8
We spoke to Anton S. Huber, member of the Divisional Board of Directors of the Automation and Drives Division about the new Siemens strategy for the pharmaceuticals market. The expansion of process automation is an important step towards increasing growth and productivity of the Siemens AG. Now Siemens AG is increasingly focusing on the pharmaceutical and biological industry within this context. What’s so new about that? Huber: It’s not the branch that’s new. New is the way in which we want to help these customers to deal with the challenges of the future. The long years of experience on which we can relay are quite decisive. Our cus- tomers‘ requirements are extremely diverse and range from products and systems, through automation solu- ! ? a reasonable migration route to the next, more productive technology. Increasingly sharper restrictions imposed by official agencies, constantly growing pressure of costs and enormous spendings for research and development of new drugs. How does the pharmaceutical industry react to this in your opinion? Huber: Like in every other indus- try, pharmaceutical companies are also under increasing pressure to de- liver shareholder value and therefore must at least yield the capital costs. To achieve reasonable dividends, they have to reduce the time-to-mar- ket of their products and improve production efficiency while at the same time considering increasingly sharper restrictions on the part of governments or regulatory bodies. The key to success is to concentrate on the essentials and to optimize. Ray Scherzer of GlaxoSmithKline put his finger on it at the ISPE Conference in January: “The production costs in pharmaceutics are still about 40 % of ! ? total costs to- day, much more than the R&D costs.” This shows clearly where fu- ture cost saving can be achieved. And what does that mean for Siemens? Huber: Our strength is an innov- ative product portfolio. But we also know that this alone is not enough. The market is demanding a change in emphasis towards competence-relat- ed business models with regional or global orientation. This means that our experience and know-how are crucial for our customers. This re- sults in a new strategy where we want to involve the customer and his re- quirements in the process much ear- lier. Let’s call it a concerted action. So this strategy is more than just a combination of products and systems? Huber: Exactly! It is the bundling of all competencies and resources to implement them efficiently and pro- ductively in this segment of the mar- ket. It is our strategy to support cus- ! ? ! ? tions right up to plant and process optimization. It is becoming more and more apparent however that the pharmaceutical industry wants more from us than just electronics and computer know-how. And how do you meet these demands? Huber: The pharmaceutical in- dustry is looking for suppliers who are familiar with their processes – in- cluding the specific plant technology and regulation requirements – sup- pliers who live and act in the same en- vironment and therefore help as a certified industry expert in the imple- mentation of solutions and optimiza- tion of their processes. For us this means we have to build up compre- hensive industry know-how. An im- portant step in this direction was the purchase of Axiva. With its extensive knowledge, Axiva is making our port- folio complete – whether in process engineering, technological develop- ment or plant construction. It en- ables us to integrate industry-specific requirements in our products and systems even more specifically and to adapt them even better to market re- quirements. Siemens is a valuable partner to this industry for another reason: the high speed of innovation in this in- dustry which results in a fast technol- ogy change. Our customers can be certain that a company like Siemens has the power to keep up with this rush of innovation in the long term and will make sure that there is always ! ? tomers in the optimization of their manufacturing process and to in- crease the value of their company. The nucleus of this strategy is, as al- ready mentioned, our comprehen- sive process know-how, a solid un- derstanding of the rules and regula- tions and an international compe- tence network that enables us to provide the necessary knowledge lo- cally. Let me underline this important aspect with an example: A leading Biotech company was looking for ways to increase production efficien- cy. Together with the customer we first analyzed new measuring meth- ods and a possibility for using Ad- vanced Process Control. At first, this approach did not bring the desired results. It soon became clear to all in- volved departments that the first step had to be improving the process de- sign. And that is exactly what we are now doing. This excursion into the “real world” demonstrates the importance of an integrated method based on process know-how is for our cus- tomers. Process News 9th Edition April 1 2002 INFOS, NEWS AND TRENDS FROM THE WORLD OF PROCESS AUTOMATION C on ont en en ts ts The changing pharmaceutical industry Following years of relative stability, the pharmaceutical industry has undergone pronounced changes in recent years. Fusions, strategic alliances and spin-offs characterize a phase of consolidation that has not yet reached its end. Exploding R&D costs for new treatments, expiring patents, low-price products displacing profitable products on the market, health service reforms in almost all industrial countries and increasingly strict regulations are forcing this industry to find new ways of optimizing costs. Only companies who are highly innovative and faster than their competitors in developing new drugs and products will survive. The neck-breaking speed in the research of new drugs is rendering valid patents useless. To have a chance in this market companies have to exploit all the advantages of new fields of science such as biotechnology, seek cooperation with other innovative partners and at the same time get the best out of the highly qualified employees in this industry. The only answer to these challenges lies in optimizing the processes and finding more effective manufacturing methods while at the same time increasing investments in research and development. A shorter time- to-market and a substantial cut in costs with the aid of integrated automation solutions taking into account the whole life cycle of a plant are at least as important as a slim production. Teja Ulrich, ARC Advisory Group, Düsseldorf Focus on Pharma Siemens goes new ways in supporting pharmaceutical companies in optimizing their business activities (Continued on page 2) Focus Pharma B 2 Siemens supports scale up at Novartis, USA B 3 GlaxoSmithKline applications in the UK and Australia B 4/5 Focus on Pharma: A concept made to measure for the pharmaceutical industry Document management with MES system Integrated concept for biotech Clean room Monitoring with Siemens Axiva B 6 Yamanouchi, Netherlands, was convinced by industry know-how Simatic PCS 7 at NovoNordisk, Denmark B 7 Customer-focused service package Failsafe systems/ safety concepts Products B 7 Siemens-Milltronics MultiRanger offers new functions From around the world B 8 Success stories, Net news, fairs

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Page 1: 9th Edition April 1 2002 Process News - Siemens · highly innovative and faster than their competitors in developing new drugs and products will survive. The neck-breaking ... solutions

We spoke to Anton S. Huber,member of the Divisional Board ofDirectors of the Automation andDrives Division about the newSiemens strategy for thepharmaceuticals market.

The expansion of processautomation is an important steptowards increasing growth andproductivity of the Siemens AG.Now Siemens AG is increasinglyfocusing on the pharmaceuticaland biological industry withinthis context. What’s so newabout that?

Huber: It’s not the branch that’s

new. New is the way in which we want

to help these customers to deal with

the challenges of the future. The long

years of experience on which we can

relay are quite decisive. Our cus-

tomers‘ requirements are extremely

diverse and range from products and

systems, through automation solu-

!

?

a reasonable migration route to the

next, more productive technology.

Increasingly sharperrestrictions imposed by officialagencies, constantly growingpressure of costs and enormousspendings for research anddevelopment of new drugs. Howdoes the pharmaceuticalindustry react to this in youropinion?

Huber: Like in every other indus-

try, pharmaceutical companies are

also under increasing pressure to de-

liver shareholder value and therefore

must at least yield the capital costs.

To achieve reasonable dividends,

they have to reduce the time-to-mar-

ket of their products and improve

production efficiency while at the

same time considering increasingly

sharper restrictions on the part of

governments or regulatory bodies.

The key to success is to concentrate

on the essentials and to optimize. Ray

Scherzer of GlaxoSmithKline put his

finger on it at the ISPE Conference in

January: “The production costs in

pharmaceutics are still about 40 % of

!

?

total costs to-

day, much more

than the R&D

costs.” This shows clearly where fu-

ture cost saving can be achieved.

And what does that mean forSiemens?

