Fette Compacting Magazine 2012 En

Fette Compacting Magazine 2012 1

FETTE COMPACTING MAGAZINE 2012

WHAT’S NEXT?

FE35 The Fastest for Pro-duct Changeovers0 - 13

New eShopFast and Direct Page 18

Quantity and Quality The Potential of “Pharmerging Markets”Page 6

InterviewTrends in Pharma- ceutical ProductionPage 7

EfficiEncy GuidEThe New Guidance System for all Questions Related to Tableting Technology

2

CONTENTS

3 EDITORIAL

4 A GREAT COMPANY The Fight against Neglect-

ed Tropical Diseases

6 QUANTITY AND QUALITY The Potential of “Pharmerging Markets”

7 INTERVIEW Trends in Pharmaceutical Production

8 PATENTS Significant for the Pharmaceutical Industry EXCELLENT reddot design award for the FE55

9 NEW OPENING Competence Center Brazil

10 WORLD PREMIERE FE35 The Fastest for Product Changeovers

14 FE55 - PURE EFFICIENCY New Standards for Tablet Production

15 GALENICS AND LABORATORY Development Close to Production

16 SPECIAL OPERATION Technical Field Service

17 THE FOUNTAIN OF YOUTH System Refurbishment

18 NEW eSHOP Fast and Direct

19 EFFERVESCENT TABLETS Demanding Process, Perfect Solution

20 OEE CONSULTING Improving the Entire Process

21 TRAIN FOR SUCCESS Training Services at Fette Compacting

22 EXCELLENCE UNITED Digital Service Portal

23 WHAT’S NEXT Exhibition Dates 2012

The whole is greater than the sum of its parts. Based on this idea, we developed the Fette Compacting Efficiency Guide, the new guidance system for our entire product and service range. The Efficiency Guide combines three areas of expertise: technology, service and competence.

At some articles in this

magazine you will find

so called QR-codes. With

the help of a little supple-

mentary program for your

Smartphone such as

i-nigma you can access

additional content.

TEcHnOLOGy covers all prod-ucts in tableting technology: from tablet presses, to peripherals, and tableting tools.SERVicE includes all services related to machinery and equip-ment, such as: spare parts supply, installation, system upgrades, and technical field service.cOMPETEncE is the generic term for our process-related services. This includes our training programs and compression trials, as well as application and OEE consulting and engineering.

For us, efficiency means to have these elements interact perfectly according to the individual needs of each user. The Efficiency Guide is designed to help you to quickly and easily locate all the relevant information and contacts for all matters concerning tableting. We have marked the corresponding contents in this magazine with the help of the Effi-ciency Guides scheme.

EFFICIENCY GUIDE

SERVICE

TECHNOLOGY

COMPETENCE

10 – 13

WORLD PREMIERE FE35 All about the new machine in the fE Series


EDITORIAL

OLAF J. MÜLLERCEO Fette Compacting

dear Readers,

“Be efficient” – in 2011 we made this motto the central promise of Fette Compacting and presented the first tablet press of a new generation. Now we are celebrating yet another world premiere. During its development, we followed our guiding idea of effi-ciency again. With the new FE35 we present to you a tablet press which offers you the fastest product changeovers of its class. This makes the FE35 the ideal basis for the tablet production of the future,

Excellent technology is, however, only one element of efficient pharmaceutical production. Equally important are services which help customers to make the best possible use of this technology. We have therefore further developed our offering and adopt-ed a new classification system. Along with “Technology” and “Service”, we have added a new dimension to our product range

which we have named “Competence”. “Competence” refers to the knowledge which supports you to improve your processes and make your tablet production ready for the future. This is why the combination of Technology, Service and Competence will become an integral characteristic of our offering. For us, efficiency means to make these three elements work together perfectly in order to meet your requirements – anytime, any place worldwide.

I would like to invite you to discover our new offering – in this edition of our magazine “What's Next?”, on our new website, when talking to our employees in sales and field services, or in one of five global Competence Centers.

Olaf J. MüllerCEO Fette [email protected]

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4

According to WHO estimates, out of the 2.7 billion of the poorest people on the planet, more than one billion are in-fected with a Neglected Tropi-cal Disease (NTD). A total of 149 countries are affected with these 17 different diseases, and 30 countries are affected by at least six or more of these tropi-cal diseases, including sleeping sickness, leishmaniasis and lymphatic filariasis. The WHO has taken it upon itself to elim-inate these often deadly diseases worldwide. In January this year, 13 international com-

4

Working Towards Better

Health In line with its corporate philosophy of “Human Health Care”, the Japanese pharma-ceutical company Eisai has committed itself to finding solutions for health and supply

panies (among them Bayer, Eisai, Merck, Novartis and Sanofi), the Bill & Melinda Gates Foundation, the United States and British govern-ments, the World Bank and the governments of the countries affected by these diseases signed a declaration, pledging to stamp out the ten worst tropical diseases by 2020 in a concerted effort. The emphasis will be on the manufacturing and distribution of medicines as well as on developing imple-mentation programs in the affected regions.

problems worldwide. In an agreement with the WHO, Eisai will be supplying 2.2 billion 100mg tablets of the drug Diethylcarbamazine (also known as DEC) over the next 8 years free of charge for the treatment of lymphatic filaria-

The Japanese pharmaceutical company Eisai, together with five other partners, is supporting the World Health Organization (WHO) in an initiative targeting “neglected Tropical diseases” in developing nations. Eisai is sponsoring the medicines required, which the company will be manufacturing in its new production and research facility in Vizag, india using tablet presses from fette compacting. fette compacting is supporting the project with a complimentary set of compression tools.

A GREAT COMPANY“This is an extremely significant project

for Eisai – it helps the patients and also

offers us the chance to establish our

supply chain in markets we haven’t

served until now.”

