Tableting solutions for the pharmaceutical industry

The new business model from Romaco sets valuable incentives for meeting customer requirements. For the design of innovative solutions, Romaco relies on its unique knowledge portfolio. With its diverse brands, Romaco focuses on important technologicalfields of competence. The single product lines offer the optimum

prerequisite for the development of comprehensive solutions.Romaco promises its customers professional project handling, fast delivery times and a reliable service. Through this, Romaco provides its customers with a considerable boost to their earning and financial power.

Creating Value – best price/performance ratio

Romaco wins over its customers by offering an outstanding price/performance ratio over the entire life cycle of its products. In this way, customers can systematically optimise their cash flow. With efficient production and service management, Romaco prepares its customers for future long-term commer-cial success.

Delivering Solutions – high application expertise

Romaco offers integrated solutions for the growing markets of pharmaceuticals, cosmetics, food and industrial applications. Here, the customer benefits from the synergetic effects that result from the close collaboration of all the Romaco brands. This internal technology transfer imparts a con-siderable development potential and is the basis for comprehensive solutions.

Exploiting Technologies – strong brands

Romaco is synonymous with European engineering on the highest level. With its seven brands, the company is widely recognised around the world. Continuity and progress are the keys to a strong posi- tioning on the market. Romaco relies on the profound knowledge and the long-time experience of its employees.

Beyond Technology

Requirements and solution

The real tablet press performance in daily life and hence the quality and cost of tablet- ing operation, depends on the optimisation of various requirements in a production environment such as equipment, personnel, product mix and powder/granule properties. Different machine types and models (from one or from different manufacturers) vary strongly in their real life performance. ldentifying the best machine for the job starts with analysing all these require ments and ranking them, while taking into consider-ation future challenges.

This allows you to make a sound invest-ment for now and in future.

Romaco Kilian offers a broad portfolio of tablet presses and accessories of highest standards, providing a tailored fit to your requirements for • Mono-layer tablet production• Multi-layer tablet production• Core-tablet (Tab-in-Tab) production

Delivering Solutions

»Romaco Kilian finds reliable solutions even for complex challenges and various types of tablets which ensures great flexibility and excellent OEE values for us.«

Dr. Hans-Jörg Kilian, member of the board for manufacture and technology centre, Berlin-Chemie, Germany

As well as solutions for• Laboratory• Scale-up• Production

As a solution provider, Romaco Kilian has the ability to listen to your needs and to support you by identifying the most suitable tablet press.

Single-layer tablets

• Single-layer tableting with a maximum output of 1,020,000 tablets per hour

• Optimised filling systems for products with various flow properties

• Special coatings for particularly abrasive products

• Compression of any tablet form possible• Self-learning control system

Multi-layer tablets

• Multi-layer tableting with a maximum output of 510,000 tablets per hour (rotary press) or 450 tablets per hour (single stroke press STYL’ONE)

• Special fill shoe system: compression of up to five layers with three different products

• Vacuum system to avoid cross-contami-nation between the tablet layers

Core-tablets (Tab-in-Tab)

• Precise core feeding system with high capacity for different formats (up to 140,000 tablets per hour)

• Automatic core positioning system with very high precision (±0.2 mm)

• High-performance camera ensures a continuous core localisation

• Automatic correction of the core position • Single or double layer core-tablets or bulls

eye tablets

Effervescent tablets

• High speed production of effervescent tablets

• Including reliable and break-free transfer to downstream equipment

• Mono- or bi-layer production• High yield with very sticky products• Clear separation of the layers in bi-layer

production• Tablet press and connected tube filler

out of one hand

Pharmaceutical tablet presses for any demand

Romaco Kilian provides innovative standard and special tableting solutions.Decreasing batch sizes, frequent product changes and increasing cost pressure – the pharmaceutical industry is facing major challenges. Romaco Kilian provides an ade-quate response with its innovative standard or special tableting solutions; ensuring that companies are well prepared for the inter-national competition and benefit from the excellent productivity, great flexibility and high equipment availability.