Huber: Our strength is an innov-

ative product portfolio. But we also

know that this alone is not enough.

The market is demanding a change in

emphasis towards competence-relat-

ed business models with regional or

global orientation. This means that

our experience and know-how are

crucial for our customers. This re-

sults in a new strategy where we want

to involve the customer and his re-

quirements in the process much ear-

lier. Let’s call it a concerted action.

So this strategy is more thanjust a combination of productsand systems?

Huber: Exactly! It is the bundling

of all competencies and resources to

implement them efficiently and pro-

ductively in this segment of the mar-

ket. It is our strategy to support cus-

!

?

!

?

tions right up to plant and process

optimization. It is becoming more

and more apparent however that the

pharmaceutical industry wants more

from us than just electronics and

computer know-how.

And how do you meet thesedemands?

Huber: The pharmaceutical in-

dustry is looking for suppliers who

are familiar with their processes – in-

cluding the specific plant technology

and regulation requirements – sup-

pliers who live and act in the same en-

vironment and therefore help as a

certified industry expert in the imple-

mentation of solutions and optimiza-

tion of their processes. For us this

means we have to build up compre-

hensive industry know-how. An im-

portant step in this direction was the

purchase of Axiva. With its extensive

knowledge, Axiva is making our port-

folio complete – whether in process

engineering, technological develop-

ment or plant construction. It en-

ables us to integrate industry-specific

requirements in our products and

systems even more specifically and to

adapt them even better to market re-

quirements.

Siemens is a valuable partner to

this industry for another reason: the

high speed of innovation in this in-

dustry which results in a fast technol-

ogy change. Our customers can be

certain that a company like Siemens

has the power to keep up with this

rush of innovation in the long term

and will make sure that there is always

!

?

tomers in the optimization of their

manufacturing process and to in-

crease the value of their company.

The nucleus of this strategy is, as al-

ready mentioned, our comprehen-

sive process know-how, a solid un-

derstanding of the rules and regula-

tions and an international compe-

tence network that enables us to

provide the necessary knowledge lo-

cally.

Let me underline this important

aspect with an example: A leading

Biotech company was looking for

ways to increase production efficien-

cy. Together with the customer we

first analyzed new measuring meth-

ods and a possibility for using Ad-

vanced Process Control. At first, this

approach did not bring the desired

results. It soon became clear to all in-

volved departments that the first step

had to be improving the process de-

sign. And that is exactly what we are

now doing.

This excursion into the “real

world” demonstrates the importance

of an integrated method based on

process know-how is for our cus-

tomers.

Process News9th Edition April 1 2002

I N F O S , N E W S A N D T R E N D S F R O M T H E W O R L D O F P R O C E S S A U T O M A T I O N

CCononttenentsts

The changing pharmaceutical industry

Following years of relative stability, thepharmaceutical industry has undergonepronounced changes in recent years.Fusions, strategic alliances and spin-offscharacterize a phase of consolidation thathas not yet reached its end. Exploding R&Dcosts for new treatments, expiring patents,low-price products displacing profitableproducts on the market, health servicereforms in almost all industrial countriesand increasingly strict regulations areforcing this industry to find new ways ofoptimizing costs. Only companies who arehighly innovative and faster than theircompetitors in developing new drugs andproducts will survive. The neck-breakingspeed in the research of new drugs isrendering valid patents useless. To have achance in this market companies have toexploit all the advantages of new fields ofscience such as biotechnology, seekcooperation with other innovative partnersand at the same time get the best out of thehighly qualified employees in this industry.The only answer to these challenges lies inoptimizing the processes and finding moreeffective manufacturing methods while atthe same time increasing investments inresearch and development. A shorter time-to-market and a substantial cut in costswith the aid of integrated automationsolutions taking into account the whole lifecycle of a plant are at least as important asa slim production.

Teja Ulrich, ARC Advisory Group, Düsseldorf

Focus on PharmaSiemens goes new ways in supporting pharmaceutical companies in optimizing their business activities

(Continued on page 2)

Focus Pharma

B 2 Siemens supports scale up at Novartis, USA

B 3 GlaxoSmithKline applications in the UK and Australia

B 4/5 Focus on Pharma: A concept made to measure for the pharmaceutical industry

Document management with MES system

Integrated concept for biotech

Clean room Monitoring with Siemens Axiva

B 6 Yamanouchi, Netherlands, was convinced by industry know-how

Simatic PCS 7 at NovoNordisk, Denmark

B 7 Customer-focused service package

Failsafe systems/safety concepts

Products

B 7 Siemens-Milltronics MultiRanger offers new functions

From around the world

B 8 Success stories, Net news, fairs

Page 2: 9th Edition April 1 2002 Process News - Siemens · highly innovative and faster than their competitors in developing new drugs and products will survive. The neck-breaking ... solutions

Could you define whatSiemens offers in a little moredetail?

Huber: As I already pointed out,

we have expanded our portfolio by

numerous acquisitions and adapted

it to the pharmaceutical industry. Let

us start with the field. In the pharma-

ceutical industry we have the prob-

lem that we cannot yet measure and

record everything we wish to know.

We control many processes via indi-

rectly derived parameters. At the mo-

ment we are working with the phar-

maceutical industry on new methods

of recording process variables online

to have biological process variables

available in addition to physical and

chemical variables.

On the control level we have a

strong position with our Simatic

PCS 7 process control system as part

of the Totally Integrated Automation

concept. The pharmaceutical indus-

try with its regular combination of

primary and secondary processes can

fully exploit the advantages of this au-

tomation concept. Of course, the sys-

!

?

tem is enhanced by ready-to-use

functions for typical pharmaceutical

tasks and validation.

We have also closely followed the

rapid development in information

technology connecting our process

control technology to the enterprise

resource planning system (ERP) and

have expanded our competence in

this field with the acquisition of Orsi

and Compex. With an Industry Suite

made to measure for the pharmaceu-

tical industry, we have an MES sys-

tem in our portfolio with which in-

formation from all areas of produc-

tion and management can be net-

worked.

When implementing their pro-

jects our customers expect us to use

modern design tools. We therefore

apply models to visualize both the lo-

gistic processes (layout planning) and

the manufacturing process itself us-

ing simulations but also to exploit ex-

isting potential for improvement.

Needless to say, all these compo-

nents I have just mentioned are only

used as is suitable for the specific ap-

plication. The solution may very well

be a combination of all components

or use just one of them. The cus-

tomer’s requirements are decisive.

That sounds almost too goodto be true but a little tootheoretical. What does the fieldexperience tell?

Huber: For many years the phar-

maceutical industry has been one of

our customers, and we have handled

a large number of projects all over the

world. Our experience in these pro-

ject management projects and the

methods developed for handling

such projects are an important part of

our strategy. In the daily practice of

such projects, every single compo-

nent in the overall strategy is con-

stantly being tried and improved.

Is this strategy geared to theGerman market or has it a globalperspective?

Huber: Just as the pharmaceutical

industry follows its customers we do

!

?

!

?

The regulationjungle

T oday’s pharmaceutical indus-

try is doubly blessed. On the

one hand an affluent society

is constantly demanding new drugs

and on the other hand legislators

and governing authorities impose

increasingly strict regulations. Both

have to be satisfied. Increasing the

efficiency while at the same time ob-

serving all regulations – apparently

two contradicting goals. In order to

meet these challenges, suppliers such

as Siemens are playing an increas-

ingly important role for the pharma-

ceutical industry.

