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Solutions and strategies for a changing industry Systems and Solutions for the Process Industry process news 10 th edition October 3 | 2005 s Focus on Pharma Focus on Pharma Listening to Leaks: Acoustic leak inspection on process pumps with Sitrans DA 400 Good as Gold: Braumat used for malt production at Viking Malt Listening to Leaks: Acoustic leak inspection on process pumps with Sitrans DA 400 Good as Gold: Braumat used for malt production at Viking Malt Solutions and strategies for a changing industry

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Page 1: process - automation.siemens.com€¦ · Siemens Participates in US FDA ... The HEG can simulate the resulting ... process news 3/2005 ment. Siemens is well positioned to be an

Solutions and strategies for a changing industry

Systems and Solutions for the Process Industry

processnews

10th edition October 3|2005

s

Focus on PharmaFocus on Pharma

Listening to Leaks:

Acoustic leak inspectionon process pumps with Sitrans DA 400

Good as Gold:

Braumat used for malt production at Viking Malt

Listening to Leaks:

Acoustic leak inspectionon process pumps with Sitrans DA 400

Good as Gold:

Braumat used for malt production at Viking Malt

Solutions and strategies for a changing industry

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proce

9 12 29

In the buffer preparation at Chiron in Rosia,Simatic PCS 7 and Simatic Batch handle allprocess automation tasks including batchcontrol

RFID technology can contribute notonly to higher process visibility butalso to higher product safety

Railway waggon weighing atKali France is greatly facilitatedby Siwarex FTA

CONTENTS2

n

3 EDITORIAL

4 NEWSSimatic PCS7 automates space flightsimulation system

Siemens Participates in US FDAPharmaceutical Inspectorate Training

Mettler Toledo and Siemens: Partnership brings first results

Award-winning flow meters at Manila Water

Strategic alliance with SAP

FOCUS

Pharmaceutical Industry

6 Setting Out for New SuccessIntegrated, multidisciplinary solutionsfor the pharmaceutical industry

9 Success at ChironSimatic PCS7 and Simatic Batch at Chiron Vaccines in Rosia, Italy

Integrated building and automation solution in Liverpool, UK

Reference project for the filling andfreeze-drying of pharmaceuticals inMarburg, Germany

12 New FrequencyRFID in the pharmaceutical industry

15 Envolving toward PerfectionSimatic technology facilitates FDA CFR21Part11compliance in Courtoy tablet presses

16 Global ExpertiseAutomation and validation of a Xian Janssen plant

18 Digital ReportsGood manufacturing practice in drugmanufacturing plants

19 Perfect PackageSiemens builds ultramodern logistics center for Merckle/ratiopharm

20 Off the RollSimotion C in packaging line for band-aids

22 Recipes for OperationSimatic WinCC flexible for pharma production

23 Qualified SupportApplication software development in compliancewith FDA 21 CFR 11

process news 3/2005

Tablet press Cover picture: Siemens AG

Ch

iron

Siem

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AG

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ess

32

Dear Readers!In this issue, we’re not only taking a look at the

current landscape of the process industry and at the

automation and drive systems that keep it running.

We’re also using this unique opportunity to look back

at 10 very exciting years – because that’s how long it

has been since the first issue of Process News was

published. And that’s how long we’ve been working to

bring you timely information about subjects that

interest you, as well as insights into our strategies and

plans for the future of process automation.

We’re extremely pleased that, by and large, we’ve

been successful in these efforts – at least that’s what

reader surveys in 1998 and 2005 have indicated.

Particularly, the recent survey, which was conducted a

few months ago, reveals a consistently favorable

impression of the value Process News provides you,

our readers. The majority of those polled consider it

an informative, expert, and highly professional

publication. We’ll do our best to ensure that Process

News will remain exactly that in the years to come.

The main focus of our current issue is on the

pharmaceutical industry, an industry that is just

emerging from a turbulent period in which both the

market and the regulatory environment have changed

profoundly. The pharmaceutical industry can employ

intelligent solutions along the entire value chain to

respond faster and more effectively to these

challenges, as shown in examples from Italy, the

United Kingdom, Belgium, and Germany.

With our expertise in important areas such as

qualification and validation, and in technologies such

as RFID, we can support the pharmaceutical industry

in implementing these solutions effectively.

We hope that, as with past issues, you’ll find

interesting ideas and suggestions in this edition of

Process News!

Sincerely,

The Braumat process control system helps to ensure aconsistently high malt quality in a new malt house inLithuania

3

news

24 Guaranteed ResultsVaccine production at Virbac with Simatic PCS7

26 Flexibility and Process ReliabilityChromatography process at Schering isautomated with Simatic PCS7

CASE STUDIESFood and Beverage

28 Tradition Meets TechnologyPointek level monitoring in whiskey production

Weighing Technology29 Calibrated for Quality

Siwarex FTA for weighing railway wagons

Food and Beverage32 Good as Gold

Braumat used for malt production at Viking Malt

Glazing Systems34 Stepping into the Future

Simatic PCS7 automates glazing systemproduction

TECHNOLOGYProcess Instrumentation

30 Listening to LeaksAcoustic leak inspection on process pumps withSitrans DA400

35 DIALOGUE

EDITORIAL

process news 3/2005

Siem

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Kal

i Fra

nce

Cornelia DürrfeldEditor in chief, Process News

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process news 3/2005

4 NEWS

The High Enthalpy Tunnel Göttingen(HEG) of the German Aerospace Center

(DLR) is a wind tunnel designed to simu-late high-temperature hypersonic airflows,which occur, for instance, during the reen-try of space vehicles into the Earth’s at-mosphere. The DLR selected Siemens solu-tion provider Bertram Elektrotechnik GmbHto revise and modernize the overall designof the system’s control technology. One keyobjective was to upgrade the automationsolution of the HEG for a broader range ofoperating conditions in order to accommo-date future applications and requirements.A visualization solution was also needed tosubstantially enhance the ease of use andflexibility of the existing operator controls,and to provide the capability to enter vari-able test parameters as well as to display re-producible test parameters. In addition, theupgrade needed to enable convenient, on-the-fly diagnostics of control tasks inprogress.

The Simatic PCS 7 V6.0 process controlsystem met all of these requirements, andis now controlling and monitoring all of theindividual operations of the system. Allprocesses are visualized, and on-the-fly in-tervention in ongoing processes is possible.

The HEG was originally designed to sim-ulate hot airflows surrounding spacecraftduring reentry. This involved the simulationof airspeeds up to 22,000 kilometers perhour. The range of potential applicationshas now been expanded to include, amongothers, investigations of innovative air-breathing supersonic propulsion systemsable to reach airspeeds of up to 10 times thespeed of sound at an altitude of 30 kilome-ters. The HEG can simulate the resultingflow conditions for several milliseconds. Inthe measurement section of the tunnel,high-speed measuring methods are used tostudy scale models. The resulting data aresubsequently processed with appropriatealgorithms to calculate the aerodynamicsand thermal stresses encountered with thetested configuration. �

Simatic PCS 7 automates space flightsimulation system

Find out more:www.siemens.com/pcs7E-mail: [email protected]: [email protected]

Two Siemens experts participated intraining approximately 30 FDA Inspec-

tors, 16 FDA Reviewers, and other FDA per-sonnel. The training, organized by the FDA’sOffice of Regulatory Affairs, covered a broadrange of topics geared toward FDA’s emerg-ing risk-based and science-based regulationsand corresponding inspection methodolo-gies. This training is an important step in therollout of these initiatives.

Siemens, a recognized industry leader inprocess analytical technologies (PAT), wasasked to participate in this training and tofocus on PAT for biologics by sharing projectexperiences. �

The High Enthalpy Tunnel Göttingen(HEG) is automated with Simatic PCS 7

Model of the CRV/X-38 space gliderin the HEG (1:24 scale)

Data collected during experiments inthe HEG are processed to yieldquantitative results

All

pict

ure

s: D

LR

Siemens Participatesin US FDAPharmaceuticalInspectorate Training

Find out more:www.siemens.com/pharmaE-mail: [email protected]

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process news 3/2005

5

Find out more:www.siemens.com/automationE-mail: [email protected]

Find out more:www.siemens.com/processinstrumentationE-mail: [email protected]

T he Manila Water Company is re-sponsible for production, treat-

ment and distribution of water, as wellas for operating the sewage system inthe east zone of Manila, Philippines, azone that has five million inhabitants.A total of twelve Sonokit ultrasonicflow meters were recently installed bySiemens for Manila Water at severalpoints in the pipe system. The flowmeters are equipped with integrateddata loggers and can send messagesvia SMS, ensuring continuous datarecording. Moreover, the devices arevery reliable in operation and requirelittle maintenance.

Siemens installed the devices attwelve measuring points without in-terrupting the water supply. For therepair and maintenance services of theultrasonic flow meters, Siemens wasrecently recognized as “Suki” vendorby the Manila Water Company. Thisaward is given by Manila Water to sup-pliers and contractors who have pro-vided quality products and services. �

Mettler Toledo and Siemens:Partnership brings first results

As a partner of Siemens, Mettler Toledo markets com-patible product combinations for the efficient au-

tomation of weighing functions. The new product linefor high-precision weighing is the result of a coopera-tive agreement that the two companies initiated in Sep-tember 2004.

The digital Modulo WM weighing modules and theModulo WMH weighing platforms from Mettler Toledouse the Siwarex FTA high-resolution weighing elec-tronics, and are thus integrated with Simatic controltechnology. Tested product combinations are identi-fied by a certificate from the two companies, guaran-teeing problem-free installation and flawless func-tionality.

The Modulo WM weighing modules and Modulo WMHweighing platforms are based on the principle of elec-tromagnetic force compensation and provide rapid, pre-cise weight measurements. The compact, rugged hous-ing contains the load cell and all of the electronics. �

Strategic alliancewith SAP

S iemens and SAP are working together tocoordinate their IT product lines. This

strategic alliance was formed in June of thisyear with the objective of achieving the“real-time company” through the efficientcoordination of IT processes, from businessmanagement to production. In this collab-orative solution, the two companies aresupporting the ISA 95 industrial standard,with SAP focusing on business solutions andSiemens on MES and control systems.

The coordinated line of products andservices is designed to be industry inde-pendent. It will enable companies to re-spond swiftly and flexibly to fluctuations inthe volume of orders while maintaining lowmaterials and product inventories to mini-mize time to market for new products, andto operate their plants at high levels of pro-ductivity. The certification process for the in-terfaces between Simatic IT and NetWeaveris nearly complete, and Simatic IT productswill then be certified as “Powered by Net-Weaver.” �

Award-winning flow meters at Manila Water

Siem

ens

AG

The digitalweighingmodules andweighingplatforms fromMettler Toledoincorporate theSiwarex FTAhigh-resolutionweighingelectronics

Find out more:www.siemens.com/processinstrumentationE-mail: [email protected]

For the repair and maintenance servicesof the ultrasonic flow meters, Siemenswas recently recognized as “Suki” vendorby the Manila Water Company

Siem

ens

AG

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6Pharma

FOCUS

The pharmaceutical industry in the 21st century: New opportunities

In the past, pharmaceutical produc-

tion processes were dictated by very

restrictive legislative specifications.