Sanjit Singh Lamba, Managing Director, Eisai Knowledge Centre


sis. The amount sponsored is based on a projection by the WHO, which plans to use a combined therapy method utilizing two out of three an-ti-parasitic agents, one of which is DEC. From 2013 to 2020, Eisai will provide DEC to over 250 million people, and in doing so, help close the gap in the supply of pharmaceuticals. “This is an extremely signifi-cant project for Eisai – it helps the patients and also offers us the chance to establish our supply chain in markets we haven’t served until now,” says

Sanjit Singh Lamba, Managing Director of the Eisai Knowl-edge Centre in Vizag, India, where the DEC tablets will be manufactured.

flexibility and Quality

Made Possible by fette

compacting

However, the involvement in the project will by no means affect productivity – thanks to the high-performance tablet press from Fette Compacting – a model 3200i with a Pmax turrets with 110 stations. The high f lexibility of the machine

enables the production of large numbers of drugs alongside ongoing production.

“We are proud to be support-ing such an important interna-tional health care project. That is why we have provided Eisai with a complimentary set of 130 punches and the accompa-nying segments. Additionally, colleagues in our subsidiary in India will continue to support the project domestically,” says Olaf J. Müller, CEO of Fette Compacting.

A GREAT COMPANY

Eisai Co., Ltd is a

Japanese pharmaceuti-

cal company that

researches, develops

and markets products in

the fields of integrative

neurosciences (e.g.

Alzheimer’s), integrative

oncology (e.g. vaccines)

and vascular diseases.

With its global network of

research laboratories,

production facilities and

affiliates, Eisai is actively

involved in all aspects

of international health

care. Through its corpo-

rate philosophy, Eisai

has committed itself to

making valuable contri-

butions to the field of

human health care.

Eisai has over 11,000

employees worldwide

and is headquartered in

Tokyo, Japan.

About Eisai

2.2 billion tablets until 2012:

Production with a Fette

Compacting 3200i at Eisai’s

in Vizag

Dr. Margaret Chan, Director-General of the World Health Organization (WHO), and Haruo Naito,

CEO of Eisai, seal the agreement on cooperation to combat neglected tropical diseases

6

In the emerging economic regions in Asia and South America economic standards are not the only thing rapidly approaching the western mod-el. While there is still a lot of catching up to do with regards to material goods such as cars, clothing and electronics, on the other hand life expectancy

QUANTITY AND QUALITY

Rising income levels as well as new lifestyle and

eating habits are increasingly changing the face of

disease in emerging economies such as india, china

and Brazil. These regions, however, offer more than

huge sales potential. for the large pharmaceutical

companies, they are becoming increasingly attractive

as production sites.

and lifestyle – especially die-tary habits – seem to resemble western ones more and more. This also dramatically shifts the disease patterns for these regions: chronic diseases are now on the rise. A higher life expectancy, obesity and physi-cal inactivity – due to increas-ing wealth – are causing new

health problems. The consult-ing company PriceWaterhouse-Coopers estimates that the number of people suffering from high blood pressure in developing countries will rise to one billion by the year 2025. A similar picture is emerging for the development of diabe-tes. However, these markets continue to ref lect a very high level of diversity: In part, the great differences in income and life expectancy not only within but also between these coun-tries make it difficult to clearly characterize the demand for pharmaceutical products.

from consumer to Producer

– The case of india

The emerging economies are not just a lucrative market for the pharmaceutical industry. These regions are becoming ever more important pillars in the global delivery chain as production locations. For ex-ample, in recent years, India

Since 2006, fette compact-

ing has been represented by

its own subsidiary in india.

What role does the company

now play on the indian

market?

We can be very proud. Within a short time, we were able to estab-lish ourselves as the market leader for high-speed tablet presses. In the last three years we were able to win leading Indian pharma-ceutical companies like Cipla, Lupin or Ipca, and also subsidiaries of international companies such as Eisai as customers.

Last year, fette compacting in Goa opened its own compe-

tence and training center. Has this step been worthwhile?

Yes, absoutely. We offer training opportunities of the highest standards for up to 20 people. Clients can train their personnel on

different machines and can, for example, carry out test press runs without interrupting their own production. In our next step, we want to strengthen our local engineering so we can tailor our tableting technology services to the needs of the Indian market by working closely with headquarters in Schwarzenbek.

Where do you see the highest potential for the pharmaceu-

tical industry on the indian market?

Even though the health sector has grown tremendously in the previous years, to date only approximately 30 percent of the popu-lation has access to medical services comparable to those in big industrial nations. Theres great potential for the future. For one, rising sales opportunities for pharmaceuticals. Second, pharma-ceutical companies offer attractive opportunities to invest in re-search, development and production, thanks to highly qualified graduates and an improved infrastructure.

interview with Venkat Venkatasubramanian, Managing director of fette compacting india

The Potential of “Pharmerging Markets”

– in terms of volume – was able to develop into the third largest pharmaceutical industry world-wide. Now, India offers not only quantity, but also quality. These days, the production facilities meet international standards and offer a broad spectrum of manufacturing processes. This has been recog-nized by domestic as well as foreign pharmaceutical compa-nies, who increasingly invest in the region. Approximately half of its entire pharmaceutical production is currently sold abroad, which is equivalent to 8.2 billion US dollars. India can also look forward to a positive future: Its domestic market, its research and development capacities as well as the com-petitiveness of its pharmaceuti-cal production show enormous growth potential for the next five to ten years.


interview with dr. christoph

Ebensperger, Head of

Business Segment Life

Sciences Horvath & Part-

ners Germany

How will the pharmaceutical

industry change over com-

ing years?

