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Pharmaceutical Rotary Presses XL 800 The modular powerhouse for maximum performance XL 800 XL 400 XL 200 XM 12 XL 100 XP 1

XL 800 - EquipNet · XL 800: Packed with Innovations: The largest member of the KORSCH family of rotary presses for the pharmaceutical industry, the KORSCH XL 800 was de-

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Pharmaceutical Rotary Presses

XL 800

The modular powerhouse

for maximum performance

XL 8

00

XL 4

00

XL 20

0

XM 12

XL 10

0XP

1

XL 800: Packed with Innovations:

The largest member of the KORSCH family of rotary presses for the pharmaceutical industry, the KORSCH XL 800 was de-signed and developed for high-volume 24-hour production.

This modular power pack is full of proprietary technol-ogy. With its impressive compression force of 4 x 100 kN and exchangeable turret with up to 95 punch stations, the XL 800 increases tablet output by approximately 19 to 34 %

Number of punch stations 95 87 71 59 45

Number of compression stations 2 2 2 2 2

Execution EU/TSM BBS BB B D D35

Main compression force max.

Rolle 250 mm kN 100 100 100 100 100

Precompression force variable

max., Roll 250 mm kN 100 100 100 100 100

Precompression force,

alternative, Roll 110 mm kN 20 20 20 20 20

Bi-layer-capability optional Yes Yes Yes Yes Yes Yes

Tablet diameter (max.) mm 11 13 16 25 34

Filling depths, single-layer max. mm 18 18 18 22 22

Press speed min-1 5–90 5–90 5–90 5–90 5–60

Tablet output, single-layer max. tabs/h 1.026.000 939.600 766.800 637.200 324.000

Tablet output, bi-layer max. tabs/h 513.000 469.800 383.400 318.600 162.000

Pitch circle diameter mm 840 840 840 840 840

Height of the tablet max. mm 8,5 8,5 8,5 8,5 8,5

Machine dimensions mm/L x W x H 2.264 x 1.387 x 2.095 – Dimensions are identical for all versions

Motor KW 22 22 22 22 22

KORSCH XL 800 Technical Data

Technical modifications reserved.

The maximum compression force varies as a function of the tablet/

punch size and output. The maximum output varies as a function

of the material, tablet/punch size and compression force.

The new KORSCH XL 800 is in accordance with the valid safety

and accident prevention regulations and with the regulations of

the workmen´s compensation board of chemistry. The tablet press

has the CE certificate and has been tested according to EMC regu-

lations.

compared to competitive technology. The XL 800 features fast retooling, extremely smooth operation, easy access to all components, fast cleaning, minimal material loss and outstanding tablet weight control. Exclusive KORSCH “through-the-wall” technology permits maintenance during production to reduce downtime to a minimum. The XL 800 fulfills all GMP and FDA requirements and is 21 CFR Part 11-compliant.

A New Dimension in Performance.

XL 800

1 The multi-function columnThe key to the through-the-wall concept. Contains all drive components and connections for utilities. Double door for access to the technical area.

2 The compression roller stationsFour identical, completely enclosed compression roller col-umns. Pre and main compression force of 100 kN. Hydrau-lic retraction for cleaning and turret removal. Digital display of roll position on touch screen HMI.

3 The exchangeable turretNew single-sided turret bearing assembly. Turret removal in 10 minutes. No validation/qualification necessary following turret change.

4 The drive systemThe frequency-controlled servomotor and the planetary-gearbox are housed in the multi-function column. Special

toothed belt for power transmission for smooth operation with no temperature increase that could affect production.

5 The carrier plateCentral machine component with patented bearing system for smooth, vibration-free operation.

6 The head pieceSelf-supported construction. New window design with vi-bration damping elements. Impact resistant MAKROLON window construction.

7 Power feederNew, lightweight 2-chamber feeder design with frequency drive control.

8 The dust extraction systemNew dust extraction design – minimizes material loss to 1%.

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Convincing details ...

Adaptable:

Modular designThe XL 800 is based upon the use of standard modules. Since many of the components are identical with the ones used in other proven members of the XL family, production is particularly economical. In addition, the modular design

permits unlimited flexibility to accommodate a wide range of production requirements. The XL 800 platform offers a single layer, bi-layer, double-sided bi-layer, and product containment (glovebox and WIP) capability.