This prevented the pharmaceutical

industry from benefiting from tech-

nological progress in the fields of

automation and process technology

to the same degree as other indus-

tries. Driven by growing market

pressure and developing problems in

medicine supplies, the FDA has

recognized that the pharmaceutical

industry will not be able to develop

and produce safe, effective and

affordable medicines in the future

under the existing specifications.

Taking a fresh approach to issues

such as quality and safety on the

basis of risk-based process control

and understanding, the FDA is now

allowing the pharmaceutical industry

to exploit new solutions in the areas

of process automation, validation and

monitoring.

Siemens has observed and been

involved in this development from

the start, and has earned a reputa-

tion as a leading technology expert in

innovative fields such as process

analytical technology (PAT).

process news 3/2005

ment. Siemens is well positioned to be animportant partner to the pharmaceuticalindustry in the optimization of these keyareas, as Anton S. Huber, member of the

The challenges the pharmaceuticalindustry faces are immense and var-ied. The US Food and Drug Adminis-

tration is aware of this. In recent regula-tions, it explicitly urges the industry toexploit innovative technologies and to ben-efit from the progress made in automa-tion and information technology. Thesechanges affect virtually all companiesinvolved in the supply chain of drugs, fromthe chemical or biotechnical producers ofthe active ingredients, to the manufactur-ers of the various dosage forms, and all theway through to the distributors of pack-aged pharmaceutical products.

The pharmaceutical industry needs sup-pliers that can deliver effective solutions torespond to this new environment. A surveyof 66 pharmaceutical companies revealedthat two thirds of companies want to estab-lish supplier relationships that are bettercapable of addressing their strategic chal-lenges. The study, conducted by Siemens incooperation with PricewaterhouseCoopersat the beginning of 2005, also revealed thatthey see the greatest potential for improve-ment in four central areas of the pharma-ceutical industry: manufacturing perform-ance, supply chain optimization, qualitystep change, and improved asset manage-

Integrated, multidisciplinary solutions for the pharmaceutical industry

Setting Out for New SuccessThe pharmaceutical industry is experiencing a period of transition and must adapt itself to a totally new marketlandscape. The industry must deal with pricing pressures due to health service reforms and expiring patents, drasticallyincreasing costs for research and development, and changes in the product portfolio – moving away from blockbusterstoward more targeted drugs that must be produced in smaller batches. With a wide-ranging product and service offering,process expertise, and experience from numerous other industries, Siemens offers multidisciplinary solutions with whichthe pharmaceutical industry can continue to be successful in this new market landscape.

board of Siemens Automation & Drivesstates: “We are perfectly prepared to assistin these areas based on the experience thatSiemens has in numerous other industries.

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7

Sou

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20

05

The majority of pharmaceutical employees taking part in this study are of theopinion that they will benefit from an integrated multidisciplinary approach.Buying-in of additional know-how is one of the main areas of potential benefit.

„We are perfectlyprepared to assist thepharmaceuticalindustry in reachingtheir goals.“

Anton S. Huber, member of the board of Siemens Automation & Drives

The topic of supply chain automation andoptimization is one of the fields where weare an accepted, well-known, and knowl-edgeable supplier. We are familiar with

improvements to manufacturing perform-ance within the chemical industry and inquality in the food and beverage industry.Behind our products and solutions is a

breadth and depth of experience that noother supplier can match. We work togetherwith a large network of partners and solu-tion providers. Together, we can addressthe many different requirements of thepharmaceutical industry and provide thenecessary multidisciplinary expertise. Withour Competence Centers, we have alsogeared our organization to the growingdemands of our customers for industry-specific solutions and consulting.“

Focused competence

“The Competence Center Pharma has thetask of aligning the broad Siemens portfo-lio specifically to the pharmaceutical indus-try. First, that means bringing this solu-tion competence closer to the customer,directly into projects. Second, it also meansincorporating the industry-specific knowl-edge gained from this proximity to the cus-tomer into our industry suites – in otherwords, bringing together customerrequirements and Siemens’ capabilities“,explains Dr. Wolfgang Scheiding, head ofthe Competence Center Pharma atSiemens. He, too, stresses the benefits of abroad portfolio and, therefore, the possi-bility of a multidisciplinary solution: „Inthe pharmaceutical industry it is notenough to possess only automation knowl-edge.“ Along with to innovative productsand systems from the field to the MES level,all based on Totally Integrated Automationand Totally Integrated Power, Siemens alsooffers solutions for particularly sensitiveclean rooms. Siemens can provide inte-grated solutions for access authorizationor clean room monitoring. In addition toprocess engineering solutions for productlead time reduction using online analytics,improvements in internal company logis-tics and minimization of expenses in stor-age and commissioning are important –where Siemens offers solution from its

Siem

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AG

(Continued on page 8)

Do you think there is added value for a tru-ly multidisciplinary combined approach

from solutions providers?

Have you used this type of approach before?

What do you understand by “an holistic approach”?

Buying multidisciplinary knowledge & experience

Cost efficiency in project handling

One price offer for combined services & one project leader

Success secured project implementations

Speeding-up project implemetation

All encompassing approach

One global project leader, two separate invoices possible

0 10 20 30 40 50 60 70 80 90 %

30

2% Don’tknow

85% Yes

10% No

5% Don’tknow

23

21

20

18

15

7

52% Yes

46% No

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process news 3/2005

Key issues in the pharmaceuticalindustry

With a tailor-made range of GMP-compatible solutions and services,Siemens supports its customers in the pharmaceutical industry bydriving improvements in all key areas of production.Manufacturing ExcellenceB Process knowledgeB AvailabilityB Process reproducibilityB Ease of useTo ensure continually optimum productivity in the pharmaceuticalindustry, processes and work steps must be perfectly adapted,controlled, and monitored by a flexible and in-line system. With acomplete portfolio of automation and optimization systems, both forindividual machines and complex production plants, Siemensprovides the right solutions.

Overall Quality ExcellenceB Quality by designB Total quality managementB Right first time qualityB Real-time product releaseUsing an integrated approach, including tools for process analysisand evaluation, a wide range of solutions for process analysis andautomation, as ell as Advanced Process Control tools, Siemenssupports its customers in the integration of quality assurancemeasures within the process. This enables a better understanding ofthe aspects of production that are relevant to quality.

Supply Chain ExcellenceB Production logisticsB Warehouse integrationB Demand-driven supply netB Collaborative manufacturingOn the basis of a broad portfolio of products, systems, and services,Siemens offers integrated solutions for the entire supply chain,enabling all processes and areas of the productivity chain to belinked. As a result, production can be adapted to actual marketrequirements more effectively, more efficiently, and above all, moreflexibly. Continuous traceability of all products and processes alongthe productivity chain can thereby be guaranteed.

Optimal Asset ValuationB MaintenanceB Asset managementB Downtime managementB Maximizing operational efficiencyB Maximizing flexibilityIntegrated diagnostic functions and asset management tools, fromthe equipment level to the manufacturing execution level, simplifyproduction planning, improve maintenance processes, and optimizethe exploitation of all resources. In addition, the flexibility ofproduction is increased by solutions for adaptable and recipe-controlled process and production management.

logistics and assembly portfolio. Needless tosay, all solutions Siemens offers meet goodmanufacturing practice (GMP) requirements.

Another responsibility of the CompetenceCenter is to further innovation for the phar-maceutical industry. As Dr. Wolfgang Scheidingstates: “In the areas of process analytical tech-nology (PAT) and radio frequency identifica-tion (RFID), for example, we have a clear edgeover other providers in the market because wehave the multidisciplinary expertise that isindispensable for these projects. Several PATprojects at well-known pharmaceutical com-panies are already in progress, making Siemensone of the first companies to implement thistechnology – which is central to much of theFDA’s recent push on innovation – in the phar-maceutical industry. RFID technology is becom-ing increasingly attractive to the pharmaceuti-cal industry for use in combating counterfeit-ing of drugs, which causes billions in damagesto the pharmaceutical industry, and also putthe patient at risk. Once again, we benefit herefrom our experience in other industries.” �

„In thepharmaceuticalindustry it is notenough to possessonly automationknowledge.“

Dr. Wolfgang Scheiding,head of the CompetenceCenter Pharma

Siem

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Find out more:www.siemens.com/pharmaE-mail: [email protected]

8Pharma

FOCUS

(Continued from page 7)

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triggers batch and recipe execution, in-cluding the required sterilization, decont-amination, and cleaning procedures – en-hancing flexibility in recipe managementwhile ensuring compliance with CFR 21Part 11 and GAMP 4 through its audit trailand electronic batch record features. Withthis project, Siemens once again demon-strated the benefits of implementing state-of-the-art automation and control tech-nology in pharmaceutical production. �

Simatic PCS 7 and Simatic Batch at Chiron Vaccines

Integrated SuccessSiemens has proven its project and automation expertise at the ChironVaccines sites in Rosia, Italy. With state-of-the-art technology and anexperienced project team, Siemens implemented an integrated solutionthat handles all process automation tasks, including batch control, andinterfaces easily with all third party packages used in the plant.

Chiron VaccinesChiron Vaccines, the world's fifthlargest vaccine company, hasfacilities located throughoutEurope, the United States, andAsia. The company is the world'ssecond largest manufacturer offlu vaccines, and has importantmeningitis, pediatric, and travelvaccine franchises. ChironVaccines is the leading vaccinemanufacturer in the UK,Germany, and Italy.

The buffer preparation at Chiron in Rosia was automated with Simatic PCS 7

qualification and validation of both pro-cess and plant.

Integration of DCS and batch control

The solution provides the complete inte-gration of the distributed control systembased on Simatic PCS 7 V6.0. The SimaticBatch system for batch process control alsointerfaces with all third-party packagesused in the plant such as ultrafiltrationsystems, centrifuges, and pure steam.Moreove, it provides time synchronizationfor all the plant systems and packages, aswell as acquires, centralizes, and elabo-rates all process-related values and pro-vides a high-level security system for man-aging user access rights. Simatic Batch

Chiron Vaccines is one of the world’sleading vaccine manufacturers. In2002, Chiron decided to construct a

new plant at its Rosia site for the produc-tion of glycoconjugate vaccines to combatmeningitis. Though it faced several strongcompetitors, Siemens Italy won the orderfor the complete automation of the newplant because it was able to supply a com-prehensive integrated solution for processand batch control using Simatic PCS 7 andSimatic Batch.

