successful tableting may2015web tcm11 25547

engineering for a better worldgea.com

We live our values.Excellence • Passion • Integrity • Responsibility • GEA-versity

GEA Group is a global engineering company with multi-billion euro sales and operations in more

than 50 countries. Founded in 1881, the company is one of the largest providers of innovative

equipment and process technology. GEA Group is listed in the STOXX® Europe 600 index.

GEA Pharma Systems

GEA Process Engineering nv

Bergensesteenweg 186, B-1500 Halle, BelgiumTel +32 2 363 8300Email: [email protected]

Successful Tableting

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operational excellence

For more than a hundred years, our innovation, driven by our passion forexcellence, has pioneered tablet compression technology, allowing pharmaceuticaland industrial companies to prosper, produce extraordinary products and changepeople’s lives.

The innovations described in this brochure include a unique technology thatindependently and simultaneously measures and controls both tablet weight andhardness, and a weight control system that provides increased sensitivity at lowerforces. Our presses offer an extended dwell time—up to 300%—resulting in higheroutputs and enhanced productivity. And that’s just the tip of the iceberg.

To meet your production challenges, we have developed a higher level ofunderstanding of ingredient and manufacturing variables. And by implementing thephilosophy of Six Sigma to reduce critical process variation and lean manufacturingto eliminate waste, our technologies and expertise can help you to produce a betterquality tablet, reduce the risk of product failure, improve your cash flow and improveyour bottom line profit.

Our technology is world renowned for its reliability, flexibility and economy. We offertruly rapid changeover solutions, increased productivity, flexibility and safety. But it’smuch more than that; it’s about how we work with you, the customer. We understandyour needs; we use our expertise and know-how to develop solutions and optimiseprocesses that bring your products to market quickly and provide the commercialadvantage you need.

Why GEA?

2/3

1.0Innovative TechnologyOur Beating Heart

In fact, innovation is at the heart of all our products; it’swhat makes them different. The quest for continuous

innovation is the force that drives us every day, andflexibility, performance, accuracy and control are the

criteria that focus our thinking. Everything we do isaimed at improving these key factors to help you to

make better products and improve productivity.

We’re leaders, not followers. We go our own way. Wemarch to the beat of our own drum. We never try to

copy or emulate, and that’s what gives us our edge, ouradvantage. That might mean that the road to success

may be longer, but the end-product is better.

The GEA experience is not just about buying a product,it’s about us working with you, getting to know you and

understanding your requirements. It’s about customercare, know-how, service and communication, and

benefiting from the dedicated group of people whomake up the GEA family—a team of experts who listen to

each other, respect each other and help each other tofind the best solutions.

We stand for what we believe in, which is whycustomers who buy from GEA stay with GEA.

Innovation brings challenges, but it’s a challenge we welcome.

We’re constantly looking to overcome hurdles with new technology and present new, unique

solutions to the pharmaceutical industry.

“Working for a company that putsprogress and innovation first makesleaving the house every day veryappealing and stimulating. And,seeing the orders come in makesme feel positive about the future,my job security and my colleagues.Finally, working with customers allover the world is a greatopportunity; I really feel like I’mmaking a difference.”Isabelle, Dispatch

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Contents1.0 Innovative Technology

Our Beating Heart 5

Higher Weight Sensitivity, Extended Dwell Time 6–7

Independent Weight and Hardness Control 8–11

2.0 The PERFORMA™ Range of Tablet Presses 12–19

PERFORMA™ Lite 13–15

PERFORMA™ P 16–17

3.0 The MODUL™ Range of Tablet Presses 18–25

MODUL™ P 21

MODUL™ S 20–21

MODUL™ D 24–25

4.0 Bi-Layer Tableting: The GEA Way 26–27

5.0 Containment 28–29

6.0 Successful MUPS Production 30–31

7.0 Control Systems 32–33

8.0 Integrated Systems 34–35

9.0 Continuous Processing Technology 36–39

10.0 Data Sheets 40–45

11.0 Customer Care 46–49

12.0 Our History 50–51

13.0 Summary 52

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How it WorksAs the punch head touches the pre-compression roller, theAir Compensator allows the roller to lift until the requiredcompression force is achieved. By measuring thedisplacement of the roller using a Linear VariableDisplacement Transducer (LVDT), it is possible to measurethe height of the tablet at pre-compression and, accordingto a strictly linear relationship, the weight. Similarly, byadjusting the pressure in the Air Compensator, it’s possibleto adjust both the compression force and the dwell timewithout reducing the linear speed of the machine. Thesame principle can be applied at main compression tomaintain a constant density/porosity on some of the pressmodels.

Every application is different and tablet presses need to beset according to the characteristics of the material feedand the specific production requirements. The AirCompensator enables fine adjustments to be made to alloperational parameters; thus, users can achieve the desiredsecurity of outcome without compromising on machinespeed and plant productivity. The main compression AirCompensator also acts as an effective tooling-protectiondevice should compression forces rise above tolerances.

No other presses in the world have this technology. The Air Compensator improves product output, overcomescompression issues and facilitates the pressing of smalltablets. It makes the impossible possible. The superiorprocess control improves tablet quality by continuouslycontrolling both tablet weight and tablet hardness—optimising dissolution and bioavailability—as opposed to only weight in a conventional system.

Offering weight control at pre-compression, extendeddwell times for complex formulations, higher yields, costsavings and faster setup, the Air Compensator enables youto control two critical quality attributes instead of one.Operation is key, of course, and full training is offered toensure optimal operation and productivity.

1.0Innovative TechnologyHigher Weight Sensitivity, Extended Dwell Time

Ultimate flexibility in tablet compression

• extended dwell times at pre- andmain compression by up to 300%

• constant dwell times regardless ofmachine speed

• high-sensitivity weight control

• every tablet compressed to thesame hardness

• automatic tablet rejection forincorrect weight and hardness.

Air Compensatorthe unique driving force behind

GEA tablet presses

The Air Compensator has a prosaic name; however, it's anything butordinary. At the very core of GEA innovation, it’s what makes ourtablet presses different, and better. It makes them special and it’s whypharmaceutical companies all over the world choose the GEA brandwhen performance, flexibility and process control really matter.

Fitted to the pre-compression station of every GEA press, the AirCompensator is a unique device that comprises a piston-mountedroller that can move within an air cylinder. The air pressure inside thecylinder is monitored and controlled by the tablet press controlsystem, which determines the pre-compression force applied to thetablets and ensures that it remains constant. The air pressure anddistance between upper and lower rollers are set up to allow the rollerto move a few tenths of a millimetre at each pre-compression. Thevariation in die filling will result in a change in tablet height at pre-compression, as the force applied always remains constant.

This novel concept offers a number of unique advantages:• as all the tablets are pre-compressed to the same density, any

thickness variations are directly proportional to weight variations

• the strict linear relationship between tablet height and weight makesthe setup much easier and faster, resulting in higher yields

• the sigma% of the height of the pre-compressed tablet is identical tothat of the tablet weight, compared with the sigma% of a forcesignal, which does not relate to tablet weight at all

• higher sensitivity at low compression forces and when compressingsmall tablets compared with the more common force-controlledmethod

• it is the fastest tooling protection system available; the AirCompensator pressure will always be less than the maximum forcethat can be applied on the tooling

• the Air Compensator can be used in constant force mode at the maincompression stage to ensure constant tablet hardness and porosity

• the displacement of the compression roller results in longer dwelltimes (up to 300%), better de-aeration, less hardness and cappingissues and much higher outputs; on some press models, the maincompression dwell time can be set in the control system, meaningthat it will remain constant regardless of the linear speed of themachine.

“The challenge of global travelsuits me perfectly. Meetingcustomers all over the world anddoing the very best I can for themgives me a great sense ofsatisfaction. Out there, I amrepresenting the company and Ifeel it is my responsibility to leavepeople with the best possibleimpression of what we do and who we are.”Niels, Customer Care

When tablet weight is monitored at pre-compression,the main compression station is available for a secondpermanent control loop, which is totally independentfrom the weight control loop. This second loopeliminates tablet hardness fluctuations andautomatically compensates for machine warm-upeffects.