The trend of consolidation, which has persisted for some time, will continue. The enor-mous pressure from rising costs is forcing pharmaceutical companies to implement mas-sive cost-cutting measures and to plan their marketing, re-search, production and logis-tics projects efficiently. In ad-dition, the market for new drugs appears to be limited. On the one hand, this is due to the fact that common diseases today are already relatively easy to treat. On the other hand, market access is becom-ing increasingly difficult due to critical assessment by spon-sors. As far as the marketing of existing medicines is con-cerned, rapidly growing na-tional economies, such as Chi-na, India or Brazil, continue to hold great potential. The most suitable products here would be “brand generics”, i.e. drugs which contain patent-free sub-stances marketed under an independent name.

GLOBAL, FLEXIBLE AND LEAN Trends in Pharmaceutical Production

How will the large pharma-

ceutical companies react to

global demand? What does

this mean for the interna-

tional supply chain?

The global production and supply chains are already very complex. What experience in recent years has shown is that it is not enough to only carry out specific optimizations at individual stations of the sup-ply chain. It is more about optimizing the process as a whole. Naturally, costs also play an important role. Never-theless, it is not sufficient to simply be cheap. If the phar-maceutical giants had previ-ously relied on purchasing third-party materials, then currently – due to extremely problematic cases – they are again increasingly paying at-tention to quality. This is also because many new forms of therapy require highly person-alized drugs. While volumes will be reduced significantly, product diversity will increase. This means that the whole supply chain from the produc-tion of active substances to the formulation up to the packag-

ing must become a lot more more f lexible – with consistent and uncompromising quality – and at reasonable prices, too.

What will this mean for pro-

duction and for the suppli-

ers of special machines?

Blockbusters are an outdated model. In the future, the pro-duction of drugs with such large turnovers will most likely be the exception and no phar-maceutical firm will be able to base its strategy solely on the development of such products. The risk of failure would sim-ply be too great. This will have tangible effects on production and machine construction. For example, if we analyze Overall Equipment Effectiveness (OEE), we discover that already at this point in time it often lies below 20%. The trend to-wards “Lean Six Sigma” and other modern methods in manufacturing which have been customary for a long time in e.g. the automobile industry will continue. Right now, the possibilities for pharmaceutical production are by no means exhausted. New opportunities present themselves through the optimum linking of sales fore-casts and production “make to order”.

Manufacturers of special ma-chines that emphasize f lexibili-ty and quality and are able to provide the industry with the right offers have outstanding prospects. This is where an

intimate understanding of the customer will become a deci-sive factor – especially interna-tionally.

Machine tool manufacturers can achieve a sustained com-petitive edge if they start work-ing together with pharmaceuti-cal manufacturers early on in the development process and adapt their products and ser-vices even more closely to the needs of their customers.

Dr. Christoph Ebensperger,

Head of Business

Segment Life Siences

Horvath& Partners

Germany

8

EXCELLENT!red dot design award for the FE55

To what extent do patent

rights offer sufficient

protection for the pharma-

ceutical and medical tech-

nology industries today?

The protection of intellectual property is of central impor-tance for the drug and medical products sector due to the enormous investments in R&D. If the legal instruments – specifically primary and secondary patents – are used appropriately, patent rights today continue to offer suffi-cient protection. This assumes

PATENTS Dr. Gisbert Hohagen is a

partner at the international

law firm Taylor Wessing.

He specializes in intellectual

property rights with an

emphasis on patent rights.

that an organization not only manages its own patents but also enforces its legal rights against its competitors. That happens very reluctantly at times.

is it worthwhile investing

in R&d today when you

consider the increasing pro-

liferation of generic drugs?

Definitely yes. Generic drugs are only allowed to be brought onto the market after the pat-ent rights – including addition-al protection certificates – and

Fette Compacting had an excellent start to the year. The company received the red dot design award 2012 for the newly designed tablet press FE55. “The user immediately experiences the design vocab-ulary of the tablet press, with rounded edges, ergonomic design, and its high functional quality,” said the internation-ally renowned jury. Some 1,800 companies from 58 countries submitted entries in 2012, but only the best won. At a formal gala in Essen on the 2 July, Fette Compacting and Domi-nic Schindler, the designer of the FE55, are to be presented with the prize.

“The award is a fitting tribute to the achievements of our employees,” says Olaf J. Müller, managing director of Fette Compacting, highlighting the teams effort. “What is really good about this award is that, not only is the technical capa-bility honoured, but all those involved; the technicians, the development engineers, the colleagues in marketing and sales, and rightly everybody worldwide can be proud.”

Significant for the Pharmaceutical Industry

the exclusive information rights to the original product have expired. Sometimes sev-eral months pass before the generic drug appears on the market after the exclusive rights have expired. Therefore, it is still worthwhile to invest in your own R&D.

Which trends are becoming

apparent where internation-

al patents are concerned?

The industry is in an uproar since the recent decision by the Indian patent office to grant

the domestic generic drug manufacturer Natco a compul-sory license from Bayer for the cancer drug Nexavar®. But compulsory licenses are nothing new. This decision is so controversial because Nexavar® is not a drug that is used to fight typical “third-world diseases”. The case of Nexavar® remains on the table and other similar decisions concerning compulsory li-censes in other developing nations have yet to be ad-dressed.

