Pharmaceutical Rotary Presses

XL 100/Pro/WipCon®

Small-Scale Rotary Tablet Press

For Product Development

And Clinical Trials

XL 8

00

XL 4

00

XL 20

0

XM 12

XL 10

0XP

1

The KORSCH XL 100/Pro/WipCon® ...

Advantages

✓ Flexible R&D Concept – Fully portable small scale machine – Exchangeable turret capability for any

size tablet development – Only very small quantities of powder

are needed – Reduced volume feeder design

✓ Design Advantage – Ergonomic design permits unpreceden-

ted access to the compression zone – Production scale performance in a

development scale machine – Operator convenience and operational

excellence – Ultimate convenience for maintenance

and service

✓ Easy Set Up – Manual hand wheel for tablet set-up – User-friendly operator interface – Minimum number of control screens

for ease of use

✓ Full Instrumentation – Upper/lower/pre/main compression

force – Ejection force – Theoretical punch displacement

✓ Touch Screen Control – Press force control and single tablet

rejection capability – Comprehensive data collection and

analysis capability – Real time display and batch data

documentation

✓ Full Documentation – Full GMP compliance: documentation

according to GAMP4 with risk analysis available

– Comprehensive validation protocols and on-site execution

✓ Containment Solution – WipCon® solution available for potent products

XL 100

... for Formulation Development and Small Batch ProductionThe KORSCH XL100 is an innovative tablet press for product development, scale-up, and clinical batch produc-tion. The XL100 offers a new standard in GMP, extreme accessibility to the compression zone, an exchangeable turret for maximum flexibility, and a combination of quick-disconnects and smooth surfaces that permit fast clea-ning and changeover. The machine is extremely robust and rugged, offering a pre compression capability of 10 kN, and a main compression capability of 60 kN, contained in a unique structu-ral design that eliminates vibration to the head piece and base frame. Every technical detail of the XL 100 has been meticulously developed for operator convenience and operational excellence. From the special steel for the turret and die table, to the precision toothed belt for the main drive, the XL 100 offers pro-duction scale performance in a develop-ment scale machine.

XL 100 For Product Development and Clinical Trials

✓ Small Scale✓ Exchangeable Turret Capability 12/10/8 EU or TSM Tools✓ 10 kN Precompression Force✓ 60 kN Main Compression Force✓ 120 RPM Press Speed Capability✓ Fully Instrumented✓ Fully Portable✓ Large Touch Screen Flush Mounted for Ergonomic Operation✓ PharmaResearch® and PharmaControl® Upgrade Possible

XL 100 Pro For Product Development, Clinical Trials and Comprehensive Data Analysis

✓ Integrated PharmaControl® (weight control)✓ Single Tablet Rejection with Reject Log✓ Batch Data Recording / 21 CFR Part 11 Compliant✓ Integrated PharmaResearch®

✓ Extensive Data Acquisition and Analysis✓ Graphical Display of Forces and Displacement✓ Statistical Evaluation and Reporting✓ Complete Data Storage and Export

XL 100 WipCon® For Contained Product Development and Clinical Trials

✓ Isolator Concept for Highest OEL Capability OEB 5 ✓ RTP for Powder, Tablets, Tools and Parts Transfer✓ Split Valve Connections for Material Inlet and Tablet Outlet OEB 4✓ Cleaning Philosophy through Glove Ports: Manual Vacuum, Water Spray Gun, Compressed Air and Manual Drying and Decontamination✓ Negative Pressure Control in Isolator/Glove Box (-80Pa)

Faster Development

with Less Material

The XL 100 Pro permits the execution of full compaction studies with limited material quantities. The XL100 may be fully instrumented for the measure-ment of precompression force, main compression force, ejection force (seg-mented cam), and scrape off force, to permit product development para-meters to be evaluated and stored. KORSCH offers the PharmaResearch®, a Windows based data acquisition system that permits storage, analysis, and export of compression and ejec-tion force data. In combination with PharmaControl® 3 press force control or PharmaResearch®, the XL100 Pro of-fers a fully integrated solution for expe-dited product development and clinical batch production.

Optional

Product DevelopmentModule:

PharmaResearch®

Data Collection / Analysis

Optional

Clinical BatchModule:

PharmaControl® 3Automatic Weight Control

Machine Control Module (all Pro Machines)Secure Login, Parameter Adjustments, Display of Press Forces,

Event Log, Alarm Log, Product Recipe

The Pro CapabilityFull Compaction Studies With Limited Material Quantities in One HourFully Documented Clinical Batches with Event, Alarm, and Reject Logs

Touch Screen Control

✓ An integrated, color touch-screen displays critical process para- meters and offers a simple and user-friendly control environment.