If a company wants to sell its

products in America, it has to satisfy

the requirements of the FDA regula-

tions CFR 21. But this is not a situa-

tion limited to the USA. The Euro-

pean regulatory bodies are also con-

stantly renewing or extending their

regulations that make up the current

Good Manufacturing Practice

(GMP).

A document entitled “Good Prac-

tices for Computerized Systems in

Regulated Environments” published

only in January describes how au-

tomation systems are to be imple-

mented and validated.

Only a very structured procedure

will ensure successful validation. The

document and the annex 15 to the

EU regulations “Qualification and

Validation” both underline the sig-

nificance of this kind of procedure

and stress how important it is for the

pharmaceutical industry to cooper-

ate closely with its partners. This is

where the technological know-how

can be found that is necessary for sat-

isfying all the regulations in every

time phase of a process. And only

those companies who know how to

use this know-how to further their

own interests will be successful. The

pharmaceutical industry needs sup-

pliers like Siemens who can supply

this kind of know-how and experi-

ence – more than ever before. ■

David Selby, Selby Hope Int. Consultancy,

Director of the Int. Board of ISPE

2

It is a long, hard road from thechemical composition of a newdrug in the laboratory to theapproved drug that is ready forthe market. The new Novartispharmaceutical pilot plant facilityin East Hanover, New Jersey, has akey role in the scale up of newdrugs. The facility not onlyproduces new ingredients forclinical trials, but also developsthe methods and processes andrefines them to industrialsuitability. Critical to these stepsare consistency and processvalidation, which are achievablewith the open, distributedarchitecture of Totally IntegratedAutomation.

A bout 90 percent of the pro-

jects undertaken in the pilot

plant involve batch process-

ing in small, manual actions instead of

one continuous process. The facility’s

control methodology was developed

around a fully distributed I/O archi-

tecture with tightly integrated hard-

ware and software to document con-

ditions that can be incorporated into

the final manufacturing processes.

Siemens was responsible for the

configuration, commissioning and

operator training during the con-

struction of the new pilot plant facil-

ity and also supplied a broad range of

field instrumentation from Sitrans

transmitters to Sipart PS valve posi-

tioners. The automation solution is

based on the Siemens Totally Inte-

grated Automation concept with the

Simatic PCS 7 process control sys-

tem. This solution makes use of in-

ternationally established standards

and the open fieldbus Profibus, so it

is easily extendable and able to inte-

grate not only Siemens products, but

also equipment supplied by third-

party vendors. Moreover, it can be

quickly modified to suit new de-

mands – and it is therefore an ideal

solution for a highly innovative plant

such as the East Hanover facility. The

cost saving aspect about Totally Inte-

grated Automation concerning the

validation is immense.

Simple documentation accordingto FDA regulations

At the field level, Simatic ET 200 sys-

tems pick up the signals from the

sensors and actuators and passes

them on to the control system via

Profibus-DP. Novartis makes exten-

sive use of the intrinsically safe and

Ex-protected fieldbus system Profi-

bus-PA to establish a simple, low-

cost and smooth connection from

the field level to the control system.

An Industrial Ethernet fiber-optic

network is used for fast process in-

formation exchange and processing.

This information backbone connects

all sub-units in the control system,

making all information available

throughout the plant. PCS 7 there-

fore also improves transparency in

the plant and simplifies consistent

batch documentation in compliance

with the FDA guidelines.

Chemists can instantly gain statis-

tics on reactor agitation, tempera-

tures, pressures, records and sup-

porting equipment with a documen-

tation trail of what happened in the

process. Novartis is working on a

company-wide initiative toward elec-

tronic signatures and records. An op-

tional component of the PCS 7 sys-

tem for document management is

being considered as a future upgrade

and will help them with this task.

Gathering, compiling and storing

records for a government-mandated

retention period is much easier when

storing the data electronically in a

central depository.

Flexible foundation for a globalnetwork

More expansions are planned for the

future. Within the next few years, the

plan is to bring on available Web

technologies to simplify monitoring

and project sharing. That way,

process engineers can, for example,

easily monitor the facility and share

information among Novartis plants

all around the world. This is also one

of the first steps in building a global

knowledge and control network.

PCS 7 will help Novartis in making

this dream come true. ■

John Klaas and Troy Logan,

Springhouse

Progress throughinnovation

Siemens technology supports production scale up at Novartis, USA

Focus on Pharma(Continued from 1)

the same with our customers. At first

we concentrated on Europe and the

USA but are now increasingly ex-

panding our activities in East Asia Pa-

cific and China.

And how do you guaranteelocal support in these countries?

Huber: That is the advantage we as a

global player have. Siemens is repre-

sented in almost every country in the

world. But it is clear that such a com-

plex strategy demands more than

every single regional representative

can offer. A very important part is our

worldwide network of experts who

provide the necessary specific knowl-

edge on a regional basis. The centers

of this international pharmaceutics

community are the headquarters in

Karlsruhe as well as offices in Frank-

furt and Marburg, Manchester and

Antwerp in Europe, Springhouse in

the USA and Singapore and Shanghai

in Asia.

Moreover, our system integrators

also play an important role. They add

to our strength with their compe-

tence and great flexibility. They guar-

antee the local support in many

countries which is of great impor-

tance to the pharmaceutical industry.

It is our declared aim that our inte-

gration partners should also benefit

?

Totally integrated Automation facilitates

validation in the pilot plant

from our competence build-up in

this field.

And how do you judge yourposition in comparison with thecompetition?

Huber: To underestimate our

competitors would be an unforgiv-

able mistake, especially with regard

to specific components. However,

our advantages lie in the combina-

tion of being familiar with the cus-

tomers’ processes and offering a

product and system portfolio specif-

ically adapted for the pharmaceutical

industry.

We will strengthen our position

on the market with this strategy and I

am positive that our customers in the

pharmaceutical industry know how

to make the best of this.

Thank you for talking to us.

Cornelia Dürrfeld, Editor

!

?

Page 3: 9th Edition April 1 2002 Process News - Siemens · highly innovative and faster than their competitors in developing new drugs and products will survive. The neck-breaking ... solutions

than 10 minutes to call up data in the

original system, the response times

are now down to only two seconds.

Successful modernization

Dave Hackett, Technical Team Man-

ager at GlaxoSmithKline, concludes:

“The system changeover and valida-

tion went off smoothly and on sched-

ule. Today we benefit not only from

being able to track the process and

material flow on the same system but

also from a 15 percent increase in the

production figures.” ■

Richard Ahearne, Manchester

3Process News 1/2002

The Enzyme Precursor Plant atGlaxoSmithKline in Irvine, UnitedKingdom, is a major producer ofprimary ingredients for thecompany’s antibiotics production.To meet growing demands, theplant’s production capacity had tobe increased. In addition the newsystem had to be linked to thecompany’s own MES system andestablish an open and future-oriented solution capable oftaking on expansions andmodifications. Siemens rose tomeet this challenge and after justtwo weeks of commissioning theplant shone with a newautomation technology andgreatly improved product yield.

G laxoSmithKline, like most

important pharmaceutical

companies, has adopted a

policy of automating manufacturing

processes where possible. What

makes the plants in Irvine so differ-

ent, however, is the scale of automa-

tion – and the commitment to find

new and innovative solutions instead

of relying on established concepts as

William Melvin, the lead process

control engineer at GlaxoSmithKline

in Irvine points out. “For us, innova-

tive concepts are the key to improv-

ing the productivity and reducing

downtime – two decisive criteria in

the automation of our processes.”