Independent weight and hardness, or dual, control is aunique feature of all GEA MODUL™ and PERFORMA™tablet presses and resolves a dilemma that has plaguedthe pharmaceutical compression industry since itsinfancy. Like all great solutions, the answer is simple:physically separate the two control loops to work onseparate areas of the press. Weight is controlled at pre-compression and hardness is controlled at maincompression. As a result, weight and hardness can becontrolled simultaneously and continuously on astandard tablet press.

The dual control system enables tablet rejection basedon an out of tolerance displacement value at pre-compression or an out of tolerance compaction forcevalue at final compression. Each individual tablet ischecked twice before it is sent to the 'good-tablets'outlet chute. If one or both values exceed the pre-settolerance limits, the tablet is rejected and sent to the‘bad-tablets’ collection chute. This double checkprinciple is unique to GEA's dual control system andoffers increased tablet safety.

Existing Tablet Weight Control Loops

Force controlled system: Unlike to the standard controlsystems on most tablet presses, the GEA one does notmeasure the compaction force during maincompression for tablet weight control; the principle of“force measurement under fixed thickness” has somelimitations regarding precision, validation and transferto other machines. Indeed, the relationship betweentablet weight and compaction force under fixedthickness is

• non-linear and must be established empirically

• dependent on machine rigidity

• dependent on machine temperature.

Moreover, the sensitivity of this relationship (thevariation in force per unit variation of weight)decreases with reduced compaction force, which canlead to unacceptably high tablet weight variations withsmaller tablets and during bi-layer tableting when thecompression force on the first layer must be very low toguarantee sufficient bonding between the two layers.

This reduced lower compaction force sensitivity is alsowhy compression force measurement for tablet weightcontrol is always done during main compression —when the compaction force is highest. In addition, if thepowder characteristics change during the compressionof a batch, a control loop based on main compactionforce measurement would have to be re-calibrated ineither of the following ways:

• by changing the main compression force input value,which might alter the hardness of the tablets

• by changing the main compression height (thedistance between punch tips in the main compressionstation), which will change the thickness of thetablets.

It is not possible to re-calibrate the primary tabletweight control loop without affecting tablet thicknessor hardness.

Enhanced dual process control, superior tablet quality

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1.0Innovative TechnologyIndependent Weight and Hardness Control

Displacement controlled system: To address any issuesregarding accuracy and repeatability, GEA adopted adifferent tablet weight control principle for rotarypresses, based on

• measurement of “thickness variations under fixedcompression force” instead of “force variations underfixed thickness”

• measurement during pre-compression instead ofmain compression.

The most important characteristic of this principle isthe linear relationship between what is measured(thickness variation) and what is to be controlled(tablet weight). As the height of the powder slug atpre-compression directly correlates to its weight whenpre-compressed with exactly the same compactionforce, thickness tolerance limits—as a function ofweight tolerance—can be established in astraightforward manner. This results in

• higher control loop precision as there are no roundingerrors

• easier parameter establishment and validation, astolerance limits are calculated automatically by thecontrol system.

Furthermore, the relationship between tablet thicknessat pre-compression and tablet weight is nearlyindependent of machine rigidity, making inter-machinetransfers much easier. The influence of machinetemperature is also negligible, which eliminates tabletweight variations owing to machine warm-up at thebeginning of a production run. Moreover, a weightcontrol principle based on “displacement measurementat pre-compression” has an increased sensitivity atlower compaction force, making the system particularlysuitable for small tablets (where weight tolerance istighter) and bi-layer tableting.

Another important advantage is that the primarycontrol loop is re-calibrated by changing the pre-compression height (instead of main compressionheight in case of force control), leaving the thickness orhardness of the final tablet unaffected.

The GEA Additional Hardness Control LoopAs the GEA weight control loop measures thickness variations (displacement) at thepre-compression station, the main compression station is left unused. As such, themain compression height is set to the correct tablet thickness at the beginning of thebatch and can then be left unchanged for the duration of the batch. This operatingmode is called “tableting under constant thickness,” whereby the main compressionforce—and tablet hardness—will vary with powder characteristics. Manual orautomatic in-process sampling and analysis will detect out-of-tolerance tablethardness values and will stop the press.

Alternatively, the press can run in “tableting under constant hardness” mode byactivating a second primary control loop: a force transducer on the final compressionstation measures the individual main compression forces and calculates a movingaverage, which is then used to adjust the main compression height and keep itbetween pre-set limits. This extra “hardness control loop” will correct any tabletthickness variations and keep the main compression force—as well as tablethardness—constant.

Tablet height variations are only allowed within pre-set tolerance limits. Otherwise, analarm message is generated and the machine stops if tablet height limits need to beexceeded to maintain the appropriate compression force. Such a situation would meanthat the powder characteristics have changed to such an extent that it is impossible tomaintain all three relevant tablet parameters (weight, hardness and thickness) withintheir pre-set tolerance limits. The process would need to be stopped and powdercharacteristics and quality checked.

The hardness control loop is re-calibrated after manual or automatic sampling andanalysis, by changing the set point of the main compaction force. The change in forceset point is calculated on the basis of the difference between the real averagehardness and its target—nominal—value. Re-calibrating the hardness control loop isdone in parallel with re-calibrating the weight control loop. When the hardnesscontrol loop is switched off (in constant height mode), the individual compressionforces and their average values can still be displayed graphically on the HMI. A stopfunction is then available if the average compression force goes beyond pre-set stoplimits.

Advanced Dual ControlAdvanced dual control is fitted to all PERFORMA™ Pand MODUL™ P tablet presses and may be selected, ornot, as required. At pre-compression, the tablet weightis measured in the same way. In addition, the activemain compression Air Compressor allows dwell time tobe controlled and the applied force to be regulated foreach compression—ensuring that every tablet has thesame hardness (porosity). This system is used formedium-volume production and R&D operations whenabsolute control of all operational parameters isessential, especially when dwell times need to beextended without any loss of linear speed.

Dual RejectsDual control also allows individual tablets to berejected if they are out-of-tolerance on either weight orhardness. This feature helps to ensure the consistencyof batches and significantly reduces wastage. As such,it is of particular importance when working with high-value APIs and for R&D operations.

10/11

Benefits of Dual Control• Individual control of tablet weight and hardness

• High sensitivity weight control even for small tablets and those requiring

low compression forces

• Maintain the same dwell time regardless of the linear speed of the machine

• Improved tablet quality

• Improved productivity

• Better tablet consistency

• Reduced capping and sticking

• High-speed operation

• Dual reject feature.

1.0Innovative TechnologyIndependent Weight and Hardness Control

“Applying the latest technologies andgetting the most out of them to make ourmachines even better gives me a great senseof achievement. It makes me proud to be ableto deliver top quality equipment, within theagreed timeframe, with the project team andwith the customer.”Dirk, Assistant Operations Manager

12/13

The GEA PERFORMA™ LITE is a robust, high performance, fullyautomatic tablet press that is ideally suited to heavy duty, high-yieldapplications. The PERFORMA™ LITE is the original GEA press, thetechnology behind the entire pharmaceutical range. It is flexible,reliable, fully accessible and offers outstanding, cost-effectiveproductivity.

The PERFORMA™ LITE includes many standard features and, as withall GEA tablet presses, it also benefits from the unique pre-compression Air Compensator, providing highly sensitive weightcontrol and the option to extend dwell times by up to 300% withoutreducing linear speed. The main compression Air Compressor remainsfixed to provide tool protection.

Large, spring-loaded doors and the absence of corner pillars orcolumns allow easy access for cleaning and routine maintenance. ThePERFORMA™ LITE is compact, simple to operate, produces highquality tablets and has gained a reputation for both economy and arapid return on investment throughout the global pharmaceuticalindustry. Not a copy, not a reproduction, the first-in-classPERFORMA™ LITE may well be just the solution you need!

PERFORMA™ LITEthe essence of robust and

reliable performance

2.0The PERFORMA™ Range of Tablet PressesOriginal, Effective and Economical – PERFORMA™ LITE

Exchangeable TurretA key feature is the exchangeable turret, which allows maximumflexibility and enables product changeover in just 30 minutes using asemi-automatic exchange sequence. This minimises downtime,maximises productivity and allows easy access to the compressionarea for cleaning and maintenance.

