focus issue7

7/28/2019 Focus Issue7

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focusFOSTER WHEELERS PHARMACEUTICALS BUSINESS MAGAZINE

ISSUE 7

Technical innovation adds value


2/20

speispeispeispeispeispeispeispeispeis

fwpharmasuccessGLOBAL ROUND-UP OF RECENT WINS

Secondary

General

Infrastructure

Validation

API

Biotech

R&D

Category Key

We continue to secure significant new pharma business

around the world, across the full range of technologies:

This (10th anniversary) is a

significant achievement forthe alliance which has

delivered a large number of

high quality projects for the

Shell business since its

inception. We are looking

forward to continuing with

this alliance partnership to

enable us to deliver world-

class projects.

Foster Wheeler has

demonstrated how seriouslyit takes health and safety

management and is a fine

example to many other

companies. We would like

to see more organizations

following their lead.

The achievements to date

are very much a result of

the excellent working

relationships that have been

developed between the

Aramco Overseas Company

and Foster Wheeler teams.

INVISTA has been

delighted with the qualityof services and support

provided by Foster Wheeler

throughout this strategically

important project for LYPC.

All parties should be

congratulated on the

successful start-up and

many achievements of

this project.

Without the commitment,

professionalism, and hard-working attitude of the

whole Foster Wheeler team,

we could not have achieved

this challenging target,

which some people did not

believe we could meet.

Elsewhere, our clients continue to value the qualityof our teams and the facilities we design and build.


3/20

focus

2 Global round-up - recent wins

4-5 Singapore successes

6-7 Practical containment

8 Design innovations for Celgene

9 Happy birthday Basel!

10-11 Airflow modeling in clean rooms

12 New cross-containment solutions

13 Novartis China safety celebrations

14-15 Investing in China

16-17 Good Engineering Practice

18-19 Supporting ISPE

blished by

ter Wheeler

nfield Park

ading

kshire RG2 9FW

w.fwc.com

naging Editors

olyn Greenhalgh

ector, Strategic Planning & Marketing

bal E&C Group

0118 913 2494

[email protected]

queline Hogarty

ior Marketing Consultant

bal E&C Group

0118 913 2167

[email protected]

duced by FW Graphics Group

Foster Wheeler 2007

focus ON ADDING VALUE

At a time of great

change in the industry,Im pleased to introduce

an edition offocus thatdemonstrates our

ability to move with the

times and illustrates the ways in which the

Foster Wheeler team continues to add value

in terms of technical developments and

project delivery.

In Singapore we continue successfully to

deliver major greenfield site projects for

clients, including clients making their firstinvestment in that country. In China we are

safely building a major API plant while

maximizing local content. In Switzerland we

celebrate our Basel offices tenth birthday

and the completion of an innovative oral solid

dosage plant.

Elsewhere, we have used advanced

simulation technology to improve clean room

performance and applied our expertise to a

packaging line for a potent compound.

In addition, our technical specialists continue

to work at the forefront of technology in

containment and the regulatory environment.

We remain fully committed to providing

dependable and flexible service and creative

input to our pharmaceutical clients.

Clive MullinsVice president

Global business development

Pharmaceuticals, biotechnology, healthcare


4/20

This is a major milestone for our globalpharmaceutical operations as itrepresents the first world-scalepharmaceutical project for which 100%of the detailed engineering has beenundertaken by our Singapore office.

Novartis Singapore PharmaceuticalManufacturing is a center of excellence

for its solid dosage form manufacturing.One of the guiding principles for thedesign of this plant was lean manufacture

and the process-oriented layout increasesthe plants eff iciency.

In March this year, we handed over thisfacility to Novartis on receipt of thetemporary occupation permit, following

an inspection by the SingaporeGovernments building controlinspection team.

At peak there were around sixty staff inthe engineering and procurement team,

with about forty Foster Wheeler sitesupervisory and support staff - 90% ofthe latter being locally recruited.

4 focus

majormilestonesinsingaporeSUCCESSFUL COMPLETION

We have successfullycompleted a greenfieldoral solid dosagemanufacturing facility

for Novartis at theTuas Biomedical Parkin Singapore.

Mike Brocklebank

Manager, pharmaceuticalsSingapore


5/20

We have been awarded an engineering, procurement,

construction management and commissioning services contractby GSK Biologicals for a new vaccines production facility inSingapore. This state-of-the-art facility includes two production

buildings, a quality control and administration building and autilities building, all on a site of more than 8.8 hectares in theTuas Biomedical Park.