One of the plants in Irvine is the

so-called Enzyme Precursor Plant

(EPP) which plays a central role in

the production of a functional sub-

group of the antibiotic Amoxycillin.

For this plant, a new control system

was to be implemented which met

the requirements for an integrated

information management. At the

same time the modernization was to

improve the process control and in-

crease the productivity of the impor-

tant product pre-stage.

“The concept that Siemens pre-

sented was viewed as very innovative.

It employs new strategies and tools

that help us in handling our produc-

tion more flexibly and efficiently”,

William Melvin goes on. “In addition

to that, existing structures could eas-

ily be integrated into the new sys-

tem.” This backward compatibility

with simultaneous use of modern

communication and automation sys-

tems is one of the great advantages of

the PCS 7 system.

Conversion in just two weeks

Since the EPP is a continuous process

and production was not to be inter-

rupted during changeover, the entire

commissioning of the new control

system had to be completed within

the two-week production stop during

the annual plant shutdown. In this

phase, PCS 7 was able to show all its

strengths. The two PCS 7 systems of

the EPP could be linked quickly and

easily with the MES system thanks to

the integrated OPC interfaces. Indus-

trial Ethernet is used as a system and

plant bus and in the field level,

Profibus-DP links the distributed

Simatic ET200 M systems with the

control system. The signals of the

field devices are transmitted to these

stations via Profibus-PA.

The EPP is already ideally equipped

for future expansions. Thanks to the

open, fieldbus-based design of the

control system, almost any number

of additional I/O modules can be in-

tegrated. But there is another factor

ensuring investments made in the au-

tomation solution. “We deliberately

have a policy of standardizing on a

supplier as far as possible. In this way

we not only have considerable bene-

fits in terms of training and spares

stocking, it also means that our engi-

neers are already familiar with the de-

sign and handling of the system when

additional functionality is required

from the system so that we save addi-

tional costs.”

A concept for a future

Since being commissioned, the new

automation solution is running to the

full satisfaction of the project team.

Output at Irvine is currently running

as much as greater than four percent

than previously, with weekly yields

likely to rise even further. Glaxo-

SmithKline has found a system with

PCS 7 that reliably increases the flex-

ibility and productivity of the EPP. It

is therefore no surprise that the ex-

cellent strategic cooperation with

Siemens will be continued in further

projects. ■

Richard Ahearne, Manchester

Productivity pushGlaxoSmithKline relies on integrated DCS solution

When GlaxoSmithKlinemodernized the control system fora spray granulation process inBarnard Castle, theysimultaneously reconstructed thematerial tracking system based onSimatic PCS 7 standardcomponents. As a result, theprocess and material flow can bemonitored and controlled on acommon platform. Not only theoperating personnel benefits fromthe simple handling and clarity ofthe integrated solution. The newsystem was also able to increasethe production capacity by 15percent.

B arnard Castle in Durham

County in the UK is a sec-

ondary-manufacturing site

for GlaxoSmithKline. Active phar-

maceutical substances such as antibi-

otics of the cephalosporin family is

processed into end products. An im-

portant step in the process is granu-

lation. The granulation towers are

some of the largest of their kind in

the world being more than four sto-

ries high, and each of them being ca-

pable of processing batches of nomi-

nally 500kg. The task was to equip

these towers with a modern automa-

tion system and at the same time to

integrate them into one common

control system and the correspond-

ing material tracking system.

Independent of PC-reliantsystems

GlaxoSmithKline had already con-

sidered the integration of process

control and material tracking in a

common system early on because the

new control architecture was not to

be based on PC-reliant systems if

possible. However, most convention-

al material tracking systems operate

on a PC-basis. The project team of

Optimal Industrial Automation, en-

trusted with the planning and execu-

tion of the modernization, therefore

decided to design a network-oriented

solution with industrial standard

components and the Profibus field-

bus system based on the Simatic

PCS 7 process control system.

Expandable with highfunctionality

The installed system tracks the move-

ments of all the raw materials re-

quired for the process and provides

information about the location, con-

tent and status of the intermediate

bulk containers used for product

transportation. Sub-systems such as

material discharge, cleaning systems,

blenders and packaging lines are also

recorded.

All components of the automa-

tion solution communicate via a

Profibus network. The new system is

not only modularly expandable at

any time but is also much more effi-

cient than the old solution. Whereas

in the past it sometimes took more

Two in one systemMore efficient production in GlaxoSmithKline’s granulation process

GlaxoSmithKlinechooses PCS 7 for their

plant in Australia

G laxoSmithKline had two main goals

when they decided to expand and

modernize two of the clean rooms in

their production plant at Boronia (suburb of

Melbourne), Australia: more flexibility and

greater production capacity. The company

had already had some positive experience

with the process control system Simatic

PCS 7 at their site in Irvine, UK. This and the

strong local presence of Siemens were the de-

cisive factors for GlaxoSmithKline opting for

a long-term automation strategy based on

PCS 7 at Boronia as well.

Siemens Australia was also able to secure

the order for configuration of the software

system. Here too, excellent references and co-

operation between Siemens Australia and the

Centers of Competence in Singapore and

Belgium were the essential arguments in fa-

vor of Siemens. In the scope of the project

Siemens supports GlaxoSmithKline in defin-

ing the process automation and is responsi-

ble for the configuration, delivery and com-

missioning of the PCS 7 control and visual-

ization system. ■

Marek Lisik, Melbourne

Barnard Castle is the production site for

several potent antibiotics

Page 4: 9th Edition April 1 2002 Process News - Siemens · highly innovative and faster than their competitors in developing new drugs and products will survive. The neck-breaking ... solutions

With a comprehensive concept specially adapted to the problems and requirements of a specific industry, Siemens has opened up anew chapter in the cooperation with its customers. This combinationof systems, solutions and services has just one aim: to supportpharmaceutical and biotech companies in achieving a shorter time-to-market in their production and in optimizing their processes.

ing networking and integration of

the various business levels and de-

partments is one of the main con-

cerns of the new concept. These

strategies help increase the informa-

tion flow between the different lev-

els, allowing for a slimmer and more

effective planning and control of

production processes – an impor-

tant step towards flexible and low-

cost production.

Proven standards and newconcepts

Siemens exploits the traditional

strengths of its portfolio. It is hard to

imagine a modern pharmaceutical

plant without efficient and reliable

analyzers and automation systems.

Siemens is especially pushing forward

the development of new in-line analy-

sis systems with numerous new devel-

opments. Important pharmaceutical

and biological process parameters can

now be continuously collected in real

time and this means that a reliable

measurement for optimizing the

process is available for the first time.

Siemens provides a field-proven

range of solutions for the control

level with the Simatic S7 series of

controllers that recently offer failsafe

and highly available devices. Anoth-

er important component of the

Siemens portfolio is the Simatic

PCS 7 process control system which

is supplemented by a series of made-

to-measure software libraries for the

Primary, Secondary and Utilities

sections. Standardized function

blocks for the control and monitor-

ing of field devices such as valves,

motors, controllers or process mod-

ules such as cooling, pressure and

temperature control save a lot of

time in configuration and commis-

sioning of a system.

A special software package for

batch control according to the S88

standard is just as much a part of

the concept as a detailed plant and

process model that can be used to im-

plement applications such as a con-

tinuous Material Tracking System.

All these components can be embed-

ded in a comprehensive MES system

that integrates the various modules

in a common information network.

