FOYA Supplement to November/December 2008 Pharmaceutical ... · The 2008 Facility of the Year...

2 Supplement to PHARMACEUTICAL ENGINEERING

Articles3 Introduction

The 2008 Facility of the Year Awards

Overall Winner – 2008 Facility of the Year4 Pfizer Manufacturing Deutschland GmbH

Containing a New Era in Pharmaceutical Manufacturing

Category Winner – Facility Integration10 Boehringer Ingelheim

Category Winner – Equipment Innovation12 Bristol-Myers Squibb

Category Winner – Operational Excellence18 IDT Biologika GmbH

Category Winner – Project Execution20 F. Hoffmann La Roche AG

Cover PhotographPhoto courtesy of PfizerManufacturing DeutschlandGmbH.

Table of Contents

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ISPE would like to thank the following Facility of the Year Category Winners’ key projectparticipants for their generous advertising support which made this Supplement possible.

Advertiser's IndexCOMECER .................................................................................................... 9FIKE ............................................................................................................ 7GEA PROCESS ENGINEERING ....................................................................... 15GRONINGER ............................................................................................... 24HOSOKAWA .............................................................................................. 14IPS ............................................................................................................ 13LANG UND PEITLER AUTOMATION ............................................................... 21LSMW ....................................................................................................... 23SKAN ........................................................................................................ 17VTU ENGINEERING ..................................................................................... 22

www.facilityoftheyear.org

Supplement to PHARMACEUTICAL ENGINEERING 3

Introduction

The 2008 Facility of the Year Awards

The Facility of the Year Awards(FOYA) program, sponsored byISPE, INTERPHEX, and Pharma-

ceutical Processing magazine, recognizesstate-of-the-art pharmaceutical manu-facturing projects that utilize new andinnovative technologies to enhance thedelivery of a quality project, as well asreduce the cost of producing high-qual-ity medicines.

Now entering its fifth year, the an-nual FOYA Awards program effectivelyspotlights the accomplishments, sharedcommitment, and dedication of individu-als in companies worldwide to innovateand advance pharmaceutical manufac-turing technology for the benefit of allglobal consumers.

Each of the 2008 submissions wasreviewed by an independent, blue-rib-bon judging panel of global representa-tives from the pharmaceutical design,construction, and manufacturing sectors,including:

• Andy Skibo, Judging Panel Chair- Senior Vice President of Global En-gineering, MedImmune

• Jim Breen – Vice President of ProjectManagement, Johnson and Johnson

• Chaz Calitri – Senior Director ofGlobal Engineering, Pfizer

• Andrew Ellis – Vice President ofEngineering & Technology of Con-sumer Healthcare, GSK

• Christian Ilsøe – Vice President ofQuality & Validation Assurance, NNE

• Brian Lange - Director of Engineer-ing, Merck & Co.

• Geoff Monk – Vice President of Glo-bal Engineering Services, ScheringPlough

• Shinichi Osada – Chief MarketingManager, Pharma, Hitachi/Ind PlantsDiv

• Jon Reed – Vice President of Corpo-rate Engineering, Genentech

• Ron Trudeau – Vice President ofFacilities Engineering, BaxterHealthcare

Pharmaceutical EngineeringFocuses on Winners

This Supplement to PharmaceuticalEngineering was developed specificallyto highlight the remarkable features andtechnologies of the company selected asthe Overall Winner of the 2008 Facilityof the Year Awards program.

The following pages also will take youbehind the construction and competi-tion curtains, featuring the CategoryWinners’ and the FOYA Judging Panel’sthoughts on:

Challenges in Facility Design• Cost pressures

• Time pressures

• Fast-changing market demands

• Advances in science and technology

• Fewer blockbusters, more custom,lower volume drugs

• Manufacturing flexibility more criti-cal

• Many newly discovered pharmaceu-tical actives from research are highlypotent

• Decreasing direct labor costs

Trends in Facility Design• Automation

• Quality by Design and science- andrisk-based approaches

• PAT

• Lean manufacturing concepts

• Use of model simulation software

• Use of skid mounted equipment

• Streamlined C&Q

• Integrating different functions in onebuilding, fostering close interaction

• Multi-purpose facilities

• Multi-product processing

• Built flexibility, allowing fast andcost-efficient adjustments to accom-modate new technologies withoutmajor renovation work

• End user/shop floor operator involve-ment early in project

2009 Facility of the Year AwardCall for Submissions

Does your company have a new or renovated facility that’s best in itsclass? Has your firm recently designed, built, or renovated a state-of-the-art pharmaceutical or biotechnology facility? If so, submit an entry forthe 2009 Facility of the Year Awards program and your firm may win thecoveted 2009 Facility of the Year Award.

In addition to sharing your innovative ideas and lessons-learned withpeers, your company will receive the benefit of high-profile mediacoverage in Pharmaceutical Processing magazine, at internationalINTERPHEX events, at all 2009 ISPE events, and right here inPharmaceutical Engineering magazine. Past winners have obtained pressattention and extensive coverage from other worldwide industrypublications.

The submission deadline for the 2009 awards program is 1 December2008. Detailed eligibility and submission information can be obtained bydownloading the 2009 Submission Package available at www.facilityoftheyear.org.


Pfizer – Overall Winner

Overall Winner – 2008 Facility of the Year AwardPfizer Manufacturing Deutschland GmbH

Afew years ago Pfizer Manufactur-ing Deutschland GmbH inIllertissen, Germany began work-ing on the answer to the question:

Can we push a button once to start theprocess and several hours later – withoutany human intervention – receive filmcoated tablets?

The answer materialized in 2007 in theform of an elegant, futuristic facility hous-ing one of the most intelligent pharmaceu-tical production plants in the industry. Thefacility, named the New Containment(NEWCON) Facility for Oral Solid Dosage,is this year’s Overall Winner of the 2008Facility of the Year Award.

