Tableting Solutions for Research and Development

Delivering Solutions – Application Expertise

We are thoroughly familiar with your products and appli-cations! Romaco specialises in engineering technologies for solid pharmaceutical dosage forms. Our concepts and system solutions are inspired by the rich experience and know-how of our 600-strong team of employees.

Creating Value – Enhanced Performance

Profit from Romaco’s excellent value for money! We help you optimise your OEE balance systematically. With our efficient production and service manage-ment, we cut the running costs for your machines and increase your output in the long term.

Exploiting Technologies – Product Diversity

Our product diversity knows no bounds! The modular concept behind Romaco machines and equipment is the key to your success. With seven product lines, we are in a position to respond promptly and flexibly to changing market requirements. Together we are stronger!

Delivering Solutions TabletingThe test laboratory KiTech is a test platform to enable you to familiarise yourself with the different Romaco Kilian technologies. Develop and optimise your tableting pro-cesses and equipment with Romaco Kilian. In KiTech, you can test your procedures and products, optimise flow properties or filling behaviour, create test batches, perform scale-up or project studies. There are

Customer-oriented solutions:

Granulation and coatingThe Romaco Innojet test laboratory, which isfitted out with all the most advanced equip-ment, is the perfect platform for all processdevelopment activities. Various laboratoryand pilot scale systems in the VENTILUS®,AIRCOATER® and VARIOSCALE® series are available for trials. A highly qualified team of experts provides support and advice to customers from all over the world.

different presses available for R&D, small scale and production together with dedicat-ed measuring equipment and experienced process specialists. Six fully equipped press rooms with the latest technology and three conference rooms for project-related discus-sions complete the offer. In the optimisation of the tableting process and troubleshooting during tablet production, Romaco Kilian is a competent partner for its customers.

KiTech services

• Consultation for powder optimisation • Compression trials with laboratory or

production machines• Scale-up analyses• Perfect simulation of all larger rotary

tablet presses• Development of solutions for custom-

er-specific applications and challenges

• Presentation and testing of the latest technology

• Different fill shoe systems for the minimi-sation of the compression force stan-dard-deviation, also when changing the tablet weight

• Training of the customer’s staff on-site or at Romaco Kilian in Cologne

Customer benefits

• Benefit from the expert knowledge of Romaco Kilian with more than 100 years of experience in tableting

• Learn from the Romaco Kilian specialists in the fields of pharmaceutics, mechanics, electronics and mechatronics

• The fastest solutions for customer- specific challenges

• Availability of the latest machines for R&D applications

• Enhancing the production efficiency• Availability of all types of compression

tooling• Benefit from the expert knowledge of the

Romaco Kilian partners: Realisation of nu-merous studies, e.g. with the University of Bonn (Pharmaceutical Technology) and business cooperations

Pharmaceuticals

Food

Chemicals

Granulate

Granulate

Coated seeds

Coated pellets

Hot melt coated granulate

Coated seeds

Coated micro-tablets

Coated apple pieces

Coated fertiliser pellets

VENTILUS® applications by industry

Exploiting Technologies

Laboratory Scale Series V 5A 025VS 040A 5VS 4

Pilot Scale SeriesV 25V 50A 15

VENTILUS® laboratory scale series

VENTILUS® V 5 laboratory scale systems are specially designed for manufacturing small batches from 1,500 ml to 5,000 ml. They are excellent process development solutions for our customers in the pharma-ceutical, food and chemical industries.

• Reliable scale-ups to the V 25 and V 50 pilot scale systems

• Process column made from stainless steel or glass

• Mobile housing mounted on castors• Touch screen with gesture recognition

and WiFi hotspot for remote control using any mobile device

• Optional: integral spray air heater for hot melt processes

VENTILUS® pilot scale series

The pilot scale systems in the Romaco Innojet VENTILUS® series are intended for batch sizes from 10 to 50 litres. They are ideal for clinical samples as well as for analysing and validating process pa- rameters.

• Reliable scale-ups• GMP design according to pharma-

ceutical regulations• Product filled and discharged pneu-

matically• Small batches or clinical samples• Compact system design• Mobile container solution also available

AIRCOATER® and VARIOSCALE®

In the smallest lab scale version, the Romaco Innojet AIRCOATER® A 025 pro- cesses batch sizes from 20 to 250 g; the next model up, the VARIOSCALE® VS 040, is designed for batches from 100 to 400 g. Tablets and solids with a wide range of shapes, sizes and densities are coated rapidly and gently with an aqueous or organic film. The mobile, all-in-one-box AIRCOATER® A 5 (batch sizes from 2 to 5 kg) and VARIOSCALE® VS 4 (batch sizes from 1 to 4 kg) can be used for larger-scale laboratory applications.