Outstanding design –

Fette Compacting’s new

tablet press FE55


Positive development in

South America

More than 100 distinguished guests accepted the invitation from Fette Compacting, including the mayor of Campi-nas, Pedro Seraphim, as well as representatives of numerous South American drug compa-nies. They were welcomed by Franziska Eichel, representing the LMT Group shareholder family. She travelled together with her sister Angela Bengel and emphasized in her wel-coming speech, how closely the success story of Fette Compacting is connected to the development of the subsidi-ary in South America. “Since the establishment of our sub-sidiary in Brazil, the countries of the region have made signif-icant progress, of which we have also benefited. We already get more than ten per cent of our sales from customers in

Schwarzenbek

Rockaway

Campinas

Goa

Nanjing

NEW OPENINGCompetence Center in BrazilIn April 2012 Fette Compact-ing opened a Competence Center for tableting technology in Brazil. In Campinas near São Paulo the company offers its Latin American clients a unique range of services: service, training, and compre-hensive press tests. The Latin American presence has strate-gic significance for Fette Compacting, CEO Olaf J. Müller explained: “Brazil is the world’s sixth largest economy. Additionally the whole conti-nent experiences an amazing growth. With our new Compe-tence Center we are right in the middle of one of the most dy-namic regions of the world. From 2007 until now the turn-over of tablets has doubled in Brazil.”

Unique offering: global

network of Competence

Centers in all relevant markets

Latin America and the pros-pects are very encouraging.”

Expanding Service Business

The positive expectations of Fette Compacting are closely linked to the new center of excellence, said Dr. Michael Heinrich, CEO of LMT Group: “Campinas is the fifth Compe-tence Center for tablet technol-ogy. We are now represented in all emerging markets of the pharmaceutical industry with unique facilities where we

make our full range of services available to our clients locally. This allows us to expand the rapidly growing service busi-ness.” In addition to Brazil Fette Compacting operates identically equipped centers in China, India, the United States, and at its headquarters in Schwarzenbek near Hamburg. There, experts are trained that carry the know-how of Fette Compacting to the worldwide Competence Centers.

Top: Pedro Serafim, Mayor of Campinas und LMT shareholders Angelika Bengel and Franziska Eichel

Bottom: Edilson Viola, Managing Director of Fette Compacting America Latina, and Mayor Serafim

10

fETTE cOMPAcTinG fE35 – The Fastest for Product Changeovers

The FE35 is Fette Compacting’s second machine in the new FE Series. It offers customers the fastest product changeover of all tablet presses in its class. The FE35is a single rotary press that can be fitted with up to 51 punch stations, enabling the production of approximately 370,000 tablets per hour. However, it is the rapid product changeover that makes this new machine so efficient: For example, Fette Compacting estimates that the turret can be removed within a mere 15 minutes. All other components of the new machine are also optimized for fast changeover.

TECHNOLOGY

10


What makes all this possible in record time is an all-new design as well as a number of technical innovations. The newly de-signed pressing cell ensures that all components can be accessed in an optimal manner when they are to be refitted or cleaned. Additionally, the FE35 sets new standards in produc-tivity. Fette Compacting has successfully implemented many innovations introduced last year with the FE55 to the second machine of the new FE Series.

With the newly-developed Fill-O-Matic (patent pending), customers can increase the product output or the produc-tion capacity with a wide array of products up to 100%. The die table segments in the FE35 are also a new development. Despite a larger pitch circle diameter of 325mm, these segments have the same weight as segments with a smaller pitch diameter.

mentation of this principle is the foundation for quick product changeovers.

It starts with the layout of the machine, which allows for quick and easy access to all modules. When changing the turret, all operational steps are fully automated or can be exe-cuted tool free. Furthermore, all supply lines are connected to the machine via a single plug.

Another highlight of the FE35 is the new exhaust unit which can be connected above, under or to the side of the press. The remov-al or installation of the unit itself, for example for cleaning, takes only seconds. As with the FE55, operators can align the table on which the filling unit is located via a lever, which is accurate down to 30 microme-ter. Also, the FE35 features the completely new Human Ma-chine Interface developed by

Fette Compacting is also break-ing new ground with the con-struction and function set of its compression rollers. The FE35 is the only machine in its class with upper and lower compres-sion rollers that can be adjusted automatically, as well as pres-sure measurement cells with integrated measuring amplifiers and drive units with a new posi-tion measurement system. This results in much shorter refitting times – operators no longer have to move to reference marks after a turret change, and can calibrate the measure-ment cells at the operations terminal using software.

TRi.EASy design: Easy

Operation as a Basis for

Quick Product changeovers

Likewise, Fette Compacting has consistently implemented its new TRI.EASY concept in the FE35. The idea behind this concept is that technology can only be efficient when it is equally easy (EASY) in all three (TRI) aspects of operation, refitting and maintenance. Hence, the TRI.EASY design focuses on the user and guar-antees smooth operation re-gardless of the experience and qualification levels of its opera-tor. With the FE35, the imple-

Fette Compacting. Peripheral devices can be connected via a standardized plug-and-play interface, in which all the cables and the dust extraction unit are integrated.

Optimized construction

and drive

The mechanical design of the FE35 is also new. The optimized structural frame allows for low-vibration operation and reduces noise output. The new direct torque drive features an enormous reserve capacity, easy maintenance and low heat gen-eration. This is made possible in part by the revised cooling de-sign of the drive compartment. Customers may choose between an integrated and an external switch cabinet. As with the FE55, the housing of the FE35 is made of an FDA-approved high-performance plastic.

After the introduction of the FE35 prototype at ACHEMA 2012, Fette Compacting plans to ship the first units in spring 2013.

The AIO from Pharma Technology is the ideal partner for the new FE-Generation. The unique combination of deduster, metal detector and NIR Checkmaster connects to the tablet press via a standardized plug-and-play interface. The full inte-gration of all cables and the dust extraction unit is

an exclusive development for Fette Compacting. For more information visit www.fette-compacting.com or use the QR-code for direct access to the product brochure.

AiO A perfect match

12

...if you had to switch to a new product in your tablet production

process? Or, in other words: Are you aware of all the challenges

that your production lines will be facing in the next few years?