All components of the new strate-

gy can be used both as stand-alone

modules and as complete solutions

and can be individually detailed. Nat-

urally, all components in the Pharm-

Focus concept meet the requirements

of the 21 CFR standard.

An integrated Engineering Support

Tool collects and manages all the en-

gineering information. This consider-

ably simplifies documentation for val-

idation. The Advanced Control

and Modeling module allows

a tailored analysis as well

as simulation and opti-

mization of all process-

es on the basis of a

modern modeling

system.

4 Process News 1/2002

A Concept made to measureThe new Siemens strategy for Pharma focuses on customer benefit

Pharmaceutical production isbeing increasingly governed bylaws, regulations andspecifications. Documentmanagement is becoming a realfocal point which manual systemswill not be able to cope with in thelong term. The ManufacturingExecution System (MES) from thenew Siemens concept for Pharmasimplifies recording anddocumentation of all processes ina pharmaceutical plant –naturally according to the 21 CFRPart 11 specifications.

R egulation agencies such as the

US Food and Drug Adminis-

tration (FDA) or the Euro-

pean Community Pharmaceutical

Industry Commission keep a keen

eye on the production of pharmaceu-

ticals to ensure that all process steps

observe strict principles. Particular

emphasis is placed on compliance

with the current Good Manufactur-

ing Practice (cGMP) and Good Clin-

ical Practice (GCP) standards. The

new regulation 21 CFR Part 11 (Elec-

tronic Records, Electronic Signa-

tures) deals with the areas of elec-

tronic signature and authorization,

electronic batch records and docu-

ment management. By using a so-

phisticated MES solution it is much

easier to implement the valid regula-

tions and to achieve a high return on

investment with a company-wide

document management and quality

assurance.

Standardized components andopen structures

One of the essential advantages of the

MES concept is in its open system ar-

chitecture. This facilitates the easy in-

tegration of software products from

different manufacturers through

standard IT interfaces. All the neces-

sary functions such as Batch Systems,

Material Manager, Laboratory

Information Management Sys-

tems, Production Order Manager or

Tracking Systems can be implement-

ed modularly so that functional over-

lap is avoided.

This special MES structure guar-

antees a high percentage of standard

components. The customized solu-

tion is therefore simply configured

instead of being elaborately pro-

grammed. At the same time this solu-

tion provides greater flexibility for fu-

ture modifications and lower mainte-

nance costs. Since every modification

to the software components during

commissioning of a pharmaceutical

production plant after a certain point

of time in the project requires the ap-

proval of the regulation agencies, a

standardized MES makes it easier to

calculate the configuration and com-

missioning time.

Components for moretransparency and efficiency

The Industry Suites for the MES of

the new concept for Pharma rely con-

sistently on dividing the required

functions into individual compo-

nents. The standard product Simatic

IT Components provides a number

of functions such as preventive main-

tenance, job management and mate-

rial tracking for the production man-

agement. The Simatic IT Server en-

ables easy integration and network-

ing of the application components.

The Simatic IT Production Modeler

models business and production pro-

cedures according to S95 standards

and serves to coordinate and syn-

chronize the production compo-

nents.

The Audit Trail System guarantees

that all amendments to documents

are traceably archived. This structure

is a prerequisite for automation of the

documentation management accord-

ing to 21CFR11. Therefore, the set of

standard components of the Pharm-

Focus MES concept naturally include

a Compliance Manager that is in full

accordance with 21CFR11. ■

Torsten Rossollek, Nuremberg

Good Life SciencePractice

Manufacturing Execution System takes good care of the document jungle

F rom the raw materials han-

dling through chemical syn-

thesis steps or biological pro-

duction to formulation and right up

to packaging and shipment of the

finished product, Siemens has devel-

oped a complete package that covers

all areas of pharmaceutical produc-

tion. At the same time, the increas-

Automated

document

management in

accordance with

21CFR11

Concept with integrated know-how

All these individual components are

held together and supported by a cru-

cial component: the process and in-

dustry know-how of Siemens staff,

which has already proved an impor-

tant success factor in numerous pro-

jects. This know-how is also what

makes the Siemens strategy a concept

that not only provides a modular and

flexible software and hardware plat-

form but that is firmly rooted in

process and industry competence

from the very start. It makes no dif-

ference whether you want to opti-

mize a biological process or improve

the system-wide documentation –

with its new concept, Siemens always

has the right solution. ■

Jean-Jacques Lieners, Karlsruhe

Page 5: 9th Edition April 1 2002 Process News - Siemens · highly innovative and faster than their competitors in developing new drugs and products will survive. The neck-breaking ... solutions

5Process News 1/2002

Production processes in the lifescience market are changing,from conventional chemicallysynthesized pharmaceuticals tomore and more biotechnologicallyproduced pharmaceuticals. Thesenew production methods needeffective real-time monitoring andcontrol to guarantee a low-cost,safe and high quality production.Modern control and analysisconcepts are the key to effectiveprocess control in biotechnology.

A dvanced Process Control

(APC) is a control method in

form of process models, used

for conducting production processes.

It helps to obtain additional process

knowledge, understand interactions

between process variables, explain

non-linear relationships and handle

multi-parameter systems. This maxi-

mizes process capacity, yield and

product quality, saves on energy and

raw materials and at the same time

reduces process variations and inter-

ventions.

However, the basis of APC is

that the actual chemical or

biological process is mir-

rored as realistically as

possible in the control

concept so that the in-

teraction of the indi-

vidual process para-

meters is appropri-

ately covered. In biological processes

this especially means taking into ac-

count the various metabolic path-

ways that are strongly dependent on

the environment in the fermenter.

Inline analysis closes theinformation gap

However, to ensure that Advanced

Process Control always knows what is

happening in the reactor, a number

of physical and chemical parameters

have to be continuously monitored.

Up to now substrate and nutrient

contents, metabolite formation and

bio-mass concentration were ob-

tained trough laboratory, off-line

methods, yielding results up to sever-

al hours after sampling and fed into

the process computer off-line. This

fact markedly limits the ability to

control and optimize fermentation

processes, bearing in mind the rela-

tively long times required for labora-

tory analysis. At the same time seri-

ous problems may occur in the bio-

logical process when the process is

not kept exactly at the optimum set-

points. Inline measuring methods

ensure that the parameters are con-

tinuously measured and evaluated al-

most under real-time conditions.

In recent years, Siemens has de-

veloped new analyser systems for

process analysis that can generate a

continuous and up-to-date image of

the process. The ICR-FT (Ion-Cy-

clotron Resonance Fourier-Trans-

form) mass spectrometer Quantra,

for instance, can measure nitrogen

and carbon monoxide in bio-reactor

off-gas of the bio-reactor simultane-

ously with an extremely high mass

resolution – two components that

play an important role in the growth

of micro-organisms.

Integrated concept for thetransparent bio-reactor

Based on the theoretical process

know-how and understanding of the

metabolic pathways inside microor-

ganisms, a rough rigorous model is

developed and refined with the real-

time information obtained by in-line

process analytics. The integrated Ad-

vanced Process Control solution for

bio-reactor control which Siemens

developed as part of the Life Science

Suite consists of APC Tools that are

all integrated into the Simatic PCS 7

process control system. These tools

are interfaced via an OPC client

channel to the Win CC server, and

make use of the SCADA-system Win

CC-database (Historian) and data

obtained by the ICR-FT Mass Spec-

trometer Quantra. APC therefore

represents an important link between

the planning and scheduling func-

tions of the execution level and con-

trol functions. By using APC, Simat-

ic PCS 7 is expanded by a powerful

process optimization function and

ensures not only a more efficient

process control but at the same time

greater transparency in production,

leading to shorter batch run times,

lower production costs, caused by for

example optimal use of resources. ■

Ingrid Maes, Antwerp

Everything under controlIntegrated process optimization concept for biotech processes

quirements of the individual produc-

tion plants.

