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FOSTER WHEELERS PHARMACEUTICALS BUSINESS MAGAZINE ISSUE 7

Technical innovation adds value

eispeispeispeispeispeispeispeispeispeisp fwpharmasuccess
GLOBAL ROUND-UP OF RECENT WINS

We continue to secure significant new pharma business around the world, across the full range of technologies:

Category Key
Secondary General Infrastructure Validation API Biotech R&D

Elsewhere, our clients continue to value the quality of our teams and the facilities we design and build.
This (10th anniversary) is a significant achievement for the 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 worldclass projects. Foster Wheeler has demonstrated how seriously it takes health and safety management and is a fine example to many other companies. We would like to see more organizations following their lead. INVISTA has been delighted with the quality of 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 hardworking attitude of the whole Foster Wheeler team, we could not have achieved this challenging target, which some people did not believe we could meet.

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.

focus ON ADDING VALUE

At a time of great change in the industry, Im pleased to introduce an edition of focus that demonstrates 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 first investment 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.
Published by Foster Wheeler Shinfield Park Reading Berkshire RG2 9FW UK www.fwc.com Managing Editors Carolyn Greenhalgh Director, Strategic Planning & Marketing Global E&C Group T 0118 913 2494 E carolyn_greenhalgh@fwuk.fwc.com Jacqueline Hogarty Senior Marketing Consultant Global E&C Group T 0118 913 2167 E jacqueline_hogarty@fwuk.fwc.com Produced by FW Graphics Group Foster Wheeler 2007

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Global round-up - recent wins Singapore successes Practical containment Design innovations for Celgene Happy birthday Basel!

10-11 Airflow modeling in clean rooms 12 13 New cross-containment solutions Novartis China safety celebrations

14-15 Investing in China 16-17 Good Engineering Practice 18-19 Supporting ISPE

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 Mullins
Vice president Global business development Pharmaceuticals, biotechnology, healthcare

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majormilestonesinsingapore
SUCCESSFUL COMPLETION

We have successfully completed a greenfield oral solid dosage manufacturing facility for Novartis at the Tuas Biomedical Park in Singapore.

This is a major milestone for our global pharmaceutical operations as it represents the first world-scale pharmaceutical project for which 100% of the detailed engineering has been undertaken by our Singapore office. Novartis Singapore Pharmaceutical Manufacturing is a center of excellence for its solid dosage form manufacturing. One of the guiding principles for the design of this plant was lean manufacture and the process-oriented layout increases the plants efficiency. In March this year, we handed over this facility to Novartis on receipt of the temporary occupation permit, following an inspection by the Singapore Governments building control inspection team. At peak there were around sixty staff in the engineering and procurement team, with about forty Foster Wheeler site supervisory and support staff - 90% of the latter being locally recruited.

Mike Brocklebank Manager, pharmaceuticals Singapore

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Foster Wheeler is working closely with GlaxoSmithKline Biologicals to create a major new vaccines manufacturing facility in Singapore.

greenfieldtriumph
NEW VACCINES PRODUCTION FACILITY
We have been awarded an engineering, procurement, construction management and commissioning services contract by GSK Biologicals for a new vaccines production facility in Singapore. This state-of-the-art facility includes two production buildings, a quality control and administration building and a utilities building, all on a site of more than 8.8 hectares in the Tuas Biomedical Park. Our Asia Pacific team in Singapore, together with specialists from 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 our Singapore 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 their project director, David Callaert, both to maximize the rate of progress 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 2008 which 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 realizing billions 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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practicalcontainment
SUCCESSFUL, STRUCTURED APPROACH

Huw Thomas Principal pharmaceutical engineer

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.

Articles on containment typically start by identifying the drivers behind an increasing focus on containment for pharmaceutical manufacturing, namely: Active pharmaceutical ingredients (APIs) are becoming more targeted and hence of higher potency. Internal and external environmental, health and safety pressures are pushing for engineered controls rather than relying on personal protective equipment. At this point a bewildering array of containment devices and jargon is presented along with claims such as test results with lactose using SMEPAC show average >1g/m3 for an 8hr TWA performance Fig 1 shows the hierarchy of risk assessment methods, with the bottom tier of standards and guidelines used to

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Full paper available at http://www.fwc.com/publications

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QRA Factor-Based Risk Assessment Qualitative Risk Assessment