The project was extremely complex,and required careful project managementin order to satisfy the customer's needsand to achieve compliance with CFR 21Part 11 and GAMP 4 regulations, as well as

process news 3/2005

9FOCUSPharma

Find out more:www.siemens.com/pharmaE-mail: [email protected]

Ch

iron

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10Pharma

FOCUS

The company focuses its research anddevelopment in three main areas:the development of blood screening

tools that help prevent the spread of infec-tious diseases; vaccines for adults and chil-dren; and biopharmaceutical productswhich focus on infectious diseases andcancer.

Headquartered in Emeryville, Califor-nia, the company has research centers inthe US and Europe, and manufacturingsites spread across the world, including avaccine production facility in the UK. It is atthis UK facility in Liverpool where Siemenshas been working closely with Chiron tobuild a new facility (Site 4) close to the exist-ing site in-line with the highest standardsof regulatory compliance.

Chiron's Liverpool site is already one ofthe world's largest facilities for the produc-

tion of flu vaccine. Ongoing investment inthe site is designed to consolidate Chiron'sposition as the world's fifth largest pro-ducer of vaccines and second largest man-ufacturer of flu vaccine. This is comple-mented by the new Site 4 facility, which isplanned to ultimately replace the currentprimary production plant. The vaccine pro-duction process consists of a number ofdiscrete stages. The level of automationprovided at each stage depends on thenature of the operation. Throughout theprocess, package systems – such as incu-bators, blast chillers, centrifuges, ultra fil-tration, motor control centers and utilities– interface with the overall Process ControlSystem to ensure that the batch productionactivities progress through the discretestages, and that the necessary batch data,including environmental monitoring, is

collected and available for in-process con-trol, recording and reporting.

Additional value

The decision to go with Siemens on the newproduction facility was based on the qual-ity of the engineering team in the executionthe project, and provides an excellentexample of where a customer could lever-age the value of Totally Integrated Automa-tion. It was key that the engineering teamcould deliver to the time, cost, specifica-tion and quality criteria set out at the begin-ning of the project, but what set Siemensout from the competition was the addi-tional value brought to Chiron’s invest-ment during the project implementationphases and afterward through the serviceand support team. Siemens approached thesolution with a view to provide a total solu-

Ch

iron

Integrated building and automation solution in the UK

Joint OfferChiron is one of the world's largest developers of vaccines, blood testing and biopharmaceuticalproducts. With a turnover of $1.7 billion and 5,400 people employed around the world, Chiron is aformidable force in global pharmaceutical development. As a company, they see research andinnovation as keys to their success.

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11

tion bringing together all potential areas ofautomation and drives products – processcontrol, instrumentation, drives, motorcontrol centers – and the wider Siemensareas, such as Siemens Building Technolo-gies. This had the impact of showing a fullycoordinated approach to Chiron's businessrequirements that went beyond automa-tion, instrumentation and control. By uti-lizing the knowledge from the life sciencescompetence center, local engineering sup-port, as well as product and service capa-bilities, Siemens proved that it combinedindustry knowledge and engineering andautomation expertise to provide the rightsolution. Simatic PCS7 is the key technol-ogy in giving Chiron improvements in

operation and productivity. This in turnensures future proofing with Totally Inte-grated Automation, and the initial solutionoffered will be further developed to includeintelligent Motor Control Centers (MCCs).In addition by interfacing PCS7 with thebuilding heating and ventilation systemsand building management system suppliedby Siemens Building Technologies, fullenvironmental monitoring will be possi-ble. The project has been fully engineeredby Siemens in the UK.

Although this is the first Siemens instal-lation at the Liverpool facility, Site 4 Engi-neering Manager Harald Rueckl, who waspreviously based at Marburg, had com-pleted several PCS7 installations. This, com-

bined with the approach of the Siemens UKteam, gave him confidence that the projectwould be completed on time and to thequality, cost and incorporating engineer-ing standards and specifications estab-lished by Chiron.

Indication of confidence

As an indication of the confidence nowgained by Siemens, a PCS support contracthas been secured, further underpinningthe relationship between the two compa-nies. �

Reference project for the filling and freeze-drying of pharmaceuticals

Siemens was also very successful inanother Chiron project on the Marburgsite: building a new filling andlyophilization plant for therapeutics andvaccines. Drug manufacturing alwayshas high demands as far as FDA andGMP requirements are concerned.

In this case, however, therequirements were even more stringent,as the project had to deal with an asepticprocess: Any microbial contamination ofthe process and products had to be ruledout from the start.

In addition, the new plant requiredmajor changes to the existing building,

which had to be carried out duringongoing operation. To ensure therequired clean-room conditions, Siemensupgraded not only the processtechnology, but also the entire climateand clean-room technology of the fillingprocess.

Siemens developed the conceptdesign for the GMP upgrade and tookover the basic and detail engineering,including the creation of a 3D model forventilation systems, piping systems, andcable ducts, as well as the building andinstallation supervision. The Siemensteam also supported Chiron in the

commissioning and qualification of the

whole plant in accordance with FDA and

GMP standards. In mid-December 2003,

the old plant was dismantled and the

entire building interior removed. The

first section of the new plant went into

operation at the end of May 2004. Now,

Chiron Vaccines not only has greatly

improved production installations but

can also further increase the capacity of

the plant. “The operation is now state of

the art,” says Andreas Umlauf, project

manager at Chiron Vaccines, summing

up the results of the project.

Siem

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Find out more:www.siemens.com/pharmaE-mail: [email protected]

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12Pharma

FOCUS

What is RFID?Rather than laser light, as in the case ofbarcode technology, Radio FrequencyIdentification (RFID) utilizes radio wavesfor product profiling. Essentially, an RFIDtag consists of a silicon chip and anantenna. Contrary to barcode labels,additional data can be stored and alteredduring the handling of the object. Also,one reader can read multiple tags at thesame time, without the tagged itembeing in the line-of-sight of the reader –thus speeding up the identificationprocess significantly compared tobarcode technology. There are twodifferent tag versions: active and passivetags. Active tags are equipped with abattery-powered power supply, enablinglarger memory sizes and greater readingdistances. Passive tags are powered onlyby the reading signal, which delivers justenough energy for the tag to reply.

In “closed loop” applications, RFID tagscan be reused many times, offering avery attractive cost-per-cycle ratio. “Openloop” applications, where tags are part ofa disposable packaging and informationis available over the life-time of thepackage, are becoming more and moreinteresting as well, as they offer theopportunity to track and trace items overthe entire supply chain.

Since tags can be as small as a ricegrain, application options are numerous.Today's RFID applications range from carkeys to live stock, airplane parts,consumer electronics, shippingcontainers, medical devices – even topatients who are being examined.

RFID tags will help increase logisticsand production visibilty – both in“closed loop” applications withinfactory gates and in “open loop”applications that could extend to thepatient’s bedside

RFID in the pharmaceutical industry

New FrequencyRadio Frequency Identification, or RFID, is nothing new. The technology which employs “smart tags”to track, trace and identify virtually every type of item – even human beings – has been aroundsince World War II. Within the past decade, RFID has found renewed interest. The vision of a world inwhich complete product profiles can be called up with the push of a button has tremendous appealto a number of industries. For the pharmaceutical industry in particular, it seems that RFID hasfinally come of age.

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RFID enables the tracking of goodsfrom their point of origin to create anew quality of supply chain trans-

parency. With RFID, each individual prod-uct possesses an electronic “pedigree” con-taining all relevant information on theproduct, including: the raw materials thatwere used, production data, shipping dates,storage conditions and times, handlingevents and, finally, the sale or applicationof the product. This information in turncan be used to improve everything fromproduct availability at the point of sale tostock management, lead times, investmentplanning and, ultimately, customer satis-faction.

RFID can also contribute greatly towardenhancing productivity and product secu-rity. For high-value items, RFID informa-tion can be used as a tool for product-authentication in the fight against gray

markets, theft and counterfeiting. In orderfor item level tagging to have a globalimpact, however, three major issues mustfirst be resolved: the price of the individ-ual tag, a standardization of the varioustechnologies which now exist, and improve-ment of the physical performance of RFIDin different environments. In all threecases, a solution is expected soon. Anotherimportant issue involves privacy concerns.Consumers generally do not want theirproducts to be traced after purchase. Forpatients requiring special medication, onthe other hand, a monitoring capability fortheir physicians and pharmacists can be asource of welcome added security.

Addressing key concerns

In an attempt to deal with the increasingproblem of counterfeit drugs and its impli-cations for patient safety, the US Food &

Drug Administration issued an extensivereport recommending the use of RFID as akey technology to enhance consumer med-ication safety.

These recommendations, as well asrecent US state-specific regulations on drugpedigrees mean that many pharmaceuticalmanufacturers could now rank among the“early adaptors” of item level RFID tagging.

As soon as the proof of the authenticityof a drug (related to its original, i.e. certi-fied, manufacturing data and preferable atpoint-of-sale) and measures such as elec-tronic pedigree (a record documenting thatthe drug was manufactured and distrib-uted under secure conditions) becomemandatory, in the US or on a global scale,drug manufacturers will have to comply tothese rules to stay in business. However,

Typical application areas of RFID include product logistics and distribution

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For distributors, pharmacies and hospi-tals, RFID can greatly improve the supportof operational processes by eliminatinghuman failures and increasing productthroughput. In hospitals, an RFID-sup-ported wireless infrastructure could reducepaperwork, providing hospital staff withmore time for patient care.

A long history in RFID

Siemens has extensive RFID experience invarious disciplines spanning decades: fromproduction-skid tagging in the automotiveindustry to RFID-enabled warehouse pro-cesses and material flow, access-controlsolutions and patient data recording.

Aware of the multidisciplinary characterof large scale RFID applications, Siemenshas united the expertise of various special-izations to achieve the end-to-end integra-tion needed to make RFID attractive for all

parties, and is currently working on solu-tions that specifically address the needs ofthe pharmaceutical industry. One examplecan be found in Austria, where Siemensprovided a pilot tracking and tracing sys-tem for bloodbags in close cooperation withthe local bloodbank and hospital. Cur-rently, together with the Swiss packagingcompany Limmatdruck, one of the lead-ing packaging machinery suppliers forthe pharmaceutical industry, Siemens isdeveloping new ways to attach RFID tags tothe carton or packaging of individual prod-ucts, enabling in-process writing of dataonto the tag. �

Potential applications of RFID in Life Science

Clinical B Lab specimen tracking

B Patient tracking

Supply Chain B Gray market tracking

B Protection against counterfeiting

B Product recall management

B Expiration date management

B Drug validation issues at point-of-sale

B Drug pedigree

Asset Management B Identification/Tracking of containers in the lab/production

B Container movement/history

Production B Inventory management

B Material tracking

B Production line management

Product Development B Animal identification

B Tracking of lab samples

B Tracking of patients/usage in preclinical tests

compliance to these regulations requiresserious efforts, without resulting in adirect clear (financial) benefit. With theentire industry facing more and more pres-sure regarding time-to-market, marketresponsiveness, cost reduction and flexi-bility, RFID can bring the transparency andinformation needed to improve businessprocesses, and to increase overall supplychain efficiency – something all players willbenefit from.

