WHATS NEXT?

FETTE COMPACTING MAGAZINE 2012

EfficiencyGuide
The New Guidance System for all Questions Related to Tableting Technology

Quantity and Quality The Potential of Pharmerging Markets Page 6

Interview Trends in Pharmaceutical Production Page 7

FE35 The Fastest for Product Changeovers Page 10 - 13

New eShop Fast and Direct Page 18

Fette Compacting Magazine 2012

CONTENTS

3 EDITORIAL 4 A GREAT COMPANY The Fight against Neglected 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 G ALENICS AND LABORATORY Development Close to Production 16 S PECIAL OPERATION Technical Field Service 17 T HE 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 WHATS NEXT Exhibition Dates 2012

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World Premiere FE35

All about the new machine in the FE Series

EFFICIENCY GUIDE

TECHNOLOGY

COMPETENCE

SERVICE
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.

TECHNOLOGY covers all products in tableting technology: from tablet presses, to peripherals, and tableting tools.

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 Efficiency Guides scheme.

At some articles in this magazine you will find so called QR-codes. With the help of a little supplementary program for your Smartphone such as i-nigma you can access additional content.

SERVICE includes all services

related to machinery and equipment, 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.

EDITORIAL

OLAF J. MLLER

CEO 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 efficiency 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 adopted 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. Mller CEO Fette Compacting next@fette-compacting.com

Fette Compacting Magazine 2012

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
According to WHO estimates, out of the 2.7 billion of the poorest people on the planet, more than one billion are infected with a Neglected Tropical 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 tropical diseases, including sleeping sickness, leishmaniasis and lymphatic filariasis. The WHO has taken it upon itself to eliminate these often deadly diseases worldwide. In January this year, 13 international com4

panies (among them Bayer, Eisai, Merck, Novartis and Sanofi), the Bill & Melinda Gates Foundation, the United States and British governments, 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 implementation programs in the affected regions.

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 havent served until now. Sanjit Singh Lamba, Managing Director,Eisai Knowledge Centre

Working Towards Better Health

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

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-

About Eisai
Eisai Co., Ltd is a Japanese pharmaceutical company that researches, develops and markets products in the fields of integrative neurosciences (e.g. Alzheimers), 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 corporate philosophy, Eisai has committed itself to making valuable contributions to the field of human health care. Eisai has over 11,000 employees worldwide and is headquartered in Tokyo, Japan.

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

ompany
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 anti-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 significant project for Eisai it helps the patients and also offers us the chance to establish our supply chain in markets we havent served until now, says Sanjit Singh Lamba, Managing Director of theEisai Knowledge Centre in Vizag, India, where the DEC tablets will be manufactured.
Flexibility and Quality Made Possible by Fette Compacting

enables the production of large numbers of drugs alongside ongoing production. We are proud to be supporting such an important international health care project. That is why we have provided Eisai with a complimentary set of 130 punches and the accompanying segments. Additionally, colleagues in our subsidiary in India will continue to support the project domestically, says Olaf J. Mller, CEO of 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 flexibility of the machine

2.2 billion tablets until 2012: Production with a Fette Compacting 3200i at Eisais in Vizag

Fette Compacting Magazine 2012

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

The Potential of Pharmerging Markets

companies, they are becoming increasingly attractive as production sites.

health problems. The consulting company PriceWaterhouseCoopers 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 diabetes. However, these markets continue to reflect a very high level of diversity: In part, the great differences in income and life expectancy not only within but also between these countries make it difficult to clearly characterize the demand for pharmaceutical products.
From Consumer to Producer The Case of India

In the emerging economic regions in Asia and South America economic standards are not the only thing rapidly approaching the western model. 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

and lifestyle especially dietary 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 physical inactivity due to increasing wealth are causing new

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 example, in recent years, India

in terms of volume was able to develop into the third largest pharmaceutical industry worldwide. 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 recognized by domestic as well as foreign pharmaceutical companies, 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 competitiveness of its pharmaceutical production show enormous growth potential for the next five to ten years.

Interview with Venkat Venkatasubramanian, Managing Director of Fette Compacting India

Since 2006, Fette Compacting has been represented by its own subsidiary in India. What role does the company now play on the Indian market? Where do you see the highest potential for the pharmaceu-

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.