Standards and Guidelines

Fig 1: Risk assessment hierarchy

Scale Tonne

Dustiness Micronised Powders Granules

Process Energy Milling/ Sieving

API Content 100%

Increased Containment

Kilogramme

Wet Cake Coated Tablets Creams/ Ointments

Charging/ Discharging

10%

Gram

Weighing/ Dispensing

1%

Less Containment

Fig 2: Process factors affecting required containment level

prescribe the containment solution for common, routine operations. Moving up through the tiers, the assessment methods become more complex with the top tier, quantified risk assessment (QRA), used for complex, high-risk operations that usually involve significant off-site, wide-reaching consequences, such as in high potency pharma manufacturing and nuclear installations. The methods in the two lowest tiers are the most commonly used in the pharma industry. Many companies have internal guidelines and standards, and some industry-wide standards exist. The tier-two method, qualitative risk assessment, takes into account a number of factors (Fig 2) before determining the required containment strategy. This strategy is based on industry-wide, practical operating experience that indicates which containment solution will typically give adequate containment.

Foster Wheeler has taken the tier-two approach and has applied numerical ranges to each factor in the above diagram. We have used this semiquantitative factor-based risk assessment (tier three) to assess the exposure risk of a wide range of operations in lab-, pilotand full scale manufacturing plants for highly potent and cytotoxic materials. For complex operations, this method has been found to give the following benefits: Widely different operations can be compared, making it possible to indicate which operation needs addressing first and the scale of the required improvement in the engineered containment. The rationale behind the decisionmaking is transparent and can be challenged.

The decision-making process is fully traceable from the initial process description through to the containment system design. This is very useful in avoiding opinion engineering and allows the basis and rationale behind a design decision to be challenged rather than endless and often fruitless discussion on the design itself. The Foster Wheeler structured, risk-based approach to containment design has been successfully used over a wide range of projects. These include reviewing plants during the design stage, reviewing and rapid upgrading of containment in existing plants to meet urgent operating needs, and developing future containment approaches for existing plants to achieve significant reductions in operator exposure.

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modeling clean room airflows

CFDA - A TOOL THAT PAYS FOR ITSELF

Foster Wheeler has successfully used computat analysis (CFDA) to model clean room airflows a circulation. This creates the opportunity to mod and generate savings in project schedule and in
The use of CFDA to model the airflow pattern inside sterile rooms during the early design phase allows the designer to optimize the clean room configuration. This considerably reduces the likelihood that that any lack of product protection will be observed only in the commissioning phase, when its correction is likely to cause a serious impact on plant completion. The analysis is used to identify equipment and other physical features within the room, the location of which could negatively affect unidirectional airflow, which in turn could jeopardize product protection. For example: the location inside the clean room of any equipment - and its shape - could interfere with the airflow distribution Putting CFDA into practice In Foster Wheeler, CFDA is carried out by finite element analysis. The inputs to the simulation model are: geometry of the room and of the main equipment boundary conditions (supply air velocity and 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 of sections of the volume involved in the study. In each section different colors are used to easily highlight the different values of the output from the simulation model.

Carlo Magni Senior HVAC engineer

Luca Arrighi Head of HVAC department

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Contact emilio_moia@fwceu.com www.steril.it

the location of the return grilles or return air walls could be asymmetrical the shapes of the laminar air flow area and/or of the rooms could be asymmetrical

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Fig 1

Fig 2

Fig 3

Fig 4

tional fluid dynamic and identify areas of poor ify the design, reduce risk n capital/operating costs.
Case Study We were requested by a major pharmaceutical company to study the sterile filling core at one of its operating sites in Italy. In this case we used CFDA to define the proper layout of the HVAC supply HEPA filters to guarantee that there were no backflows and/or turbulence over the working area. As shown in Fig 1, the room is occupied by one conveyor that transports sterilized vials to the filling machine and then transfers the filled vials to packaging. The filling machine incorporates one glove box to introduce the product and a second glove box that provides the caps. The conveyor is supplied with independent laminar airflow units (filter fan units) located a few centimeters above it. The first design approach was to distribute the air supply HEPA filters equally across the ceiling whereas the position of return air grilles was governed by the equipment layout. CFDA (Fig 2) identified a critical area close to the conveyor (see the left side of Fig 2) where a zone of stagnant air (blue colour) was surrounded by a high-velocity air-stream (red colour). The unidirectional airflow was therefore completely lost close to the critical area on the conveyor where the product was still exposed. Based on these results, we re-ran the simulation, removing the last row of ceiling diffusers close to the air walls. We anticipated that this would reduce the swirl velocity close to the conveyor. The result (Fig 3) was a reduction in the swirl velocity but also an increase in the stagnant area adjacent to the conveyor. Finally, a third solution was considered (Fig 4): create a closure over the conveyor area provide laminar airflow directly by means of the HVAC plant over the whole room rather than filter fan units (as in solutions 1 and 2) reduce the total supply airflow rate (hence reducing investment and operating costs) With this configuration, the problems of swirl velocity and a stagnant area close to the conveyor were both solved at the same time. The feasibility of this solution was finally checked with the clients operating personnel to ensure that the vertical closure did not limit the operations inside the room. The client regarded the study as a complete success, appreciating the high level of design achieved by the simulation model, and accepted and used the study results.