Data CollectionThe MULTI-CONTROL 5 is the latest GEA control system for rotarypresses. The system’s hardware and software are designed to allow forfull compliancy with the 21 CFR PART 11 guideline. It is a fullyautomated monitoring, control and reporting system based on aPLC/PC hardware configuration.

MC5 features• Standalone PC application (all-in-one), independent

from Windows operating system

• Microsoft Windows 7 operating system (optional Windows 8)

• 21.5” HD multi-touch widescreen

• Desktop PC or industrial IPC

• Siemens PLC (S7-300) for machine control

• Software design and lifecycle management according to GAMP and internal ISO procedures (QMS)

• Integrated help system, with user manual, machine operationmanual, mechanical and electrical drawings.

Benefits• Fast product changeover

• Accurate tablet weight control at pre-compression

• Extended dwell times and high throughput (up to 320,000 tablets/h).

14/15

Service StationCustomer service is much more than providing spare parts,

it’s about keeping our customers happy and their plantsperforming well, years after the initial sale. That’s fundamental to us; it’s what we do.

2.0The PERFORMA™ Range of Tablet PressesOriginal, Effective and Economical – PERFORMA™ LITE

16/17

The compact yet high performance PERFORMA™ Pfeatures GEA’s unique Advanced Dual Control systemthat provides precise tablet weight control (bymeasuring the tablet height at pre-compression), theability to adjust the dwell time at both pre- and maincompression by up to 300%, and a choice betweencontrolling the individual hardness of every tablet orthe average hardness of the batch within set tolerances.This flexibility is ideal for small–medium productionlevels or for R&D operations when the ability to adjustparameters quickly and easily is paramount. Thepowerful PERFORMA™ P competes extremely well withother, much larger presses, offering double the outputof similarly sized machines.

Exchangeable Turret and Exchangeable Die DiscThe PERFORMA™ P features both an exchangeableturret, which enables format changeover in just 30minutes using a semi-automatic exchange sequence,easy cleaning, and ready access to the compressionarea for maintenance, and an Exchangeable Die Disc(EDD) that enables the off-line fitting and locking ofthe dies in the disc. Using the EDD, dies can easily beblanked off to test a formulation, allowing just a singletablet to be produced per turret revolution to minimisethe use of raw materials. Otherwise, the PERFORMA™ Pcan be used in full production mode or, if higherthroughput is required, production can be seamlesslytransferred to a higher capacity GEA machine.

Bi-Layer Capability: Offering both single and bi-layerproduction, the extraordinary flexibility of thePERFORMA™ P means that it can be converted tooperate in bi-layer mode for short-term bi-layer tabletproduction.

2.0The PERFORMA™ Range of Tablet PressesSmall, Fast and Versatile – PERFORMA™ P

Features• Exchangeable turret and die disc

• High sensitivity weight control for small tablets andthose requiring low compression forces

• Dual reject feature (weight and hardness)

• Latest GEA HMI for complete process control,including peripherals, for lights-out operation

• Optional bi-layer operation.

Benefits• Medium throughput up to 286,000 tablets/h

• Flexible operation for small–medium production andR&D operations

• Maintain the same dwell time regardless of the linearspeed of the machine

• Individual control of tablet hardness.

Case StudyGEA’s PERFORMA™ P at Sanico, Belgium

At their tableting facility, Sanico uses a largenumber of conventional rotary tablet presses, whichcontrol tablet weight using compression forcemeasurement and do not have extended dwell timecapability. The MODUL™ P and PERFORMA™ P, bycontrast, allow for both equal thickness (ETC) andequal force compression (EFC) to be measuredand, consequently, offer extended and freelyadjustable dwell times at pre-compression and maincompression.

The only way to extend the dwell time on aconventional machine is to reduce the turretrotation speed, which will inevitably lead to a lowermachine output. The purpose of the collaborationbetween Sanico and GEA was mainly to investigate,qualify and, when possible, quantify, theadvantages of GEA’s innovative compressionmodes compared with conventional tablet presses.Sanico’s conventional presses are medium-scalemachines with 24–47 punch stations, depending onthe exact configuration. During a 6-month period,more than 20 different formulations were tested onthe PERFORMA™ P and its performance in terms ofmachine speed and tablet quality was comparedwith that of the conventional presses.

The results were quite sensational. The additionaldry granulation step required to compress severalformulations on the conventional machines toachieve the desired tablet quality is no longerrequired—thanks to the extended dwell time;machine speeds of 2–4 times the speed ofconventional machines were reached; in somecases, an important increase in tablet hardness wasachieved; and in many cases, capping was seen todecrease significantly or disappear completely. Theabove process improvements enable substantialsavings in production costs and a sizable reductionin product lead times. For non-problematicformulations, GEA’s innovative compressiontechnology was able to make a considerabledifference: speed increases from 25–70% have beenachieved for these formulations.

PERFORMA™ Padvanced dual control for small-

to medium-scale production

Service StationProactivity is key to good after sales service.

It’s not enough to be reactive to ourcustomers’ needs. Our role is to prevent

problems and predict future requirements, sothat our customers never need to worry.

The Exchangeable Compression Module (ECM) is the unique, distinctivefeature that sets the GEA MODUL™ tablet press apart. The patentedECM is a tremendous improvement on the exchangeable turret conceptand offers very high containment with incomparable productivity andflexibility for tablet compression. Much more than a conventionalexchangeable die table, the ECM is a sealed unit that’s isolated from theremainder of the tablet press and not only contains the turret andcompression tooling, but all the press’s product-contact parts as well.

At the end of a production run, the ECM can be removed from themachine in just 15 minutes. No machine cleaning is required, as allproduct-contact parts and powder residues are encapsulated in andremoved with the ECM; the inside and outside of the press are leftperfectly clean. A duplicate, clean ECM can then be installed in themachine in another 15 minutes.

Providing both operator and product safety, the ECM can be easilyremoved and exchanged with a replacement unit in just 30 minutes forfast product changeover and the complete line can be back in fullproduction in less than two hours. Offering easy cleaning, highproductivity and removing any risk of cross-contamination, thisextremely short changeover time results in unmatched productivityand flexibility.

Exchangeable Compression Module

innovation that sets the MODUL™ range apart

3.0The MODUL™ Range of Tablet PressesUnmatched Productivity and Flexibility

18/19

Service StationOriginal replacement parts are critical to keeping tablet pressesperforming well and extending their operational lives. Our hub

stores in Belgium, India, Japan, China, Mexico and the USAprovide a fast service to keep plants running around the clock.

The GEA MODUL™ P and MODUL™ S tablet pressesprovide similar performance and control characteristicsto their equivalent models from the PERFORMA™range—with one essential difference: the ECM. TheMODUL™ P is ideally suited for formulationdevelopment, clinical trial production and small-batch/multi-product production. The extremely shortchangeover time offered by the MODUL™ P results in atremendous increase in productivity, especially whenthe production schedule involves a succession of manysmall batches.

The MODUL™ P features the unique ExchangeableCompression Module (ECM) for standard and highcontainment applications. The ECM encloses allproduct-contact parts in a sealed unit and can quicklyand easily be removed from the machine in a containedmanner for cleaning and replaced with a pre-preparedunit to allow production to resume in 30 minutes.

While the contaminated ECM is cleaned off-line,production with another ECM can be resumed on themachine, which doesn't require any cleaning. With twoECMs and duplicated peripherals, a changeover time ofless than 2 hours can be achieved for the entireproduction line. The ECM is available in a standard orWash-off-Line version.

Features• Standard or Wash-off-Line ECM

• Single and bi-layer capabilities in standard and washable execution

• Choice of different compression modes (forcecontrol, dual control and advanced dual control)

• High sensitivity weight control for small tablets and those requiring low compression forces

• Dual reject feature

• Latest GEA HMI for complete process control,including peripherals, for lights-out operation.

Benefits• Fast product changeover, improved productivity

and a safe working environment

• Extended dwell time at pre- and main compressionwithout any loss of linear speed

• Individual control of tablet hardness

• Flexible operation for small-medium production and R&D operations with seamless scale-up

• Medium throughput of up to 244,800 tablets/h.