We can be very proud. Within a short time, we were able to establish ourselves as the market leader for high-speed tablet presses. In the last three years we were able to win leading Indian pharmaceutical 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 competence and training center. Has this step been worthwhile?

tical industry on the Indian market?

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

Even though the health sector has grown tremendously in the previous years, to date only approximately 30 percent of the population 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, pharmaceutical companies offer attractive opportunities to invest in research, development and production, thanks to highly qualified graduates and an improved infrastructure.

Global, flexible and lean

Interview with Dr. Christoph Ebensperger, Head of Business Segment Life Sciences Horvath & Partners Germany How will the pharmaceutical industry change over coming years? How will the large pharmaceutical companies react to global demand? What does this mean for the international supply chain?

Trends in Pharmaceutical Production

ing must become a lot more more flexible with consistent and uncompromising quality and at reasonable prices, too.
What will this mean for pro-

The trend of consolidation, which has persisted for some time, will continue. The enormous pressure from rising costs is forcing pharmaceutical companies to implement massive cost-cutting measures and to plan their marketing, research, production and logistics projects efficiently. In addition, 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 becoming increasingly difficult due to critical assessment by sponsors. As far as the marketing of existing medicines is concerned, rapidly growing national economies, such as China, India or Brazil, continue to hold great potential. The most suitable products here would be brand generics, i.e. drugs which contain patent-free substances marketed under an independent name.

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 supply chain. It is more about optimizing the process as a whole. Naturally, costs also play an important role. Nevertheless, it is not sufficient to simply be cheap. If the pharmaceutical giants had previously relied on purchasing third-party materials, then currently due to extremely problematic cases they are again increasingly paying attention to quality. This is also because many new forms of therapy require highly personalized drugs. While volumes will be reduced significantly, product diversity will increase. This means that the whole supply chain from the production of active substances to the formulation up to the packag-

duction and for the suppliers of special machines?

Blockbusters are an outdated model. In the future, the production of drugs with such large turnovers will most likely be the exception and no pharmaceutical firm will be able to base its strategy solely on the development of such products. The risk of failure would simply 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 towards 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 forecasts and production make to order. Manufacturers of special machines that emphasize flexibility and quality and are able to provide the industry with the right offers have outstanding prospects. This is where an

Dr. Christoph Ebensperger, Head of Business Segment Life Siences Horvath& Partners Germany

intimate understanding of the customer will become a decisive factor especially internationally. Machine tool manufacturers can achieve a sustained competitive edge if they start working together with pharmaceutical manufacturers early on in the development process and adapt their products and services even more closely to the needs of their customers.

Fette Compacting Magazine 2012

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.

Patents
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 proliferation of generic drugs? Which trends are becoming apparent where international patents are concerned?

Significant for the Pharmaceutical Industry

the domestic generic drug manufacturer Natco a compulsory 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 thirdworld diseases. The case of Nexavar remains on the table and other similar decisions concerning compulsory licenses in other developing nations have yet to be addressed.

To what extent do patent rights offer sufficient protection for the pharmaceutical and medical technology industries today?

The protection of intellectual property is of central importance 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 sufficient protection. This assumes

the exclusive information rights to the original product have expired. Sometimes several 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.

Definitely yes. Generic drugs are only allowed to be brought onto the market after the patent rights including additional protection certificates and

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

red dot design award for the FE55

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 vocabulary of the tablet press, with rounded edges, ergonomic design, and its high functional quality, said the internationally 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 Dominic Schindler, the designer of the FE55, are to be presented with the prize.
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Excellent!
The award is a fitting tribute to the achievements of our employees, says Olaf J. Mller, managing director of Fette Compacting, highlighting the teams effort. What is really good about this award is that, not only is the technical capability honoured, but all those involved; the technicians, the development engineers, the colleagues in marketing and sales, and rightly everybody worldwide can be proud.