Utilization of RFID technology in thepharmaceutical industry is not limited tosupply chain optimization or tracking andtracing applications. In fact, as the tableshows, RFID has great potential across theentire pharmaceutical value chain, also indedicated closed loop applications.

Find out more:www.siemens.com/pharmaE-mail: [email protected]

(Continued from page 13)

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15FOCUSPharma

Simatic technology facilitates FDA CFR 21 Part 11compliance in Courtoy tablet presses

Evolving towardPerfectionAt Courtoy, the future lies with constant evolution on the path towardimproved FDA compliance. “In pharmaceutics, people, above all, want qualityand reliability. This is why one of our major clients in the pharmaceuticalsector insisted on us working with Siemens,” says Wouter Happaerts, chiefsoftware designer at Courtoy. In the design of a new tablet press, engineersat Courtoy greatly benefited from Totally Integrated Automation.

toy rotary tablet presses, is quite straight-forward. On rotary presses, all parts in con-tact with the product, and all product for-mat parts, are concentrated around thecentral turret or die table. This turret – com-plete with punches, dies, powder feeder,scraper, ejection finger, dust extractionnozzles, and the tablet chute – is integratedinto one self-contained box, allowing for acomplete machine changeover by a singleoperator in 30 minutes.

Integrated, open automation solution

Jürgen Boeckx, research and developmentmanager at Courtoy, stresses the impor-tance of automation in regulatory compli-ance: “Control elements such as SimaticWinCC, which we use in our presses, or the

Find out more:www.siemens.com/pharmaE-mail: [email protected]

Courtoy N.V. near Brussels, Belgium,is the leading manufacturer of ro-tary tablet presses. The company is

part of Niro Pharma Systems, and hasbeen designing and building versatile ro-tary tablet presses for over 80 years.

Today’s tablet production operations arefaced with two seemingly contradictory de-mands: being able to safely handle morepotent drugs, and reducing overall pro-duction costs. At the same time, batch sizesare decreasing and production planningmust allow for maximum flexibility. No sin-gle solution existed to meet all of theseneeds simultaneously.

This is why Courtoy developed the ex-changeable functional module (EFM) which,as applied to the latest generation of Cour-

The Modul tablet press uses a new, modular conceptthat also ensures better levels of compliancy

integrated Simatic S7-400 controller andfieldbus technology, have the potential tocontinue development toward ever betterregulation compliance.” Moreover, becausethe Simatic WinCC-based SCADA solutionoffers the potential for superior integra-tion on the end-user side, Siemens equip-ment is the standard setup for Courtoy’sModul press.

Significant benefits

For the designers at Courtoy, the Totally In-tegrated Automation approach has broughtsome dramatic improvements in machinedevelopment. The greatly simplified field-bus cabling solved some critical designproblems, and at the software level, theCourtoy engineers fully benefited fromWinCC’s ability to integrate standard pack-ages as well as higher-level systems – forexample, for networking at the MES levelwithout extra programming.

Striving for ever better compliance

Courtoy plans to expand the integrated di-agnostic functionality with WinCC to beable to meet increasingly rigorous re-quirements from the regulating bodies.“Even though perfect compliance is toughto achieve due to the stringent regula-tions, we now have the potential to actuallyget there,” Wouter Happaerts and JürgenBoeckx conclude. �

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Automation and validation of a Xian Janssen plant

Global ExpertiseThere is no room for ambiguity in the pharmaceutical industry: strict

international guidelines regulate the production processes. Automationsystems must go through an exhaustive validation process before theycan begin operation. In modernizing the automation system of a Xian

Janssen production plant in China, Siemens has once more been able toprove its expertise in the pharmaceutical industry. Redundant systems

provide maximum reliability, and Siemens' extensive know-how consid-erably simplified validation of the systems.

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17

X ian Janssen Pharmaceutical Ltd. is ajoint venture between the Belgianpharmaceutics company Janssen,

which belongs to Johnson & Johnson, and aChinese partner. The company is consideredthe number one in the Chinese pharmaceu-tical industry and produces a wide range ofvery successful products. The Xian Janssenproduction facility, situated in the historiccity of Xian, manufactures patented drugsthat are used, for example, in mycology,gastroenterology, anesthetics, psychiatry,and neurology. The production facility com-plies with the international standards of thepharmaceutical industry and is certified inaccordance with CFR 21 Part 11.

Xian Janssen recently determined thatthe process control system implementedwhen the factory began production in themid-1980s was no longer meeting currentrequirements. The company decided toreplace the system with a state-of-the-artsolution, and chose the Simatic PCS7 pro-cess control system. A decisive factor inthe selection of PCS 7 was the ability ofShanghai-based Siemens Industrial Au-tomation Ltd. (SIAS) not only to providethe necessary engineering competence lo-cally, but also to support Xian Janssen inthe validation of the system.

Reliability through redundancy

The process control system in Xian had tosatisfy both national and internationalstandards of the pharmaceutical industry,including the specifications of the Ameri-can Food and Drug Administration (FDA),the requirements of the World Health Orga-

nization (WHO), and Good ManufacturingPractice (GMP) regulations.

The control system was divided into twosections based on the production structureat Xian Janssen: the production of phar-maceutical products in liquid form, and themanufacture of ointments. The liquid prod-uct section accounts for a much greatershare of the production. Thanks to the openarchitecture of PCS7, it was easy to link thenew process control system to the existinginfrastructure with the associated fielddevices, which considerably reduced theinvestment costs for modernization.

To ensure unrestricted availability of theautomation solution, all essential functionswere designed redundantly. This guaran-tees complete documentation of all pro-duction parameters. An extensive docu-ment management system was also imple-mented to guarantee access to all records atany time.

The process control system consists oftwo automation systems to which threeoperator stations and one engineering sta-tion for each of the two production sectionsare linked. Both sections can, therefore,be controlled completely independently.Moreover, the control and status displayfor ointment production is possible fromboth subsystems.

A special feature of PCS7 is the event-controlled synchronization of the redun-dantly designed systems. In the event of afault in one system, the control systemautomatically switches over to the otherwithout impairing the current cycles of theproduction process. There is no need to

interrupt operation for maintenance work,or to change hardware components either.

Validation support

In addition to the hardware design, soft-ware configuration, and installation of thecontrol system, the project scope alsoincluded the final validation of the system.The Siemens team helped Xian Janssen runa structured validation process based onthe V-model. The team provided specialengineering services to document everyproject step in detail, and to prove theappropriate functionality within the scopeof validation – quite a task, considering thatvalidation of such a project consists of20,000 pages of documentation, as well asnumerous test runs to prove the reliablefunctioning of the plant, which must runaccording to exactly specified criteria.

Siemens has extensive global experiencein controlling production processes in thepharmaceutical industry. Thus, the SIASproject team was able to draw on a largereservoir of knowledge, facilitating theteam’s flawless first validation of a Chineseproduction facility.

Safety in ongoing operation

The modernization of the production facil-ity at Xian Janssen was SIAS's biggest proj-ect in the pharmaceutical industry to date.

Siemens was able to impressively demon-strate its global expertise in pharmaceu-tics-specific issues (such as validation), andthat the necessary related services are alsoavailable locally.

Since implementation, the new systemhas also proven its effectiveness in ongoingoperation. The redundant design of the sys-tems provides an extremely high level ofsafety, although PCS7 has not yet had toresort to this functionality.

There have been no faults at all since thenew process control system was commis-sioned – further proof of the technologicalreliability of the implemented systems andthe competence of the Siemens projectteam. �

Find out more:www.siemens.com/pharmaE-mail: [email protected]

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Some years ago, centralized weighingoperations were introduced to phar-maceutical and biotech manufactur-

ing companies to ensure that materials in-troduced into the process were of the cor-rect type, quantity, and quality. Now, newelectronic dispensing systems provide fur-ther significant efficiency and quality gainsover manual operations.

In a typical manufacturing executionsystem (MES) environment, coordinationbetween the ERP level and the shop floorlevel is essential to execute the planned op-erations. The MES must be able to managethese complex operations reliably and effi-ciently. In order to fulfill the bill of materi-als associated with the weighing and dis-pensing orders, concepts such as campaign

or order weighing and container allocationare applied.

The Simatic IT MES offers drug manu-facturers an integrated solution that in-cludes weighing and dispensing. Weighingand dispensing orders are downloadedfrom the ERP system through an XML-based interface (Simatic IT Data IntegrationService), and can then be handled directlyby authorized operators.

Orders can be sequenced and dispatched,or split into phases, and the necessary in-formation will always be available for fulltracking and tracing – from raw materialsto the pallet in the warehouse. This appliesin particular to wall-to-wall MES solutionsthat need to guarantee consistent qualityfor incoming goods that are received,

tested, and released for production. TheSimatic IT solution for weighing and dis-pensing also features direct links with var-ious scales and bar-code readers, allowingthese operations to be fully automated.

Efficient downtime management

The Simatic IT OEE-DTM (Overall Equip-ment Efficiency and Downtime Manage-ment) product option provides consistentmonitoring and control of a plant’s effi-ciency in an intuitive, easy-to-use environ-ment, and is closely integrated with theSimatic IT Production Suite.

The standard functionalities providedby Simatic IT and Simatic Batch are tightlyintegrated, leveraging the full potential ofTotally Integrated Automation, includingSimatic PCS 7 and Simatic Batch. Batch dis-patching, material management, electronicbatch recording, and batch reporting aresome of the standard and native function-alities provided by this close integrationbetween the various Siemens productswithin the portfolio. �

Good Manufacturing Practice in DrugManufacturing Plants

Digital ReportsOne main objective of the pharmaceutical industry is to makeprocesses standard and repeatable throughout all manufacturingfacilities. Electronic batch reporting and documentation, asprovided by Simatic IT, offer significant benefits over traditionalpaper-based solutions.

Find out more:www.siemens.com/pharmawww.siemens.com/simatic-itE-mail: [email protected]

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Siemens builds ultramodern logistics center for Merckle/ratiopharm

Perfect PackageSiemens Logistics and Assembly Systems has built a logistics center for theMerckle/ratiopharm pharmaceutical group at the company’s Ulm/Donautallocation in Germany. This highly automated logistics center is setting newbenchmarks in the field of pharmaceutical distribution centers, with anoutput of about 1,000 pallets and 170,000 picks per day.

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For this project, Siemens upgraded theequipment in the existing goods dis-tribution center and linked the mate-

rial flow to the new logistics center. The dis-tribution center was retrofitted with thelatest Simatic S7 generation of materialhandling controls, and the drive and con-trol equipment of the S/R machines was alsomodernized. The Siemens material flowsoftware also links both the new and exist-ing warehouses to the SAP LES (logisticsexecution system) software in a uniformmanner.