The fE35 is the perfect machine for all future requirements. it is

the second model in the brand new fE Series, and has the shortest

product changeovers of its class, plus an extremely easy to use

control system thanks to the fette compacting TRi.EASy design.

So, how fast do you want to change now?

12

How fast can you change...

FAST

CHANGEOVER

Three factors are critical to efficiency in tablet production: Productivity, flexibility and the availability of facilities. With its unique configuration, the fE35 sets new standards for quick product changeovers, thereby equipping you with the prerequisites for efficient production.

nEW fiLLinG uniTThe innovative filling system guarantees easy and reliable delivery, even for complex product mixtures and a significant increase of production capacity. An assembly without tools allows for short refitting times, and the precise alignment of the filling table ensures minimum product waste.

nEW TuRRET New, more compact segments, a higher number of dies and an innovative construction guaran-tee maximum output and make changing the turrets a simple process.

nEW cOMPRESSiOn STATiOnSThe FE35 is the only machine in its class with upper and lower com-pression rollers that can be adjusted automatically, as well as pressure measurement cells with integrated measuring amplifiers and drive units with a new position measurement system. The result: Much shorter refitting times – operators no longer have to move to reference marks af-ter a turret change, and can calibrate the measurement cell from the opera-tion terminal.

TECHNOLOGY

Fette Compacting Magazine 2012 13Fette Compacting Magazine 2012 13

How fast can you change...

nEW EXHAuST uniTWhether upwards, downwards or on the side, the FE35 is equipped with a new exhaust unit that offers maximum flexibility when connecting to an exhaust system. And the best news: during a product change, the unit can be removed, cleaned and reinstalled in the blink of an eye.

CHANGEOVER

nEW TABLET cHuTEThe new tablet chute is integrated in the column, guaranteeing smooth oper-ation at all times as well as unrestricted access to all sides of the machine.

Watch an

animation of

the turret

exchange.

14

The FE55 is the first tablet press of the new FE Series by Fette Compacting. The FE55 fulfills its promise to set new industry standards in productivity, f lexibility and availability. Since its world premiere at Interpack 2011,

FE55 - PURE EFFICIENCY New Standards for Tablet Production

Easy turret changing – due to the Fette Compacting TRi.EASY Design users can refit the FE55 very fast

TECHNOLOGY

Fette Compacting has received 12 orders by customers from all regions and market segments worldwide.

The FE55 is the first machine of its size with which users can produce more than 90 percent

Machine design+ Housing made of FDA-certified high-

performance polymer+ Optimal geometric surfaces for easy

handling and fast cleaning+ All components with product contact

made of stainless steel+ 360° access+ Window flaps can be opened even when

peripheral equipment is connected

new torque drive+ Modern high-performance torque direct drive + Maintenance-free and energy-efficient+ External or internal switch cabinet for maximum

flexibility+ Power and control sections are separate+ Power cabinet with innovative cooling concept+ All peripheral equipment and machine connections

on a single panel

of all standard tablet types without additional investments or costly upgrades. In addition to mono- and bi-layer tablets, users can also directly compress non-granular powder. The new Fill-O-Matic filling system guarantees effortless filling,

even when using complex pow-der mixtures. This drastically improves productivity. One feature which guarantees a high performance during the actual tableting is the FE55’s unique ratio of punches to area (up to 87 punches on 1.6 square

new turret+ Unique ratio of punches to area guarantees

maximum productivity+ One turret for all applications+ Fast and easy turret exchange with cams and

punches+ Turret featuring mechanical coding ring for

avoiding assembly errors+ Fast format changeover thanks to segments+ Coded tablet scraper+ One central multi-functional plug for oil,

air and power

An Overview of the Highlights:

14


Fette Compacting doesn‘t only develop efficient tableting machines for mass produc-tion. In galenics, too, the market leader‘s presses are very common: World wide there are well over 100 machines used for research and development. The most commonly used models are the 102i (for smaller volumes) and 1200i (for medium and larger volumes). These types allow research that is oriented as close as possible to later production. Core sizes like compression roller geometry, veloc-ity and compression force are identical to the large production machines with over 100 punching stations. Simultaneously, the galenics models can press batches of only a few tablets or even individual pieces – an important aspect especially for very expen-sive medications and substances. This allows researchers to collect all necessary data for the subsequent production process. Since 2010, Fette Compacting has acquired exclu-sive international distribution of the 52i Series of mobile galenics presses.

The advantages of such a production- oriented development are clear: Due to the reliable data, costs for up-scaling (the trans-fer of development production to the major production process) as well as Time to Mar-ket are minimized. Therefore profitability can be estimated during development. Dur-ing production, the development on Fette Compacting machines ensures higher output, less product losses and improved machine runability.

GALENICS AND LABORATORY Development close to production

FE55 - PURE EFFICIENCY New Standards for Tablet Production

Easy turret changing – due to the Fette Compacting TRi.EASY Design users can refit the FE55 very fast

use the QR code

to watch a video

with all steps

of the turret

exchange:

new innovative tablet chute+ Innovative and absolutely reliable tablet sorting+ Significantly less floorspace thanks to tablet discharge

position in the column+ 360° access+ Compact unit without cables or hoses+ Dust-proof+ Sample batch within 4 seconds during production

using patented system+ All parts with product contact made of stainless steel for fast

and efficient cleaning

meters) as well as a newly patented batch sampler for the production of bi-layer tablets. Instead of the usual 20 seconds required, sampling of the first layer takes only four seconds. Users can therefore reduce product wastage sixfold. A novel, internal tablet outlet chute ensures uninterrupted and smooth production. A special control mechanism prevents sample tablets or damaged tablets from blocking the outlet.