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happybirthday!
10 YEARS IN BASEL

Peter Sala General manager, Basel office

Office opened: First project: Moved to new office: Completion of first EPC project: Latest plant completed:

November 1997 Centeon, Marburg, Germany, validation services for a blood fractionation plant 2000 2005 for Metalor in Switzerland Celgene

Foster Wheelers Basel office is 10 years old and is delivering against the objectives set at its founding.
Our office in Basel was set up in 1997 to serve the pharmaceutical industry in the German-speaking area of Switzerland. Since then our multi-discipline, multi-lingual team has 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 feasibility studies, master planning, design, simulation modelling, 3D modelling, engineering, procurement, construction management, start-up, qualification and validation. Plant types include pilot and production plants for APIs (both for chemical synthesis and biotechnology), oral solid dosage plants, semi solids, creams, ointment and sterile fill-finishing plants. In celebrating this important milestone, Peter Sala, general manager, recognized the vital contribution of the team in the Basel office, many of whom have been with him since its 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 and effectively integrated with other Foster Wheeler offices when local clients invest overseas.
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Werner Schoeneck Senior project manager

designinnovations
CELGENES CAESAR PROJECT
A number of innovative design features were incorporated, including: White line concept Ordering unprinted or partially pre-printed (so-called white) packaging material and then printing exact data on to it, as and when required. Dispensing isolator Sieving and weighing processes for the highly potent APIs are contained in a state-of-the-art isolator. Split valve technology All material transfers from the dispensing isolator up to the capsule filling machine are contained and the connections are provided with split valve docking systems. Full glass wall panels The main rooms in the production and the packaging area are divided by fully transparent glass wall panels, creating a feeling of space and light. Energy saving MINERGIE is a sustainability brand for new and refurbished buildings which is registered in Switzerland and around the world. For the Celgene project, the standard was applied by installation of wood pellet heaters on the hot water boilers, heat recovery on the HVAC systems and the use of treated rainwater for sanitary use.

Foster Wheelers Basel office has successfully completed Celgenes greenfield oral solid dosage manufacturing facility, featuring many design innovations.
Celgene is a US-headquartered biopharmaceutical company primarily engaged in the discovery, development and commercialization of therapies designed to treat cancer and immunological diseases. Located in the lovely Three-Lake region of Switzerland, Celgenes new facility will produce REVLIMID (lenalidomide) in capsule form. This drug is used in combination with dexamethasone for the treatment of multiple myeloma, a type of bone marrow cancer. Our lump-sum contract included engineering, procurement, construction management and validation for all nonarchitectural and civil engineering activities, 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, a warehouse, QA laboratories, utilities and infrastructure.

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Emilio Moia Manager, contamination control & containment

crosscontamination
RABS 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.
Dust containment, and therefore mitigation of the risk of crosscontamination, is the great challenge in designing an oral solid dosage (OSD) multi-product facility. A common approach applied until now is to segregate process equipment, 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 months during the revamp of an existing production suite. Any alternative solution must protect both the operator and the product, and avoid 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 (as reported in focus 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 and safety requirements. Specific Application A multinational company, interested in this new approach, commissioned the Steril team to construct and install the modified RABS on the clients blister packaging machines, all placed within one single room but each dedicated to different OSD mediumactivity products. The timescale for the project was challenging, with production down-time limited to months 3 and 4: design and construction: installation, start-up: validation: months 1 and 2 month 3 month 4

Our project team achieved this schedule and the blisterpackaging machines, complete with modified RABS, are operating successfully, meeting key regulatory and safety criteria. 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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Contact emilio_moia@fwceu.com www.steril.it

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novartischina
WORLD-CLASS SAFETY
It will initially cover an area of over 200,000 m2 and will be a global supply center for Novartis chemical operations. Site celebrations To celebrate the April safety milestone, we arranged for staff, contractor management, the workforce and our client to attend a safety presentation on site, which included the presentation of thank-you gifts to everyone who has contributed to this achievement. During the safety presentation, our construction manager Ben Rees reminded everybody of the risks inherent in construction work and of the need to minimize these risks by always working safely and observing safety procedures. Ben gave credit to the whole workforce for reaching such a significant safety milestone by adhering to all the safety principles. He also stressed that the project still has a long way to go before completion. In closing, Ben reminded everybody of the need always to wear the light eye protection provided. He reiterated the project ideal of ensuring that every worker leaves site every day without an accident or an injury. World-class performance Novartis project manager Jerry Hourihan then restated the project policy of safe working and said that the safety record achieved to date on this very important project in China was of a world-class standard. He looked forward to reaching the next safety milestone and said that it could be achieved by everybody continuing to work safely and sticking to the well-established safety procedures. Fantastic four! And in August 2007, the team did reach the next impressive milestone - four million safe hours without an LTI. Congratulations to everyone involved!