NEWCON turned unconventional processing concepts –including the single-room concept, high automation requiringno operator interface, and PAT applications – into a safe andefficient manufacturing reality for the production of the smok-

ing cessation product Chantix®.In an era where industry faces cost and time pressures and

changing market demands, Facility of the Year Award judgesviewed NEWCON’s achievements as innovative, resourceful,

and pioneering, not only in containmentproduction, but in the entire field of phar-maceutical manufacturing.

A Market-Driven DecisionIn 2005, Pfizer Manufacturing DeutschlandGmbH in Illertissen, Germany was pro-vided with a preliminary sales forecast pro-jecting a rising demand for Chantix® (Euro-pean product name: Champix®), a smokingcessation product with the active pharma-ceutical ingredient varenicline, which helpsadults quit smoking by reducing smokingcessation withdrawal symptoms and thecraving for cigarettes.

Pfizer manufactures varenicline in LittleIsland, Ireland, and at the time was con-ducting secondary production (tablets) atPfizer Illertissen’s pilot containment facil-ity, Illertissen Containment (ICON).

“It became crystal clear that our existing

Containing a New Era in PharmaceuticalManufacturingby Rochelle Runas, ISPE Technical Writer

NEWCON exterior view.

Pfizer Manufacturing Deutschland GmbHOverall Winner (and Category Winner in Process Innovation)

Project: New Containment Facility for Oral Solid Dosage (NEWCON)Location: Illertissen, GermanyArchitect: PhC PharmaConsult, HeidelbergConsultant: PhC PharmaConsult, HeidelbergConstruction Manager/Project Manager: Hans Sägmüller, PfizerIllertissenSize: 83,958 sq. ft. (7,800 sq. m.)Cost: US $55 million (39 million Euros)Product: Chantix®/Champix®

Key Project Participants:AximaComecerGE FanucGerteis

GlattIMAImtech

Koppenhoefer and PartnerRotanServolift

Continued on page 6.

www.facilityoftheyear.org

Deadline for

Submissions

1 December

2008

2009 Facility of the Year AwardsCALL FOR ENTRIES

9

The Facility of the Year Awards are an annual program that recognizes state-of-the-art pharmaceutical manufacturing projects utilizing new and innovative technologies to improve the quality of projects and to reduce the costs of producing medicines. This unique program provides a platform for the pharmaceutical science and manufacturing industries to showcase their accomplishments in facility design, construction, and operation.

For additional information about the Awards program, and access to the online submission form, visitwww.facilityoftheyear.org.



pilot containment facility would not be in the position to supportthe lifecycle of this product and was never intended to,” saidHolger Weyhers, PhD, Director of Production, Pfizer Manufac-turing Deutschland GmbH.

Driven by the urgent need for greater production capacity, in2005, Pfizer Illertissen embarked on the design for the NEWCONproject. Time pressure was further intensified by the successfullaunch of Chantix® in the US the following year, pushing up theproject completion date by six months. Nevertheless, the 7,800sq. m. facility was completed in late 2007 after a constructionperiod of just 25 months.

Pioneers in Containment ManufacturingPfizer Illertissen, which specializes in the oral solid dosageform production of highly potent compounds involving complexcontainment requirements, was already breaking new groundin containment manufacturing at its ICON pilot facility.

During the first planning phase of ICON, Pfizer Illertissenwas faced with a challenge that is increasing in frequency in thepharmaceutical industry: many newly discovered pharmaceu-tical actives from research are highly potent, requiring extraor-dinary measures to protect the production staff and the envi-ronment.

Instead of opting for the usual spatial isolation of individualprocess stages and using conventional, physically demandingprotective suits with external supply, ICON designers devel-oped a single-room concept in which all contained productionequipment was located in a single high containment moduleand largely automated.

The safe inward and outward transportation of the sub-stances and products are ensured by vacuum systems and split-valve containment technologies. Inside the production area,laser-controlled, driverless transport vehicles move the con-tainers with the materials to the weighing and granulationarea, to the tablet press, and to the coaters.

All process stages are controlled and monitored from aseparate control center so that employees do not come intocontact with any dust that might be generated during the tabletproduction run.

This novel containment concept was put into operation inICON in 2003 and served as the prototype for the NEWCONproject. “We already had established the design and operationalprinciples for containment manufacturing,” said Weyhers. “Wesimply kept what was good.”

Lessons in AutomationWhile the initial focus of NEWCON’s design was on operatorsafety, the road to that goal also led planners to improving theoperational efficiency attained in ICON.

While largely automated, at ICON, the operator needs totrigger the next process sequence. “Operators need to go to theirpersonal computer and program specific directions into thesystem,” said Georg Bernhard, Director, Right-First-Time, PfizerGlobal Manufacturing. “For example, ‘pick up the bin fromlocation A and bring it to location B.’ Once that transfer isfinalized, then you program in, ‘mix for nine minutes, etc.’”

At NEWCON, the process is completely automated. “We had

Single containment module.

AGV transport to a unit operation.

“Driven by the urgent need for greaterproduction capacity, in 2005, Pfizer

Illertissen embarked on the design for theNEWCON project.

...the 7,800 sq. m. facility was completedin late 2007 after a construction period of

just 25 months.”

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all the logic of the sequence,” said Bernhard.“You push the button, everything starts onits own, and at the end you have the tablet.Operators supervise the entire process froma control center. This frees operators upfrom this kind of work.”

One area is which automation did notwork as well was in the weighing and dis-pensing of micronized API. “Micronized APIcauses problems with commercial off-the-shelf equipment,” said Bernhard. “Maybe itneeded to be coarse. But to build a solutionwould have taken too long. We tried feed-ers, different solutions, and in the end optedfor a manual process for this part inNEWCON.”