State-of-the-art warehouse

Items coming directly from the adjoiningproduction facilities and items deliveredfrom external suppliers arrive on euro pal-lets in the high-bay warehouse, which has28,000 storage spaces. There, they are auto-matically stored double-depth by six S/Rmachines. The employees on manuallyoperated picking cars take original boxesdirectly from the stored pallets, attach a

bar-code label to each box,and then push it onto thecontinuous conveyor inte-grated into the pickingcar. Conveyor belts per-manently fitted in the rackaisles take the markedboxes directly from thecontinuous conveyor onthe picking car and trans-port them to the head ofthe rack structure, wherethey are collected and for-warded toward the order-picking hall.

Original boxes designated to be shippedas complete boxes are sent directly to dis-patch, while those intended for a mixedorder with other drugs go to the transitwarehouse.

Pharma

Find out more:www.siemens.com/pharmaE-mail: [email protected]

Automation makes manual work easier

The transit warehouse is dedicated to cus-tomized picking, and the efficiency of thework is supported by a pick-to-light (PTL)system in the nine picking aisles.

One special feature of the plant is a pre-cise check weigh linked to the PTL system.The orders are weighed on a movableweighing unit after each filling process. Thehigher-level computer system can assign aprecise weight to each retrieval process.Automating the monitoring of the pickingquality prevents errors.

At the end of the picking zone, theemployee acknowledges the entire orderand pushes the tray bearing the order boxback onto the conveyor track. This takes thebox to the next order-picking station.

The completely picked mixed boxes arethen collected into a single material flowwith the original boxes, and temporarilystored in eight central walking beamdevices, where they stand ready for pack-aging according to the individual order atthe large and small package stations.

More flexible and accurate

The new distribution center went into oper-ation at the end of 2004. Merckle/ratio-pharm is very satisfied with the center’sperformance, as increased flexibility andimproved accuracy help ensure customersatisfaction. Both individual mail items andlarge packing drums can be quickly assem-bled and dispatched as needed in the dis-tribution center. �

Weighing of orders significantlyreduces the number of errors

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Simotion C in packaging line for band-aids

A Straight LineUntil the end of 2003, a large share of the band-aid production at BSN medical in Hamburg waspacked by hand. The old packing line needed to be automated. For this project, BSN medical founda committed and competent partner in Vector Vepackungstechnik GmbH, with Siemens as theelectrical installations provider. Nearly 20 machine modules were equipped with the Simotionmotion control system, and could, therefore, be commissioned step by step, independently of eachother – allowing even the very tight schedule for this project to be met.

process news 3/2005

BSN medical GmbH & Co. KG, a coop-erative of divisions of Beiersdorf AGand the British company Smith &

Nephew, addresses the clinical “medicalcare” market segment worldwide, in whichproducts for wound dressing play an im-portant part. The bandage materials are pro-duced by proven machines taken over fromthe parent company, Beiersdorf. The au-tomation of product packing was long over-due because the problematic link to the pro-duction machines had always delayed mod-ernization. A BSN team finally addressedthis problem at the beginning of 2003.

Due to the expansion of the sales marketafter the merger with Smith & Nephew, andto the need to set an example for othercompany divisions, the project was undergreat pressure to succeed – and quickly.Thanks to the committed cooperation of allof those involved, the entire packing linewas installed after only seven and a halfmonths’ development and constructiontime, in the second week of December 2003;full production in three shifts commencedat the beginning of 2004.

Twin-portal robot copes with highproduct volume

The packing line consists of two folder boxassemblers, a box closer, a side packer fordispatch boxes, and a twin-portal robot –the real heart of the line. The band-aids areproduced in long webs and stored as rolls.A cutting machine spools off smaller rollswith band-aid lengths of 5, 10, or 20 meters.These rolls are then cut according to the de-sired width. In total, the plant feeds about10 box types with about 70 products fromwidely different kinds of band-aids in 20 de-livery formats.

The wide variety of products that theplant has to cope with is sometimes tricky.

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The twin-portal robot of the packing line

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“A robot solution cannot cope with smallformats. Therefore, we suggested a portalgrabber system that picks up all band-aidrolls simultaneously,” says Klaus Zott, re-gional sales manager of Vector, explainingthe necessity of an individual top-loadersolution. “Moreover, the cutting machine isheavily exposed to the band-aid adhesive.For this reason, quite a lot of free spacemust be left in front of the machine formanual cleaning and servicing of the cut-ting device, which means the traversingdistance for the portal is very long. We havetherefore designed a twin-portal machine,in which two groups of grabbers at differ-ent traversing heights pick up the band-aid rolls alternately and place them in theboxes.”

Complete equipment and motioncontrol expertise

The two box assemblers (with four axeseach), the box closer (seven axes), and theside packer (eight axes) are fully controlledby Simotion C230. A Simatic S7-300 withthe FM 357 track and positioning controlleris used in the twin-portal robot. The HMI ofboth the individual machines and the over-all plant is provided by Simatic Multi Pan-els with touch screens. All components ofthe plant communicate via Profibus DP, and

manager Bernhard Bandel and his teamhave installed an exemplary packing plantthat operates reliably. With the decision toinvolve Siemens as both a complete sup-plier and a provider of engineering serv-ices for the project, Vector concentrated itscapacities in a consistent and strategicallyeffective manner. The convincing use ofSimotion motion control has since led theparent company, Beiersdorf, to adoptSimotion as a solution for motion controltasks as well. �

process news 3/2005

Find out more:www.siemens.com/packagingE-mail: [email protected]

the individual machines are linked byDP-DP couplers. Communication via thesafety-oriented Profisafe protocol re-duces the wiring effort considerably, assafety devices such as safety door con-tacts or emergency stop switches can beconnected directly to the distributed pe-riphery.

The handling of the product variety ismade much easier by this motion con-trol-based automation. The individualmotion parameters of the motion controlaxes are saved for every box type and canbe called up by the according recipes. Theoperating personnel has to make only afew manual setting changes for the formatchange, so the plant can respond very flex-ibly to the current delivery situation.

Based on this highly consistent commu-nication, the automation system offers thepossibility of telediagnosis and teleser-vice – a service that both Vector and BSNmedical greatly appreciate. “Support mustcome fast, when it is needed,” says electri-cal engineer Claus Goldberger, stressingthe high availability requirements at BSNmedical.

Successful project

The Hamburg-based medical productsmanufacturer is very satisfied. Project

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Graphic visualization improvesease-of-use

The box closer

Placing the band-aids into the folded boxes

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Find out more:www.siemens.com/wincc-flexibleE-mail: [email protected]

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The production of pharmaceuticals issubject to more stringent restrictionsand requirements than in almost anyother industry. Simatic WinCC flexible2005 provides comprehensive processdocumentation functions to supportcompliance with GMP requirementssuch as CFR 21 Part 11, while alsoensuring a maximum level of safetyand transparency even at the panellevel.

Documentation and safety are keyconcerns in pharmaceuticals pro-duction. Any intervention in the

manufacturing process that could affectproduct quality must be documented. A de-tailed audit trail must record any changes,including when and why and by whom theywere made. Preventing changes by unau-thorized persons is equally important.

These requirements can now be fullymet with Simatic WinCC flexible 2005 – andnot just in conjunction with PC systems,but even with Simatic Class 270 and 370panels.

Access security, audit trail, andelectronic signature

The user management function of SimaticWinCC assigns specific rights to users ina hierarchical order. Users are forced tochange their passwords at certain intervalsto increase access security. A selectablepassword history, automatic user logoffafter prolonged inactivity, and accountblocking after several wrong password en-tries are additional protective functions inWinCC flexible.

The Audit option in WinCC flexible 2005can be used to define quality-relevant vari-ables and data. Changes to these variablesare monitored and recorded in the audittrail along with a time stamp, the logged-inuser, and the name of the variable, plus theold and new values. The system also pro-vides commentary options (which may bevoluntary or obligatory) concerning whythe value was changed. In particularly crit-

ical interventions, the system requires anelectronic signature: the user must validatethe change by entering his or her password.

Pharma-compatible engineering

WinCC flexible 2005 not only monitors thevariables of the production process, butalso any changes in the system. This is acritical task, because without appropriatedocumentation, the system loses its vali-

dation. The Change Control option auto-matically records any configuration changesin the change log: who made what changein which object, complete with a time stamp.The automatic version control supports func-tions such as comparison and rollback.

More efficient configuration

An intuitive library concept that also con-tains pre-engineered objects supports fastand effective configuration. Picture blockscan be changed from a central location. Alarge number of intelligent assistants pro-vide useful functionalities such as simpleproject generation or graphical object tra-jectories. As a result, WinCC flexible en-sures that the configuration of machinesand plants is not only compliant with theguidelines of the pharmaceutical industry,but also quick and convenient. �

Simatic WinCC flexible for pharma production

Recipes for Operation

HighlightsFlexible use

B For use at machine level and processlevel

B Suitable for applications with panels aswell as PCs

B Configurable with engineering softwareand for use in the most diverseautomation solutions

B Usable worldwide (multilingual)

Maximized configuration efficiency

B Easy-to-use interfaceB Intelligent toolsB Reusable picture blocksB Multilingual configurationsB Convenient migration of configuration

data from the ProTool family

Innovative HMI concepts

B Systemwide access to variables andimages

B Distributed user terminalsB Local control-room solutionsB Link to the office world

A part of Totally Integrated Automation

B In Simatic Step 7, Simatic iMap, andSimotion Scout

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Application software development in compliance with FDA 21 CFR 11

Qualified SupportThe application support for the automation of packaging machines providedby Siemens for its customers in the machine building industry is backed bymore than 20 years of experience. Seasoned specialists support thedevelopment of a packaging machine from its conception and configurationto its implementation, on-site commissioning, and optimization.

process news 3/2005

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The Application Centers for MotionControl Solutions are distributedaround the globe, with 13 locations

in seven countries. They provide industryknowledge and technology expertise forthe development and optimization of mo-tion control solutions in machine building.More than 100 application engineers workclosely with customers to develop the bestpossible application for each machine basedon standard components – from a detailedanalysis of the present configuration andrequirements to the resolution of technicalissues, a feasibility analysis, and the imple-mentation proposal. This approach givesmachine builders much greater planningcertainty.

If the customer wishes, the ApplicationCenter will configure the application andsupply all of the equipment, including thecontrol console, based on a wide range of

industrially proven solutions and standardapplications. Siemens also provides appro-priate training programs to ensure that thecustomer will be able to maintain, modify,and expand the solution in-house. This sin-gle-source concept reduces the number ofinterfaces, and creates synergies in the con-ception, testing, and optimization of themachine solution so that both the com-plexity and the cost of machine develop-ment can be substantially reduced.