Our Asia Pacific team in Singapore, together with specialistsfrom our Milan office, continues to make good progress on this

complex project. There are around 140 personnel currently

working on detailed engineering and procurement in ourSingapore office under the guidance of project director Zoran

Serbedzija. Many of our team worked with Zoran on a previous,similar, project for GSK Biologicals in Gdll, Hungary.

We are working closely with the GSK Bio project team led by theirproject director, David Callaert, both to maximize the rate ofprogress and to identify and solve problems and issues before

they arise.

Construction is in the civil and structural phase and is on

schedule. We expect mechanical completion in December 2008which will overlap with commissioning activities now being

planned by our commissioning leadership team.

This latest award reflects GSK Biologicals' continued

confidence in the quality of our people and in our

biotechnology expertise and track record. Key to our success

in winning this contract was the performance of the Foster

Wheeler team on the client's new vaccine facility in Hungary,

which is now complete, as well as our ability to leverage this

successful experience for the new Singapore facility.

In addition, our 30-year track record of delivering safe and

successful projects in Singapore strongly demonstrates our

position as one of the leading local EPC contractors in a

location where we are currently playing a key role in realizingbillions of dollars of our clients' investments across a number

of industry sectors.

Franco Anselmi

Chief Executive Officer

Foster Wheeler Asia Pacific

focus

greenfieldtriumphNEW VACCINES PRODUCTION FACILITY

Foster Wheeler is working closely

with GlaxoSmithKline Biologicals

to create a major new vaccinesmanufacturing facility in Singapore.


6/20

Articles on containment typically start byidentifying the drivers behind anincreasing focus on containment forpharmaceutical manufacturing, namely:

Active pharmaceutical ingredients(APIs) are becoming more targetedand hence of higher potency.

Internal and external environmental,health and safety pressures are

pushing for engineered controls ratherthan relying on personal protectiveequipment.

At this point a bewildering array ofcontainment devices and jargon ispresented along with claims such astest results with lactose using SMEPACshow average >1g/m3 for an 8hr TWAperformance

Fig 1 shows the hierarchy of riskassessment methods, with the bottom tierof standards and guidelines used to

focus6

Huw Thomas takes a step back

and outlines a practical,

systematic and transparent

approach to containment selection

that Foster Wheeler has developed

and uses regularly.

practicalcontainmentSUCCESSFUL, STRUCTURED APPROACH

Pharma i

Full paper available at

http://www.fwc.com/publications

Huw Thomas

Principal pharmaceutical

engineer


7/20

prescribe the containment solution forcommon, routine operations. Moving upthrough the tiers, the assessmentmethods become more complex with thetop tier, quantified risk assessment (QRA),used for complex, high-risk operationsthat usually involve significant off-site,wide-reaching consequences, such as inhigh potency pharma manufacturing andnuclear installations.

The methods in the two lowest tiers arethe most commonly used in the pharmaindustry. Many companies have internalguidelines and standards, and someindustry-wide standards exist.

The tier-two method, qualitative riskassessment, takes into account a numberof factors (Fig 2) before determining therequired containment strategy. Thisstrategy is based on industry-wide,practical operating experience thatindicates which containment solution will

typically give adequate containment.

Foster Wheeler has taken the tier-twoapproach and has applied numericalranges to each factor in the abovediagram. We have used this semi-quantitative factor-based risk assessment(tier three) to assess the exposure risk ofa wide range of operations in lab-, pilot-and full scale manufacturing plants forhighly potent and cytotoxic materials. Forcomplex operations, this method hasbeen found to give the following benefits:

Widely different operations can becompared, making it possible toindicate which operation needsaddressing first and the scale of therequired improvement in theengineered containment.

The rationale behind the decision-making is transparent and canbe challenged.

The decision-making process is fullytraceable from the initial processdescription through to the containmentsystem design. This is very useful inavoiding opinion engineering andallows the basis and rationale behinda design decision to be challengedrather than endless and often fruitlessdiscussion on the design itself.