While automation was a significant aspect of the NEWCONproject, Weyhers recommends not over-engineering. “Avoidbeing trapped in automation. I’m a fan of operators being ableto intervene if they have to. If something goes wrong, you havethe opportunity at least to switch to a manual mode. Otherwise,you’re in deep trouble.”

A dual operator interface was implemented with the mainportion at the control center and a second interface at line incase of at worse events so that operators are in a position to dosomething directly with the equipment, said Weyhers.

Improvements in PATProcess Analytical Technology (PAT) applications also wereimproved upon with the goal of aggressively moving towardreal-time release for the product. “We are very proud of the PATimprovements,” said Bernhard.

In the mixing and granulation process, Near Infra-Red (NIR)spectroscopy is used to check whether the mixture is homoge-neous and the active substance is present in equal doses in allthe tablets. Not only is the data used to verify the quality of theproduct, but it has the potential to shorten blending cycles.

For the tablet press, a special device was developed to extractcoarse directly from the press in order to measure tablet

Notes from the Judging Panel – What Impressed Them

This project used the ICH concepts of Design Space as the basis for aunique approach to process innovation. PAT applications were installedat key process steps to support adaptive process control. A singlecontainment module houses all process equipment for the production ofthe dosage form. All internal containment transport is handled by anautomated laser AGV system. Material transport is also integrated intothe AGV system. The installation has achieved a Design Exposure Limitthat does not require the use of PPE, as the automation level is designedfor no operator interface.

Concludes on page 8.



potency. The vision is for this continuous online analysis toreplace the time consuming, manual HPLC testing in thefuture, and to allow staff to respond swiftly in the event of faultsor irregularities. Pfizer Illertissen is currently gathering dataand plans to file this PAT application with the authorities bythe end of this year, Weyhers said.

Lean Concepts Optimize ThroughputThe concepts of lean manufacturing also were applied to iden-tify bottlenecking and potential improvements. With modelsimulation software, NEWCON production processes were il-lustrated virtually and optimized.

“We wanted to achieve line balance, meaning the focus is toequally load the major unit operations of compounding, corecompression, and film coating,” said Weyhers. “Our findingshad an impact on equipment size and selection, and this wasdone up front.”

The NEWCON team of experts was able to achieve synchro-nized unit operations. As soon as the first process stage iscompleted, the next batch is brought in, so that up to threebatches can be produced in parallel. This semi-continuousproduction sequence has resulted in a significant increase inoutput compared with ICON. NEWCON has a capacity of abillion tablets per year in three-shift operations round the clockand five days a week.

With the implementation of principles of lean manufactur-ing, Bernhard said they were able to reduce the operator levelby 66 percent, which corresponds to an increase in efficiency of300 percent. Together, with an increase in the batch size, therealso was a reduction in the production costs by 42 percent,compared with ICON.

Streamlining C&QThe philosophy of improving and streamlining NEWCON’sdesign also was applied to NEWCON’s Commissioning andQualification (C&Q) approach.

PAT technology. Compression operation (incl. PAT application).

“If we used the conventional approach of ‘the more thebetter,’ we simply would have missed the timeline. We had tocome up with something different,” said Weyhers.

“We have a saying within Pfizer Global Manufacturing:Shamelessly steal good ideas. We simply made use of the ISPEGAMP® 4 Guide.”

“Based on risk assessment, we categorized our systems intoDirect, Impact, and Non-Impact systems and this really helpedto funnel down the overall validation approach and unburdenthe organization,” said Weyhers. “We managed to shift themajor chunk of the workload toward the vendors.”

“At the end of the day, it’s the product that counts,” saidBernhard. “The equipment and facility serve one purpose, andthat’s to produce a good, safe, quality product for the patient.We focused on what was important, and I’m happy that thislogical approach is becoming more and more prevalent in theindustry.”

Crazy Can Lead to PioneeringThe vision for NEWCON started a few years ago with a team ofexperts asking crazy questions and answering with ‘why not?’said Bernhard.

Today NEWCON provides pioneering ideas for the future,not only in containment production, but for the entire field ofpharmaceutical manufacturing, said Bernhard.

“It is certainly plausible that the degree of automation thatPfizer Illertissen has achieved in NEWCON will be standard forthe pharmaceutical sector in one or two decades,” said Bernhard.“And it is just as likely that the fully-automated containmenttechnology will then be used not only for highly potent sub-stances, but also in other areas of pharmaceutical manufactur-ing. For example, perhaps the single-room concept can beapplied to a packaging line.”

“These days, with cost pressures, decreasing direct laborcosts, and market challenges, automation should be consideredin facility design in order to be competitive in this industry.”

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Category Winner – Facility Integration

Boehringer Ingelheim

Boehringer Ingelheim – Facility Integration

To accommodate a growing number of development projectsand to promote the application of new technologies,Boehringer Ingelheim (BI) erected the new Pharmaceuti-

cal R&D Building in Biberach, Germany.This state-of-the-art facility integrates all major functions of

pharmaceutical development – formulation, process develop-ment/scale-up, clinical supplies manufacture, and packaging/labeling – in one building.

The Value of SynergyBI’s key goal is to bring value to patients by researching anddeveloping innovative pharmaceutical medicines. The Biberachsite represents not only the largest of BI’s R&D centers withinthe global network of interlinked R&D facilities, it also is theirglobal center for research in the areas of central nervousdiseases, metabolic diseases, respiratory diseases, and a keyglobal skill center for development.

The existing premises for pharmaceutical development atthe Biberach site had been distributed in several buildings andneeded substantial upgrading, including additional laboratoryspace.

In 2002, a planning process resulted in the decision to createa new building that should house all relevant disciplines ofpharmaceutical development, providing a basis for the optimalexploitation of synergies between all functions.