Jim Gibson General manager, Shanghai operation

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 Technology Company Ltd., for this new manufacturing facility in Jiangsu Province.

Left to right: Ben Rees, Jerry Hourihan, Bin Lu, project manager, NTCC (a main construction contractor); and Vito Yue, project HSE manager, FW.

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investinginchina
CRITICAL SUCCESS FACTORS

Jimmy Zhang, VP China, and Andy Allen, global chemicals business leader, offer some sound advice on important issues for companies looking to invest in the Chinese market.

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Jimmy Zhang

Andy Allen

Chinas average GDP growth rate of 8.1% over the past 20 years has transformed the economy of this large and diverse country. Its rapidly-growing domestic market, coupled with a surging export trade in finished goods, make China a favoured location for many inward investors.
Important factors to be considered prior to making such an investment include: An understanding of the government permitting process and requirements Can local content be maximized to achieve lower costs? Intellectual property protection Risks in execution, HSE and plant quality Effective site selection Investment areas in China can be roughly divided into three main categories: 1. The East coast, with a significant local base of expertise and well-developed infrastructure 2. The middle area of China, where logistics are more challenging and there is currently little major investment 3. The North West region, where there are significant cost benefits along with higher risks in general There is a variety of industry parks available, ranging from state-level development zones offering greater likelihood of project approval and less risk of government policy change, to local development areas, where disadvantages frequently outweigh the cost benefits, particularly for foreign investors. Local design institutes There are many Chinese design institutes (CDIs), one of which will usually need to be involved and site selection will impact on the CDI selection, as many are regionally based. Location also affects the choice of construction company; civils companies tend to be localized and can influence the local municipality planning departments. A JV partner might bring its own CDI, and insist on making the decision on selection. Permitting requirements are wellestablished, and inward investors need to use a CDI for much of this work. How this CDI is selected and managed is fundamental to the whole process, and one where our services are in demand. Local content As a general rule, the higher the local content, the cheaper the out-turn pricing for the project. It is usually most costeffective to use a CDI for the majority of the 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 new regulation early this year, which allows international contractors to apply for a design license with some conditions. Currently, the contractors local office handles project management, including engineering management. Local supply sources Most, but not all, items of equipment are available locally and importation of equipment needs close management. What are the challenges? Local suppliers might be cheap, but are typically less reliable on delivery of equipment and documentation Quality can be variable and good advice is essential in this area Certain technology suppliers will insist that some equipment items are imported from a shortlist of vendors to keep process performance guarantees Before cost estimating starts, an indicative equipment list is required to put together a procurement plan of local/imported equipment Adopting local standards and codes will save money, but it is essential to ensure that this does not cut across corporate standards Local knowledge The engineering market is very stretched in China, so local knowledge in selecting the right team is essential. With the right advice leading to the adoption of appropriate strategies, projects can be executed at a cost well below typical Western levels.

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This article forms a prcis of a paper available at http://www.fwc.com/publications

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goodengineeringpractice
AN INCREASINGLY IMPORTANT ROLE

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).
Since the introduction of the ISPE Baseline Guide for Commissioning and Qualification (C&Q) there has been an emphasis on GEP . The newly approved ASTM 2500 standard for Specification, Design and Verification of Pharmaceutical and BioPharmaceutical Manufacturing Systems places an increased emphasis on the use of GEP as part of the life cycle for verification and qualification of systems and facilities as fit-for-purpose for the manufacture of active ingredients and pharmaceutical products. Recently, regulatory bodies have focused more on the use of risk-based approaches to identify those areas which are critical to patient safety. Knowing and understanding the entire process chain has become even more important. The new ASTM standard addresses the following areas: risk-based approach science-based approach critical aspects of manufacturing systems quality by design GEP subject matter expert (SME) use of vendor documentation continuous process improvement

Bob Adamson Validation manager

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GEP is a disciplined approach to the specification, design, procurement, installation and C&Q of the facility and equipment systems, from project inception through each subsequent phase. The key initial step is a clear definition of user and business requirements, related directly to, and based on, critical product quality attributes and process parameters. GEP should consider: operation, ergonomics and maintenance safety, health and environment industry guidance and statutory requirements and should: provide a professional approach to project management supply appropriate documentation manage change

During the design phase, GEP provides an audit of HAZOPs, GMP , materials of construction, layout, operation and maintenance, and constructability. Does the design meet user requirements and can the design be constructed as intended? During the detailed design phase, C&Q planning needs to develop at a pace similar to that of the project and must be fully integrated into the overall project plan. It is useful for the quality assurance group to audit the GEP although they may rely on an independent audit. C&Q is a GEP activity and is a wellplanned, well-documented and wellmanaged engineering approach to the start-up and turnover of systems and equipment to the end user.