new HMi+ 19” touch-screen for maximum overview+ Swift access to key functions via 12 pictogram buttons+ Easy operation thanks to full keyboard+ Dust-protected USB connection+ No mechanical drives+ Win7® embedded operating system+ Visual operating software from Fette Compacting+ SQL server database+ All surfaces are easy to clean+ No ventilation slots or openings+ Ergonomic operating height

new compression stations+ New adjustable compression rollers for easy operation+ Three compression stations for maximum flexibility+ Mono, direct compression and double-layer tableting

on a single machine+ Double-layer tableting with identical compression rollers

and filling devices+ 50 % longer compression dwell time+ Pressure rollers can be parked quickly for simple turret

replacement+ Extremely simple replacement of measurement cells

for product changeovers


16

Without detailed training, the service work on complex machine engineering technol-ogy is not feasible, but at Fette Compacting the basis for our technical field services is

SPECIAL OPERATIONSEngineering for tableting machines is high tech. Many details determine the performance of the systems. fette

compacting offers perfect service conditions with its specially trained technical field service – worldwide and

around the clock. The 24 hour help desk makes it even easier to contact us.

exceptional: All of the approxi-mately 50 service technicians working worldwide have train-ing as electricians/system engineers and mechanics. Thanks to this unique dual

Production downtimes are very expensive. With

its 24 hour help desk, fette compacting ensures

fast help for its clients any time, day or night.

If you experience problems with a machine, “first aid” must be available immediately. Fette Compacting provides a “Help Desk” for its cus-tomers, which is globally accessible by phone. At the other end of the line we have service an expert available round-the-clock, who know tablet technology in detail. If necessary (and with an existing connection), he can access the machine via the internet. “However, in some instances it may suffice to give simple tips and instructions over the phone,” service manager Thomas Bunsen explains. “If there is a bigger problem we send out a service technician as quickly as possible. The help desk is staffed around the clock, 365 days a year.”

Servicehotline tablet presses

Tel.: + 49 (0) 41 51 12 483

[email protected]

24 hour help deskAlways ready!

qualification the experts can provide an overview of the entire system during in-spection, maintenance or calibration – an important prerequisite in order to main-tain the machines in perfect condition.

Practical example of initial installation of a new machine: The service technician is on site and monitors the delivery into the workshop and ensures the safe handling of the ma-chine being lifted out of the crate. “It is extremely impor-tant to us that our specialists monitor the entire process from the beginning,” Bernd Klingenhof, director of field services at Fette Compacting explains. As a result they are

responsible for every detail during installation – the electrical connections, the installation of the compres-sion-dies, the operational test-ing, and the basic instruction. “When our specialists are fin-ished, we guarantee a fully functioning and perfectly cali-brated machine,” Klingenhof confirms. Other important aspects are the geographic and especially cultural proximity of the service technician to the client. “Not only do we operate globally, we also have trained technicians in all the relevant markets who originate from the respective regions,” Klingenhof points out. “This puts us much closer to the clients and the colleagues know how to read between the lines.”

Service worldwide – Technical Field Service at Fette Compacting

SERVICE


THE FOUNTAIN OF YOUTH

Four months and 500 man-hours later: For a French pharmaceutical company, the tablet specialists from Fette Compacting overhauled the tablet press PT 3090 and turned it into a system that almost resembles a new ma-chine. Now the client receives a machine that is electrically and technically up to date and is also equipped with new control and technology. Additionally, it has a new torque drive (in-stead of a conventional drive) “The machine is almost com-pletely gutted,” said Marcus

Background: General overhaul

To construct robust and durable machinery – that is a central requirement for the tablet specialists at Fette Compacting. Against this background, the general overhaul of older machines makes sense in many in-stances: Again and again used models come back to the production site at Schwarzenbek. Here they are rebuilt and returned to the market in an almost new condition - often accompanied by very specific equipment requirements from the customer. There is also a whole range of additional benefits. Subse-quently the availability of spare parts is assured, the experts offer the systems with warranty. In addition, certified service personnel is available for used ma-chinery.

Before After

System refurbishment at Fette Compacting

Czudny, technical director of the department Refurbished Machinery at Fette Compact-ing explaining the first step of treatment. “We remove covers, the rotor and much more. In the end, only the vertical col-umns remain. After that the system is rebuilt step by step.” Not only is the result impres-sive, which is clearly shown in the pictures, even performance and warranty of the overhauled system are in accordance with those of a new one. – The planned and highly efficient production can begin!

18

Actually is seems pretty easy: A worn-out part in the interior of the tableting machine has to be replaced. But what is the exact name of the part, if you want to reorder it? The new eShop from Fette Compacting uses an especially intuitive and user friendly website interface. The user gets a quick answers and saves precious time.

What is the part that has to be replaced on the machine – and how do i find it quickly and directly in the

catalog? fette compacting‘s new eShop significantly clarifies the ordering of spare parts. This is due to

a very intuitive website.

Guided to the component

After logging in, users find the spare parts most common to them in a separate area – in a lot of cases this is the quickest method. Especially interesting is a second shopping area. Here, you first enter the name of the machine, then a view of the model appears on the mon-itor. The search for the compo-nent is then largely intuitive: The user clicks on an area of

FAST AND DIRECT New eShop

SERVICE

the machine (“top area”, “middle area”, “lower area”) and is guided to the the com-ponent by more and more detailed views of the machine. Subsequently, the eShop shows a photo of the component in-cluding explanation, different part sizes (if applicable), current stock availability, arti-cle number and price of the component. The order can be placed directly by using the

web shopping cart. Alterna-tively, users can print out an “offer” – if they don‘t have the authority to make the invest-ment themselves.

The eShop will start in the fall of 2012, first in Germany, Denmark, The Netherlands, Switzerland, Spain, Luxem-bourg and France.