Different but RelatedPharmaceutical development of drug products encompassesseveral disciplines, which are functionally related, but requiredifferent prerequisites that were reflected in the facility design,including:

• Formulation development uses laboratories for small-scaleexperiments to develop preliminary formulations with newcompounds for first clinical trials and subsequently designformulations for the market use.

• Process development/scale-up requirespilot plant facilities equipped with allmachinery necessary to develop and op-timize manufacturing processes readyfor transfer to commercial production.

• The manufacture of clinical trial sup-plies requires adequate space and equip-ment in full compliance with all interna-tional GMP requirements.

• To support international clinical trialprograms, a globally organized unit forthe coordination of all BI clinical trials,including GMP packaging/labeling op-erations is to be integrated.

GMP Standards forDiverse Products

One of the major goals of the project was the

Exterior view of the pharmaceutical R&D building.

Boehringer IngelheimCategory Winner – Facility Integration

Project: Pharmaceutical R&D Building BiberachLocation: Biberach, GermanyProject Management: Boehringer Ingelheim Pharma GmbH & Co. KGArchitect: Henn ArchitektenDomestic Engineering: Ingenieurbüro MayerGeneral Contractor: Axima GmbHSize: 95,357 sq. ft. (8,859 sq. m.)Cost: US $64.7 million (46 million Euros)Product: Clinical trial supplies phase I – IV for oral solids and liquids,sterile drugs/parenterals, highly potent compoundsKey Project Participants:ECOSLohr GmbHRepass GmbH

RieberStarksstrom Systeme GmbH

Stotz GmbHWaldner


Column-free areas support flexible use of rooms and equipment.

creation of state-of-the-art GMP facilitiesfor the manufacture of solid, liquid, andparenteral clinical trial supplies. All rel-evant international GMP standards had tobe met. Since all clinical trial phases fromI to IV had to be supported, multi-purposefacilities and equipment were made avail-able for manufacturing operations withbatch sizes from one up to approximately200 kg, depending both on the availabilityof drug substance and the trial size.

“Since the pilot plants are operated un-der full GMP, process development andsubsequent clinical trial supplies manufac-ture can occur in the same premises, with-out additional technology transfer,” said Dr. Manfred Fiebig ofBoehringer Ingelheim R&D.

Important features of the applied GMP concept within thefacilities are:

• zoning concepts for all three GMP facilities (solids manufac-ture, sterile area, packaging/labeling) with airlocks provid-ing a clear separation from the non-GMP area, supported bybuilding design and technical control systems

• processing rooms with adjacent technical areas and acces-sible cleanroom ceilings for technical installation above,allowing maintenance without disturbing the process flow

• corridors function as a buffer area, guaranteeing ideal roomconditions within the processing rooms

Handling Highly Active Compounds in aDevelopment Environment

A challenging task for the project team was the creation of areasfor safe handling of highly potent actives without compromisingthe flexibility necessary in a development environment.

“The creation of safe handling of highly potent activeswithout compromising flexibility represents a strategic advan-tage in a field where a trend to higher potent compounds can be

Boehringer Ingelheim – Facility Integration


This building project achieved the integration of all major pharmaceuticaldevelopment functions into one building without disruption of ongoingoperations. Flexibility across a broad variety of processes and batchsizes is achieved through the use of building layout and zoning conceptsthat include open production areas. Areas for handling potent compoundsalso were created without compromising the flexibility necessary fordevelopment activities. Throughout the project there was a focus onpromoting synergies necessary to execute effective product and processdevelopment work.

observed,” said Fiebig.The solution derived from a longer planning and testing

phase and resulted in a two-way approach for the new building:

• For larger scale operations, special HVAC systems weredeveloped, which lead to a significant reduction of dustexposure by technical means in the pilot plant, providing theoption to handle highly potent compounds down to OELs ofapprox. 10 µg/m³ (‘SMP area’).

• Two separate isolator suites for handling highly potentcompounds (OEL > 0.1 µg/m³) were installed, capable ofGMP manufacture and development work in small scale.

Isolators and equipment are operated under GMP conditionsand are suitable for formulation development and manufactur-ing of small-scale clinical trial supplies.

The introduction of downflow booth technology combinedwith a sophisticated HVAC system in the pilot plants extendsthe range of workable compounds down to OELs of approx. 10µg/m³, without compromising safety at work or process flexibil-ity. Filter units are designed for dust-free maintenance andexchange; all processing rooms are monitored with pressureand overflow controls.

HVAC system.


Category Winner – Equipment Innovation

Bristol-Myers Squibb

Forecasting a 20-year business plan, Bristol-Myers Squibb(BMS) developed and implemented a new strategy todiscover and develop innovative medicines to address

significant areas of unmet medical needs. These areas includeaffective (psychiatric) disorders, Alzheimer’s/dementia, ath-erosclerosis/thrombosis, diabetes, hepatitis, HIV/AIDS, obe-sity, oncology, rheumatoid arthritis, and related diseases aswell as solid organ transplant.

To further develop its product pipeline,foster collaboration among numerous func-tions and facilities, and sustain on-timedelivery of future clinical supplies, BMSdesignated its New Brunswick, New Jer-sey, US campus as a Pharmaceutical De-velopment Center of Excellence. To createthis Center, BMS embarked on its ClinicalSupplies Manufacturing and Drug ProductTechnology Expansion Project.

Striving for Excellence inClinical Supplies ManufacturingThe production of clinical supplies involvesadded complexity in comparison to mar-keted products by virtue of the lack of fixedroutines, variety of clinical trial designs,complex packaging designs, and the in-creased risk of cross-contamination. Thecomplexity of the project was increasedwith the integration of innovative isolationtechnology.