MODUL™ PECM technology with

advanced dual control for R&D and small–

medium production for single and

bi-layer tableting

20/21

Standard ECMThe standard ECM provides a closed environment that ensurescontamination levels outside the machine remain below 10 µg/m3. Thisis ideally suited for non-potent pharmaceutical applications in which adust-tight seal provides adequate protection when the doors of thepress are opened. The ECM can then be safely removed for cleaning ina designated area, usually with a simple air hose. There is no furtherneed to clean the inside of the press or the room in which it operates.

High-Containment ECM with Wash-off-Line (WOL-ECM)CapabilitiesThe WOL-ECM has been specifically designed for tableting operationsusing highly potent APIs to keep operators safe from harmfulcompounds, without the use of cumbersome air suits, and to preventcross-contamination. The WOL-ECM maintains the concentration ofharmful APIs in the environment around the tablet press below 1µg/m3.

Made from corrosion-resistant materials, the WOL-ECM can beremoved from the press and washed separately, using strongdetergents, without any risk of damage. Washing takes place in asealed environment using a special wash skid that avoids the need toopen the ECM or remove any components (such as punches) and usesthe minimum amount of water and detergent. The WOL-ECM can beopened for final manual rinsing and drying without any risk of toxicmaterial becoming airborne. All electrical components, or componentsthat cannot be constructed from suitably corrosion resistant materials,such as cams and bearings, are kept outside the confines of the ECMso do not require cleaning.

The fast product changeover time of just 30 minutes is particularlysignificant for high containment operations as the same operation ona standard isolator-based system can take up to 16 hours.

Benefits• Fast product changeover

• Reduced downtime

• Dust protection for working environment

• Easy cleaning in safe area

• Wash-off-Line facility for high containment applications

• No need for air suits.

3.0The MODUL™ Range of Tablet PressesUnmatched Productivity and Flexibility

3.0The MODUL™ Range of Tablet PressesA Range of Opportunities and Solutions

“For me, there’s no such thing asa typical day at work. As a processengineer, I am involved inevaluating our existing systems,finding solutions for customer-specific needs and developingnew and innovative products. Thisversatility makes my job veryinteresting and challenging. It alsoallows me to work with colleaguesfrom different departments andwith customers from all over theworld, for demonstrations, trainingor to help them get the best out ofour systems.””Frederik, R&D Process Engineer

The MODUL™ S features the unique ExchangeableCompression Module (ECM) for standard and highcontainment applications. The ECM retains all product-contact components within a sealed unit that canquickly and easily be removed for cleaning andreplaced with a pre-prepared unit to allow productionto resume within 30 minutes.

The standard ECM maintains a contamination leveloutside the press of less than 10 µg/m3, which is idealfor all non-toxic pharmaceutical operations. The ECMkeeps the environment around the press dust free,allows fast product changeover and ensures thatproduction can continue while the ECM is beingcleaned. The Wash-off-Line ECM maintains acontamination level outside the press of less than 1µg/m3 for pharmaceutical tableting operations usinghighly potent or toxic compounds such as antibiotics,hormones or oncology drugs. This washable ECM canbe removed from the machine in a contained mannerand washed off line.

Dual Control for Flexibility and PerformanceThe MODUL™ S is the high output version of theMODUL™ P. It is a larger, heavier machine that benefitsfrom the Standard Dual Control system that allowstablet weight, hardness and dwell times to becontrolled to meet operational requirements. The largerturret on the MODUL™ S also provides a longer feederlength to achieve optimal residence times during diefilling, especially for products that do not flow well. Thishelps to reduce capping at very high throughput levels.

Features• Standard or Wash-off-Line ECM

• Tablet weight and hardness control

• High sensitivity weight control forsmall tablets and those requiring lowcompression forces

• Latest GEA HMI for complete processcontrol, including peripherals, forlights-out operation.

Benefits• Fast product changeover, improved

productivity, cross-contaminationprevention and a safe workingenvironment

• High throughput of up to 405,000 tablets/h

• Reduced risk of capping and lamination

• Extended dwell time at pre-compression.

22/23

MODUL™ SECM technology for high throughput

and fast changeover applications

Case Study Haupt Pharma

As the need to process highly potent APIs becomes increasinglyimportant, Haupt Pharma has cultivated a centre of excellence forthis specific application. Tablet compression, from both acontainment and processing perspective, is still one of the mostchallenging unit operations in solid dose manufacturing. Withgrowing demand for contract manufacturing, CMOs need to beable to produce a huge variety of products at an economicalspeed, even when they comprise challenging formulations.Additionally, specific health and safety challenges arise whenpotent APIs are processed, requiring the use of equipment thatcombines very high flexibility with high productivity and anappropriate containment performance. GEA’s MODUL™ rotarypresses meet these criteria at Haupt Pharma’s Münster, Germanysite.

Whereas most pieces of unit operation equipment (granulation,drying or blending) were assessed to be adequately contained, thetransfer steps were a potential area of concern. Haupt Pharmaopted for Müller drums in combination with GEA’s BUCK® MC splitbutterfly valves. Owing to its mechanical complexity, the tabletcompression process demanded special attention, therefore HauptPharma decided to use GEA MODUL™ presses.

The Haupt Pharma Münster site has assessed the containmentperformance of its four MODUL™ S presses intensively bymeasuring particle load in the production environment underoperating conditions. The four presses produce a huge number oftablets. When the turret of the single-sided press is equipped withBB tooling, it is able to produce up to one million tablets per hour,having been fitted for up to five-fold multi-tip tooling. Additionally,product changeover can be achieved in less than 2 hours, duringwhich all product-contact parts are removed in a containedmanner. A second ECM and second set of peripheral equipment arebrought to the compression area and allow production to resume inless than 2 hours. The first set of parts is then cleaned off-line in adedicated washing area, with no interference to manufacturing.

After a successful placebo-based site acceptance test (SAT), thepresses were taken into clinical production and air samples weretaken to assess their containment capability. Sampling heads wereplaced close to the most critical areas that had been identified by arisk analysis. Seven series of tests were done, comprising 26individual measurements. The results were below the detectionlimit of 0.001 µg/m3.


Service StationOur on-site service guarantees a fast reaction

time from our experienced engineers, providingknow-how, commitment and practical help when

you need it most.

The MODUL™ D is the largest press tablet in the GEA range. It featuresthe Dual Control system, an Exchangeable Compression Module (ECM)and all the standard features, with one important addition: double-sided production for super-high volume applications or bi-layerproduction.

The MODUL™ D features a larger turret, containing up to 89 punchstations and making it capable of production levels in excess of 1 million tablets per hour. It is the machine of choice for high volumeapplications when minimal downtime and environmental protectionare key.

Bi-Layer Production: The GEA WayThe MODUL™ D manufactures bi-layer tablets using a unique GEAprocess: it measures the weight of each layer independently to ensurethe correct drug delivery profile; however, most tablet presses canonly accurately assess weight when a high force is applied. High forcesresult in dense tablets that are difficult to bond together, makingseparation of the layers, or capping, almost inevitable.

Exchangeable Compression Module (ECM)The MODUL™ D features the unique Exchangeable CompressionModule (ECM) for standard and medium containment applications.The ECM retains all product-contact components within a sealed unitthat can quickly and easily be removed for cleaning and replaced witha pre-prepared unit to allow production to resume within 30 minutes.

The standard ECM maintains a contamination level outside the pressof less than 10 µg/m3, which is ideal for all non-toxic pharmaceuticaloperations. The ECM keeps the environment around the press dustfree, allows fast product changeover and ensures that production cancontinue while the ECM is being cleaned.

Dual Control for Flexibility and PerformanceThe MODUL™ D benefits from the Standard Dual Control system thatallows tablet weight, hardness and dwell times to be controlled tomeet operational requirements. The larger turret on the MODUL™ Dalso provides a longer feeder length to achieve optimal residencetimes during die filling, especially for products that do not flow well.This helps to reduce capping at very high throughput levels.

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Features• Unique GEA bi-layer manufacturing option

• Contained ECM

• High sensitivity weight control for small tablets andthose requiring low compression forces

• Tablet hardness control

• Large front and rear door for easy access

• Latest GEA HMI for complete process control,including peripherals, for lights-out operation.