High-end high speed tablet presses

• cool - fast - clean• Single- and double-sided rotary presses• Available in four configurations: for single-layer and

multi-layer tablets, core-tablets (Tab-in-Tab) as well as for tamper-resistant formulation (TRF)

• Optimised for heat sensitive products like lbuprofen• Hygienic design for easy, fast and effective cleaning• For applications that require a maximum level of

efficiency at a minimum level of wear • Compression of more than 1 million tablets per hour

Delivering Solutions

Standard tablet presses with exchangeable die table

• Suitable for a wide variety of pharmaceutical applications

• Compression of all types of granulates including bad-flowing products

• Output of up to 330,000 tablets per hour

Laboratory and pilot plant presses

• Versatile single stroke presses for R&D applications, small batch sizes and clinical batches

• As rotary machines also usable for pilot productions• Suitable for all types of tablets• Pressing of up to five layers with three different

products• Core-tableting (Tab-in-Tab) feature available• Highly automated analysis software for R&D operation

or in-process troubleshooting

Accessories

• TabTrans• Tablet check unit• Deduster/metal check• External lubrication system• Vacuum cleaner• Bulk fill• Die table storage device• Die table transport trolley• 2nd set of change parts• Change part storage trolley• Compression tooling• Tool storage and cleaning

Exploiting TechnologiesKTP 420X / 590X / 720X series from Romaco Kilian

HMI screen Hygienic designDie table slide-out system

New design - new level of performance

The „iF design award”-winning tablet press-es of the KTP series from Romaco Kilian are versatile high speed tablet presses for the pharmaceutical industry. In the latest model series of the KTP, Kilian has applied its extensive know-how to many different product features and behaviours. This is combined with current customer requirements for efficiency, product opti- misation and in-line quality data aquisition.

The series is characterised by high equip-ment availability, hygienic design and a fast and easy format change. The KTP series is available in the following configurations: • Mono-layer• Bi-layer• Mono- + bi-layer• Core (Tab-in-Tab)• TRF – tamper-resistant formulation• For Bad-flowing materials

Cool - fast - cleanThe Romaco Kilian KTP Series is based on an advanced and thoroughly convincing design principle cool - fast - clean.

Coolstands for the reliable cooling of the pro-cess area to below 30 °C. This makes the technology ideal for processing temperature sensitive medications such as lbuprofen. Special compression rollers, bolts and bea-rings ensure low mechanical friction. The efficient cooling of the torque drive and V-ring seal (for the die table) prevents the formation of heat.

Fastdenotes the optimised change-over, clea-ning and start-up times of the rotary press and the nominal high speed. • Up to 1,020,000 tablets per hour for

mono-layer• Up to 510,000 tablets per hour for bi-layer• Up to 140,000 tablets per hour for core

tablets

The die-table, tablet chute and fill shoe can be swung in or out, so that fewer adjustments are required. Changing the product or format is simple as no special tools are required. Thanks to the ingenious design, cleaning work is restricted to a minimum.

Clean refers to the optimised hygienic design, which improves product quality and ensures the process is more reliable. The hermetic separation of the compaction area and the machine compartment means tablet dust does not get into the bottom of the machi-ne. The patented punch bellows protect the tablets from contamination with lubricants.

Exploiting TechnologiesThe Romaco Kilian S 370 Primeand S 250 SMART

Patented brake magnetsDie table production: highest precision Fast exchange of die table

The small giant Many pharmaceutical manufacturers search for a robust, reliable and compact tableting machine. Romaco Kilian meets these requi-rements with its rotary tablet presses S 250 SMART and S 370 Prime. With an output of 330,000 tabs/h, the exchangeable die table and the suitability to compress any powder mixture, it is ideal for small and mid-sized batches.