The project brought early and late phasecGMP clinical manufacturing and develop-ment scale-up together a single facility tocreate a Pharmaceutical Development Cen-ter of Excellence. Construction of the projectwas phased to allow full implementation oflessons learned in containment, and pro-cess automation technology was integratedinto already existing operations.

Compressing the Critical PathPhase One of the project implemented astate-of-the-art Clinical Supply Operations

Bristol-Myers Squibb – Equipment Innovation

Bristol-Myers SquibbCategory Winner – Equipment Innovation

Project: Clinical Supplies Manufacturing and DrugProduct Technology Center ExpansionLocation: New Brunswick, New Jersey, USEngineering/Design: IPS, Inc.Construction Manager: Torcon, Inc.Size: Phase One 93,110 sq. ft. (8,650 sq. m.); Phase Two 39,300 sq.ft. (3,651 sq. m.)Cost: Phase One US $53,719,000 (38 million Euros); Phase Two US$36,968,000 (26 million Euros)Product: Solid and liquid dosage forms, including sterile productsKey Project Participants:Air & Electric EquipmentAir & SpecialitiesAmerican Leistritz ExtruderAvon Drywall ContractorsBOC EdwardsBuffalo Air HandlingCarlisle Life Sciences

(CPS Barrier)CarrierCrisdelDancker, Sellew, and

Douglas CommercialInteriors

Donald C. Rodner, Inc.Fine PaintingFoley Power SystemsFromkin Brothers

GQS Innovation, Inc. (VAI Automation, Inc.)

GroningerIndependent Balancing/Air

Balancing Engineers, Inc.Independent Sheet Metal,

Inc.Integrity Piping SolutionsK.B.I.Kinetic SystemsKosson GlassL.B. BohleLCS, Inc.Long Island Fire DoorsMcGiver Spray SystemsMunters Corporation/

IndustrialDehumidification Div.

Niro, Inc.Omni InstrumentationPapp Iron WorkPenntech Machinery Corp.PMDI Architectural SignagePyromax, Inc.Quick ResponseR. Baker & SonServolift LLCSiemens Building TechnologiesSkan AGS.M. ElectricSP IndustriesSteris Corp.Thermal Product SolutionsThyssen KruppVAL Floors

BMS CSO/DPTC facility.

Continued on page 14.

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(CSO) expansion facility, including fullcontainment for expanded Oral SolidDose (OSD) operations, and according toa BMS spokesperson, the most flexibleclinical-scale continuous barrier line inthe US for sterile products. This facility

based and potent compound operations.Phase Two built upon the technolo-

gies in Phase One and added additionalprocessing space to the OSD clinical op-eration and a new stand-alone ProductTechnology Center (PTC) for develop-ment scale-up activities. The addition toOSD operations allows the manufactureof long term stability batches within theCSO facility in at least one-tenth com-mercial scale.

Innovation in IsolationTechnology

The Phase One expansion was segre-gated into three manufacturing zones:Parenteral, OSD Band 1 through 4, andOSD Band 5.

The CSO Parenteral area is equippedwith an isolated vial filling line to sat-isfy both sterility and containment re-quirements. Features of the filling lineinclude:

• manufacture in a full nitrogen envi-ronment for safe solvent processing

• manufacturing of a full range of vialsizes

• filling technology that utilizes peri-staltic or rotary piston pumps

• automatic loading of the freeze-dryerwith no trays or rings that can alterheat transfer between the shelf andthe vials

• standard and cold-shelf loading ofthe freeze dryer

Isolated tablet press.

“The goal was to create a flexible facility capable ofperforming multi-product clinical scale manufacturing and

processing solvent-based and potent compound operations.”

was designated for manufacturing OSDbatches up to 400 Kg and parenteralliquid fill batches up to 250L. The goalwas to create a flexible facility capable ofperforming multi-product clinical scalemanufacturing and processing solvent-

Concludes on page 16.

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This project implemented a unique combination of innovative isolatortechnology on existing equipment used in the manufacture of clinicalsupplies. Multiple filling technologies also are implemented, includingclinical scale autoloading of lyophilizers. The project also implementedunique automation techniques involving the retrofitting of wirelesstransmitters onto existing equipment.

• use of product thermocouples within the isolated environ-ment

• capping under full Grade A/Class 100 conditions• automated differential pressure control scheme to maintain

containment of potent compounds• exterior vial wash capability to remove any product residues

The OSD Band 4 Manufacturing Area includes processingrooms focused on the production of oral solid dosage clinicalmaterials. The area was designed for operations handlingActive Pharmaceutical Ingredients (APIs) categorized as Band4 and below. The OSD Band 4 area was expanded in Phase II toinclude the Long Term Stability (LTS) area. The LTS areaincludes processing rooms focusing on the production of oralsolid dosage clinical materials and handling API categorized asBand 4 and below and also includes one room capable ofhandling solvent coating of up to Band 5 compounds. Themanufacturing of LTS batches aids product scale-up and tech-nical transfer into commercial manufacturing sites with batchsizes at least one-tenth commercial scale.

The OSD Band 5 area is used for OSD operations handlingAPIs categorized as Band 5 and includes two processing suites.

Integrated contained high shear granulator and fluid bed processor.

Primary equipment containment utilizes several isolation/con-tainment technologies, including closed system processing equip-ment, contained material transfer systems, and isolated equip-ment and operations. The two OSD processing suites support avariety of contained OSD operations, such as wet and drygranulation, bin tumble blending, compression, encapsulation,tray drying, and dry milling.

More Space for More InnovationPhase Two of the project was designed to build upon theinnovation in Phase One and add supplemental processingspace and scale to the oral solid dose clinical operation. Addi-tionally, a new Product Technology Center focuses on R&D andscale-up for future CSO technologies.