The Foster Wheeler structured, risk-basedapproach to containment design hasbeen successfully used over a wide rangeof projects. These include reviewingplants during the design stage, reviewingand rapid upgrading of containment inexisting plants to meet urgent operatingneeds, and developing future containmentapproaches for existing plants to achievesignificant reductions in operator exposure.

focusfocus

Fig 2: Process factors affecting required containment level

Fig 1: Risk assessment hierarchy

Standards and Guidelines

Qualitative RiskAssessment

Factor-BasedRisk Assessment

QRA

Scale DustinessProcessEnergy

APIContent

IncreasedContainment

Tonne Micronised Milling/ Sieving 100%

LessContainment

Kilogramme

Gram

Powders

Granules

Wet Cake

Coated Tablets

Creams/Ointments

Charging/Discharging

Weighing/Dispensing

10%

1%


8/20

The use of CFDA to model the airflowpattern inside sterile rooms during theearly design phase allows the designer tooptimize the clean room configuration.This considerably reduces the likelihoodthat that any lack of product protection willbe observed only in the commissioningphase, when its correction is likely tocause a serious impact on plantcompletion. The analysis is used toidentify equipment and other physicalfeatures within the room, the location of

which could negatively affectunidirectional airflow, which in turn couldjeopardize product protection.

For example:

the location inside the clean room ofany equipment - and its shape - couldinterfere with the airflow distribution

the location of the return grilles orreturn air walls could be asymmetrical

the shapes of the laminar air flowarea and/or of the rooms could beasymmetrical

Putting CFDA into practice

In Foster Wheeler, CFDA is carried out byfinite element analysis.

The inputs to the simulation model are:

geometry of the room and of the mainequipment

boundary conditions (supply air velocityand temperature)

thermo-physical properties of the air

The outputs of the simulation model are:

velocity distribution

particle distribution

particle path

temperature distribution

The software generates a number ofsections of the volume involved in thestudy. In each section different colors areused to easily highlight the different valuesof the output from the simulation model.

modeling clean room airflowsCFDA - A TOOL THAT PAYS FOR ITSELFFoster Wheeler has successfully used compu

analysis (CFDA) to model clean room airflowcirculation. This creates the opportunity to m

and generate savings in project schedule an

Carlo Magni

Senior HVACengineer

Pharma i

Contact

[email protected]

Luca Arrighi

Head of HVACdepartment

focus8


9/20

The first design approach was todistribute the air supply HEPA filtersequally across the ceiling whereas theposition of return air grilles was governedby the equipment layout.

CFDA (Fig 2) identified a critical areaclose to the conveyor (see the left side ofFig 2) where a zone of stagnant air (bluecolour) was surrounded by a high-velocityair-stream (red colour). The unidirectionalairflow was therefore completely lost close

to the critical area on the conveyor wherethe product was still exposed.

Based on these results, we re-ran thesimulation, removing the last row ofceiling diffusers close to the air walls.We anticipated that this would reduce theswirl velocity close to the conveyor. Theresult (Fig 3) was a reduction in the swirlvelocity but also an increase in thestagnant area adjacent to the conveyor.

Finally, a third solution was considered(Fig 4):

create a closure over the conveyor area

provide laminar airflow directly bymeans of the HVAC plant over thewhole room rather than filter fan units(as in solutions 1 and 2)

reduce the total supply airflow rate(hence reducing investment andoperating costs)

With this configuration, the problems ofswirl velocity and a stagnant area close tothe conveyor were both solved at thesame time. The feasibility of this solutionwas finally checked with the clientsoperating personnel to ensure that thevertical closure did not limit the operationsinside the room.

The client regarded the study as acomplete success, appreciating the highlevel of design achieved by the simulationmodel, and accepted and used thestudy results.

Case Study

We were requested by a majorpharmaceutical company to study thesterile filling core at one of its operatingsites in Italy. In this case we used CFDA todefine the proper layout of the HVACsupply HEPA filters to guarantee that therewere no backflows and/or turbulence overthe working area.

As shown in Fig 1, the room is occupied

by one conveyor that transports sterilizedvials to the filling machine and thentransfers the filled vials to packaging. Thefilling machine incorporates one glove boxto introduce the product and a secondglove box that provides the caps. Theconveyor is supplied with independentaminar airflow units (filter fan units)ocated a few centimeters above it.

nal fluid dynamic

identify areas of poorthe design, reduce risk

apital/operating costs.