S 370 Prime The S 370 Prime was developed to enable fully automatic pharmaceutical production for low initial capital investment. The press is designed and manufactured in Germany, guaranteeing the highest possible quality. The fact that tablet control systems can be connected directly means that in-process and automatic weight controls are now pos-sible on the press. Extreme precision goes hand in hand with constant high quality, ensuring an output of 330,000 tab-lets per hour - typical German-made.

Reliable - robust - compact• All electronic components are

integrated in the machine body• No external electrical cabinet required,

saving valuable space on the production floor

• Machine can be easily moved to another position in the production area if required, giving added flexibility

Technical highlights• GAMP compliant automation• Fast turret exchange due to the integrated

die table lifting system• Patented, wear-free brake magnets• Easy replacement of all components and

wear parts• Large, intuitive 19“ touch panel (HMI)• Direct connection of tablet control sys tem

and other complementary equip ment such as dedusters or metal check units

S 250 SMARTThis machine is characterised by high production stability and outstanding quality results. The latest model series of S 250 replaces tried-and-tested technologies with a state-of-the-art control unit and ex-changeable die table.

The S 250 SMART is available as:• SMART Tradition• SMART Classic

Exploiting TechnologiesRomaco Kilian KTP 180X

Easy access Easy cleaning Self-explanatory menu

Compact model for various requirements The KTP 180X is a compact rotary tablet press for the pharmaceutical industry which meets a wide variety of different require-ments. The machine offers unique scale- up possibilities and is the ideal solution for R&D applications, clinical batches and small-scale production.

It is available in two configurations: • KTP 180X Production• KTP 180X Laboratory

Monitoring system and data acquisition• Completely automated machine without

hand wheels• Operation via an integrated HMI with a

12’’ touch screen• Monitored machine parameters in the

R&D version: upper and lower compres-sion forces, ejection force, pre-pressure force, upper and lower punch displace-ment measurements

• Data acquisition system integrated into the operating software

Very good accessibility and easy operation• Fast and easy cleaning of the production

area with opened window flaps: minimi- sation of change-over and cleaning times

• Mechanical area easily accessible for maintenance work

• Easy access to all product contact parts for assembly and disassembly without tools

Technical highlights• Exchangeable die table in a very compact

design• Unique scale-up possibilities due to a

scientific approach • Patented wear-free brake magnets• Optional individual selection by means of

compressed air

Exploiting TechnologiesSTYL’ONE series from Romaco Kilian

New exchangeable worktable Easy core positioningInnovative filling system

The R&D solution

The Romaco Kilian STYL’ONE is a single punch tablet press for R&D applications and the production of clinical batches. The machine offers outstanding versatility and is suitable for all types of tablets. STYL’ONE has been developed for mono-, multi-layer (max. 5 layers with 3 different products) and core tablets (Tab-in-Tab).With its ability to replicate all types of rotary production presses and the intelligent PAT software ANALIS, the STYL’ONE is a most valuable instrument, saving you time, powder and thus money during the develop- ment of new formulations. Apart from developing new formulations, the STYL’ONE can also be utilised to opti-mise compression behaviour, or to trouble-shoot errors in existing processes.

STYL’ONE series is available in twoconfigurations:• STYL’ONE Classic• STYL’ONE Evolution

STYL’ONE Classic – for smart and economic tablet development

The STYL’ONE Classic features a produc- tion speed of up to 900 tablets (mono-layer) per hour and full instrumentation for punch displacement, compression- and ejection force measurements. It allows to set cus- tomised cycles for filling phase, upper punch approach phase, compression phase, relaxation phase, ejection phase, selection phase, upper punch withdrawal phase, all adjustable between 5 milliseconds and 2 seconds. Automatic controlled compaction studies, based either on force or displace-ment, save time (e.g. 10 tablets in a row with compression forces from 10 kN to 19 kN).

The STYL’ONE Classic can compress tab- lets of up to 40 mm tablet diameter, up to 34 mm filling depth and up to 50 kN pre- and main compression force.