The PTC area is designated to perform both process develop-ment and scale-up. Batch sizes for the PTCrange from 20Kg to 100Kg and are manu-factured using different unit operations andprocesses. Although the operations per-formed within the PTC area are character-ized as non-GMP activities, the qualifica-tion, maintenance, and operation strate-gies provide sufficient support for futurechangeover to cGMP operations. In addi-tion, the area is designed for operationshandling API categorized as Band 1 through4.

Isolated single pot process with dryer andisolated automated sampler.

“Phase Two of the project was designedto build upon the innovation in Phase Oneand add supplemental processing spaceand scale to the oral solid dose clinical

operation.”

SKAN US Inc, • 2655 Industrial Lane • Broomfield, CO 80020 • Phone +1 866 381 7685 • [email protected]

CONGRATULATIONS BRISTOL-MYERS SQUIBB,CATEGORY WINNER, EQUIPMENT INNOVATION,2008 FACILITY OF THE YEAR AWARD.

WE ARE HONORED TO HAVE BEEN THE MAJOR SUPPLIEROF THE ISOLATORS FOR THE FILL-FINISH AND OSD OPERATIONS FOR YOUR FACILITY

Ins. Safety by containement_US_Letter:A4 Poster Druck 19.2.2008 15:14 Uhr Seite 1


Category Winner – Operational Excellence

IDT Biologika GmbH

Innovative and promising vaccines to fightmajor global diseases and new technolo-gies enabling efficient production of those

vaccines are market drivers that led IDTBiologika to build the facility for the pro-duction of Live Human Viral Vaccines, IDT201 in Dessau-Rosslau, Germany.

IDT used the latest technologies in ster-ile production and operational expertisegained from more than 10 years of contractmanufacturing experience to design thefacility.

Frontloading SolutionsThe project expands IDT’s Dessau site from one to two buildingsfor vaccine production. The new building includes two differentaseptic production lines for egg-based and cell culture produc-tion and implements Restricted Access Barrier Systems (RABS)and robotic systems to maximize flexibility and improve pro-duction efficiency.

The expansion allows IDT’s capacities to produce viral vec-tors from process development through Phase 1 and 2 clinicaltrials and up to manufacture of batches for Phase 3 testing, andsubsequent commercial production. IDT’s new facility is one ofa few in Germany and worldwide that has the capacity for large-

scale, campaign manufacture of batches of different vaccineproducts.

Constructed within 19 months and operating since the endof 2007, the project involved several new and prototype solu-tions, posing major challenges in implementation and opera-tion, said IDT officials.

“But these were resolved by extraordinarily cooperativeplanning and design by IDT and its infrastructure unit’s sub-contractors in the design and prototyping phase, thus front-loading all problem resolutions and excluding expensive fail-ures after implementation,” said IDT officials. “Extensive pro-

totype modeling and testing had been done.”

Sterility Does Not Haveto be Lifeless

The building’s colorfulness and transpar-ency signal new ways of designing sterileproduction work environments. Sterilitydoes not have to be lifeless, according toIDT representatives.

Cleanrooms with glass walls, materiallocks with glass doors, and glassed-in pas-sageways for flat surfaces, allow completevisibility, and meet the most rigorous stan-dards for cleanliness. Trust in personneland product is inspired through opennessand transparency.

Combining Technology andOperational Expertise

The multi-purpose facility consists of stricthorizontal division of service areas and theserviced areas into four levels. A strategy

IDT Biologika GmbH – Operational Excellence

IDT Biologika GmbHCategory Winner – Operational Excellence

Project: Facility for Production of Live Human Viral Vaccines, IDT 201Location: Dessau-Rosslau, GermanyArchitect/Designer: Heene + Proebst GmbHProcess Engineering: BIDECO GmbHGeneral Contractor: Technik-Energie-Wasser Servicegesellschaft mbHSize: 50,568 sq. ft. (4,698 sq. m.)Cost: US $37,470,000 (26 million Euros)Products: Live recombinant and non recombinant viral vaccines forhuman useKey Project Participants:AARBELIMEDEHRET Labor-u.PharmatechnikFranz Ziel GmbHLaservorm GmbH

Mayer Ing. Büro für TGANeuberger

GebäudeautomationThe Automation Partnership

LTD

TIRAWaldner AnlagenbauWAVE Biotech AGZETA

Exterior view on the west side of the new facility.


was devised to guarantee the shortest sup-ply and disposal routes: the production areais located at the building’s center with main-tenance level and air conditioning systemslocated above and the media supply for theproduction area below. All operations areas much as possible contained in cleanroomsand contained technical systems.

Roller culture used for virus productionhas been fully automated in Class A (100)cleanrooms using robots.

Two production lines were created fordifferent aseptic manufacturing technolo-gies with a fumigation lock, automated laser technique foropening eggs, and Restricted Access Barrier System (RABS) forprocessing eggs on one line. The other line has robots for cellculturing and virus propagation. The production area alsoincludes a second cooling system for -80°C storage, fully auto-mated CIP/SIP, and continual wastewater inactivation.

Large cleanrooms classified B (10,000) and C (100,000) allowlong-term space for climate chambers of every temperaturerange making virus production on various cell substrates anddifferent technologies possible.

Since the vaccines currently being manufactured are livevirus vaccines which cannot be sterile filtered, the use of optimalaseptic production technologies was critical. These technologiesinclude an automatic disinfection hose for eggs, a laser foropening the eggs, a RABS for extracting the embryos, and the useof a hose-sealing system for creating all hose connections duringproduction. The use of these technologies achieves a closedprocess for the entire chain of production steps.