The headquarters of the

Argentine pharmaceutical

company Roemmers in

Buenos Aires

EFFERVESCENT TABLETS Demanding process, perfect solution

Pharmaceutical effervescent tablets place exceptional demands on tableting. The source material is sensitive and tends to cling to the punches. Argentinean pharmaceutical manufacturer Roemmers Laboratories (www.roemmers.com.ar) approached Fette Compacting when they wanted to build a new production line

the tablet and the result is 100 % cGMP-compliant.

Both systems have been in use since early 2012, producing more than 80,000 tablets an hour each. The tablet presses are filled by using equipment from Glatt – an Excellence United Partner – which is connected through an intelli-

and modernize a second for effervescent tablets. The tablet-ing experts recommended a single rotary press of the type 2090i with a compression chamber coating system. This powders the punch with magnesium stearate, prevent-ing the material from adhering to the punch. The coating leaves no residue on

gent and standardized inter-face to a higher level control system. Roemmers always has full access to all production data.

Since then, Roemmers has bought a third type 2090i tablet press. This is equipped with a double punch and re-places an old machine from a local supplier. This has been a resounding success: By using the Fette Compacting ma-chine, Roemmers increased output by 200 %.

“The key factors for us were the high productivity and the quality of the solution Fette Compacting provided, namely a reliable process that enables us to manufacture effervescent tablets that are cGMP- compliant,” said Dr. Julio Luna, Pharma Plant Manager at Roemmers.

COMPETENCE

20

Many individual factors inf luence the economics of a production process in the pharmaceutical industry. Common causes of costly downtime for example are cleaning and tooling intervals not optimally planned or com-plicated maintenance. At the same time product quality is key. Even minimal deviations during medication production lead to sorting. This is exactly where the consulting by Fette Compact-ing for the Overall Equipment

Improving the entire process

With it‘s “OEE consulting”, fette compacting offers

users a service which is unique to the market. The prom-

ise: The production process becomes more efficient, the

systems are used more effectively and costs decrease.

OEE CONSULTING

Effectiveness (OEE) starts. As the only provider of tablet technology, Fette Compacting has developed a consulting service that includes the tableting itself as well as the upstream and downstream processes. Together with the user, the experts at Fette Com-pacting define which systems and processes should be optimized and consequently analyze the entire production process, the tool and machine use as well as the skills of the user.

COMPETENCE

during analysis the follow-

ing aspects are focused

upon:

– Tool Management:

How are the tools handled? Can the quality of the prod-ucts be improved?

– Maintenance Manage-

ment: How efficient are the maintenance processes - can downtime for a machine be shortened?

– customized Training:

What is the know-how of the employees? For example, can costly operator errors be avoided in the future?

– Production Excellence:

A look at all production data: Can changes on a machine improve output?

“Subsequently detailed plans are developed with the pharma-ceutical producer on how pro-duction needs to be changed so that costs decrease and quality increases,” explains Fabian Prehn, OEE-Consultant at Fette Compacting. The company evaluates experiences of all OEE consulting projects and uses the findings in order to further develop the service. “Our expe-rience shows that an OEE pro-ject has immediate results, the OEE level (see graphic) increas-es by at least 10 percent. This is a major contribution to increas-ing the efficiency of the pro-cesses and a key investment in the value chain.”

increase of OEE through a consulting project

Calculating OEE

Availability

Production time

(365 days = 8760 h)

- Cleaning time- Changeover time- Downtime- Maintenance and

inspection

= 52%

Performance

Output

(8760 h × capacity)

effected by:Production speedProduct transferFormat changeHandling

= 58%

Quality

Product quality

loss of material/ features:- Weight- Hardness- Thickness- Wear- Visual appearance

= 95%

= OEE Level 29% 52% 58% 95%


In hardly any other industry sector is training as important as in the pharmaceutical indust-ry. The reasons are obvious: Due to advanced technology, products are manufactured in huge quantities, which include maximum quality standards. It is self-explanatory that it needs expert knowledge to operate production machinery. Howe-ver, especially in the phar-maceutical industry, with its dynamic development and re-search, it needs more: The pro-ducts and production processes change constantly – and of course that also refers to the machinery.

How can operators be prepared for this challenge? Fette Com-pacting organizes individual training for their clients that can be accurately adjusted to the respective production re-quirements and the implemen-ted system technology. The training modules are structu-red in such a way that they correspond to the level of knowledge of the personnel to be trained and to the requi-rements of the respective com-panies.

TRAIN FOR SUCCESSA lot depends on the know-how of your employees. On the one hand, they have to ex-

ecute the cleaning and refitting of the machines quickly and without mistakes; on the

other hand for example they have to react properly and quickly in the event of machine

breakdowns. it is obvious, that every operating error can be costly. Our training servic-

es are therefore an important contribution to your economic success.

The basis for this is a modular training concept – we customize your program from this “kit”. The beginning is the basic course “Fundamentals of tablet-ing”. For one day we explain the mechanical design and opera-ting principle of the tablet press. After that, however, it is “in medias res”: For example, parti-cipants learn how to raise pro-duction speed using practical exercises.

Our other modules then provide for specialization. They cover calibration and maintenance of the systems as well as details of the electronics, and the right maintenance or operating tech-nique. The program is rounded off with a continuing education service for special applications such as setting up a production process for multi-layered tablets. We also offer additional courses in which – for example – a quick turret change or the ins-tallation of a die table package is explained.