Multi-Function Column

✓ Permits direct access to the complete electrical system, including the PLC and all related compo-nents.

Carrier Plate

✓ Eliminates the transmis-sion of vibration from the compression zone to the machine frame, resulting in quieter and smoother operation.

Machine Base

✓ Permits direct access to the main motor, feeder motor, and mechanical drive system.

The XL 100/Pro/WipCon® Concept in Detail

XL 100, XL 100 Pro

Compression Roll Assembly

✓ Provides a 10 kN pre and a 60 kN main compression force capability and the ability to swing beyond the pitch circle of the turret, to facilitate turret exchange.

Power Feeder

✓ A variable speed rotary feeder provides a production scale design on a development scale machine.

✓ A gravity feeder may be easily interchanged to permit the evaluation of product flow properties.

Exchangeable Turret

✓ The exchangeable turret offers extreme versatility, with the ability to utilize B, BB, and D press tools on a single machine.

✓ The turret may be easily removed in less than 10 minutes.

✓ Mixed turret offering D, B and BB press tools

in a single turret.

Compression Zone

✓ Completely isolated and fully accessible, the press zone offers a new standard in GMP for a development scale machine.

✓ Extensive quick disconnect design permits rapid dis-assembly and cleaning.

XL 100, XL 100 Pro

PharmaResearch®

Comprehensive Data

Acquisition and Analysis

PharmaResearch® is a Windows-based system that offers data acquisition and analysis for press force and punch dis-placement data. The system displays press force waveforms in real time and permits on-demand data collec-tion. The system can collect data lo-cally or write the data to a networked SQL server for centralized data storage and analysis. The system can work with the following tablet press instru-mentation:✓ Precompression Force✓ Main Compression Force ✓ Ejection Force✓ Scrape-Off Force✓ Die-Wall Force✓ Punch Displacement

The data analysis is automatic and provides a statistical assessment of:✓ Peak Force✓ Area Under The Force-Time Curve✓ Contact Time✓ Rate of Force Application✓ Rate of Force Decay

XL 100 Pro Development & Analysis

The XL 100 Pro includes production style controls

for clinical batch production and an integrated

data collection and analysis capability for product

development. The result is a comprehensive and

user-friendly control system that permits fully docu-

mented clinical production, with the ability to collect

and analyze data at any time.

The XL 100 Pro offers an expedited product develop-

ment process using minimal material quantities and

a streamlined clinical batch capability.

Advantages

✓ Press Force Control and Data Acquisition in an

Integrated Control Platform

✓ Fully Self-Contained and Portable

✓ Large Touch Screen Flush Mounted for Ergo-

nomic Operation

✓ Pull Out Key Board and Integrated Mouse

✓ Expedited Compression Force Profiles

✓ On Demand Sampling

✓ 21 CFR Part 11 Compliance

✓ Network Connectivity to SQL Server for Central

Data Storage

✓ Workstation Data Analysis Module for Network

Solution

Properties

✓ Free format graphic and statistical analysis to

allow the export of many data formats.

✓ Reports can be automatically generated in a varie-

ty of data formats with and without an electronic

signature.

✓ Charts can be dimensioned, comments added,

formatted and exported before being processed

in the MS Office world.

✓ Fingerprint recording during production. Overlay

Technology allows safe and quick recognition of

subsequent waveforms.

✓ Correlation Analysis to establish a “Knowledge

Database” that serves to easily compare the

properties of known and unknown ingredients.

The database enables the user to correlate mea-

suring values from the tableting process and

derived and externally recorded quantities (e.g.

tablet hardness, density, etc.).

✓ Compaction Analysis allows evaluations e.g.

Heckel plot, energy, work of compression, con-

tact time, compressibility.

✓ “Built-in” PAT function, i.e. the database is au-

tomatically filled with process data thereby hel-

ping to define and complete PAT requirement for

Knowledge Space and Design Space.

Data Acquisition

KORSCH XL 100 / XL 100 WipCon® Technical Data

Technical modifications reserved. The new KORSCH XL 100 / XL 100 WipCon® is in accordance with the valid safety and accident prevention

regulations and with the regulations of the workmen´s compensation board of chemistry. The new KORSCH XL 100 / XL 100 WipCon® has the

CE certificate and has been tested according to EMC regulations.