The new standard stipulates a process that uses the SME/engineering discipline expert to independently verify the documentation. The impact of this approach is to reduce costs by focusing the validation effort on product quality and critical attributes. It empowers the engineer SMEs to be responsible for all other aspects of product and production processes through GEP . The whole process relies on GEP , which is the basis of verification and confirmation of fit-forintended-purpose.

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Download the full paper from our website: http://www.fwc.com/publications

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eispeispeispeispeispeispeispeispeispeisp

ispeaward
18 YEARS OF ENERGETIC SUPPORT

Julian Salomon receives ISPE Award for outstanding leadership

In recognition of his long-term, enthusiastic support, the global ISPE organization has recognized Dr Julian Salomon, now retired from Foster Wheeler, for his Outstanding Leadership to the ISPE UK Affiliate. ISPE marked the occasion with a presentation by John 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 a US-based society. Julian, then a key figure in our expanding pharma business, was a significant driving force in gathering support and pulling together the UK Affiliate committee. He subsequently saw the affiliate grow to 1,500 members, with active representation in five areas of the UK. In 1999 Julian received the UK Fellow Award in recognition of his outstanding contribution to the UK Affiliate, and retired from the committee in March this year after 18 years active participation.

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peispeispeispeispeispeispeispeispeispeis commitmenttoispe
EXHIBITIONS AND PRESENTATIONS

We have been busy attending, exhibiting and presenting at various global ISPE conferences and seminars, as well as playing an active role in several committees.
In Copenhagen in February, Bob Davies, principal biotech consultant, led a training session on biopharmaceutical process development and Bob Adamson, validation manager, led one on commissioning and qualification. The first educational seminar held by the ISPE Turkey affiliate took place in March. The main theme of the event was containment and expert speakers included John Nichols, our global pharmaceutical technology director. Nano- and micro-technology for pharmaceutical products and processes was one of the strands of the April seminar in Paris, chaired by John Nichols. At the same event, Paul Frey, principal pharma consultant, presented a bottomline approach to the modification of a water-for-injection system. Barcelona in May saw Bob Davies present on biopharmaceutical manufacturing facilities and in June, Richard Chacksfield, principal technical engineer, presented on effective operational simulation at an ISPE UK Northern Region seminar. Mike Brocklebank was part of the organising committee for the 2007 Singapore conference in June, at which Zoran Serbedzija co-hosted a workshop with Schering-Ploughs Garith Connor on pharmaceutical facility project management viewed from a contractors perspective.

In Durham in the UK in July, Mark Dickson, senior process engineer, presented on step-change technology, understanding process kinetics and matching equipment to the process. Publications Baseline Guide Volume 1, 2nd Edition: Active Pharmaceutical Ingredients, a Revision to Bulk Pharmaceutical Chemicals, was published in June 2007. It incorporates and builds on new regulations and guidance. The revised guide was developed by an integrated US-European team. John Nichols was technical consultant for the European team and was also a member of the steering committee, a contributing author to the chapter on containment, and lead author for the glossary. Dennis Fortune, principal architect, was a contributing author to the chapters on facility layout and architecture. Interphex 2007 We exhibited at Interphex, one of the leading trade shows for the industry, which hosted 16,000 industry professionals at the Jacob K Javits Center in New York during a three-day period in April. Interphex is now the event at which the annual Facility of the Year (FOYA) Category Winners are announced. In his capacity as Chair of the FOYA Committee, Clive Mullins, our global pharma director, hosted the presentation of the 2007 awards to the successful companies at a dinner in the impressive surroundings of the Yale Club.

Clive Mullins hosting the annual Facility of the Year Awards during Interphex

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Download papers from our website at www.fwc.com/publications

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Forthcoming events are listed on our website at www.fwc.com/enewsroom/events.cfm

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

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

Plant operation Maintenance Site remediation

PHARMACEUTICALS - BIOTECHNOLOGY - HEALTHCARE

fw_pharma@fwc.com www.fwc.com