Commissioning and validation support

The support provided by the automationand drive systems specialists from the Ap-plication Centers always includes the com-missioning and optimization of the ma-chine, from parameterization and pilotoperation to personnel orientation andtraining. This comprehensive support iscomplemented by a hotline and remote

Find out more:www.siemens.com/motioncontrolE-mail: [email protected]

service. All of these activities help ensurethat the machine will function flawlessly inactual operation.

The application specialists excel at de-signing software specifically for pharma-ceutical packaging applications that arebased on the Simotion automation system,and that are specified, developed, tested,and documented in accordance with the V-model. Such an application has recentlybeen developed in ST-Code in accordancewith IEC 61131, with integrated motioncontrol functions as a “validation-proof shiftregister” for modular machine designs, andin cooperation with a leading maker of blis-ter machines.

Optimized support from A to Z

In the past few years, many machinebuilders have already benefited from thecumulative experience of the expert teamsin the Application Centers for Motion Con-trol Solutions. Optimized product selectionand integration, the reliance on standard-ized and open solutions, an in-house high-tech machine test center, plus customer-specific project management are only someof the advantages that result from close col-laboration between machine builders andSiemens. �

Pharma

Expert teams in the Application Centers are supporting customers in the packagingmachine industry worldwide in the development of their machines

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requirements, it is then stored freeze-dried or in liquid form in cold rooms at 4degrees Celsius. The entire process takesplace in a special building and requires 48hours from start to finish.

The manufacturing process is subject tothe same requirements as are applied tothe production of human medicines. Theprocesses must therefore run in accor-

T he active pharmaceutical ingredi-ents of the vaccines are obtainedfrom cell or bacteria cultures. These

ingredients are then transferred understerile conditions to one of the formulationvessels of the Bio 4 preparation unit. Afterformulation and quality control, the vac-cine is portioned in 3-milliliter doses invials and then packed. Depending on the

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24Pharma

FOCUS

Passionate aboutanimal health:Virbac

The health of pets and farm ani-mals all over the world is thepassion of Virbac. The company,which is headquartered in Car-ros, near Nice, is one of theworld's leading producers of vac-cines and therapeutics for ani-mals. Virbac manufactures ap-proximately 3,000 products in itschemotherapy and biotherapydivisions. In addition to vaccines,the company's portfolio includesnumerous antibiotic, antipara-sitic, anti-inflammatory, derma-tological, and ophthalmologicalproducts in almost every admin-istering form used in veterinarymedicine.

Simatic PCS 7 facilitates monitoring andoperation of the process

Vaccine production at Virbac with Simatic PCS 7

Guaranteed ResultsDogs, cats, cattle, horses – most of these animals will come into contactwith Virbac products at some point in their lives, as the French companyis one of the leading manufacturers of animal vaccines. In theproduction of these vaccines, the same strict regulations apply as in theproduction of human medicines. Most recently, the Simatic PCS 7process control system is ensuring that Virbac's products always complywith the pertinent regulations with regard to safety and effectiveness.

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25

dance with GMP specifications and therequirements of the AMM (Autorisation deMise sur le Marché, the guidelines regulat-ing approval of medicines in France).

Controlled process in a sterileenvironment

The Bio 4 preparation unit consists of foursimilar tanks with different holding capac-ities, operating independently of eachother. In each of these tanks, pH, pressure,temperature, and the weight of the rawmaterials are monitored throughout themixing process and stored in a batch log.Load cells on every tank also continuouslymonitor the weight of the tank and sus-pension. Because the entire process mustrun under absolutely sterile conditions, theplant includes clean-in-place (CIP) and ster-ilize-in-place (SIP) systems.

Proven system under new control

“Our preparation unit is now more than 10years old, and the corresponding automa-tion system was no longer state of the art,”explains Philippe Gugi, production man-ager at Virbac.

“We were therefore looking for a newsolution for the plant control that wouldlargely automate all production stages,but still leave us the opportunity to addingredients to the vaccine manually,” addsPhilippe Astruc, biology production man-ager at Virbac.

For the technical implementation of amodern automation solution, Virbacapproached Siemens in nearby Nice. Thecompany chose Siemens not only becauseof the technical advantages of SimaticPCS 7, but also because of Siemens' geo-graphical proximity. It was very importantto those responsible for this project at Vir-bac to have a competent partner with a localpresence.

Virbac's technical and quality assurancedepartments worked together closely withthe Siemens project team on the modern-ization of the systems. Simatic PCS 7 waschosen as the automation system. The datafrom the processes are acquired via Profi-bus DP and transferred to the control sys-tem. Profibus DP guarantees not only a fastdata flow to all sensors and actuators of thefour production tanks and to the CIP and

SIP systems, but also the activation of theagitators and the weighing equipment.

“In this way, we were able to achieve theresponse times we need in the processes,”explains Thierry Simon, project technicianat Virbac.

Several specific functions were alsoadded to the process control system. Forexample, the status of the plant compo-nents is color coded so that the currentoperating state is always visible at a glance.The system automatically takes intoaccount the fact that certain process stateshave an expiration date. If, for example, acleaned plant is not sterilized within fivedays, it loses its “cleaned” status and mustbe cleaned again before sterilization. If aprocess unit has been sterilized, this statusexpires after three days.

“With Simatic PCS 7 we can ensure con-tinuous traceability of the products and theprocesses,” says Thierry Simon. The pro-duction data are saved simultaneously inboth control stations.

Philippe Gugi adds: “At the end of everylot, documentation is created for the batchand saved for the duration of the legallyprescribed storage time. In addition, theoperator can add an electronic signature tothe batch documentation.”

Excellent results

Simatic PCS 7 has been in operation in thepreparation unit at Virbac since mid-Sep-tember 2004, and to the customer’s com-plete satisfaction. The traceability andrepetitiveness of the lots have been signif-icantly improved. Those responsible at Vir-bac were also satisfied with the course ofthe project. “We fully achieved our goals,and budgets and deadlines were met,”Philippe Gugi confirms.

The next projects are already beingplanned. For example, another formulationplant is soon to be expanded. �

Find out more:www.siemens.com/pharmaE-mail: [email protected]

The systems of preparation unit Bio 4 are being controlled by Simatic PCS 7

Vir

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process news 3/2005

E stablished by Ernst Schering in Berlinin 1851, Schering AG has alwaysranked among the great innovators in

pharmaceuticals. Schering began researchon sex hormones in 1921, and in 1961 thecompany presented the first preparation forhormonal contraception. Today Schering isone of the leading producers of prepara-tions for gynecology, andrology, and diag-nostics. APIs for these pharmaceuticals aremanufactured at the Bergkamen plant. Theactual preparations for the internationalmarket are then produced in various phar-maceutical plants in Europe, Asia, andSouth America. At its API production facil-ity in Bergkamen in Northern Germany,

Schering operates several plants for micro-biological and chemical processes. Resourcesemployed to guarantee the absolute purityof the final API products include two sepa-ration systems based on the HPLC (high-pressure liquid chromatography) process.The API is filtered through a column filledwith silica gel at high pressure to dissolveand remove any remaining impurities untilonly the pure API remains.

The result of years of cooperation

In the past, Schering purchased its HPLCcolumns complete with their proprietarycontrol system from the same manufac-turer. The downside of this approach was

that any change in the process control wasextremely complex and costly, which, ofcourse, raised the life-cycle costs of thesesystems. Late in 2002, Schering decided tochange its approach and opted for a solu-tion that would be based on open industrystandards and support easy changes of pa-rameters and recipes. The selection of theright automation system was not just a tech-nical decision. It also required a high levelof confidence in the partner that would in-stall and commission the system, becausethe pharmaceutical industry processesproducts that are often extremely costly.One kilogram of an API may easily cost tensof thousands of euros.

Chromatography process at Schering is automated with Simatic PCS7

Flexibility and ProcessReliabilityFlexibility, reliability, and the ability to provide complete documentationare just some of the requirements that process control systems must meetin today’s pharmaceutical industry. In two separation systems for activepharmaceutical ingredients (APIs) in its Bergkamen plant, Scheringdecided to replace the existing control systems with newer technologythat would make it convenient and cost-efficient for the company todefine and change recipes in-house. In this project, Schering decided tocontinue a long and successful partnership by relying once again on theexpertise of Siemens.

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API Plant B at the Bergkamen site

26 FOCUSPharma

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The cooperation between Schering andSiemens has continued for many yearsand has proven its value in numerousprojects. In the 1980s, Schering used typeR-30 Siemens controllers, which were sub-sequently replaced with Teleperm M mod-els. The decision to convert the HPLC sys-tems to Simatic PCS7 with Simatic Batch wastherefore not only a decision to upgrade tothe latest technology generation, but also avote of confidence in Siemens as a partner.

Maximum performance in minimum time

Siemens was responsible for the entirehardware and software installation and the

engineering of the control system. In addi-tion, Siemens trained the Schering em-ployees and provided support in the vali-dation of the system.

As always when a functioning plant is in-volved, this project had to be completed ina very short time frame. The contract wasissued in mid-December 2002, and projectwork began promptly in January 2003. Thefactory acceptance test was completed bythe end of January, and the system wascommissioned in mid-March 2003. Theproduction system was then validated be-fore the two HPLC columns were started upin early May 2003. A special challenge, par-ticularly in this short time frame, was the

fact that Version 6.0 of PCS7 was being in-troduced while the project was under way,and the customer wanted to adopt this lat-est release of the control system right fromthe start. But the Siemens team managed toclear even this additional hurdle and inte-grated the new version with no major prob-lems. The Schering plant is now operatingwith an automatic process control systembased on the latest technology.

Getting a grip on a complex process

The HPLC columns are operated in batchmode, which requires a sampling rate inthe millisecond range. Direct communica-tion via Profibus between the process con-trol system and the interconnected drives,sensors, and actuators enables the controlsystem to access process information rap-idly, and to promptly respond to the currentprocess situation.

The individual recipes are composed ofas many as 400 different recipe parametersthat are accessed from a library. To achievethe range of functionalities required bySchering, many special applications werederived from the basic functions that ex-isted in SCL. These new applications weredeveloped in WinCC and Visual Basic toprovide such functionalities as the creationof parameter images, check images, andchromatograms.

With this new solution and thanks to themodular and open design of the entire sys-tem, the customer can now use the graphi-cal user interface to create new recipesswiftly and easily with in-house resources.Changes and adjustments can now be madeat any time, without major complexities orexpense. For both companies, the projectrepresents the continuation of a successfulpartnership that has lasted for many years.For Schering, it also marks the importanttransition to a production environment thatfinally provides the desired flexibility. �

Find out more:www.siemens.com/pharmaE-mail: [email protected]

View of a reactor in API Plant B, whereSiemens has automated an HPLC systemwith Simatic PCS 7 and Simatic Batch

Berlin-based Schering AG is a leader in researchamong the large pharmaceutical manufacturers

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28Food and Beverage

CASE STUDY

clear. Pointek instruments use a uniqueinverse-frequency approach to capacitancetechnology that ensures accurate, reliable,and repeatable level detection. Traditionalcapacitance devices measure voltage dropor current flow and are affected by changesin material propertie. However, Pointeksensors monitor the effect of capacitancebased on frequency change. Because evensmall level changes create large changes infrequency, the result is better resolutionand accuracy.