XL 100 WipCon® Development & Analysis

✓ Minimum space requirements, portable design

✓ Best cleaning / decontamination results for

product specific demands

✓ Optimized glove port configuration

✓ All types of make/break connections possible

✓ High containment range for lab scale and

medium size batches OEB 5 (1 μg/m³ > OEL >

0.1 μg/m³) with RTP transfer system

✓ Medium containment range for small production

batches OEB 4 (10 μg/m³ > OEL > 1 μg/m³) with

split valve connections

✓ Connection to Wip tablet deduster on same

containment level OEB 4 (10 μg/m³ > OEL >

1 μg/m³)

✓ Negative pressure control and safe-change filter

box attached or separate, depending on space

availability

Number of Punch Stations 12 10 8

Number of Compression Stations 1 1 1

Press Tools EU/TSM BB B D

Main Compression Force kN 60 60 60

Precompression Force kN 10 10 10

Tablet Diameter (max.) mm 13 16 25

Filling Depths (max.) mm 6-10-16-18 6-10-16-18 6-10-16-18

Turret Speed min-1 20-120 20-120 20-60

Tablet Output tabs/h 86.400 72.000 29.000

Pitch Circle Diameter mm 118 118 118

Tablet Thickness (max.) mm 8 8 8

Machine DimensionsXL 100 StandardXL 100 Pro

mm/L x W x H818 x 665 x 1.584

1.335 x 665 x 1.665818 x 665 x 1.584

1.335 x 665 x 1.665818 x 665 x 1.584

1.335 x 665 x 1.665

Machine Weight kg 530 530 530

Electrical Load KVA 4.5 4.5 4.5

High Containment

Solution

The KORSCH XL 100 WipCon® is an in-novative tablet press and offers a com-prehensive wash-in-place (OEB 3) and high containment (OEB 4 / 5) capa-bility for product development, scale-up, and clinical batch production of highly hazardous products. Therefore, the KORSCH XL 100 WipCon® comple-ments operator safety and operational excellence. The XL 100 WipCon® can be fully instrumented for the measure-ment of precompression force, main compression force, ejection force (seg-mented cam), and scrape off force to permit product development para- meters to be evaluated and stored.

Containment

KORSCH 24/7 Service Hotline: +49 30 43576-300 • E-Mail: berlin@korsch.de

97

00

04

08

–0

3/2

00

9

KORSCH After Sales Support

KORSCH AG

Breitenbachstraße 1

13509 Berlin

Deutschland/Germany

Tel. +49 30 43576-0

Fax +49 30 43576-350

E-Mail: berlin@korsch.de

KORSCH Schweiz GmbH

Holdermattstraße 11

P.O. Box 428

4632 Trimbach

Schweiz/Switzerland

Tel. +41 62 21282-92

Fax +41 62 21282-94

E-Mail: gauer@korsch.de

www.korsch.de

KORSCH America Inc.

18 Bristol Drive

South Easton, MA 02375, USA

Tel. +1 508 238-9080

Fax +1 508 238-9487

E-Mail: sales@korschamerica.com

Hotline: +1-800-KORSCH-1

KORSCH UK

Tel. +44 (0)151 427 8909

Fax +44 (0)151 427 8909

Mobile: +44 (0)7780 708 788

E-Mail: avery@korsch.de

PT. KORSCH Asia Pacific

German Centre Building

Jl. Kapt. Subijanto Dj., BSD

15321 Tangerang,

Indonesien/Indonesia

Tel. +62 21 5376-216/-217/-218

Fax +62 21 5376-219

E-Mail: roestel@korsch.de

KORSCH France

Tel. +33 (0)4 72 71 48 34

Mobile: +33 (0)6 31 10 79 96

E-Mail: balfin@korsch.de

Service / MaintenanceService from KORSCH ensures safe and reliable performance of your press, it will help to minimise down time, maintain yield optimisation and ultimately assist in extending the life of the tablet press. Regularly scheduled maintenance will ensure a reliable and smooth running tablet press. Call us and make use of our expertise!

OEM Spare PartsNon OEM spare parts may seem inex-pensive, but in the end, they are more costly. KORSCH OEM spares are manu-factured to original tolerances and from specified materials, to insure precision, performance, and extended working life.All critical spare and wear parts will be delivered worldwide from stock within 24-hours.

TrainingComprehensive training certification pro-grams to establish internal experts and insure self-sufficient operation. We train on theory and practice in tableting, ma-chine set up & operation, calibration and trouble shooting at your premises or in the KORSCH TRAINING CENTER.