• Ideal for developing galenics• Visual checks of the process through

an industrial glass cover• Pilot scale system A 15 available for batch

sizes from 10 to 15 kg

VENTILUS® V 25 and V 50 pilot scale systems

The VENTILUS® applies a homogeneous coating to an API pellet in a MUPS tablet

AIRCOATER® A 025 and VARIOSCALE® VS 040 desktop units

Versatile, multi-functional tablet presses for the application in R&D

Research and development play a key role in the pharmaceutical industry. With the innovative tableting solutions from Romaco Kilian, companies are able to lay the founda-tion of a successful and growing business. With their fully instrumented measuring systems, the R&D and scale-up equipment from Romaco Kilian meet all customer requirements in the fields of research and development and clinical sample production.

Single punch tablet presses for R&D applications and sample production

• Compression of up to five tablet layers with up to three products

• Completely automated and instrumented• Different fill shoe systems for precise

product feeding analysis• Production simulation with any type of

tooling• Compact presses with very little footprint• Also available in containment configura-

tion

“ANALIS” software solutions for R&D applications

• Basic galenics-package: The modular software package for data acquisition and processing of compression tests

• Open system, PC based with interfaces to all common industrial standard sys-tems

• Intuitive operation• Standard reports such as Heckel-plot,

force vs durability as well as customised reports

• Additional software module: In combina-tion with a STYL’ONE R&D press, “ANA-LIS” can run trials fully automated, with different pre-defined parameters

• Extended galenics-package: turns your laboratory press into a fully automated laboratory robot

• Tab-in-Tab testing on a laboratory scale in order to avoid “capping” or to see the core behaviour when pressing

• Multi-layer testing with minimum quanti-ties of product

• Simulation of different rotary production presses and analysis of the scale-up be-haviour at up to 400,000 tablets per hour

• GMP production module with weight moni-toring for sample production

Rotary tablet presses for R&D applications

• Easy handling and robust design similar to large production machines

• Unique scale-up possibilities due to a scientific approach

• Perfect simulation of all larger rotary presses

• Extensive user-specific data acquisition possibilities

Exploiting TechnologiesSTYL’ONE series from Romaco Kilian

Tablet press + measuring instrument

The Romaco Kilian STYL‘ONE is a single-stroke tablet press and measuring instru-ment in one, which targets the following applications:• Research • Production of clinical batches • Scale-up • Product optimisation

It is suitable for compressing any type of tablets as:• Mono-layer tablets • Multilayer tablets (up to 5 layers with

3 different products) • Core tablets

The machine is available in two configura-tions:• STYL‘ONE Evolution • STYL‘ONE Evolution High Containment

The configuration can be tailored exactly to your individual requirements.

The faster and more efficient path to new formulations Thanks to ANALIS, the PAT (process analyt-ical technology) software, the STYL‘ONE can perform fully automatic compression studies in addition to force or displacement controlled cycles. The roller compaction package RoCo™ Pack can be used both to replicate production presses and to manufacture pellets.

It provides a very convenient tool for granu-lation studies.

Realistic scale-upAll standard rotary presses can be replicat-ed on the STYL‘ONE, which allows realistic simulations of production presses with up to 2.6 G punch acceleration at speeds of up to 390 mm/s (e.g. up to 104 rpm on a KTP 420X).

Rapid production support The STYL‘ONE’s simulation capabilities also help optimise existing tableting processes, so that the ideal parameters for the produc-tion press can be determined using less product and in less time.

Inexpensive clinical batches The STYL‘ONE is a high speed single-stroke tablet press which achieves up to 1,750 tablets an hour (in mono-layer mode).

When equipped with the production module for:• Indirect weight control (based on the

filling) • Tablet chute with tablet selection • Batch report and 21 CFR Part 11 software it is perfect for the inexpensive production of clinical batches, thanks also to the quick and easy set-up process.