With “Monitoring+”, Siemens

Axiva offers a comprehensive service

package that covers the entire life cy-

cle of the monitoring system. The

concept includes clean room analysis

and monitoring concept develop-

ment taking into account the re-

sources the customer and his suppli-

ers and service providers have. Dur-

ing set-up, Siemens Axiva chooses

and purchases the components that

are best suited for the application and

takes care of their installation, wiring

and networking. The service package

also includes commissioning of the

system and the necessary calibration

and recalibration measures.

Qualification included

Naturally, the pharmaceutical pro-

duction of drugs demands compli-

ance with the regulations of national

and international authorities such as

the FDA (Food and Drug Adminis-

tration). The “Monitoring+” concept

therefore also embraces fully validat-

ed solutions, GMP-compliant execu-

tion (Good Manufacturing Practice)

as well as SOP concepts (Standard

Operating Procedures) and applica-

tion-specific SOP. In addition to a

fully integrated documentation, the

“Monitoring+” package also includes

offers for system operator and staff

training as well as regular mainte-

nance and servicing of the equip-

ment.

The modular, flexible and ex-

pandable concept structure ensures

that the systems of the “Monitor-

ing+” package from Siemens Axiva

grow with their tasks. Moreover,

great emphasis is placed on the net-

working capability of the system.

Owing to the interfaces to access con-

trol systems, operating data informa-

tion systems (ODIS) and SAP but al-

so to climate control and to process

control systems, “Monitoring+” can

be easily integrated into the control

and information landscape. ■

Winfried Claßen, Frankfurt

The Plus in InformationInnovative concept for clean room monitoring

Integrated control and analysis systems

make process optimization easier

The requirements for the control ambient conditions in the sterileproduction of drugs but also in other industries such as the

manufacture of cosmetics or the production of microchips have becomestricter and stricter in recent years. Temperature, humidity and pressure aswell as concentrations of airborne particles and germs must be kept exactlywithin the specified limits to avoid production faults. Systems of the“Monitoring+” concept from Siemens Axiva record, visualize and documentclean room conditions continuously and in accordance with GMP.

W hen producing under ster-

ile conditions, it is not

enough to assess the clean

room class once. Since the slightest

deviations of critical parameters of a

clean room, such as permitted con-

centration of dust particles, tempera-

ture, moisture and pressure, can have

a significant influence on the quality

of the products, the continuous

recording, monitoring and docu-

mentation of these variables is be-

coming increasingly important.

Know-how from a singleprovider

When planning and implementing

an appropriate monitoring concept,

it is advantageous to work with a

partner who has a profound know-

how in this sector. The specific expe-

rience in this field helps in recogniz-

ing and considering the special re-

Clean room monitoring in strict accordance with GMP

is an important aspect of production

Page 6: 9th Edition April 1 2002 Process News - Siemens · highly innovative and faster than their competitors in developing new drugs and products will survive. The neck-breaking ... solutions

Yamanouchi Europe BV had high hopes when they first invested in a fullyautomated ointment production in Meppel in the Netherlands, but theautomation system quickly became a harsh disappointment. Thereforethe company was very skeptical when Siemens presented its automationsolution for this problem. However, after the first initial meetings itbecame immediately clear that Siemens not only spoke the language ofthe pharmaceutical industry but also had the necessary know-how tosuccessfully complete the project.

with the automation system, but it

soon became evident that the system

supplier did not have the necessary

know-how to adapt the system to the

complex process requirements. The

problem with the standard control

system arose because two batches

were in production at the same time,

each producing their own reports.

There was also a partial time overlap.

Industry know-how was decisive

Yamanouchi therefore finally decid-

ed to place the contract for replacing

the plant automation with a different

supplier. When comparing the bids

of the competing potential suppliers,

the price/performance ratio of the of-

fered automation system was not the

only factor that played an important

role. “We wanted to make sure our

problems were understood this time.

The industry know-how of the po-

tential supplier was therefore a very

decisive factor”, as Herman Rozema

points out. It was here that Siemens

was able to convince with a sophisti-

cated and mature concept and excel-

lent references. “Siemens immediate-

ly gave us the impression that they

understood what the process was all

about. They realized quickly what the

problem was, asked the right ques-

tions and made sense.”

The new system is based on the

Simatic PCS 7 process control system

and the Batchflexible software. In ad-

dition to that, Yamanouchi selected a

barcode reader and the option to

connect the control system to an SAP

system. Integration with the office

automation system is also planned

for a later stage.

In on it from the very start

Henk Damhuis, production operator

for Yamanouchi in Meppel, was in-

volved in the planning of the new sys-

tem from the start. This guaranteed

that the system was implemented in a

user-friendly and process-oriented

way. It also means that Henk Dam-

huis is now able to help the operating

personnel and make minor modifica-

tions to the automation system.

Moreover, Yamanouchi had the op-

portunity to test the new system pri-

or to commissioning. “Halfway

through the construction of the sys-

tem we looked at the standard mod-

ules in The Hague. By this we could

gain experience with the new system

and identify certain problems. The

system was modified as far as possible

in accordance with the wishes of the

operator who will ultimately work

with it”, Henk Damhuis explains.

Greater transparency in theprocess

All these factors contributed to the

system being commissioned without

any problems. Thanks to the modifi-

cations, the ointment production is

now not only operating without a

hitch but also in strict compliance

with FDA-regulations as Henk

Damhuis concludes with satisfaction.

“The barcode scanner serves to veri-

fy that the correct ingredients are

added in the correct quantities. The

plant now complies with the require-

ments of the American Food and

Drug Administration, who is partic-

ularly interested in the procedures

and the tracking and tracing func-

tionality of the system.” ■

Henk Kleiju, The Hague

A matter of trustIndustry know-how was decisive with Yamanouchi Europe

With a new plant for producinghuman growth hormone (hGH),Novo Nordisk not only wanted tobring its process control and plantautomation up to date but at thesame time to reorganize itsproduction according to GMPspecifications. The Simatic PCS 7process control system and theBatch flexible software packagehave made their contribution toachieving these goals.

N ovo Nordisk is a focused

healthcare company and the

world leader in diabetes care.

In addition, Novo Nordisk has a lead-

ing position within areas such as

haemostasis management, growth

hormone therapy and hormone re-

placement therapy. Novo Nordisk

manufactures and markets pharma-

ceutical products and services that

make a significant difference to pa-

tients, the medical profession and so-

ciety. Novo Nordisk employs approx-

imately 16,000 people in 68 countries

An important product of the com-

pany is human growth hormone,

hGH, which is used for treating

growth retardation in children and

growth hormone deficiency in adults.

In Denmark, hGH is produced in a

biotechnological process, then puri-

fied and finally filled and packed for

selling.

Purification plant

As capacity in the existing purifica-

tion unit was insufficient, Novo

Nordisk decided to build a new plant

for this process stage. At the same

time they wanted to optimize the lo-

gistic processes in production in or-

der to improve the cost effectiveness

of the process. Another aim was to

automate the process as far as possi-

ble with a modern control system and

to improve the working environment

of the employees..