Benefits• Fast product changeover, improved productivity,

cross-contamination prevention and a safe workingenvironment

• High throughput of up to 1,069,000 tablets/h

• Dual Control reduces wastage and ensures batchconsistency

• Extended dwell time at pre-compression

• Reduced risk of capping and lamination.

Features of the GEA MODUL™ Tablet Presses

Advanced Dual Control: The Advanced DualControl system provides precise control of

tablet weight (by measuring the tablet heightat pre-compression), the ability to adjust dwelltime at both pre- and main compression by upto 300%, and a choice between controlling the

individual hardness of every tablet or theaverage hardness of the batch within set

tolerances. This flexibility is ideal for small-medium production levels or for R&Doperations where the ability to adjust

parameters quickly and easily is paramount.

Dual Rejects: Advanced dual control alsoallows individual tablets to be rejected if they

are out-of-tolerance on either weight orhardness. This feature helps to ensure theconsistency of batches and significantly

reduces wastage. As such, it is of particularimportance when working with high-value

APIs and for R&D operations.

MODUL™ Ddouble output or bi-layer production


Service StationProcesses and best practices change. Ourservice engineers keep up to date with the

latest techniques and technologies to help youkeep ahead of the rest.

For a variety of reasons, including patent extensions, new therapeuticdevelopments and marketing, to name a few, pharmaceuticalcompanies are increasingly developing bi-layer tablets. To reducecapital investment, modified tablet presses are used to develop andproduce such tablets; however, to manufacture quality bi-layer tabletsand overcome issues with layer separation, insufficient hardness,inaccurate individual layer weight control, cross-contaminationbetween the layers, reduced yield, etc., the process should be doneusing purpose-built machinery. Using a modified tablet press may notbe the best way to produce a quality bi-layer tablet under GMPconditions, especially when high production output is also required.

Making bi-layer tablets with a standard press can be difficult. Themajority of double-sided tablet presses with automated productioncontrol are limited by their use of compression force to monitor andcontrol tablet weight: separation of the two individual layers is often aproblem—a consequence of insufficient bonding between the twolayers during final compression.

It is essential to measure the weight of each layer independently toensure the correct drug delivery profile; however, most tablet pressescan only accurately assess weight when a high force is applied. Highforces result in dense tablets that are difficult to bond together,making separation of the layers, or capping, almost inevitable.

GEA’s double-sided tablet presses have beenspecifically designed and developed for the high-speedproduction of quality bi-layer tablets and provide

• displacement weight monitoring/control for accurate and independent weight control of theindividual layers

• low compression force exerted on the first layer to avoid capping and separation of the two individual layers

• increased dwell time at pre-compression of both first and second layer to provide sufficient hardnessat maximum turret speed

• maximum prevention of cross-contaminationbetween the two layers

• a clear visual separation between the two layers

• maximised yield.

The GEA process uses tablet height at pre-compressionto calculate weight, not force applied. This means thatthe weight can be calculated accurately at lowcompression forces, leaving the final bonding of thetwo layers and the density control to be achieved atmain compression.

How It’s DoneThe unique GEA method is both simple and effective. Ituses the Air Compensator-derived dual control systemto measure the height (and, therefore, the weight) ofthe first layer at pre-compression. The maincompression force for the first layer remains relativelylow. The second layer is then filled on top of the firstlayer and the height is measured at pre-compression inthe same way. Main compression of the second layerbonds the layers together and measures the forceapplied to calculate the hardness of each bi-layertablet. This process provides very accurate weightcontrol of each layer, ensures optimum bonding andprovides the consistent hardness required. Bi-layertablet production using this unique method is onlyavailable on the GEA MODUL™ D tablet press.

Benefits• Accurate weight control for both layers at

pre-compression

• Effective bonding

• Accurate tablet hardness control at main compression.

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4.0Bi-Layer Tableting: The GEA Way

Containment issues are becoming an increasingly important aspect ofsolid dosage form production. Active pharmaceutical ingredients(APIs) are becoming evermore effective, with more than 50% of allnew chemical entities (NCEs) being classified as potent (OEL <10 µg/m3), and, at the same time, the health, safety andprotection of operators, all over the world, is being put under anincreasingly intense spotlight.

GEA has a long history of expertise and an unparalleled depth ofexperience in the field of containment. The company not only offers acomprehensive range of robust and compliant containment products,it also boasts unrivalled experience in identifying the most appropriatesolution and a thorough understanding of containment risk analysis.We don’t just know about containment, we live and breathe it.

MODUL™ Tablet PressWhen dealing with highly potent substances, owing to the complexgeometry of tablet presses, compression is the most challenging stageof the tablet manufacturing process. All MODUL™ tablet presses arebased on the GEA Exchangeable Compression Module (ECM) concept.The ECM is a small and completely isolated section in the machine; itcontains all product-contact parts and can be quickly and easilyremoved from the press in a contained way. This means that the pressitself remains powder-free and requires no cleaning. The Wash-off-Line feature allows the ECM to be washed and cleaned away from themachine without any risk to the operator or environment.

This is the only concept that combines containment with productivity.Whereas, in the past, tablet presses were out of operation for 8–12hours for cleaning (manual or wash-in-place), GEA's ECM technologymeans that a full product changeover can be achieved in less than 2hours. All product-contact parts are contained in an isolated dust-tightmodule, which can be disconnected and removed in minutes. Anotherclean and prepared Wash-off-Line (WOL) ECM can then be installedand the tablet press is ready for a new product. Off-line washing andcleaning is done away from the tablet press area, allowing the machineto do what it has to do—make tablets.

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5.0ContainmentMarket Leading Expertise and Experience

Compared with other press containment

concepts, WOL offersthe following benefits:• no special room is required

(no drain or water connectionsinside the room)

• small compartment, less contamination

(the ECM represents 30% of the entire press)

• only 30 L/min waterconsumption compared with

120 L/min on a WIP tablet press

• less waste water to be treated

• the inside of the press is notwashed: no corrosion risk

• no risk of water leaking insidethe press and contaminating the

mechanical compartment

• no second wash cycle required after removing

the feeder/tooling

• faster and more efficientwashing and cleaning of the entire tableting line

• very high containment leveland practical in daily use

• much lower investment cost

• much lower operational cost.

Multiple Unit Pellet System (MUPS) Segregation SolutionProducing Multiple Unit Pellet System (MUPS) tablets usingconventional bin blending to feed a tablet press is reported by manypharmaceutical manufacturers to pose significant challengesregarding process yield, productivity and batch content uniformity asa result of the tendency of MUPS blends to undergo particlesegregation.

The granule size distribution of the MUPS pre-mix is typically between50 and 200 µm. Moreover, the bulk density of the pellet phase isgenerally greater than 0.7 g/cm3, whereas the density of the excipientmixture is 0.4–0.6 g/cm3. These significant differences in averageparticle size and density make a MUPS mixture extremely sensitive tosegregation. It is, therefore, vital to maintain blend uniformity duringstorage, transport and feeding of the MUPS formulation into the tabletpress, right up to when the blend is fed into the dies for compression.

To increase process yield and guarantee tablet quality, GEA hasdeveloped an innovative new MUPS production method — acontinuous dosing, blending and compression system — thateliminates these production inefficiencies and product quality risks.Segregation is kept to an absolute minimum and online processmonitoring detects out-of-specification tablets.

The Patented GEA MUPS SolutionTwo loss-in-weight screw feeders are installed above the tablet press;one feeds the pellets and the other feeds the premixed excipients.Both the pellets and excipients are continuously fed into a conicalribbon blender above the tablet press, which mixes the two productstreams into one uniform MUPS formulation stream, which feeds thetablet press. The fill level of the blender is accurately controlled as itdetermines the residence time in the blender and hence the blendingtime.

The transfer tube from the blender to the tablet press feed framemeasures approximately 60 cm and could induce segregation ifdirectly connected to the paddle feeder. To avoid this, a special valvewas developed by GEA to ensure “plug flow” via a vertical powderfeed tube: the powder dosing valve or PDV. The PDV is mounted justabove the inlet of the paddle feed frame and driven by a separateelectromotor. Finally, the design of the feeder base plate and paddlewheel have been modified to avoid segregation, as well as pelletdamage, in the feed frame.