Building in Efficiency and FlexibilityWith the ability to fumigate all production rooms with formalin,it is possible to change production campaigns on each produc-tion line within 12 hours. Since the separate production roomsare fully independent from one another, it is also possible to

IDT Biologika GmbH – Operational Excellence


Using experience over 10 years of production of viral vaccines as adesign tool, this project’s use of unique transparent building features,manufacturing area adjacencies, material handling, and equipmenttechnologies is anticipated to result in a four-fold increase in productioncapacity. Two different aseptic production lines for egg-based and cell-culture production implement RABS and robotic systems to maximizeflexibility and improve production efficiency.

facilitate a campaign switch step by step, room by room (fromUSP to DSP).

Through the use of robots to process roller bottles, thepersonnel required for this step was reduced by half and at thesame time a higher production safety could be guaranteedthrough improved aseptic production conditions.

Equipping the rooms with standard media panels supplyingall available media and mobile hanging media panels capableof being adjusted into nearly every position in each of thecleanrooms, makes it possible to introduce new equipment atany time and significantly increase production capacity.

Highest Level of ContainmentAccess to the building, various production areas, and cleanroomsis controlled by an electronic access system. All handling of openvirus material occurs under at least Class II safety work-benches. Using robots during production of infectious materialin sub-pressure conditions fulfills the highest level of contain-ment, thus protecting employees from infection. Deviationsfrom target values are signaled on internal and external moni-tors. Connecting, disconnecting, and sealing hoses are done athigh temperature with hose-sealing devices. Eye washes insterile disposable bottles are, in an emergency, better alterna-tives than conventional systems.

Cell and virus propagation in disposable fermentor systems. Flexible docking station for utilities andwaste water.


Category Winner – Project Execution

F. Hoffman La Roche AG

To make their innovative cancer drugs available as quicklyas possible to an increasing number of patients, Rocheinitiated expansion of its Penzberg, Germany site.

The expansion project, called “Biologics IV,” increases pro-duction capacity for Trastuzumab, the Active PharmaceuticalIngredient (API) for the anti-breast cancer drug Herceptin®. An“ultra fast track” project execution strategy resulted in deliver-ing a large, technically complex project ahead of schedule,under budget, and to the complete satisfaction of the user.

A Compelling MotivationHeadquartered in Basel, Switzerland, Roche is one of theworld’s leading research-focused healthcare groups in the fieldsof pharmaceuticals and diagnostics. The company is a worldleader in in-vitro diagnostics and drugs for cancer and trans-plantation, a market leader in virology, and active in othermajor therapeutic areas such as autoimmune diseases, inflam-mation, metabolic disorders, and diseases of the central ner-vous system.

To make their innovative biotechnologically produced can-

cer drugs avail-able to an in-creasing numberof patients, aphased expan-sion of Roche’sBiologics capac-ity was initiated.This involved sev-eral major pro-jects in the Rochegroup, includingBiologics IV.

The scope ofBiologics IV in-cludes a four-story high building containing two highly auto-mated, recipe controlled production lines, each centered onthree 12,500 Liter fermenters and downstream processing. Theproject also included associated laboratory and office space.

Biologics IV achieved its first production batch just 36months after the start of conceptual design.Once running at full capacity, Biologics IVwill enable supply for 100,000 additionalHerceptin patients per year.

Project team members largely credit theirsuccess to innovative and effective projectexecution strategies and integrated team-work.

High Performance ProjectOrganization

“Leadership and organization, besides allthe technical aspects, is very crucial for aproject like this,” said Project Director ClausHerrmann.

Setting up a high performance projectorganization includes several key planningpractices, including identifying and priori-tizing key stakeholders, said Herrmann. “Ifstakeholders are popping up down the road,that’s not a good thing because they comeup with some new requirements.”

Another practice is securing the bestavailable resources and giving them clearlydefined roles and responsibilities. “You needleaders, including your general planner,construction management, suppliers, and

F. Hoffman La Roche AG – Project Execution

F. Hoffmann La Roche AGCategory Winner – Project Execution

Project: Biologics IVLocation: Penzberg, GermanyArchitect: Koppenhöfer & Partner GmbHEngineer: Roche Pharma Global EngineeringEngineering Contractor: LSMW GmbH – Total Life Science SolutionsConstruction Manager: SIBC GmbH – A Turner & Townsend Co.Size: 355,209 sq. ft. (33,000 sq. m.)Cost: US $460 million (327 million Euros)Product: Trastuzumab (API for Herceptin®)Key Project Participants:Alfa LavalBolzBinderChemgineeringChristEndress & HauserGEA-DieselGemüImtech

KardexLang & PeitlerMCEMilliporePallPharmatecSartoriusSchindler

SiemensStadler + SchaafStedimVal-ItVogelbuschVTUWaldnerZeta

Biologics IV office and laboratory building.


automation contractor, with strong leader-ship capabilities,” said Herrmann. “With-out strong leaders a project like this tendsto be uncontrollable.”

Herrmann offers three top tips when itcomes to setting up a high performanceproject organization:

• Share your compelling vision andstrategies.

“In our case, it was to make this drugavailable for patients,” said Herrmann.

• Get the Users on board from day one.“If they come in toward the end of the project and tell you whatthey really need, that causes change orders you can avoid hadthey been involved from the very beginning,” said Herrmann.

The Users, led by Dr. Juergen Wahl, head of Biotech Produc-tion Penzberg, were key team members. The Users were fullyintegrated into the project team from day one and took part inevery aspect of the project, resulting in the Users receiving afacility in which they were fully trained, leaving them free tofocus on production.

• Proactively manage information flows.“In a large and complex project like this, we spent about onemillion man hours on engineering and automation,” said

Herrmann. “You have to coordinate all these disciplines andmake sure everybody is working toward the same goals. Thisrequires a lot of information flow and that doesn’t flow by itself.You have to catalyze it.”

