clients towards a structured solutionto their problems, however large or small.

For membership enquiries and details offuture events please visit www.tvlsn.org

Steril’s comprehensive range of productsincludes vertical and horizontal laminar air flow (LAF) benches, biosafety cabinets andisolators for powder containment.

A continuous research and developmentprogramme maintains Steril’s equipment at theforefront of LAF and containment technology.

In addition, Steril also designs and installscomplete clean rooms ranging from class ISO5 to ISO9 and can provide cost-effective solutionsto problems such as air purity, sterility, cross-contamination and pressure balance.

e-mail: sterilmfg_info@fwceu.comwww.steril.it

Foster Wheeler’s pharmaceutical equipment manufacturing division

f.qxd 06/12/2004 10:12 Page 26

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

f.qxd 06/12/2004 10:12 Page 28