The CLS 200 has a high frequency oscil-lator with the sensor encapsulated in theprobe tip. The sensitive tip is a very accu-rate and repeatable switchpoint, and theprobe is unaffected by material build-up,humidity or moisture. The device is easy toinstall and calibrate.

Technology helps ensure quality

Reliable level detection helps the plant dealeffectively with the foam produced in thewash stills, preventing spills and protectingthe process. One of the other major bene-fits is consistency of distillate, because theburners operate only when needed. Thisalso reduces staff and maintenancerequirements, freeing the operators forother duties, and allowing production tocontinue on weekends. “This technologyhelps us ensure quality product andenhance efficiency, “ said Willie Thomsonfrom the Dufftown Distillery. “It’s an idealmeeting of our time-honored traditionswith modern technology.” �

Pointek level monitoring in whiskey production

Tradition MeetsTechnologyWith its unique inverse-frequency approach to capacitance technology,Pointek level monitoring instruments can reliably detect foam levels. Thishelps ensure the high quality of the whiskeys produced at the renownedDufftown distillery.

A t the Dufftown Distillery in the High-lands of Scotland, William Grant &Sons Distillers Limited has pro-

duced fine Scotch whiskey since 1866,including Glenfiddich, the best-selling sin-gle malt whiskey in the world. Qualityingredients and careful process monitoringare vital to the art and science of whiskeymaking. First, malted barley and water aremixed in a mash-tun, a round metal vesselwith mechanical stirrers, to produce wort(sugar solution). Wort is cooled andpumped into pear-shaped fermenting ves-sels called wash stills, where operators addyeast, and the mixture produces wash(weak spirit). The wash is distilled tostrengthen and purify the spirit.

The spirit is then matured in oak casksfor a minimum of eight years to becomeScotch. In the wash stills, prior to vapor-ization, foam is produced that can result inboiling high levels of froth mixing in withthe “low wines” from the first stages of dis-tillation. To control the foam, the burnersmust be turned off, then restarted, as thefoam dissipates. The Dufftown plantwanted to automate the wash still operationto control foam. Because foam is neitherliquid nor air, it has traditionally beenimpossible to detect with older level meas-urement equipment such as floats orvibrating forks.

Better resolution and accuracy

In 2003, the distillery installed a SiemensPointek CLS 200 instrument on the neck ofeach wash still. When foam reaches the tipof the instrument probe, the CLS 200detects it and automatically turns off theburners. It restarts the burners when thefroth level diminishes and the sensor is

Find out more:www.siemens.com/processinstrumentationE-mail: [email protected]

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29CASE STUDYWeighing Techology

Find out more:www.siemens.com/siwarexE-mail: [email protected]

The Kali France factory, near Mulhouse,supplies customers (primarily inFrance) with potassium and magne-

sium products. The salts are loaded readyfor sale on railway wagons.

In modernizing the company’s automa-tion system, Kali France was also on thelookout for a new, more modern solutionfor weighing the wagons, because the sys-tem currently being used was no longerstate of the art. A decisive criterion was thatthe new system had to be calibratable,because the wagons go directly into sale.

Integrated solution

The new solution consists of a combinationof robust Siwarex CC stainless steel loadcells, which are resistant to the aggressive

salts, and a Siwarex FTA weighing proces-sor, which is integrated directly into thenew Simatic S7-300 controller. The per-sonnel can monitor and operate all of theprocesses locally with an OP270 operatorpanel. The weighing control can be inte-grated into the factory-wide automationsolution via Industrial Ethernet so that thescales’ parameters can also be changedremotely.

The measures for certifying the cali-bratable weight measurement by theFrench calibration authority DRIRE havebeen taken over by the Alsace Pesage com-pany, which has years of experience inthis field. The basis for certification of theSiwarex FTA weighing processor was theEuropean certificate for application as

nonautomatic weighing instrument. Thissimplified the certification procedure con-siderably.

Positive experience all around

Marc Pupka, technical manager at KaliFrance, especially appreciates the integra-tion of the weighing processor into theautomation system: “It allows us to com-bine the diagnostic functions of the weigh-ing module with the high functionality andflexibility of an automation system. The dis-tributed monitoring of the system alsoreduces the response times in the case ofoperating problems. Failures can now beeliminated without an employee having tobe directly at the scales.” Since Siwarex canalso be used for other jobs such as propor-tioning control or quality control, mainte-nance at Kali France is easier as well.

All in all, those responsible at Kali Franceare very impressed by the many advantagesof the Siwarex FTA processor. Siwarex isnow being used as a standard weighingsystem in the automation solutions at KaliFrance. �

Siwarex FTA for weighing railway wagons

Calibrated for qualityThe products of Kali France are loaded onto railway wagons in Wittenheim, near Mulhouse, anddispatched for sale. A crucial criterion for the modernization of the company’s weighing system,therefore, was that the new solution had to be calibratable. That was no problem for the SiwarexFTA weighing processor, which is also convincing in day-to-day production. The smooth integrationinto the automation solution considerably simplifies the weighing processes.

Potassium and magnesia salts are loaded ready for sale on railway waggons

An OP270 panel is used for localmonitoring and operation of theweighing process

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30Process Instrumentation

TECHNOLOGY

R egular plant inspections used to benecessary to detect faults or wear onpumps. Leaks at pump valves could

be detected by experienced staff from theoperating noise. Other methods, such assystems that employ comparative observa-tions, allowed only relatively general state-ments to be made about the condition ofpumps or pump valves. Neither method

was sufficiently reliable or consistent, andfrequent unexpected failures were theresult.

Acoustic pump diagnosis

Sitrans DA 400 now allows continuous sta-tus monitoring of oscillating displacementpumps. The diagnostic system detects theslightest leakage on the pump valves

through the structure-borne noise of thepump system, and thus enables damage tobe detected in its early stages of develop-ment. The principle of acoustic diagnosticsis based on the fact that a structure-bornenoise in the ultrasonic range occurs at leakpoints due to cavitation. This noise can be detected online by external structure-borne noise sensors. The piezoelectric sen-sor of the Sitrans DA 400 measures thenoise emission of the cavitation, which ispropagated as structure-borne noise (in theultrasonic range greater than 20 kiloherz)in the pump housing with a piezoelement.

Sitrans DA 400 consists of an evaluationunit and the structure-borne noise sensors,which are simply mounted on the outside

Acoustic leak inspection on process pumps with Sitrans DA 400

Listening to LeaksMany process pump owners would like to see a great improvement inthe availability of these often process-critical components. With theSitrans DA 400 diagnostic device, Siemens has developed a solutionwith which the slightest leaks can be detected reliably on pumps.

Flow measurement technology at FrieslandFoods Cheese

Friesland Foods Cheese produces various types of cheese that are sold underdifferent brand names. In Bedum, the Netherlands, the company recently built anew cheese production facility with two production lines.

In many areas of production, Friesland Foods Cheese uses Siemens flowmeasurement technology in the new plant – in total, 45 magnetic-inductiveSitrans FM flowmeters and 11 Sitrans FC Coriolis mass flowmeters.

Friesland Foods Cheese was impressed by the high quality of the flowmetersand the positive experience the company has had with these systems over the last10 years. The flexible equipment concept and the simple commissioning andmaintenance of the devices were further important advantages.

Good experiences and an excellent price/performance ratio where decisivefactors in favor of Siemens

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of the pump, and can therefore be retrofit-ted to existing pumps. The diagnostic sys-tem can easily be integrated into existingequipment or control systems via ProfibusDP or PA.

Exact and reliable measuring results

The system can even determine the func-tionality of each individual pump valveselectively – from a leakage of just 2 per-cent. The diagnostic device also allows thecontinuous, simultaneous, and independ-ent monitoring of up to four valves on onepump. Four other universal inputs areavailable for the external sensors, for mon-itoring other important wearable parts orprocess variables.

A particularly important factor for theowners of pumps is the reliability and infor-mation content of the monitoring. Thepump and system also produce noise thatcan interfere with the signal evaluation ofthe structure-borne noise sensors. There-fore, the evaluation of the signal takes intoaccount that no cavitation occurs eitherwith an open valve or a closed, intact valve,and the measured noise level thus corre-sponds to the working noise of the pump.The appropriate application software forthe diagnostic system suppresses this noiselevel and other interference noise so that auseful signal, free from side effects, isobtained for evaluation.

Continuous monitoring

Displacement pumps can now be moni-tored continuously for the first time withacoustic diagnostics. This enables condi-tion-based preventive maintenance, whichallows the operational reliability and avail-ability of the pump – and thus ultimatelythe productivity of the entire system – to beconsiderably increased. �

Find out more:www.siemens.com/processinstrumentationE-mail:: [email protected]

Efficient, durable, and safe according to SIL2: Sipart PS2

Using Sipart PS2 with an external, non-contactingposition sensor is beneficial especially in very criticalapplication conditions. The magnetic non-contacting position sensor (NCS) is made up of asensor control and a permanent magnet gives exactreadings of rotary or linear angles. With lineardrives, the magnet is attached to the spindle formeasuring the position. On rotary drives, themagnet is attached to the cam shaft for measuringthe corresponding angle. Since no forces are transmitted through levers, rollers, orjoints, the position control is absolutely free of wear.

Sipart PS2 electropneumatic positioner is also uses piezo technology to control theflow of compressed air while consuming only minimal power. The pneumatic maincontrol triggers opening and closing the pressurized air supply, so the air itselfperforms the task. The piezo control is only used to trigger the main control andconsumes very little power for this task. Another benefit of piezo technology: thepositioner consumes only two percent of the compressed air required by conventionalpositioners – resulting in substantial savings over time.

The Sipart PS2 electropneumatic positioner is now also suitable for safety-relevantapplications with requirements up to SIL (Safety Integrity Level) 2.

The SIL qualification for the 4-20 milliampere versions, including HARTcommunication for simple drives, was conducted by Siemens in cooperation withexida.com.

Economic benefits of valvediagnostic over the life cycle

(Source: Feluwa Pumpen GmbH, Mürlenbach)

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without valve diagnostics

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32Food and Beverage

CASE STUDY

The principle behind the malting pro-cess is very simple. The first stage isthe steeping, in which barley and wa-

ter are stored in large containers to initiatecontrolled germination. After approxi-mately two days, germination begins, thekey enzymes are released, and the barleygains just the right friable consistencyneeded for the subsequent brewing pro-cess. After five to seven days, germinationis ended by the kilning process, a specificdry blowing action that, within one or twodays, gives the barley just the right tasteand color required for the type of beer thatis is intended for.