Aligned:

Modular Machine Design

Peripherals

• Tablet deduster• Metal-detection unit• Tablet output• Tablet collection system• Tablet sampling unit• Dust extraction unit

Head piece

Material feed • Automatic window • Illumination • Air intake

Multi-function column

Utility lines • Hydraulic system for compression rollers • Turret drive

Operator interface

Color touch screen operator inter-face installed on swing arm, control

cabinet or wall

Carrier plate

Vibration-control elements, turret and turret bearing assembly • 4

identical compression-roller stations • Cam-track holder • power feeders

• Drives for turret and feeder assemblies • Discharge chute

Machine base

Access openings • Utilities for peripherals

Base plate

Height-adjustable feet • Stainless-steel base floor panels

Control cabinet

Allen Bradley-PLCor SIEMENS SPS control

Control unit

PharmaControl®

Single tablet rejection

Printer interface

Data storagefor all data to permit seamlessdocumentation

Versatile:

Ultimate Flexibility

Single-layer tablets• Variant 1: XL 800 double ro-

tary press with pre- and main compression force of 100 kN

• Variant 2: Pre-compression force 20 kN, main compres-sion force of 100 kN

2+3-layer tablets• Variant 3: 2+3-Layer kit for

the production of 2+3-layer tablets

• Variant 4: Double 2+3-layer kit to produce two 2+3-layer tablets per revolution.

WipCon® • Variant 7: Glovebox access to

compression zone for product containment applications.

WIP• Variant 6: XL 800 with

wash-in-place capability

WIP

Coated tablets• Variant 5: Optional “3C”

package for the production of compression coated tablets.

Revolutionary:

The multi-function columnThis is the central assembly of the XL 800 and features welded-steel construction covered with stainless steel pa-nels. It connects the machine base with the head piece. The back consists of a double door that permits access to the inside of the column, which contains the following:

• All intake and exhaust air lines for dust extraction and cooling• All electrical connections• Central lubrication unit• Frequency-controlled turret drive• Main gearbox• Power supply and utilities for head piece• Hydraulic unit for automatic adjustment of the four compression-roller columns and the lifting arm for turret changing• Optionally available swing arm for operator interface

Above: Open multi-function column

– the backbone of the machine

Left: Through-the-wall design – double door

for access during production

Flexible:

The exchangeable turretThe one-sided turret bearing system and the lifting arm make it possible to completely remove the exchangeable turret –including dies, punches and the upper cam track– in only 10 minutes. As a result, it only takes 2 to 4 hours to completely retool and clean the machine. No qualification or validation is necessary following the turret change.

Another advantage: Optionally available guide bushings of hardened steel, mounted in the upper and lower turret to

extend production life, and to eliminate the need to replace the entire turret. In addition, die plates of premium steel substantially reduce scoring, and insure peak performance over the long term.

Turrets available for EU or TSM B and D tools. Each turret is equipped with the complete cam track, and the turret service/transport cart.

Above: The turret – easily accessible and

easy to clean

Upper left:. Turret changing–a simple

operation with the hydraulic lifting arm

Lower left: The transport cart – with exchangeable turret

Columnless:

The head pieceThe head piece is mounted directly on the multi-function column. Self-supported columnless welded-steel con-struction guarantees optimum access to the compression compartment. The head piece supports three generously dimensioned MAKROLON windows that completely en-

close the compression compartment. The head piece also includes the lighting for the compression compartment, access openings for the material feed, as well as air and lubricant lines.

The head piece – enclosed by stainless steel panels

inside and outside with – optionally available with cellular lock

Identical:

The compression roller stationsThe machine features four identical, completely enclosed compression roller columns, each capable of providing 100 kN of compression force. The compression columns may be rotated and retracted using a hydraulic drive – to permit easy cleaning, roll service, and turret removal.

The compression roller stations are enclosed by heavy-duty, steel guide columns with ground nickel-plated surfaces, which permit optimal cleaning. Bearings for the upper and lower compression rollers, the servomotors for roll adjust-ment, the press force sensors and the roll position mea-surement system are all mounted inside the column – for service free operation.

The compression-roller column – completely sealed

to prevent the entry of dust or cleaning agents

Vibration-free:

The baseThe base houses the vibration-control elements that sup-port the carrier plate and absorb axial and radial forces. This patented design guarantees vibration-free and extremely silent operation (< 75 dBA).