STYL’ONE Evolution – from research to scale-up at production speed

STYL’ONE Evolution can perform controlled automatic compaction studies in addition to force and displacement controlled com-paction cycles. It allows real replication of production presses with punch acceleration of up to 2.6 g and 390 mm/sec compaction speed. The high performance single stroke tablet press has an output of up to 1,750 tablets (mono-layer) per hour. Therefore scale-up to realistic production speed (e.g.100 rpm on a KTP 420X) is pos-sible. The availability of press profiles for all major rotary tablet presses ensures a fast and easy setup phase. The roller compaction package RoCo™ allows the production of ribbons and gives you a tool for easy granulation studies. The STYL’ONE Evolution is available as an enhanced operator safety version and as a high containment package.

Exploiting TechnologiesAccessories

RQ 100 ToolingTablet transportation

One partner responsible for all

Romaco Kilian delivers more than just tablet presses. We provide tableting solutions from a single source. With Kilian accesso-ries we enable our cus tomers to take full advantage of integra ted custom fitting. This allows for better performance through the entire process. We provide support from one contact without interfaces. A true one stop shop!

TabTrans - for fast, clean, compact and damage-free tablet transfer TabTrans is more than just a conveyor belt. lt is more than just bringing tablets from A to B. lt isolates the tablets, it controls and guides even fragile effervescent tablets intact to any downstream equipment. lt de-dusts tablets on the way to the downstream equipment and has an integrated metal detection and reject /sample gate. This all-in-one compact unit signifi-cantly reduces the overall line length.

Tablet check units Direct connection with the Kilian tablet press enables our customers to have sample tablets checked automatically. The collected data can be used for auto-matic in-process control with real inline weight regulation and be displayed in the batch report.

Deduster/Metal checkTablet dedusting and metal detection are integrated and controlled by the tableting system. Available from different brands and in various executions.

External lubrication system External stearate spraying and dosing device for the efficient compaction of sticky products. This lubricates the punch pressing surfaces and die walls for an improved tab-let quality while keeping the ejection forces at the lowest possible level. Vacuum cleanerlndustrial vacuum cleaners perfectly fitted to the requirements of the tablet press.

Bulk fill Next step in a fully automated pharma production. Automatic drum or container change controlled via your HMI.

Transport trolley/Storage device For optimised die table change, easy transportation and safe storage – perfectly adjusted to your equipment.

Change part storage trolley Lockable and movable storage device for a 2nd set of change parts, providing sys-tematic part storage with shadow-board system for completeness check at a glance.

Tooling High quality compression tools matching the required application, available for all different tool standards.

Compression tool storage and cleaning Professional equipment for fast and economic tool cleaning and storage.

Pressure measuring for scale-upDetailed project analysis Detailed product analysis

Romaco Kilian - KiTech KiTech, Romaco Kilian‘s test laboratory, aims to provide customers with direct access to a vast range of know-how in the field of powder analysis, from granulation through compression to analysis of the end product.Alongside compression tests and studies or training for customer employees, Romaco Kilian also particularly focuses on ways to optimise tableting processes and systems in order to achieve maximum overall equip-ment effectiveness (OEE).

Analysis – scale-ups – training • Optimal testing of product and tableting

properties in the lab and on laboratory presses

• Advice on product optimisation using different granulation methods

• Scale-up simulations for all large rotary presses

• Scale-up verifications on production pres-ses

• Six fully equipped pressing rooms and three conference rooms for compression tests and project surveys

• Training for operating and maintenance staff on various levels ∙ Basics ∙ Advanced ∙ Pro

Enhanced performance and efficiency• Analysis and optimisation of all machine

parameters to enable full use to be made of capacity and enhance efficiency

• Access to all current machine features such as: ∙ Different fill shoe systems ∙ Smooth running compression rollers

• Development of new machine features for specific customer products

• Optimisation consulting for existing processes

Exploiting TechnologiesRomaco Kilian - KiTech

Creating Value – Romaco generates added value for the customer across the entire life cycle of its solutions

• Romaco is interested in a long-term solution partnership with its customers

• Romaco is familiar with its customers’ critical success factors throughout the different life cycle phases of our jointly developed solutions

• The range of services from Romaco is specifically designed for these phases and is delivered through the appropriate modular components

• Romaco optimises the internal process- es so that the customer can benefit from more secure decisions within the time gained

• In April 2014 the new business unit Romaco Systems was founded within the Romaco Group: the aim of this unit is to integrate the offering of the Romaco Group into comprehensive solutions

We understand the business model of our customers and with a diverse portfolio we offer the best price/perfor-mance ratio for generating additional cash flow.