The project team invested a great deal of time and effort toensure the contractors were fully integrated into the spirit of theproject. Team building workshops and social events to celebratesuccess were a welcome feature of the project. Challenges wereopenly discussed with the contractors in a “no blame” culturewith suggestions welcomed, evaluated, and acted upon.

Starting in project initiation and continuing through quali-fication, Herrmann organized a series of workshops where thechallenges, risks, and solutions were systematically identified,analyzed, and resolved. The critical series of workshops devel-



This multi-building example of ultra fast track project execution achievedits first production batch 36 months after the start of conceptual design.The final project cost was below budget and resulted in high satisfactionratings from the owner. The turnover of the manufacturing facility wasaccomplished three months ahead of the original schedule and theturnover of the production line for monoclonal antibodies was completedfour months ahead of schedule.

Concludes on page 21.Amzeige 177mm x 123mm 13.02.2008 12:49 Uhr Seite 1

Probedruck

C M Y CM MY CY CMY K

Solutions from a single source

- Concept and Basic Design- Functional Specification- DCS-Integration- Support of Commissioning and Qualification

Client:Location:

Period:Project:

Roche DiagnosticsPenzberg, Germany2004 2007BIOLOGICS IV

Rely, like 2008 Facility of the Year Category WinnerRoche Diagnostics on Biotech-Project Biologics IV, onuncompromising, multi-vendor automation solutionswithout interfaces and tailored to your needs.

As one of the leading multi-vendor suppliers ofcomplete automation solutions for the chemical andpharmaceutical industries we are automatically closerto the spot – to your processes and your location: inGermany, Belgium, Switzerland, Austria, the CzechRepublic, Poland and China.

Lang und PeitlerAutomation GmbHAm Herrschaftsweiher 2567071 LudwigshafenGermanyTelefon 0 62 37/9 32-0Telefax 0 62 37/9 32-1 00

www.langundpeitler.com

Automation. Solution. Competence.



oped the highly successful and innovative execution strategiesfor design, procurement, construction, and commissioning.

The complete Penzberg team developed a close cooperativerelationship with their Roche colleagues who were simulta-neously constructing a new biotech production facility in Basel,Switzerland. The exchange of knowledge and experience washighly valued by both teams. This led directly to cost and timesavings when solutions to common problems were implementedon both projects.

Time and Cost Saving StrategiesA schedule analysis showed that the equipment and pipinginstallation and automation software development drove thecritical path during construction.

Building on experience of past projects, the team realized thatskid mounted equipment reduced process equipment installa-tion time from weeks to days. “We constantly strive to reduce ourcapital costs,” said Herrmann. “A major factor in our success isnot ‘reinventing’ solutions to known problems. The use of skidmounted equipment is a tried and tested solution in Roche.”

The project team also focused its attention on automation.Borrowing software techniques from the telecom industry, thehuge volume of process automation software was broken downinto small modules and additional programming resource wasapplied to compress the writing and testing time.

The final compression of the schedule was achieved byanalyzing the commissioning and qualification steps required.Everything possible was commissioned and qualified in thefactory. The actual field commissioning and qualification wasmanaged using “Petrochem Shut Down” techniques. The workwas subdivided into small tasks and two seven-day week shiftswere employed to reduce the commissioning/qualification timeto a minimum.

For the Cleaning and Sterilization in Place, which wascritical to the success of the facility, the Users brought thepractical knowledge from every day experience and the designengineers developed the system around the operative require-ments. The resulting systems run efficiently.

The facility’s Manufacturing Execution System (MES), in-cluding Electronic Batch Recording, was developed in a similarmanner. The MES delivered a reduction of labor cost and anincrease of production process quality.

Fermentation area with glass facade.

Austria · Germany · Italy · Switzerland

Engineer ing

www.vtu.com

Engineeringfor Pharmaceutical Plants

www.vtu.com

C o n c e p t u a l D e s i g n

B a s i c E n g i n e e r i n g

P r o j e c t M a n a g e m e n t

G M P C o m p l i a n c e

P e r f e c t S o l u t i o n s b y

a P e r f e c t T e a m

LSMW GmbH

Head Office

Lotterbergstr. 30

70499 Stuttgart

Germany

Phone: +49 711 8804-1800

[email protected]

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GERMANYSTUTTGART AUSTRIA SWITZERLAND

POLAND THE NETHERLANDS

▪ BERLIN ▪ BIBERACH ▪ FRANKFURT ▪ LEUNA ▪ LEVERKUSEN ▪ LUDWIGSHAFENNUREMBERG ▪ PENZBERG ▪ ▪ ▪ LINZ ▪ VIENNA ▪BASEL ▪ ZURICH ▪ ▪ GDANSK ▪ WARSAW ▪ WROCLAW ▪ ▪ HELMOND

CONSULTING ENGINEERING CONSTRUCTIONVALIDATION TECHNICAL FACILITY MANAGEMENT

▪ ▪▪

www.lsmw.comLSMW IS PLANNER AND CONTRACTOR FOR LIFE SCIENCE & CHEMICAL INDUSTRY

WE KNOW WHATCHALLENGES ARE

CLIENT: GSK BiologicalsLOCATION: Dresden, GermanyPERIOD: 2005 - 2007PROJECT: New Facility for the Production of Flu Vaccine

CLIENT: Hermes PharmaLOCATION: Wolfsberg, AustriaPERIOD: 2007 - 2008PROJECT: New Production Facility for Solid Dosage Forms

CLIENT: Roche DiagnosticsLOCATION: Penzberg, GermanyPERIOD: 2004 - 2007PROJECT: BIOLOGICS IV

New Biotechnological Production Facility with 2 Multi-Product Linesfor the Production of Monoclonal Antibodies

“2008 Facility of the Year Category Winner”

Total Life Science Solutions

2008_02_AZ-USA-facility-award.indd 1 13.02.2008 14:18:30

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