Outstanding design Fette Compactings new tablet press FE55

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

NEW OPENING
Competence Center in Brazil
In April 2012 Fette Compacting opened a Competence Center for tableting technology in Brazil. In Campinas near So Paulo the company offers its Latin American clients a unique range of services: service, training, and comprehensive press tests. The Latin American presence has strategic significance for Fette Compacting, CEO Olaf J. Mller explained: Brazil is the worlds sixth largest economy. Additionally the whole continent experiences an amazing growth. With our new Competence Center we are right in the middle of one of the most dynamic regions of the world. From 2007 until now the turnover of tablets has doubled in Brazil.
Positive Development in South America

Latin America and the prospects are very encouraging.

Expanding Service Business

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

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 Competence Center for tablet technology. 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 business. 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.

Schwarzenbek Rockaway Nanjing

Goa

Unique offering: global network of Competence

Campinas

Centers in all relevant markets

Fette Compacting Magazine 2012

TECHNOLOGY

Fette Compacting FE35

The Fastest for Product Changeovers

The FE35 is Fette Compactings second machine in the new FE Series. It offers customers the fastest product changeover of all tablet presses in its class. The FE35 is 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.

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What makes all this possible in record time is an all-new design as well as a number of technical innovations. The newly designed 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 productivity. 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 production 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.

Fette Compacting is also breaking new ground with the construction and function set of its compression rollers. The FE35 is the only machine in its class with upper and lower compression 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. This results in much shorter refitting times operators no longer have to move to reference marks after a turret change, and can calibrate the measurement cells at the operations terminal using software.
TRI.EASY Design: Easy Operation as a Basis for Quick Product Changeovers

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 executed 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 removal 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 micrometer. Also, the FE35 features the completely new Human Machine Interface developed by

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

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 guarantees smooth operation regardless of the experience and qualification levels of its operator.With the FE35, the imple-

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 generation. This is made possible in part by the revised cooling design 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.

AIO

A perfect match
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 integration 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.

Fette Compacting Magazine 2012

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TECHNOLOGY

How fast can you change...

...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?

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.

FAST
NEW FILLING UNIT The 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.
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NEW COMPRESSION STATIONS The FE35 is the only machine in its class with upper and lower compression 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 after a turret change, and can calibrate the measurement cell from the operation terminal. NEW TURRET New, more compact segments, a higher number of dies and an innovative construction guarantee maximum output and make changing the turrets a simple process.

CHANG

Watch an animation of the turret exchange.

NGEOVER
Fette Compacting Magazine 2012 2012 13

NEW EXHAUST UNIT Whether 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.

NEW TABLET CHUTE The new tablet chute is integrated in the column, guaranteeing smooth operation at all times as well as unrestricted access to all sides of the machine.

TECHNOLOGY

FE55 - PURE EFFICIENCY

New Standards for Tablet Production
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, flexibility and availability. Since its world premiere at Interpack 2011, 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 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 powder mixtures. This drastically improves productivity. One feature which guarantees a high performance during the actual tableting is the FE55s unique ratio of punches to area (up to 87 punches on 1.6 square

An Overview of the Highlights:

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

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

Machine design + Housing made of FDA-certified highperformance 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

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

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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.

Galenics and Laboratory

Development close to production
Fette Compacting doesnt only develop efficient tableting machines for mass production. In galenics, too, the market leaders 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, velocity 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 expensive medications and substances. This allows researchers to collect all necessary data for the subsequent production process. Since 2010, Fette Compacting has acquired exclusive international distribution of the 52i Series of mobile galenics presses. The advantages of such a productionoriented development are clear: Due to the reliable data, costs for up-scaling (the transfer of development production to the major production process) as well as Time to Market are minimized. Therefore profitability can be estimated during development. During production, the development on Fette Compacting machines ensures higher output, less product losses and improved machine runability.

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

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 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

Use the QR code to watch a video with all steps of the turret exchange:

Fette Fette Compacting Compacting Magazine Magazine 2012 2012

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SERVICE

Special OperationS
Engineering 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.

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

exceptional: All of the approximately 50 service technicians working worldwide have training as electricians/system engineers and mechanics. Thanks to this unique dual

qualification the experts can provide an overview of the entire system during inspection, maintenance or calibration an important prerequisite in order to maintain 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 machine being lifted out of the crate. It is extremely important 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

24 hour help desk Always ready!