RoCo™ PackMultilayer (5 layers with 3 products) Replication of production presses

Basic galenics-package• Easy and intuitive operation• Either integrated as part of the press or as

press-independent additional software• PC based, with interfaces for data export

to other common systems• Pre-defined standard reporting for fast

compression analysis• Data such as compression force and ejec-

tion force can be collected and saved for further analysis in every step of the tests, for single tablets or for defined batches

• Easy configuration possibilities for cus-tomer-specific analysis reports

• Enables the import of data and its analysis

Extension module• Automation of the R&D protocol saves

time and powder• Generates specific compression pro-

files (e.g. cosmetics, food, fundamental research)

Multi-layer and Tab-in-Tab module• Individual customer parameters deter-

mine the process of the compression tests, each layer of a multi-layer tablet can be pressed with different profiles

Exploiting Technologies“ANALIS” software solutions for the R&D process

Production module• For the documentation of clinical samples,

all common quality data will be collected• Weight monitoring, stearate spraying

system, tablet sorting (good/bad) • Best batch quality

Advantages• Shorter development times• Easy data exchange with different superi-

or systems• Fully automated execution of test runs

On-line help Compression curvesDefinition of the layers

Exploiting TechnologiesKIM – Kilian In-line Measurement system

The window to the inside of a tablet

The Kilian in-line measurement system (KIM) for the STYL‘ONE Evolution is a non-destructive method for determining powder deformation properties. Ultrasonic sensors in the upper and lower punches transmit and receive transverse and longitu-dinal sound waves. The powder is analysed up to 5,000 times per second during com-paction. The compression force and the sound veloc-ity are subsequently shown as a function of the density.

The Poisson’s ratio, which is an indicator of the pressure transmitted to the die wall, can then be derived from this information together with the modulus of elasticity of a powder.

Quicker than ever to the perfect formu-lation KIM supplies quantitative values for a powder’s deformation characteristic (elastic, plastic, brittle).

APIs and excipients can be combined with one another systematically – right from the start!

KIM thus quantifies any changes to the mixture of active process ingredients and excipients compared to previous test series and points the way for further optimisations. Trial & error tests can be dispensed with in favour of more targeted development pro-cesses, which save development time and make do with less product – for a perfect formulation that is quality optimised.

Process analysis and optimisationKIM measures the influence of a granulation process on tabletability, so that the process as a whole is optimised. Analyses based on KIM also help optimise the production process for existing products depending on the tableting speed; the para-meters of the production press can then be adapted accordingly.

The determination of the percolation threshold reveals the minimum required amount of an excipient during the research phase, so that this substance’s deformation characteristic is the dominant mechanism of product tabletability. The optimum exci-pient particle size can thus be established for a product which already exists.

Deformation characteristicOperating principle Tableting speed

Compact rotary press for R&D applications

The KTP 180X is a rotary tablet press for the pharmaceutical industry. The equipment of-fers unique scale-up possibilities which are based on a scientific approach. The compact machine is the ideal solution for R&D appli-cations and is also suited for clinical batches and small batch production. It is available in two configurations: • KTP 180X Laboratory• KTP 180X Production

Exploiting TechnologiesRomaco Kilian KTP 180X

Unique features from Romaco Kilian offer efficient processes for R&D applications• 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 windows: Minimisation of change-over and cleaning times

• Mechanical area completely accessible for maintenance work

• Easy access to all product contact parts and 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

Easy cleaningSelf-explanatory menu Easy access

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

Customer Service

Remote Assist with smart glassPartGuardTraining

Upgrades &

Retrofits

Training&

Seminars

RemoteAssist

Maintenance

Die tables &

cam tracks

High-tech machining center – for highest precision

Seamless quality controlaccording to ISO 9001

Quick delivery due to lean production

Expert hotline – real-time telephone support

Remote-connection for online diagnosis and check of the machine

parameters

Call-4-Service – immediate support at the push of a button

Romaco Kilian Academy:

Seminars and training for all �elds of tableting (based on more than 100 years of tableting experience)

Scheduled training per calendar year and individually planned on request

Maximum Output with minimum wear thanks to optimal maintenance

Maintenance contracts for regular checking, calibration and maintenance of the equipment

MQ included (maintenance quali�cation) in each maintenance

For each machine type:

Retrofit-kits: turnkey solutions with electrical cabinet, control unit and HMI

E-Upgrades: newest control unit and HMI

Upgrades to new/better machine features (e.g. smooth-running

pressure rollers)

2018

/ 06

Romaco Kilian GmbHScarletallee 1150735 KölnGermany

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

www.romaco.com