The openness and expandability

of the system were crucial factors in

the search for a suitable control sys-

tem. In addition it was important for

Novo Nordisk that the system soft-

ware could be created compatibly

with the S88 standard. Simatic PCS 7

was easily able to meet both these re-

quirements. Moreover, the excellent

price/performance ratio of the

Siemens offer also played an impor-

tant part in the decision.

The batch control was automated

with the Batchflexible software pack-

age. Siemens also supplied the entire

switchgear for the new purification

unit. Novo Nordisk’s engineering

company NNE had developed their

own system components for batch

reporting and material handling,

which could easily be linked to the

control system by the integrated OPC

interfaces of PCS 7.

Fast and easy commissioning

The easy handling of PCS 7 in the im-

plementation of the new DCS-system

was convincing. The new concept re-

lies consistently on fieldbus and Eth-

ernet-based communication systems.

This allows for a faster installation of

the communication network. Short-

er installation times also lead to a

quicker operation start-up for the en-

tire system. Thanks to the smooth in-

tegration of the Batchflexible software

the batch control is now also a part of

the control system which has consid-

erably improved the transparency of

the process.

Ever since production started,

PCS 7 has been totally convincing in

operation. The convenient and func-

tional process visualization gives the

operators an optimum view of all

processes. The plant and the control

system have been running to Novo

Nordisk’s full satisfaction since being

commissioned and, thanks to the

openness and flexibility, the compa-

ny can be sure that the plant is always

equipped to meet new challenges in

this rapidly growing market segment.

Kasper Agerbaek, Kopenhagen

6 Process News 1/2002

T he plant for producing a great

variety of ointments was built

in 1995. It was then equipped

with a modern automation system to

achieve maximum productivity and

process transparency. But it turned

out that the process automation was

in fact the weakest link in the com-

plex process chain, as the project

manager at Yamanouchi Herman

Rozema remembers: “The reporting

was below standard, process se-

quences were skipped and the system

was regularly out of service.”

Right from the start, Yamanouchi

tried to eliminate these problems

A Foundation for HealthyGrowth

Simatic PCS 7 at Novo Nordisk in Denmark

Process-oriented, user-friendly and

FDA-compliant: Yamanouchi is

completely satisfied with the new system

Page 7: 9th Edition April 1 2002 Process News - Siemens · highly innovative and faster than their competitors in developing new drugs and products will survive. The neck-breaking ... solutions

Process News 1/2002

Where high value products suchas pharmaceuticals areconcerned, yield, consistency andrepeatable batch processing areimportant issues. These can all beadversely affected by systemfailure, which can occur wheneversafety and reliability are ignored.Integrated safety systems withfailsafe controllers and reliablecommunication systemsguarantee not only a trouble-freebut also flexible production. As anexperienced partner to thepharmaceutical industry, Siemensdevelops safe automationsolutions based on proven andsuccessful components that areoptimally adapted to therequirements of the respectiveapplication.

N ew legislation such as the EN

954-1 and IEC 61508 regula-

tions have specified a new

field of automation technology in re-

cent years. Until now, safety related

controls, such as those involving the

shut down of equipment to protect

personnel, emergency stop circuits

and remote shut down of plant have

primarily been handled by hard

wired or solid state logic systems.

In the beginning is the processanalysis

When setting up such an integrated

safety solution, a thorough investiga-

tion of the process and its safety de-

mands has to be performed. Where

are the critical phases in the process?

What faults may occur and what are

their consequences? How can faults

be avoided from the start? All these

questions have to be answered prior

to implementing a safe automation

solution if you want to fully profit

from the possibilities of integrated

safety technology.

Siemens has developed a concept

that ranges from the initial risk analy-

sis right up to the final verification of

the Safety Integrity Level (SIL) and

from planning through to the de-

commissioning of a harzardous

plant. Siemens supports and advises

the plant owner in the safety require-

ments allocation of his processes and

develops concepts and solutions

based on field-proven failsafe and

fault tolerant components. Here,

Siemens benefits not only from

decades of experience in the field of

automation engineering but also

from its deep application know-how.

The customer can therefore be cer-

tain that he is getting a solution that

has been tailor-made to suit his

process and meet the pertinent regu-

lations for pharmaceutical plants.

More safety means greaterproductivity

The pharmaceutical industry benefits

from the integrated safety solution in

two respects. On the one hand the

safety-relevant processes are ideally

mirrored in the control system re-

sulting in improved process control

and therefore less production down-

time. At the same time an integrated

safety solution also ensures more

transparency in production. This im-

proves both product yield and batch

consistency and greatly increases the

overall productivity of the produc-

tion. ■

Jon Keswick, Manchester

The customer comes firstCustomer-oriented services from Siemens

T he new generation of the

successful MultiRanger

ultrasonic level measur-

ing instruments that has recently

become available offers a broad-

ly extended range of features.

Owing to several already inte-

grated interfaces, the Multi-

Ranger is now suited for digital

communication. Moreover, the

SmartLinx communication mod-

ule allows easy connection to

Profibus-DP and other common

fieldbus systems.

MultiRanger is of course

equipped with the latest version

of the Sonic Intelligence soft-

ware that increases the relia-

bility of the measured values,

simplifies difficult applications

and facilitates plant mainte-

nance. The MultiRanger comes

with a handheld programming

unit to make configuration and

programming as easy as possible.

With the Dolphin Plus software,

diagnosis is even simpler than it

already was. Programs or echo

profiles can now be downloaded

and sent to the service operator

for inspection via e-mail.

MultiRanger can be config-

ured individually on order so that

each customer gets a solution that

is ideally suited for the applica-

tion and offers the optimal price/

performance ratio. Field installed

MultiRangers can also be easily

upgraded to the latest version.

The electronics can simply be re-

The next generationSiemens-Milltronics MultiRanger offers even more functions

At Siemens, the customer comes first. With a complete service package, Siemens makes sure thatplant owners always get the optimum support for their projects – no matter whether the task is toplan, commission or modernize a plant. The customer can be certain that he will always be able toquickly reach a competent and committed service officer who can find the best solution to therespective problem.

placed without removing cables

or connections. ■

Janet Wile, Peterborough

Guardian Angelsof ProductionFailsafe systems ensure greater productivity

Planning and Design

ConfigurationandDevelopment

Installation andCommissioning

Operation andMaintenance

Modernization

more directly, Siemens has set up a

global competence network which is

supported by the three competence

centers in Asia, the USA and Europe

and company headquarters in Ger-

many.

These centers are there to collect

and refine the Siemens know-how

from the different branches and sys-

tems and provide it to the different re-

gions. The competence centers also

organize the continuous further train-

ing of Siemens personnel locally. ■

Carsten Köhler, Karlsruhe

tinuously optimize their processes.

The Siemens system and industry

experts are familiar with the specific

requirements of a process and the

specifications of the industry and can

therefore provide prompt and pro-

fessional support at any time. The

customer has direct access to the right

partner in every situation – this helps

him not only save a whole lot of time

but also cost and effort.

Worldwide presence

Always being at the customer’s side

– that is more than just a slogan for

Siemens. In order to look after their

customers all over world better and

F rom service & support through

training right up to financing

opportunities, all services are

individually tailored to meet cus-

tomer requirements. Siemens sees it-

self as a competent counselor and so-

lution provider for the entire life cy-

cle of a plant – from planning and

conception, through configuration

and development, installation and

commissioning up to modernization.