Production downtimes are very expensive. With its 24 hour help desk, Fette Compacting ensures fast help for its clients any time, day or night.

responsible for every detail during installation the electrical connections, the installation of the compression-dies, the operational testing, and the basic instruction. When our specialists are finished, we guarantee a fully functioning and perfectly calibrated 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.

If you experience problems with a machine, first aid must be available immediately. Fette Compacting provides a Help Desk for its customers, 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 tbunsen@fette-compacting.com Service worldwide Technical Field Service at Fette Compacting

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Before

After

System refurbishment at Fette Compacting

Four months and 500 manhours 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 machine. 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 (instead of a conventional drive) The machine is almost completely gutted, said Marcus Czudny, technical director of the department Refurbished Machinery at Fette Compacting explaining the first step of treatment. We remove covers, the rotor and much more. In the end, only the vertical columns remain. After that the system is rebuilt step by step. Not only is the result impressive, 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!
Background: General overhaul

The Fountain of Youth

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 instances: 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. Subsequently the availability of spare parts is assured, the experts offer the systems with warranty. In addition, certified service personnel is available for used machinery.

Fette Compacting Magazine 2012

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SERVICE

Fast and direct New eShop

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 Compactings new eShop significantly clarifies the ordering of spare parts. This is due to a very intuitive website.

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.

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 monitor. The search for the component is then largely intuitive: The user clicks on an area of

the machine (top area, middle area, lower area) and is guided to the the component by more and more detailed views of the machine. Subsequently, the eShop shows a photo of the component including explanation, different part sizes (if applicable), current stock availability, article number and price of the component. The order can be placed directly by using the

web shopping cart. Alternatively, users can print out an offer if they dont have the authority to make the investment themselves. The eShop will start in the fall of 2012, first in Germany, Denmark, The Netherlands, Switzerland, Spain, Luxembourg and France.

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COMPETENC E

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 and modernize a second for effervescent tablets. The tableting experts recommended a single rotary press of the type 2090i with a compression chamber coating system. This powders the punch with magnesium stearate, preventing the material from adhering to the punch. The coating leaves no residue on 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 intelligent and standardized interface 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 replaces an old machine from a local supplier. This has been a resounding success: By using the Fette Compacting machine, 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 cGMPcompliant, said Dr. Julio Luna, Pharma Plant Manager at Roemmers.

The headquarters of the Argentine pharmaceutical company Roemmers in Buenos Aires

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COMPETENC E

OEE Consulting
Improving the entire process
With its OEE Consulting , Fette Compacting offers users a service which is unique to the market. The promise: The production process becomes more efficient, the systems are used more effectively and costs decrease.
Increase of OEE through a consulting project

Many individual factors influence 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 complicated 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 Compacting for the Overall Equipment

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 Compacting 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.

During analysis the following aspects are focused upon:

Availability Production time (365 days = 8760 h) Cleaning time Changeover time Downtime M aintenance and  inspection

Performance Output (8760 h capacity) effected by: Production speed Product transfer Format change Handling

Quality Product quality

loss of material/ features: - Weight - Hardness - Thickness - Wear - Visual appearance = 95%

= 52%

= 58%

52%
Calculating OEE

58%

95%

= OEE Level 29%

Tool Management: How are the tools handled? Can the quality of the products be improved? Maintenance Management: 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 pharmaceutical producer on how production 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 experience shows that an OEE project has immediate results, the OEE level (see graphic) increases by at least 10 percent. This is a major contribution to increasing the efficiency of the processes and a key investment in the value chain.

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COMPETENC E

Train for success

A lot depends on the know-how of your employees. On the one hand, they have to execute 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 services are therefore an important contribution to your economic success.

In hardly any other industry sector is training as important as in the pharmaceutical industry. 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. However, especially in the pharmaceutical industry, with its dynamic development and research, it needs more: The products and production processes change constantly and of course that also refers to the machinery. How can operators be prepared for this challenge? Fette Compacting organizes individual training for their clients that can be accurately adjusted to the respective production requirements and the implemented system technology. The training modules are structured in such a way that they correspond to the level of knowledge of the personnel to be trained and to the requirements of the respective companies.