Fig 1 Fig 2

Fig 3 Fig 4

focus


10/20

Our office in Basel was set up in 1997 to serve the pharmaceutical industry in theGerman-speaking area of Switzerland. Since then our multi-discipline, multi-lingual teamhas built an excellent track record, executing significant projects both locally and abroad:

Local projects for local clients:Novartis, Roche, Berna Biotech, Dottikon ES, KSA

Local projects for non-Swiss clients investing in Switzerland:Baxter, Celgene, Cilag (J&J), Ferring, Werthenstein (Schering-Plough),Metalor

Projects outside Switzerland for local clients:

Novartis, Syngenta Projects outside Switzerland for non-Swiss clients:

Azupharma, Celltrion, Bilim, Pfizer, Pliva, Boehringer Ingelheim

This work has required us to deliver the whole range of services including feasibilitystudies, master planning, design, simulation modelling, 3D modelling, engineering,procurement, construction management, start-up, qualification and validation. Planttypes include pilot and production plants for APIs (both for chemical synthesis andbiotechnology), oral solid dosage plants, semi solids, creams, ointment and sterilefill-finishing plants.

In celebrating this important milestone, Peter Sala, general manager, recognized thevital contribution of the team in the Basel office, many of whom have been with him sinceits inception. He added that continued success will depend on our ability to continue to

provide an expert local service, supported by the companys global network andeffectively integrated with other Foster Wheeler offices when local clients invest overseas.

Foster Wheelers Basel office is

10 years old and is delivering against

the objectives set at its founding.

happybirthday!10 YEARS IN BASEL

Office opened: November 1997First project: Centeon, Marburg, Germany, validation

services for a blood fractionation plantMoved to new office: 2000Completion of first EPC project: 2005 for Metalor in SwitzerlandLatest plant completed: Celgene

Peter Sala

General manager,

Basel office

focus0


11/20

Foster Wheelers Baseloffice has successfullycompleted Celgenes

greenfield oral soliddosage manufacturingfacility, featuring many

design innovations.

Celgene is a US-headquartered

biopharmaceutical company primarilyengaged in the discovery, developmentand commercialization of therapiesdesigned to treat cancer andimmunological diseases. Located in thelovely Three-Lake region of Switzerland,Celgenes new facility will produceREVLIMID (lenalidomide) in capsuleform. This drug is used in combinationwith dexamethasone for the treatmentof multiple myeloma, a type of bonemarrow cancer.

Our lump-sum contract included

engineering, procurement, constructionmanagement and validation for all non-architectural and civil engineeringactivities, including site master planning,site selection, process design,manufacturing building layout, HVAC,automation and validation concept,installed cost estimate and scheduling.

The plant features high (OEL 3)containment for highly potent products,primary and secondary packaging, awarehouse, QA laboratories, utilitiesand infrastructure.

designinnovationsCELGENES CAESAR PROJECT

Werner SchoeneckSenior project manager

A number of innovative design featureswere incorporated, including:

White line conceptOrdering unprinted or partially pre-printed(so-called white) packaging material andthen printing exact data on to it, as andwhen required.

Dispensing isolatorSieving and weighing processes for thehighly potent APIs are contained in astate-of-the-art isolator.

Split valve technologyAll material transfers from the dispensingisolator up to the capsule filling machineare contained and the connections areprovided with split valve docking systems.

Full glass wall panelsThe main rooms in the production andthe packaging area are divided by fullytransparent glass wall panels, creatinga feeling of space and light.

Energy saving

MINERGIE is a sustainability brand fornew and refurbished buildings which isregistered in Switzerland and around theworld. For the Celgene project, thestandard was applied by installation ofwood pellet heaters on the hot waterboilers, heat recovery on the HVACsystems and the use of treated rainwaterfor sanitary use.

focusfocus 1


12/20

focus2

crosscontaminationRABS PROVIDES THE ANSWER

Foster Wheelers Steril Manufacturing Division has successfully

designed and installed restricted access barrier systems (RABS)

on a number of blister packing lines, improving containment

without the need for operation in multiple production suites.

Pharma i

[email protected]

Dust containment, and therefore mitigation of the risk of cross-contamination, is the great challenge in designing an oral soliddosage (OSD) multi-product facility.

A common approach applied until now is to segregate processequipment, with a dedicated production room for each unit.Although this solution reduces the risk of cross-contamination,it is very expensive and can mean a delay of several monthsduring the revamp of an existing production suite. Any alternativesolution must protect both the operator and the product, andavoid or limit to an acceptable level any risk of cross-contamination.