A tradition of successful collaboration

The production of malt is now almost com-pletely automated to ensure consistentquality. Nevertheless, the individual pro-cesses require in-depth expertise on thepart of the plant and equipment makers aswell as the automation suppliers.

Viking Malt is one of the largest maltproducers in Europe, with malt houses inLahti, Finland; Söderham and Halmstad,Sweden; and Panevezys, Lithuania. The

company’s total capacity is more than340,000 tons a year. The technical equip-ment deployed by Viking Malt comes fromSchmidt Seeger AG in Germany, a renownedspecialist in malt house equipment and si-los for grain and seeds.

The automation technology comes fromSiemens. Through its Braumat process con-trol system, the company provides the elec-tronic intelligence that allows breweriesand malt houses to control their highly sen-sitive processes and to run them fully au-tomatically, while still retaining the famoustaste.

Since Schmidt Seeger and Siemens hadinstalled the first malt tower for Viking Maltin Sweden and provided the site with tech-nical support for many years, it was onlylogical for the company to again rely on theexcellent working relationship establishedby these two proven partners for the con-struction of a second malt tower in Halm-stad, Sweden, and for setting up a new plantin Lithuania.

Given the national significance of thenew production complex in Panevezys forLithuania’s economy, its handover was cel-

ebrated on August 26, 2004, in the presenceof Lithuania’s prime minister, AlgirdasBrazauskas, and the Lithuanian ministerfor agriculture, Jeronimas Kraujelis. Inbuilding this plant, Viking Malt is re-sponding to the rising demand in the Balticstates and neighboring countries, and ismaking a major contribution to enhancingfarming in the region, which is consideredthe best growing area in the country.

Two construction methods, one principle

To meet specific local requirements, differ-ent approaches were used in constructingthe two malt houses. The company’s newmalt house in Lithuania was planned usinga flat design and was initially set up for anannual production rate of 60,000 tons. Itconsists of a flatbed steeping system, threegermination tanks, and one kiln, along with16 barley and eight malt silos, as well as theperipheral areas for receipt, drying, andcleaning of the raw materials.

From a technical standpoint, the entiresystem is characterized by numerous driveunits for transport, circulation, and han-

Braumat used for malt production at Viking Malt

Good as GoldIt’s a well-known fact that a good beer should contain nothing more than water, hops, andmalt. As far as the malt is concerned, Finland is one of the brewing industry’s major suppliers.The consistent quality of Finnish malt is due in part to the use of a process control systemadapted especially to the brewing sector.

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33

dling. The malt house alone has 200 driveunits, and 600 are located in the silo area.These units need 1,400 control signals,which are exchanged with the process con-trol system via Profibus DP. The 54 revers-ing drives in the germination tanks are con-nected to the system via ET 200S directstarters.

In Sweden, the company elected to usewhat is commonly known as a malt tower inwhich the individual subprocesses are po-sitioned one on top of the other. It consistsof 10 tapered cylindrical steeping units, sixgermination tanks, and three kilns. It hasincreased the plant’s annual productionfrom 85,000 tons to a total of 170,000 tons.Its mechanical structure requires around550 drives and follows basically the samesystem concept as the plant in Lithuania.

Made exactly according to recipe

Malt houses use sophisticated recipes fromwhich different malt grades and their dis-tinct characteristics are produced. Siemenshas developed a fully automatic recipe con-trol system for the two new Viking Malt fa-cilities, resulting in two state-of-the-art and

financially viable malt houses character-ized by predominantly fully automaticprocess cycles operated with minimumstaffing costs.

Siemens’ Braumat process control sys-tem offers just the right system environ-ment for such processes. It not only makesspecific programming and modernizationof recipes possible by means of a graphicaluser interface, but it supports flexible pro-duction planning with variable parametersand controls the individual batch processesin a fully automatic manner. All the plant’ssensors, actuators, and drives are linkeddirectly to the control system so that all rel-evant information is available at all times.Moreover, the ongoing malting process istotally transparent, from the removal ofbarley from the silo to the point at whichthe completed product is placed into stor-age.

Batch- and time-related archiving en-sures complete documentation of the entireproduction system. Process-related dataand sequences can also be accessed, whichmeans that several production processescan be centrally controlled at the same

time. The scalability of the production con-trol system installed by Siemens was alsoan important feature for Viking Malt. Uponcommissioning of the malt house in Lithua-nia, Bengt Ohlsson, managing director ofViking Malt, said: “By building this ultra-modern malt house, we have taken anotherstep toward our objective of establishingourselves as a reliable malt producer forour international customers.” During theofficial opening event, the company issueda statement that it would be doubling thecapacity of the new plant in the foreseeablefuture. �

Find out more:www.siemens.com/maltRüdiger SeligE-mail: [email protected] RuppE-mail: [email protected]

View from above: This is where the barley for malt production is stored

The new malt house in Panevezys

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Find out more:www.siemens.com/glasswww.profilit.comE-mail: [email protected]

A rchitects have long known Pilking-ton ProfilitTM as a product to be usedfor glass facades. Now, however,

demand for the glass is increasing as itsrole expands to include more decorativefunctions. The ProfilitTM system consists ofself-supporting glass channels that aremanufactured at Pilkington’s buildingglass plant in Schmelz, Germany, using aspecially developed mechanical rollingprocess.

As part of a recent cold repair, Pilkingtonsubjected the entire production site to acomprehensive refit before refiring the

new melting furnace in April 2004 and con-tinuing with the production of glass ele-ments.

Entering the 21st century

According to production manager ChristophClaesges, the technical upgrade of theplant has enabled profiled glass produc-tion to take a step into the 21st century,adapting Pilkington ProfilitTM to futuremarket requirements. A new control sys-

tem for the melting furnace, shaping unit,and utilities such as the compressor sta-tion and hydrostation were a key part ofthe upgrade. Pilkington decided to workwith Siemens on the implementation of theproject and chose the Simatic PCS7 processcontrol system.

The fully redundant system permits theuniform control and monitoring of theentire production process from one con-trol room. It is accommodated in four stan-dard cabinets and is expanded by processinstruments such as Sipart controllers,Siwarex weighing system, Sitrans P pres-sure transmitters, Sitrans FR flow meters,and Simovert Masterdrives.

Siemens was responsible for the imple-mentation of the entire project, includingthe development of the circuit diagrams,the cabling, the software configuration andparameterization, as well as the commis-sioning of the entire system. Simovert Mas-terdrives VC control the transport of theraw glass within the shaping machine andin the annealing lehr. Their functions arealso integrated into the PCS 7 interfaces.

Experienced project management

Pilkington was very satisfied with the expe-rienced project management provided bythe Siemens team, and was able to startoperations on time with no problems. Froma technological viewpoint, the company hasnow set a course for the successful manu-facture of its unique product, which beganlife as purely industrial, but which is nowwell on its way to becoming a creativedesign element in modern architecture. �

Pilk

ingt

on

Simatic PCS7 automates glazing system production

Stepping into the FutureThe ProfilitTM glazing system from Pilkington is rapidly moving beyond itsoriginal purely industrial function to becoming a design-oriented element inmodern architecture. This development has spurred a fundamentalmodernization of the company’s process control system.

Pilk

ingt

on

34Glazing Systems

CASE STUDY

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Pharma Events

Siemens is continuing to attend and support numerous interestingevents on current topics in the pharmaceutical industry. Some ofthe major events this fall are:

ISA Expo 2005, October 25 to 27, ChicagoContact: [email protected]

China-Pharm, October 25 to 28, 2005, ShanghaiContact: [email protected]

Pharmaceutical Manufacturing 2005,October 31 to November 2 , 2005, MiamiContact: [email protected]

Make2Pack Workgroup,November 15 , 2005, MilanoContact: [email protected]

ISPE Annual Meeting,November 7 to 10, 2005, Scottsdale, ArizonaContact: [email protected]

www.siemens.com/pharma

infosinfosDo you want to know more about the systems and solutions forthe process industry from Siemens Automation and Drives?Simply visit our information portal on the Internet:

www.siemens.com/processautomation

onlineonline

local

www.siemens.com/processnewsHere you can download the current issue and past issues ofProcess News in PDF format, or search directly for articles aboutspecific topics, technologies or systems in the Reference Center.

local

35DIALOGUE

process news 3-05PublisherSiemens Aktiengesellschaft,Bereich Automation and Drives (A&D), Gleiwitzer Str. 555, 90475 NurembergGermany

www.siemens.com/automation

Group Executive Management Helmut Gierse, Anton S. Huber, Alfred Ötsch

Responsible for ContentPeter Miodek

Responsible for Technical ContentCornelia Dürrfeld

ConceptChristian Leifels

EditorCornelia Dürrfeld, Siemens AG, A&D SPSiemensallee 84, 76187 Karlsruhe, GermanyTel.: +49 (0) 7 21/5 95-25 91Fax: +49 (0) 7 21/5 95-63 [email protected]

Editorial CommitteeAlexandre Bouriant, Cristiana Cerrato, Michael Gilluck, Birgit Gottsauner, Walter Huber,Keiren Lake, Bernd Langhans, Bernd Lehmann,Silvana Rau, Rüdiger Selig, Roland Wieser,Wolfgang Wilcke

Publishing HousePublicis KommunikationsAgentur GmbH, GWACorporate Publishing ZeitschriftenP.O. Box 3240, 91050 Erlangen, GermanyTel.: +49 (0) 91 31/91 92-5 01Fax: +49 (0) 91 31/91 92-5 94

[email protected]

Editor in chief: Kerstin Purucker

Layout: Jürgen Streitenberger

Copy editing:Irmgard Wagner

DTP: Doess, Nuremberg, Germany

Printed by: Stürtz GmbH, Würzburg, Germany

process news is published quarterly

Circulation: 34,500

Jobnumber: 002100 RPE53

© 2005 by Siemens Aktiengesellschaft Munich and Berlin, Germany

All rights reserved by the publisher.

This edition was printed on environ-mentally-friendly chlorine-free paper.

ISSN 1430-2292 (Print)

The following products are registered trademarks of Siemens AG:ET 200, OP270, ProTool, S7-400, SIMATIC,SIMATIC IT, SIMATIC iMap, SIMATIC Multi Panel, SIMOTION, SIMOVERT, SIPART, SITRANS, SIWAREX, STEP 7, TELEPERM,TOTALLY INTEGRATED AUTOMATION, TOTALLY INTEGRATED POWER, WinCC

If trademarks, trade names, technicalsolutions or similar are not listed above,this does not imply that they are notregistered.

The information provided in this magazinecontains merely general descriptions or characteristics of performance whichin case of actual use do not always applyas described or which may change as a result of further development of theproducts. An obligation to provide therespective characteristics shall only existif expressly agreed in the terms of contract.

Order No.: E20001-M6305-B100-X-7600

Printed in Germany

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