Enhanced Process Yield and Content UniformityThe GEA continuous dosing-blending-compressionsystem has been developed, built and extensivelytested in collaboration with a leading pharmaceuticalcompany. The results were significant:

• stable content uniformity throughout the entirebatch, decreasing the risk of batch rejection

• start-up losses were reduced by a factor of 3 (from15% down to 5%)

• process stop and restart without any product losses

• accurately controlled end-of-batch with minimalproduct loss

• the GEA Dual Control system detects and rejectstablets with increased risk of out-of-specificationpellet content.

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6.0Successful MUPS ProductionHigh Output and Optimised Yield

� Loss-in-weight screw feeders

� Drop chutes

� Conical ribbon blender

� Transfer tube

� Tablet press feed frame

� Powder dosing valve or PDV

�

�

�

�

�

�

The GEA MULTI-CONTROL 5 (MC5) fully automatedmonitoring, control and reporting system, comprisingboth hardware and software, is fully 21 CFR PART 11compliant and based on a PLC/PC hardwareconfiguration. The PLC controls the machine andcompression process (machine and production control)whereas the PC provides an operator interface for datastorage and reporting, and a wide range offunctionalities, including

• an automated audit trail

• detailed batch reporting, including operator activityand alarm logging, as well as distribution andtrending graphs

• multiple user-defined access levels

• machine parameter storage for fast start-up

• maintenance screens to check and solve electricalproblems

• database for tooling management and automaticpunch length compensation

• online help and troubleshooting functions.

• permanent OEE (overall equipment effectiveness)monitoring, including detailed reporting onavailability, product changeover time, tablet qualityand speed performance

• configurable reports, including recipe and statisticalbatch data, alarms, warnings, parameter changes,user lists and process event logs

• integrated help system, including manuals andtechnical drawings

• graphical window layout to compare recipes.

The system uses the most up-to-date Windowsoperating system and a state-of-the-art Siemens S7PLC. The menu-driven, colour graphical interface isuser-friendly and can accommodate a large number ofproduct, machine and system settings simply bytouching the correct buttons on the sensitive PCtouchscreen.

Press adjustment data is stored as a combined “Batch-Product-Tooling-Equipment-Press” record, providingoptimal recipe database flexibility. At the beginning ofa batch, product-specific parameter settings arerecalled from the database. The operator can makebatch-dependent adjustments (feeder speeds and filldepth) and, once the correct settings have been input,the operator initialises the automatic productioncontrol mode by pushing an on-screen button. Theautomatic mode can be switched on and off bypressing the same button.

The MULTI-CONTROL system provides complete controlof all production stops with clear on-screen messagesfor production alarms (production out of range,defective punch identification, etc.) and equipmentalarms (top or bottom punch jamming, pre-compressionor main compression overload, motor overload, dooropen, tablet chute obstruction, no powder, lubricationfailure, etc.). More than 100 different warnings arecontinuously monitored and automatically reportedwhen activated. All alarms are recorded in the logbook.The MC system allows easy network integration and, forfull 21 CFR Part 11 compliance, Uninterrupted PowerSupply (UPS) is a standard feature.

Data Acquisition and Analysis System (DAAS)The GEA data acquisition and analysis system (DAAS)is a combined hardware and software package thatenables in-depth analysis and characterisation of thetableting process during production. By linking theDAAS to a GEA press with an Ethernet connection,process-relevant sensor data becomes available and, asa result of the 100 kHz sampling rate, even the slightestdeviation from standard compression processparameters is recorded.

Specialised DAAS software, either laptop-based orcontained in a dust-tight cabinet with a dedicateddesktop PC, screen and keyboard, presents the sensordata in a convenient way and provides severalanalytical tools for fast signal evaluation, comparisonand the automated extraction of relevant processcharacteristics.

Optionally, one punch pair can be equipped withdisplacement sensors to evaluate the densification ofthe powder bed during compression. The relationshipbetween powder bed thickness and appliedcompression force—captured by the DAAS—will yielddetailed information about the governing powderdeformation mechanisms and the applied compressionenergy.

Apart from its significance in fundamental studies, theDAAS is also a valuable production troubleshootingtool; it provides punch-dependent statistics of allcompression events and full traceability.

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7.0Control SystemsIntuitive and Easy to Use

Service StationFree, remote assistance is available from

engineers in our customer care team whereveryou are in the world. They can also provide

remote software upgrades as required.

Tablet Weight ControlThe MULTI-CONTROL system uses the unique GEA

principle for tablet weight control: variations intablet thickness under constant force at pre-

compression are monitored and used to adjust thefill depth of the dies. These variations in thicknesshave a linear relation with the tablet weight andenable a more accurate and faster correction oftablet weight compared with traditional force

measurement at pre-compression. Otheradvantages of weight control based on

displacement measurement are

• automatic (operator-independent) setting ofreject and correction tolerance limits based on the

specified weight tolerance

• exact and fast recalibration of the primarycontrol loop after manual sample checking by theoperator or automatic IPC using the optional AWS

or Combi-Test

• higher sensitivity of the system for smallertablets and lower compression forces

The constant force at pre-compression is exertedby the unique GEA Air Compensator, providingadvantages such as extended dwell times forbetter tablet quality, even at high production

speeds.

GEA tablet presses usually operate as part of acomplete process line. Within the GEA Group, ourpartner companies supply a wide range of market-leading technology and equipment for pharmaceuticalsolid dose manufacture. By bringing together GEA’stechnologies, experience and expertise, we have theability to supply complete, integrated production linesfor any size of manufacturing facility, anywhere in theworld.

The range of equipment from within the GEA Groupincludes

• contained materials handling: IBCs, BUCK®containment valves and disposable containmentvalves

• blending and mixing: IBC blenders; high-shear mixersand blenders, post-hoist blenders and multifunctionalblenders

• granulation and drying: fluid bed dryers, spray dryers,high-shear granulators and single-pot processors

• pelletizing: high-shear pelletizing, liquid layering andpelletizing plants

• coating: tablet coating, fluid bed precision coating

• de-dusting equipment, including dust collectionequipment

• tablet analysers

• metal detectors.

The GEA tablet press also forms an integral part of theunique ConsiGma™ continuous processing technologyfrom GEA.

Benefits• Natural synergies from complementary equipment

• GEA process integration experience

• Single-source supplier: reduces administration costsand provides short, efficient communication lines

• Reduced maintenance costs

• Project scale savings.

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8.0Integrated SystemsTurnkey Plants and Peripheral Equipment

Service StationEffective training ensures that operators getthe most out of GEA technology and helpsthem to maximise productivity. Our courses

can be delivered at our training centre inBelgium or on site to meet your needs.

ConsiGma™: The Future of TabletingTablet presses have always operated continuously; until now, however, theyhave mainly been used in batch mode—because of regulatory restrictionsand the fact that granules were delivered to the press in batches. Both ofthese hurdles to continuous tableting have been removed in recent years.

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9.0Continuous Processing Technology

ConsiGma™-DCThe ConsiGma™-DC (CDC) is a compact, all-in-one, tablet productionline for direct compression formulations. It is a high-yield system thatis sufficiently flexible to be able to handle the bespoke production ofsmall volume, high-value products and high-volume generic productson the same machine with minimised start-up and shutdown losses. Itcombines accurate feeding, continuous blending, Air Compensator-enhanced GEA compression technology and the online measurementof CQAs (Critical Quality Attributes).

The modular design allows for containment, off-line (WOL) cleaningand fast product changeover. The closed coupling of feeding, blendingand compression eliminates segregation concerns. Featuring loss-in-weight feeders and the option to integrate automatic tablet samplingand analysis, the CDC is able to process batch sizes from 500 g tomany tonnes; and, with more than 100 formulations already tested,ConsiGma™-DC offers a robust and flexible manufacturing method fora wide range of products.