The basis for this is a modular training concept we customize your program from this kit. The beginning is the basic course Fundamentals of tableting. For one day we explain the mechanical design and operating principle of the tablet press. After that, however, it is in medias res: For example, participants learn how to raise production 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 technique. 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 installation 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-

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 operating and maintenance personnel directly on your own machines upon request.
Fabian Prehn Head of Training and Consulting Gain an FDA qualification 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 training@fette-compacting.com

Especially important for many pharmaceutical companies: All courses can be concluded with a final test. After the test has been successfully passed, a certificate is issued in accordance with 21CFR 211.25 Personnel Qualification.

Use the QR code to access the complete seminar program for 2012

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Digital Service Network

To ensure permanent processing safety during pharmaceutical production, we depend on precise service from engineering 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 expert at the other end of the line is immediately ready for a first diagnosis.
Connection Inside Out

Safety is paramount: Without clearance, nobody can access the machine and the connection is always from the inside out, explains Kai Laackmann, Area Sales Manager Service at Fette Compacting. If necessary, 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.

All in all, this service offers a wide variety of possibilities: For example, a detailed maintenance management can be done via the platform upon request, machine documentation is always up to date (changes are uploaded anew), and additionally theres direct access to the relevant spare parts catalog.
One Platform One Review

release the portal once. If you have to release different teleservice portals for each machine, you have many complicated review processes. That is not necessary anymore, Laackmann confirms.

Open and expandable

Additionally, there,s an indirect advantage: Since all companies of the Excellence United use the same technical platform, the clients, IT experts only have to review and

The service portal is constantly being expanded, new services can be integrated at any time. Therefore exhibitions are also an important portal for the exchange of information between the service experts and users. Visit us at one of the upcoming exhibitions and contact us!

Excellence United
With Excellence United, six technically leading companies in the field of special machine engineering founded a strategic alliance in April 2011. Bausch + Strbel, Fette Compacting, Glatt, Harro Hfliger, Uhlmann and VisioTec are cooperating to offer a range of services catering specifically to companies in the pharmaceutical, medical technology and process industries. The alliance 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 leaders and international service.
Excellence United in figures

Turnkey solutions for pharmaceutical production

The members of Excellence United

4,800 employees 600 service employees worldwide 40,000 machines installed 800 million turnover in 2011

www.excellence-united.de
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WHATS NEXT?
Exhibition Dates 2012
Expo Pack Mexico Date: 26 29 June 2012 City: Mexico City Country: Mexico AAPS Date: 14 18 October 2012 City: Chicago Country: USA Contract Pharma Date: 20 21 September 2012 City: New Brunswick Country: USA Pack Expo International Date: 28 31 October 2012 City: Chicago Country: USA CHINA-PHARM Date: 24 27 September 2012 City: Beijing Country: China Supply Side West Date: 5 9 November 2012 City: Las Vegas Country: USA

Algeria Pharma Date: 25 27 September 2012 City: Algiers Country: Algeria

Emballage Date: 19 22 November 2012 City: Paris Country: France

Interphex Puerto Rico Date: 4 5 October 2012 City: San Juan Country: Puerto Rico

P-MEC Date: 21 23 November 2012 City: Mumbai Country: India

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Fette Compacting GmbH Grabauer Strasse 24 21493 Schwarzenbek Germany Phone +49 4151/12-0 Fax +49 4151/3797 tablet@fette-compacting.com Fette Compacting America, Inc. 400 Forge Way Rockaway N.J. 07866 USA Phone +1 973-5868722 Fax +1 973-5860450 sales@fetteamerica.com Fette Compacting America Latina Ltda. Av. Cambacica, 1200 mdulo 10 Parque Imperador CEP 13097-104 Campinas / SP Brazil Phone/Fax +55 19 3796 9910 contato@fette-compacting.com.br

Fette Compacting Nanjing Machinery Co., Ltd. 8 Phoenix Road Jiangning Development Zone 211100 Nanjing China Phone +86 25 52121818 Fax +86 25 52129951 info@fette-compacting.com 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 sales@fette-compacting.in 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 infoasiapacific@fette-compacting.com Fette Compacting Iberica Calle Saturno 1 28760 Tres Cantos Spain fcib@fette-compacting.com 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 ecopac@ecopac.fr www.fette-compacting.com