The welded-steel construction is completely enclosed by stainless steel panels and features generously dimen-sioned access openings with doors to the right, left and front. Two central units are provided for the connection of peripherals.

Separate:

The control cabinetThe stainless steel cabinet contains all necessary controls and instrumentation as well as the menu-operated ma-chine controls.

The cabinet can be installed either in the GMP area or in the separate technical area. The headexchanger is standard.

User-friendly:

The color touch screenThe operator interface features a Siemens/WinCC or Allen-Bradley/WonderWare configuration. The touch screen permits comprehensive machine control, including pass-word login, product recipe, event log (electronic audit trail), alarm history, and batch data reporting.

The touch screen may be integrated into the door of the electrical cabinet, flush-mounted in the wall of the com-pression room, or mounted in a swing arm on the head piece of the machine.

Uncompromising:

The new efficiencyThe KORSCH XL-Series represents the finest technology in tablet compression equipment, with unique features and advantages that permit unprecedented flexibility.

The new TTW (through-the-wall) technology, in combina-tion with the improvements in exchangeable turret tech-nology, offers the ability to fully separate the technical and GMP area, while permitting extremely efficient cleaning and changeover.

The use of a second turret permits even greater efficiency since one turret can be cleaned and retooled off-line, while production continues on the machine.

Capable:

KORSCH EngineeringKORSCH offers a comprehensive array of technical support services to permit each customer to realize the full potential of the XL 800 technology.

Engineering support is offered to design TTW (through-the-wall) applications, and to optimize material feed and tablet handling systems. KORSCH offers integration services for peripheral equipment, including tablet packaging, tablet collection, and tablet dedusting/metal check components.

KORSCH engineers offer customized, application specific support to insure peak performance and optimal processing parameters.

Many good reasons ...

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1. Technical area2. Multi-function column3. XL 8004. White GMP area5. Control cabinet

Compliant:

21 CFR Part 11Title 21, Code of Federal Regulations, Part 11, which es-tablishes the criteria for electronic records and signatures, presents a new challenge for FDA regulated industries.

All electronic data including machine adjustments, machine faults, product recipes, and tablet sampling parameters – must be recorded and stored to insure the full integrity of the production process. The KORSCH XL 800 guarantees full compliance with 21 CFR Part 11 and supports user friendly integration into the document management system and IT infrastructure of our customers.

Comprehensive:

Customer Support & ServicesKORSCH offers an extensive customer support system on a global basis, including comprehensive programs for equip-ment installation, equipment qualification, training certifi-cation, and process optimization. KORSCH offers 24/7 tech-nical support via a SERVICE HOTLINE.

In addition, KORSCH has developed a Partnership Plan with a wide range of advantages for our key customers.

Finally, KORSCH has invested in a complete 3-D CAD sys-tem for equipment design and development. The result is exceptional documentation which simplifies spare parts identification and order processing.

Information on FDA 21 CFR Part 11Electronic records / Electronic signatures

Requirements KORSCH XL 800

Batch data management Batch function

Access control Log-in function

Audit trail Complete audit trails

Access security Mandatory password changes

☎ The KORSCH 24/7 Service Hotline: +49 30 43576-300

The KORSCH America Service Hotline: 1-800-KORSCH-1

i KORSCH representatives and KORSCH subsidiaries are

present in over 40 countries worldwide.

KORSCH 24/7 Service Hotline: +49 30 43576-300 • E-Mail: [email protected]

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KORSCH After Sales Support

KORSCH AG

Breitenbachstraße 1

13509 Berlin

Deutschland/Germany

Tel. +49 30 43576-0

Fax +49 30 43576-350

E-Mail: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

KORSCH Asia Pacific

German Centre Suite 4190

Jl. Kapt. Subijanto No. 1

15321 Tangerang-BSD

Indonesien / Indonesia

Tel. +62 21 5376 263

Fax +62 21 5376 263

E-Mail: [email protected]

KORSCH France

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

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

E-Mail: [email protected]

Service / MaintenanceService from KORSCH ensures safe and reliable performance of your coater, it will help to minimise down time, main-tain process optimisation and ultimately assist in extending the life of the coater. Regularly scheduled maintenance will ensure a reliable and smooth running coater. 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 machine set up & operation, calibration and trouble shooting at your premises or in the KORSCH TRAINING CENTER.