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The GEA tablet press is an essential component of theConsiGma™ continuous processing line for solid dosageforms. ConsiGma™ is innovative technology, unique toGEA, that meets both the demands of the regulatoryauthorities and pharmaceutical companies forcontinuous manufacturing to provide better quality andconsistency, just-in-time production and get productsto market faster in a more flexible and environmentallyconscious way. The full tablet production line consistsof the ConsiGma™ high shear granulator and dryer,combined with a GEA rotary tablet press. A special in-line blender mixes in the external phase between thesystems. The granulator and dryer section has threemodules: a wet high-shear granulation module, asegmented dryer module and an evaluation module.

The ConsiGma™ PrincipleConsiGma™ incorporates high shear granulation, dryingand tablet production into a single, continuous process.It allows users to make exactly the number of tabletsrequired to meet immediate demand with the batchsize limited only by the running time of the machine.The ConsiGma™ system is capable of undertakingparticle design and mimicking any traditional batchgranulation process—with a much higher and consistentquality resulting from its continuous production set-upand “risk-based approach” to GMP. The granules havebetter intragranular porosity, with improvedcompressibility characteristics that help tablet pressesrun more efficiently at maximum speed with hardly anyweight adjustments being required. Parametric releaseis achieved through in-line testing.

From R&D to Production on One MachineThe ConsiGma™ concept enables small amounts ofproduct to be processed and developed quickly andefficiently. And, once a formulation has been optimised,it can be reliably reproduced in pilot, clinical orproduction batches, simply by running the machine forlonger, avoiding scale-up problems and the lengthyvalidation processes that hinder bringing new productsto market faster.

Environmental BenefitsCombining processes into a single machine meansreduced space requirements, smaller buildings, smallercleanrooms, less waste and less consumption of powerand raw materials.

The MODUL™ and PERFORMA™The inherent flexibility of the MODUL™ andPERFORMA™, with multiple compression modes(conventional, hybrid, Dual Control and Advanced DualControl) and their ability to control the weight andhardness of individual tablets, makes them ideal forConsiGma™ use. Their ability to maintain a constantdwell time, regardless of throughput, fits perfectly in acontinuous line because it enables the press to changespeed during in-line sampling without any detrimentaleffect on the tablets.

9.0Continuous Processing TechnologyConsiGma™: The Future of Tableting

Continuous CoatingThe ConsiGma™ coater from GEA is

a revolutionary, new, highperformance tablet coating

technology that accurately depositscontrolled amounts of coating

materials on tablets—even if they arehygroscopic or friable. Designed

specifically to be an integral part ofthe ConsiGma™ continuous high

shear granulation and drying system,the ConsiGma™ is able to coat small

quantities of tablets at very highrates, offering improved heat andmass transfer and using much lesscoating material than traditional

technologies.

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10.0Data SheetsTechnical Data PERFORMA™ LITE Technical Data PERFORMA™ P

Tooling D B BB BBS(EU or TSM) (EU or TSM) (EU or TSM) (EU or TSM)

Maximum tablet diameter/length [mm] 25.4 16 (L=19) 13 (L=14.3) 11

Punch body diameter [mm] 25.4 19 19 19

Outside die diameter [mm] 38.1 30.16 24 22

Die height [mm] 23.81 22.22 22.22 22.22

Number of punch positions 24 30 36 39

Maximum fill depth [mm] 20 19 19 19

Top punch penetration [mm] 1 to 4 1 to 4 1 to 4 1 to 4

Maximum pre-compression force [kN] 10 10 10 10(under extended dwell-time)

Maximum main compression force [kN] 100 100 100 100

Maximum output capacity [tab/h] 157,000 220,000 264,000 320,000

Machine Specifications / Requirements

Electrical requirements 3phase+PE; 380V / 400V / 415V / 460V / 480V — 50Hz / 60Hz (nominal consumption 5.5 kW; power installed 9 kVA)

Compressed air requirements clean & dry; 7–8 bar; 500 l/min

Dust extraction requirements 150 m3/h at 15 mbar

Machine dimensions & weight W = 1,050 mm x D = 1,200 mm x H = 2,000 mm — 2,500 kg

Tooling D B BB BBS A(EU or TSM) (EU or TSM) (EU or TSM) (EU or TSM) (EU or TSM)

Maximum tablet diameter [mm] 25 16 (L=19) 13 (L=14.3) 11 11

Punch body diameter [mm] 25.4 19 19 19 12

Outside die diameter [mm] 38.1 30.16 24 22 (No die)

Die height [mm] 23.81 22.22 22.22 22.22 (No die)

Number of punch positions 24 30 36 39 51

Maximum fill depth [mm] 20 19 19 19 19

Single-Layer Setup

Top punch penetration [mm] 1 to 4 1 to 4 1 to 4 1 to 4 1 to 4

Maximum pre-compression force [kN] 10 10 10 10 10(under extended dwell-time)

Maximum main compression force [kN] 80 80 80 80 80(60 kN in case of Equal Force Compression)

Maximum output capacity [tab/h] 157,000 220,000 264,000 286,000 374,000

Bi-Layer Setup

Top punch penetration 2nd layer [mm] 9 9 9 9 9

Maximum pre-compression force [kN] 2.5 2.5 2.5 2.5 2.5

Maximum main compression force [kN] 80 80 80 80 80



Electrical requirements 3phase+PE; 380V / 400V / 415V / 460V / 480V — 50Hz / 60Hz(nominal consumption 6 kW; power installed 11.9 kVA)

Compressed air requirements Clean & dry; 7–8 bar; 500 l/m



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10.0Data SheetsTechnical Data MODUL™ P Technical Data MODUL™ S

Tooling D B BB BBS(EU or TSM) (EU or TSM) (EU or TSM) (EU or TSM)

Maximum tablet diameter [mm] 25.4 16 (L=19) 13 (L=14.3) 11

Punch body diameter [mm] 25.4 19 19 19

Outside die diameter [mm] 38.1 30.16 24 22

Die height [mm] 23.81 22.22 22.22 22.22

Number of punch positions 21 26 31 34

Maximum fill depth [mm] 20 19 19 19

Single-Layer Setup

Top punch penetration [mm] 1 to 4 1 to 4 1 to 4 1 to 4

Maximum pre-compression force [kN] 10 10 10 10(under extended dwell-time)



Bi-Layer Setup

Top punch penetration 2nd layer [mm] 9 9 9 9

Maximum pre-compression force [kN] 2,5 2,5 2,5 2,5




Electrical requirements 3phase+PE – 380V / 400V / 415V / 460V / 480V — 50Hz / 60Hz (nominal consumption 6 kW; power installed 11.9 kVA)

Compressed air requirements clean & dry; 7–8 bar; 500 l/min



Tooling D35 D B BB BBS(EU or TSM) (EU or TSM) (EU or TSM) (EU or TSM) (EU or TSM)

Maximum tablet diameter [mm] 35 25.4 16 (L=19) 13 (L=14.3) 11

Punch body diameter [mm] 35 25.4 19 19 19

Outside die diameter [mm] 52 38.1 30.16 24 22

Die height [mm] 30 23.81 22.22 22.22 22.22


Maximum fill depth [mm] 20 (25) 20 19 19 19






Electrical requirements 3phase+PE; 380V / 400V / 415V / 460V / 480V — 50Hz / 60Hz(nominal consumption 12 kW; power installed 15.5 kVA)




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10.0Data SheetsTechnical Data MODUL™ D

Tooling D35 D B BB BBS(EU or TSM) (EU or TSM) (EU or TSM) (EU or TSM) (EU or TSM)

Maximum tablet diameter [mm] 35 25.4 16 (L=19) 13 (L=14.3) 11

Punch body diameter [mm] 35 25.4 19 19 19

Outside die diameter [mm] 52 38.1 30.16 24 22

Die height [mm] 30 23.81 22.22 22.22 22.22


Maximum fill depth [mm] 20 (25) 20 19 19 19




Maximum output capacity [tab/h] 350,000 540,000 722,000 875,000 1,069,000

Bi-Layer Setup

Top punch penetration 2nd layer [mm] 11 11 11 11 11

Maximum pre-compression force [kN] 10 10 10 10 10




Electrical requirements 3phase + PE; 380V / 400V / 415V / 460V / 480V — 50Hz / 60Hz (nominal consumption 15 kW; power installed 30 kVA)


Dust extraction requirements 150 m3/h at 15 mbar (single-layer)230 m3/h at 30 mbar (bi-layer)

Machine dimensions & weight W =2,000 mm x D = 1,500 mm x H = 2,250 mm — 6,000 kg

Service is not just maintenance; it’s a mindsetIt’s a fundamental business driver that means we’rededicated to helping our customers to be moreproductive, more profitable, more cost-effective and todeliver higher quality products. For GEA, likeinnovation, it’s a critical differentiator that allows us toshine and our customers to prosper.