Especially in the pharmaceutical in-

dustry it is very important to know

that you have a competent partner at

your side because pharmaceutical

companies have to adapt to new

market situations flexibly and con-

Page 8: 9th Edition April 1 2002 Process News - Siemens · highly innovative and faster than their competitors in developing new drugs and products will survive. The neck-breaking ... solutions

Process News 1/2002

P r o c e s s N e w s

Publisher

Siemens AG,

Automation and Drives division

Responsible for content

Anton S. Huber

Editor

Cornelia Dürrfeld, Siemens AG A&D AS PAS MC

Siemensallee 84, D-76187 Karlsruhe

Tel.: (07 21) 5 95-25 91, Fax: (07 21) 5 95-63 70

e-mail: [email protected]

Editorial committee

Richard Ahearne, David Favell, Lisa Gill Gardner,

Dr. Michael Gilluck, Achim Heim,

Walter Huber, Michael Lang, Harald Mag,

Hartmut Oesten, Manfred Schirner,

Detlef Seidel, Roland Wieser

Publishing house

Publicis KommunikationsAgentur GmbH

Head of periodicals

Wolfgang Meyer

Coordination

Sabine Zingelmann

Artwork and layout

Werner Völkl

Photos

Novo Nordisk (1, 6), Novartis (2),

GlaxoSmithKline (3), Schering AG (4),

Yamanouchi (6), Fa. Egger (8)

ISSN 1430 2284

© 2002 Siemens AG

All rights reserved by the publisher. No part of

this document may be reproduced without prior

written permission from the editor. Process News

is printed on 100% recycled paper.

SIMATIC, TOTALLY INTEGRATED

AUTOMATION, SITRANS, SIWAREX, SIPART,

ET 200, SIPAN, ULTRMAT, SIMOVERT,

PROFIBUS-DP/PA, are registered trademarks

of Siemens AG. If trademarks, technical solutions

or similar are not included in the list, it does not

imply that they are not registered.

Order No. E20001-M7102-B100-X-7600004900 RPE21 0402 26.Printed in Germany

Änderungen vorbehaltenSiemens Aktiengesellschaft

Strategic Choice

W hen Pharmacia in Bel-

gium made up their

minds to implement and

integrate a new SCADA system for

two new production units, they

wanted keep to their strategy of im-

plementing one standardized SCA-

DA concept for all their future pro-

duction units within the plant, so

they defined a detailed set of re-

quirements.

The Simatic WinCC process visu-

alization environment responds

completely to this modularly com-

posed project user requirement spec-

ification, so Pharmacia opted for

Siemens.

The new washing and sterile line

for washing, sterilizing and filling

ampoules is supposed start produc-

tion at the end of this year. The sec-

ond unit consists of three semi-auto-

matic freeze dryers for filled sterile

products. Start-up for this unit is

scheduled for the beginning of 2003.

Both units will be equipped with

WinCC visualization systems. The

two projects will be executed simul-

taneously by the engineering group of

Siemens Belgium, with a common

project manager. This has the advan-

tage of eliminating unnecessary pro-

ject information interfaces and guar-

anteeing the standardization on every

level in the development. ■

Danny Reynaert, Huizingen

F R O M A R O U N D T H E W O R L D

• Stop press

+ + + + + + + + + + + +

The readers of the

Control magazine award-

ed Siemens Milltronics

the title of “favorite

supplier” for ultrasonic

level measuring systems

in this year’s annual com-

petition. Siemens scored

top results especially

with their excellent

service.

+ + + + + + + + + + +

Siemens has received an

order from Firestone

Polymers in Lake Charles,

LA. This is an expansion

of an existing system du-

plicating an existing

Siemens process

automation application

installed March of 2001.

+ + + + + + + + + + +

FAIR PREVIEWHanover Fair 2002, April 15 to 20 2002, Hanover (Germany)Fair for Industry, Automation

SEMICON Europe,April 16 to 18 2002, Munich (Germany)Conference and fair for semiconductor equipment, materials,suppliers and servicesApril 17 2002, Siemens Facility Conference (as a part of the SEMICON!)

Siemens Process Automation User Conference,October 9 to 11 2002, Philadelphia (USA)More information at www.sea.siemens.com/automat

IFAT Munich,May 13 to 17 2002, Munich (Germany)International fair for waste disposal and the environment

Siemens Glass Day 2002,May 14 to 15 2002, Toledo, Ohio (USA)Expert meeting sponsored by Siemens and the Glass ManufacturingIndustry. Learn more at www.sea.siemens.com/glass

Global Petroleum Show,June 11 to 13 2002, Calgary (Canada)The world’s largest oil and gas show

Turning the oldinto new

A t the Egger Company in

Brilon two wood chipboard

production lines were to be

automated with a modern, future-

oriented system that offers easy and

optimal integration into a total au-

tomation solution. The automation

was to be implemented using com-

ponents belonging to one system as

far as possible. In addition, it was

specified that the project should re-

tain the machines and process-tech-

nical equipment including the load

cells.

Following extensive comparisons,

Egger finally chose the Siemens solu-

tion consisting of a Simatic S7-400

controller, a number of Siwarex M

weighing processors and the Profi-

bus-DP fieldbus system. One of the

main reasons for the decision was

that the combination of these mod-

ules with the master automation sys-

tem produced a freely configurable

weighing system that could be easily

adaptable to the existing conditions.

Since the chipboard production

runs continuously around the clock

seven days a week, the conversion

had to be made during a scheduled

periodic shutdown. Two Siemens

I&S technicians converted the au-

tomation system in just five days and

also commissioned and optimized

the new system during this period.

The plant has been working ab-

solutely reliably and failure-free since

being put into operation – convinc-

ing proof of the reliability of the new

system. ■

Helmut Janus, Essen

Remote CustomerAcceptance Test

P rior to shipment of the new

Maxum process gas chro-

matograph, customers often

inspect the system at Siemens to

check if functionality and operation

fit to the specific requirements. De-

pending on the customer location,

travelling to Bartlesville, USA, Karl-

sruhe, Germany or Singapore is re-

quired.

For those who want to save travel

time and costs, the new availability of

e-Customer Inspection Test (e-CAT)

allows electronic communication

with the analytical systems located at

any of the mentioned application lab-

oratories. It is possible to observe the

system functionality from remote,

evaluate data and vary parameters –

without really having to be there.

That way, it is also possible to reduce

delivery time for the Maxum chro-

matograph.

Various levels of e-CAT are avail-

able, ranging just from electronical-

ly evaluating performance reports

and independent electronic inspec-

tion directly from customer office

up to the assisted inspection at or

through a local Siemens office or

representative.

Needless to say, extensive hands

on Factory Inspection or Acceptance

Tests are of course still available for

those who still want to personally in-

spect their new equipment. ■

Ulrich Gökeler, Housten

Power in China

A Joint Venture of Russian and

Chinese corporations is

building two type VVER

1000 nuclear power plants for Jiang-

su Nuclear Power Co. (JNPC) near

the Chinese city of Lianyungang.

Siemens Power Generation is deliv-

ering the entire DCS system for both

process and safety control. More-

over, Siemens field instrumentation

managed to finish first against very

strong competition, so that Siemens

will supply 1,400 Sitrans P transmit-

ters for process pressure and differ-

ential pressure measurement and 100

Sipan liquid analyzers for the ultra

pure water unit.

After this successful bid, Siemens

stands a good chance of winning the

field instrumentation part of the con-

tract for equipping the second block as

well. ■

Roland Roth, Karlsruhe