With this in mind, the Steril team investigated the possibility of

applying its RABS concept, developed for aseptic production (asreported infocus Spring 2005), to segregate the OSD production

equipment. It was determined that with proper modification,RABS could successfully be used, limiting investment cost,reducing facility down-time, and satisfying the regulatory andsafety requirements.

Specific ApplicationA multinational company, interested in this new approach,commissioned the Steril team to construct and install the modifiedRABS on the clients blister packaging machines, all placed withinone single room but each dedicated to different OSD medium-activity products.

The timescale for the project was challenging, with productiondown-time limited to months 3 and 4:

design and construction: months 1 and 2

installation, start-up: month 3

validation: month 4

Our project team achieved this schedule and the blister-packaging machines, complete with modified RABS, areoperating successfully, meeting key regulatory and safety criteria.

Emilio Moia

Manager,contamination control

& containment

Modified RABS technical data

0 Pa 2 Pa pressure

Air flow rate 750 m3/h (about 150 V/H due to RABS total volume of 5m3)

Dedusting system with local extraction

Local extraction at entrance blister tape and exit blistered product

Airtight structure in stainless steel with front and back window in 12mm

safety glass


13/20

focus 1

novartischinaWORLD-CLASS SAFETY

In April 2007, the

Novartis Hua project in China

reached three million safe

manhours without a

lost-time incident (LTI).

Our Shanghai operation is

providing procurement and

construction management

services to Suzhou Novartis

Pharma TechnologyCompany Ltd., for this new

manufacturing facility in

Jiangsu Province.

It will initially cover an area of over200,000 m2 and will be a global supplycenter for Novartis chemical operations.

Site celebrationsTo celebrate the April safety milestone, wearranged for staff, contractor management,the workforce and our client to attend asafety presentation on site, whichincluded the presentation of thank-yougifts to everyone who has contributed tothis achievement.

During the safety presentation, ourconstruction manager Ben Rees remindedeverybody of the risks inherent inconstruction work and of the need tominimize these risks by always workingsafely and observing safety procedures.

Ben gave credit to the whole workforcefor reaching such a significant safetymilestone by adhering to all the safetyprinciples. He also stressed that theproject still has a long way to gobefore completion.

In closing, Ben reminded everybody ofthe need always to wear the light eyeprotection provided. He reiterated theproject ideal of ensuring that every workerleaves site every day without an accidentor an injury.

World-class performanceNovartis project manager Jerry Hourihanthen restated the project policy of safeworking and said that the safety recordachieved to date on this very importantproject in China was of a world-classstandard. He looked forward to reachingthe next safety milestone and said thatit could be achieved by everybodycontinuing to work safely and sticking tothe well-established safety procedures.

Fantastic four!And in August 2007, the team did reachthe next impressive milestone - four millionsafe hours without an LTI.

Congratulations to everyone involved!

Left to right: Ben Rees, Jerry Hourihan, Bin Lu, project manager,

NTCC (a main construction contractor); and Vito Yue, project HSE

manager, FW.

Jim GibsonGeneral manager,

Shanghai operation


14/20

investinginchinaCRITICAL SUCCESS FACTORS

Jimmy Zhang, VP China, and Andy Allen,

global chemicals business leader, offer

some sound advice on important issuesfor companies looking to invest in the

Chinese market.

focus4


15/20

Important factors to be considered prior tomaking such an investment include:

An understanding of the governmentpermitting process and requirements

Can local content be maximized toachieve lower costs?

Intellectual property protection

Risks in execution, HSE and plantquality

Effective site selection

Investment areas in China can be roughlydivided into three main categories:

1. The East coast, with a significant localbase of expertise and well-developedinfrastructure

2. The middle area of China, wherelogistics are more challenging andthere is currently little major investment

3. The North West region, where there aresignificant cost benefits along withhigher risks in general

There is a variety of industry parks

available, ranging from state-leveldevelopment zones offering greaterlikelihood of project approval and less riskof government policy change, to localdevelopment areas, where disadvantagesfrequently outweigh the cost benefits,particularly for foreign investors.

Local design institutesThere are many Chinese design institutes

(CDIs), one of which will usually need tobe involved and site selection will impacton the CDI selection, as many areregionally based.