In some respects, a tablet press is unique. Unlike anyother unit operation, the tablet press operates at highspeed, under extreme pressure and within tighttolerances. It requires electrical and mechanicalcomponents, software, hardware and operators, all ofwhich have to work at maximum efficiency to achieveoptimum results. Just as operators require appropriatetraining, so the presses require regular maintenance ifthey are to perform well throughout their lifetimes.

A Proactive ApproachEven after a tablet press has left our premises, itremains part of us. That’s our 100-year legacy and ourcommitment to quality — all day, every day. We want tomake sure the press is well cared for, kept in topcondition and that it serves its owner well. To this aim,we provide a range of services tailored specifically toour customers’ needs.

Spare parts: High-quality, original parts are suppliedfrom stock at our central warehouse in Halle, Belgium,or from our hubs in India, Mexico and the USA. With adedicated co-ordinator, we guarantee a quick response,fast delivery with location tracking, transparent pricingand a customised spares list for each press.

On-site service: Our team of engineers have the know-how and experience to keep plants running efficientlyand integrate the latest developments in technology.Accurate assistance, fast reaction times, processconsultancy and improvement are all part of the service.

Remote assistance: Wherever you are in the world, youcan get access to our service engineers when you needthem most. We offer free telephone assistance,accurate troubleshooting, documented follow-ups andremote software upgrades.

Service level agreements: To meet every customer’sneeds, including preventive and scheduledmaintenance and equipment calibration, our contractscan help you to minimise unscheduled downtime,maintain tablet quality, extend the service life of yourequipment, reduce whole life costs and document andanalyse maintenance records.

Machine upgrades: Bring your presses right up to datewith a full mechanical overhaul and the latest controlsystems and software. Enhance machine output, extendits service life and receive a one year warranty onworkmanship and full IQ/OQ documentation.

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11.0Customer CareA Proactive Approach

“For the last 3 years, I’ve had a desk on myleft, and — at the end of a telephone line —the whole world on my right. Every day, I getto solve complex problems, talk to customersand pass on the benefits of my experienceand expertise. There’s no greater reward thanwhen a customer says: “Hey, that worked,thank you very much.””Fabrice, Customer Support Technician

Training and Process OptimisationEither on site or at our headquarters in Halle, Belgium,we provide a wide range of training courses for ourcustomers. All courses include both theoretical andpractical elements and are delivered by ourexperienced trainers who combine many years ofexperience with carefully researched insights into thelatest technology and process techniques.

Courses include• basic and advanced maintenance

• basic and advanced press operation

• process training

• in-house workshops and seminars with case studies

• customised training and consultancy

• customised process optimisation and consultancy.

Process TrialsOur workshops in Halle, Belgium, are available forcustomers to perform trials on the whole range of GEApresses to optimise processes and help with productformulation. All trials are conducted under thesupervision of experienced engineers who haveextensive process experience and are fully conversantwith press operation and optimisation.

Customer benefits include• reduced cost of product development

• evaluation of processes before investing capital inequipment

• refining of product formulations for easy tableting

• assessment of product characteristics and quality

• bring new products to market quickly

• ensure seamless scale-up to full production.

Pre-Owned Tablet PressesOur presses are built to last and give many years oftrouble-free service. This occasionally means that ourcustomers’ needs change, leaving a redundant pressthat is still operationally robust and reliable. When thishappens, we buy the press back, refurbish it with newcontrol systems and electrical components, give it acomplete mechanical overhaul and replace any wornparts. Then, with a new lease of life, we resell it with allthe necessary IQ/IO documentation, a full servicepackage and a one-year warranty.

Refurbished presses, when available, are supplied fromour workshops in perfect condition and include all theunique GEA features. They are extremely good valueand, properly maintained, will provide many years ofreliable service.

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11.0Customer CareA Proactive Approach

Service StationService level agreements are the easiest way to

manage your servicing needs. They extendequipment service life, reduce unscheduled

downtime, create accurate records and ensurethat machines are correctly calibrated.

For 100 years, GEA has been designing, building andservicing superior and versatile rotary tablet presses forthe pharmaceutical and other industries. As a leader intechnology and product innovation we have developed

• manual to automatic rotary tablet presses forresearch, pilot-scale and full production facilities

• presses for normal, cleanroom, contained and highlycontained environments

• presses for the production of single and bi-layertablets.

Our ongoing mission is to drastically reduce theproduction cost per tablet and to enhance the securityof the operator against increasingly potent drugs. In 1912, Edouard Courtoy founded a machine shop in

Halle, Belgium, to design and manufacture mechanicalcomponents. Aware of the growing need in the

pharmaceutical and chemical industries for specialisedproduction equipment, he began to produce tablet

presses, mixers, granulators and coating pans. By theend of 1920, Courtoy nv had established its name as a

highly reliable and knowledgeable supplier of different kinds of processing equipment to the

pharmaceutical and the chemical industry.

In 1928, the company introduced its first rotary tabletpress, the Courtoy R1. The design of this press was soahead of its time that the direct descendant of the R1,the R1/2, is still being produced today for very specificapplications. Between 1950 and 1960, the demand forCourtoy™ tablet presses grew so rapidly that theancillary items were eliminated from the equipmentrange and the company decided to concentrate all itsefforts on becoming the market leader in high-speedrotary compression machines.

The move towards GMP and automated operation wasinitiated during the 1970s. Specialty and customisedpresses for various high-tech applications, such asferrite memory cores, micro-balls and nuclear fuelpellets were designed and built. Today, most nuclearfuel produced in the world is compressed on our rotary presses.

In the early 1980s, Courtoy supplied the first fullycomputer-controlled press. Hand wheels for manualadjustment were subsequently eliminated and werereplaced with Memo Control, the first microprocessor-based control system for high-speed rotary tabletpresses. In 1991, Courtoy joined the ProcessingMachinery Division of GEI International to allow forfurther expansion.

In November 1999, GEA Group acquired thepharmaceutical division of GEI International. Today, as a global specialist in solid and liquid dosetechnology, GEA provides the services that thepharmaceutical industry needs: test facilities, technicalknow-how, process evaluation, product development,market-leading equipment, project management andongoing support.

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12.0Our history

Being in business is not just about the ‘what,’ it’s also about the ‘why.’At GEA, it’s the belief that we can make a difference, both for ourcustomers and the consumers they serve. For more than a hundredyears, our innovation, driven by our passion for excellence, has led theway in tablet compression technology, allowing pharmaceuticalcompanies to prosper, produce extraordinary products and changepeople’s lives for the better.

As a single-source supplier of world-leading, state-of-the-art tabletingtechnologies, our innovations include a unique dual control, PAT-compatible technology that monitors and controls tablet weight,hardness and density with an accuracy that cannot be achieved anyother way. Weight is controlled at pre-compression and hardness iscontrolled at main compression. As a result, weight and hardness canbe controlled simultaneously and continuously on a standard tabletpress.

GEA also offers adjustable dwell times at pre-compression (by up to300%) without slowing the press: this functionality allows an increasein dwell time at pre-compression that’s independent from machinespeed, resulting in higher outputs and more consistent tablet quality.In addition, constant dwell times with adjustable compression speedscan be used to match the production capacity of the line withoutinfluencing tablet quality. Other unique features ensure a constantflow and equal distribution of powder that are without equal, as wellas integrated data collection and analysis, and advanced processcontrol.

Our customers choose GEA products because they know theyperform, both when the application is simple and productivity is key,and when it’s complex, and only the best will do. They choose us forour customer care, our ability to coach and encourage engineers toget the best out of our technology, to provide the support they needlong before it becomes critical, and to use the joint resources of ourgroup to offer a market-leading scope of supply. Only with a GEApress can you guarantee world-class tablet production.

That’s the GEA experience

13.0Summary

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