Benefit for the customer

Across the entire life cycle• Minimal life cycle costs and low TCO guar-

antee fast amortisation of the financial investment

• The wide range of customer service prod-ucts ensures sustainable value creation

In the investment phase (designing value)• Professional consulting to increase deci-

sion-making security• Short processing and delivery times give

maximum scope for investment decision and thus optimum decision flexibility

• Customised solutions development for the optimum preparation of the imple-mentation phases (ramp-up and production)

• Reliable and customer-orientated proj-ect management according to efficient milestone principles provides professional delivery

In the ramp-up phase (leveraging value)• The production phase is reached more

quickly due to shortening of ramp-up• Transfer of expertise provides increased

security to the customer in implementing production systems at the highest level

• Minimisation of ramp-up costs

In the production phase (harvesting value)• Maintenance of the value stream due to

quick customer service response times• Best delivery times in service, format and

spare parts• Consulting on the optimisation of the OEE• Continuous training of the customer team• Extension of the life span

Creating Value describes our constant willingness to secure our customers’ – and our own – financial success.

Creating Value

Reliable – competent – globalFrom installation through the entire service life of the plant

Maintenance• Telephone support: qualified and prompt

processing of issues and questions• Internet remote maintenance: digital

access for fast and safe fault diagnosis• On-site service: the technicians of

Romaco Kilian will provide assistance on customer demand

• Maintenance contracts: preventive actions minimise the failure rate

• Machine calibrations

The Romaco Kilian academy: training on different levels on the following topics• Machine operation • Optimisation of the compression process• Special training for customer-related

tableting challenges• Access to all fields of knowledge:

pharmaceutics, mechanics, electronics

Pharmaceutical manufacturers who choose Romaco Kilian get more than just a high-quality machine. Romaco Kilian cus-tomer service is based on more than 100 years of experience in tableting and goes well beyond maintenance work and spare parts supply. The specialists of Romaco Kilian will find solutions even for the most complex applications or products and can maximise their customers’ production speed and the product quality.

Additional services at a glance:

Spare parts, format parts and change parts • Consistent quality monitoring• Fast and reliable delivery thanks to

short cycle times• High percentage of internal production

with durable special materials, manufac-tured according to lean principles

• Each part thoroughly inspected at Romaco Kilian before delivery

• An experienced repair team refurbishes the parts according to the original manufacturers specifications

Machine upgrades and retrofits• “Retrofit project”: state-of-the-art

electrical components for old machines• Individual solutions: customised retrofits

and upgrades for every machine type• Extensive portfolio: options for the

electronic retrofitting and control unit upgrades

• Flexibility in the design of the upgrades: on customers’ site or at Romaco Kilian in Cologne

Set-up• Set-up and training of the operating

personnel• Validation support• Ramp-up service: immediate

achievement of the highest degree of efficiency with the new equipment

Customer Service

Remote Service• Telephone support for real-time

assistance• Expert hot-line connection for quick

troubleshooting and problem solving• Remote connection for online diagnostics

and machine parameters control• Call-4-service function for immediate

assistance• Smart-Glass allows our experts to be

with you on the machine in real time• Parameters and software backups sched-

uled to safely store your setup parameters

2017

/ 05

Romaco Kilian GmbHScarletallee 1150735 KölnGermany

P +49 (0)221 7174 100F +49 (0)221 7174 110E kilian@romaco.com

www.romaco.com