One thing is always important to us: The training should be intensive; everybody should “walk away” with as much knowledge as possible. Therefore we limit the number of partici-

Gain an fdA

qualification

Especially important for many pharmaceuti-cal companies: All courses can be con-cluded with a final test. After the test has been successfully passed, a certificate is issued in accordance with 21CFR § 211.25 – Personnel Qualification.

fabian Prehn

Head of Training and Consulting

at Competence Center Germany

You have questions or

suggestions? Call us. We

welcome any input from you.

contact:

Fette Compacting GmbH

Training

Grabauer Str. 24

D-21493 Schwarzenbeck

Phone + 49 (0) 41 51 12 569

Fax + 49 (0) 41 51 12 77763

[email protected]

pants to a maximum of eight people who always come from the same company. This way we ensure that everybody has enough time on the equipment in our training center. By the way: This is why we prefer to train your team in one of our five Competence Centers. Of course, we will train your opera-ting and maintenance personnel directly on your own machines upon request.

COMPETENCE

Use the QR

code to access

the complete

seminar pro-

gram for 2012

22

With Excellence United, six technically leading companies in the field of special machine engineering founded a strate-gic alliance in April 2011. Bausch + Ströbel, Fette Com-pacting, Glatt, Harro Höfliger, Uhlmann and VisioTec are cooperating to offer a range of services catering specifically to companies in the pharmaceuti-cal, medical technology and process industries. The alliance

EXCELLENCE UNITED Turnkey solutions for pharmaceutical production

The members of

Excellence unitedExcellence united in

figures

– 4,800 employees– 600 service employees

worldwide– 40,000 machines

installed– € 800 million turnover

in 2011

To ensure permanent process-ing safety during pharmaceu-tical production, we depend on precise service from engi-neering experts. Excellence Uniteds new service portal provides the user access to a network of experts: With an encrypted connection and using the machine controls, contact with a target server at an Excellence United company is made. An engineering ex-pert “at the other end of the line” is immediately ready for a first diagnosis.

DIGITAL SERVICE NETWORkconnection inside Out

Safety is paramount: “Without clearance, nobody can access the machine and the connec-tion is always from the inside out,” explains Kai Laackmann, Area Sales Manager Service at Fette Compacting. If neces-sary, the experts of Excellence United network with each other. “We thus identify which machine is affected in the production line and contact the right expert. The user does not necessarily have to be the one making that decision,” Laackmann explains.

Open and expandable

The service portal is constantly be-ing expanded, new services can be integrated at any time. Therefore exhibitions are also an important portal for the exchange of informa-tion between the service experts and users. Visit us at one of the up-coming exhibitions and contact us!

All in all, this service offers a wide variety of possibilities: For example, a detailed main-tenance management can be done via the platform upon request, machine documenta-tion is always up to date (changes are uploaded anew), and additionally there‘s direct access to the relevant spare parts catalog.

One Platform – One Review

Additionally, there,s an indi-rect advantage: Since all com-panies of the Excellence Unit-ed use the same technical platform, the clients, IT ex-perts only have to review and

release the portal once. “If you have to release different tele-service portals for each ma-chine, you have many compli-cated review processes. That is not necessary anymore,” Laackmann confirms.

covers the entire valuechain: From laboratory equipment to the production of clinical samples and pharmaceuticals up to machines for the final packaging. Excellence United offers customers one-stop turnkey production solutions – an optimal combination of the technology of market lead-ers and international service.

www.excellence-united.de


Exhibition Dates 2012

Expo Pack Mexico– date: 26 – 29 June 2012– city: Mexico city– country: Mexico

contract Pharma– date: 20 – 21 September 2012– city: new Brunswick– country: uSA

cHinA-PHARM– date: 24 – 27 September 2012– city: Beijing– country: china

Algeria Pharma– date: 25 – 27 September 2012– city: Algiers– country: Algeria

interphex Puerto Rico– date: 4 – 5 October 2012– city: San Juan– country: Puerto Rico

WHAT’S NEXT?

AAPS– date: 14 – 18 October 2012– city: chicago– country: uSA

Pack Expo international– date: 28 – 31 October 2012– city: chicago– country: uSA

Supply Side West– date: 5 – 9 november 2012– city: Las Vegas– country: uSA

Emballage– date: 19 – 22 november 2012– city: Paris– country: france

P-MEc– date: 21 – 23 november 2012– city: Mumbai– country: india

fette compacting GmbH

Grabauer Strasse 24

21493 Schwarzenbek

Germany

Phone +49 4151/12-0

Fax +49 4151/3797

[email protected]

fette compacting America, inc.

400 Forge Way

Rockaway N.J. 07866

USA

Phone +1 973-5868722

Fax +1 973-5860450

[email protected]

fette compacting America Latina Ltda.

Av. Cambacica, 1200 módulo 10

Parque Imperador

CEP 13097-104

Campinas / SP – Brazil

Phone/Fax +55 19 3796 9910

[email protected]

fette compacting nanjing

Machinery co., Ltd.

8 Phoenix Road Jiangning Development

Zone

211100 Nanjing

China

Phone +86 25 52121818

Fax +86 25 52129951

[email protected]

fette compacting Machinery

india Private Limited

Regd Office:

Old No 14, New No 29, IInd Main Road,

Gandhinagar, Adyar, Chennai – 600 020

India

Phone +91 44 24405136/37

Fax +91 44 42337704

[email protected]

Competence Centre:

Plot No S 115, Phase III B

Verna Industrial Estate

Verna, Goa 403 722

India

fette compacting Asia Pacific Pte Ltd

1 Kim Seng Promenade #14-04

Great World City East Tower

Singapore 237994

Phone +65 6734 3001

Fax +65 6734 8412

[email protected]

fette compacting iberica

Calle Saturno 1

28760 Tres Cantos

Spain

[email protected]

EcOPAc S.A.

A fette compacting and

uhlmann company

30, rue Roger Salengro

94120 Fontenay-Sous-Bois

France

Phone +33 148 77 63 63

Fax +33 148 77 77 70

[email protected]

www.fette-compacting.com

Fette Compacting Magazine 2012 En

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