Location also affects the choice ofconstruction company; civils companiestend to be localized and can influence thelocal municipality planning departments.A JV partner might bring its own CDI, andinsist on making the decision on selection.Permitting requirements are well-established, and inward investors need touse a CDI for much of this work. How this

CDI is selected and managed isfundamental to the whole process, andone where our services are in demand.

Local contentAs a general rule, the higher the localcontent, the cheaper the out-turn pricingfor the project. It is usually most cost-effective to use a CDI for the majority ofthe engineering design work, as only CDIs(and JV CDIs) have the ability to chop -to approve the work.

Now, however, regulations are changing.The Chinese government issued a newregulation early this year, which allowsinternational contractors to apply fora design license with some conditions.Currently, the contractors local officehandles project management, includingengineering management.

Local supply sourcesMost, but not all, items of equipment

are available locally and importation ofequipment needs close management.

What are the challenges? Local suppliers might be cheap, but

are typically less reliable on deliveryof equipment and documentation

Quality can be variable and goodadvice is essential in this area

Certain technology suppliers willinsist that some equipment items areimported from a shortlist of vendors tokeep process performance guarantees

Before cost estimating starts, anindicative equipment list is required toput together a procurement plan oflocal/imported equipment

Adopting local standards and codeswill save money, but it is essential toensure that this does not cut acrosscorporate standards

Local knowledgeThe engineering market is very stretchedin China, so local knowledge in selectingthe right team is essential. With the rightadvice leading to the adoption ofappropriate strategies, projects can beexecuted at a cost well below typicalWestern levels.

Pharma i

This article forms a prcis of a paper available at


focus 1

Andy AllenJimmy Zhang

Chinas average GDP growth rate of 8.1% over the past 20 yearshas transformed the economy of this large and diverse country.

Its rapidly-growing domestic market, coupled with a surgingexport trade in finished goods, make China a favoured locationfor many inward investors.


16/20

Since the introduction of the ISPEBaseline Guide for Commissioning andQualification (C&Q) there has been anemphasis on GEP.

The newly approved ASTM 2500 standardfor Specification, Design and Verificationof Pharmaceutical and BioPharmaceutical

Manufacturing Systems places an increasedemphasis on the use of GEP as part of

the life cycle for verification and qualificationof systems and facilities as fit-for-purposefor the manufacture of active ingredientsand pharmaceutical products.

Recently, regulatory bodies have focusedmore on the use of risk-based approachesto identify those areas which are critical topatient safety. Knowing and understandingthe entire process chain has becomeeven more important.

The new ASTM standard addresses thefollowing areas: risk-based approach

science-based approach

critical aspects of manufacturingsystems

quality by design

GEP

subject matter expert (SME)

use of vendor documentation

continuous process improvement

Bob Adamson, Foster Wheelers validation manager in Reading,

highlights the impact of recent changes to the regulatory

framework within which the industry operates and the increased

profile this has meant for Good Engineering Practice (GEP).

goodengineeringpracticeAN INCREASINGLY IMPORTANT ROLE

Bob Adamson

Validation manager

focus6


17/20

During the design phase, GEP providesan audit of HAZOPs, GMP, materials ofconstruction, layout, operation andmaintenance, and constructability. Doesthe design meet user requirements and canthe design be constructed as intended?

During the detailed design phase, C&Qplanning needs to develop at a pacesimilar to that of the project and must be

fully integrated into the overall projectplan. It is useful for the quality assurancegroup to audit the GEP although they mayrely on an independent audit.

C&Q is a GEP activity and is a well-planned, well-documented and well-managed engineering approach to thestart-up and turnover of systems andequipment to the end user.

The new standard stipulates a processthat uses the SME/engineering disciplineexpert to independently verify thedocumentation. The impact of thisapproach is to reduce costs by focusingthe validation effort on product quality andcritical attributes. It empowers theengineer SMEs to be responsible for allother aspects of product and productionprocesses through GEP. The whole

process relies on GEP, which is the basisof verification and confirmation of fit-for-intended-purpose.

GEP is a disciplined approach to thespecification, design, procurement,installation and C&Q of the facility andequipment systems, from projectinception through each subsequentphase. The key initial step is a cleardefinition of user and businessrequirements, related directly to, andbased on, critical product qualityattributes and process parameters.

