focus issue7
TRANSCRIPT
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focusFOSTER WHEELERS PHARMACEUTICALS BUSINESS MAGAZINE
ISSUE 7
Technical innovation adds value
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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.
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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
queline Hogarty
ior Marketing Consultant
bal E&C Group
0118 913 2167
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
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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
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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
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greenfieldtriumphNEW VACCINES PRODUCTION FACILITY
Foster Wheeler is working closely
with GlaxoSmithKline Biologicals
to create a major new vaccinesmanufacturing facility in Singapore.
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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
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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
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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.
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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%
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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
Luca Arrighi
Head of HVACdepartment
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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
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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
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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.
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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
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
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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
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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.
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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
http://www.fwc.com/publications
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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.
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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
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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:
http://www.fwc.com/publications
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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
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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
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commitmenttoispeEXHIBITIONS AND PRESENTATIONS
Clive Mullins hosting the annualFacility of the Year Awards during Interphex
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7/28/2019 Focus Issue7
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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