GEP should consider: operation, ergonomics and

maintenance

safety, health and environment

industry guidance and statutoryrequirements

and should: provide a professional approach to

project management

supply appropriate documentation

manage change

Pharma i

Download the full paper from our website:


focus 1


18/20

focus8

In recognition of his long-term, enthusiastic support, the global ISPE organization hasrecognized Dr Julian Salomon, now retired from Foster Wheeler, for his OutstandingLeadership to the ISPE UK Affiliate. ISPE marked the occasion with a presentation byJohn Nichols, a director of ISPE, and Foster Wheelers global pharma technology director,

at the UK ISPE AGM which was held in our Reading, UK, offices.

Back in 1989 ISPE formed its UK affiliate, the first overseas affiliate for what was then aUS-based society. Julian, then a key figure in our expanding pharma business, wasa significant driving force in gathering support and pulling together the UK Affiliatecommittee. He subsequently saw the affiliate grow to 1,500 members, with activerepresentation in five areas of the UK.

In 1999 Julian received the UK Fellow Award in recognition of his outstanding contributionto the UK Affiliate, and retired from the committee in March this year after 18 yearsactive participation.

Julian Salomon

receives ISPE Award foroutstanding leadership

ispeaward18 YEARS OF ENERGETIC SUPPORT

speispeispeispeispeispeispeispeispeis


19/20

eispeispeispeispeispeispeispeispeispe

focus 19

We have been busy

attending, exhibiting andpresenting at variousglobal ISPE conferences

and seminars, as well as

playing an active role inseveral committees.

In Copenhagen in February, Bob Davies,principal biotech consultant, led a trainingsession on biopharmaceutical processdevelopment and Bob Adamson,validation manager, led one oncommissioning and qualification.

The first educational seminar held by theISPE Turkey affiliate took place in March.The main theme of the event wascontainment and expert speakersincluded John Nichols, our globalpharmaceutical technology director.

Nano- and micro-technology forpharmaceutical products and processeswas one of the strands of the Aprilseminar in Paris, chaired by John Nichols.At the same event, Paul Frey, principalpharma consultant, presented a bottom-line approach to the modification of awater-for-injection system.

Barcelona in May saw Bob Davies

present on biopharmaceuticalmanufacturing facilities and in June,Richard Chacksfield, principal technicalengineer, presented on effectiveoperational simulation at an ISPE UKNorthern Region seminar.

Mike Brocklebank was part of theorganising committee for the 2007Singapore conference in June, at whichZoran Serbedzija co-hosted a workshopwith Schering-Ploughs Garith Connor onpharmaceutical facility project managementviewed from a contractors perspective.

In Durham in the UK in July, MarkDickson, senior process engineer,presented on step-change technology,understanding process kinetics andmatching equipment to the process.

PublicationsBaseline Guide Volume 1, 2nd Edition:Active Pharmaceutical Ingredients, aRevision to Bulk PharmaceuticalChemicals, was published in June 2007.It incorporates and builds on newregulations and guidance. The revisedguide was developed by an integratedUS-European team. John Nichols wastechnical consultant for the Europeanteam and was also a member of thesteering committee, a contributing authorto the chapter on containment, and leadauthor for the glossary. Dennis Fortune,principal architect, was a contributingauthor to the chapters on facility layout

and architecture.

Interphex 2007We exhibited at Interphex, one of theleading trade shows for the industry, whichhosted 16,000 industry professionals at theJacob K Javits Center in New York duringa three-day period in April.

Interphex is now the event at which theannual Facility of the Year (FOYA)Category Winners are announced. In hiscapacity as Chair of the FOYA Committee,Clive Mullins, our global pharma director,

hosted the presentation of the 2007awards to the successful companies at adinner in the impressive surroundings ofthe Yale Club.

Pharma i

Download papers from our website at

www.fwc.com/publications

Pharma i

Forthcoming events are listed on our website at

www.fwc.com/enewsroom/events.cfm

commitmenttoispeEXHIBITIONS AND PRESENTATIONS

Clive Mullins hosting the annualFacility of the Year Awards during Interphex


20/20

Technical consultancy

Feasibility studies

Concept design

Site selection

Site master planning

Permitting

Environmental consultancy

Process simulation

Basic design

Detailed engineering

Project management

ProcurementConstruction management

Commissioning

Validation

Plant operation

Maintenance

Site remediation

the right people with a

can do attitude and the

commitment to deliver

PHARMACEUTICALS - BIOTECHNOLOGY - HEALTHCARE

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focus issue7

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