XL 800 - EquipNet · XL 800: Packed with Innovations: The largest member of the KORSCH family of...
Transcript of XL 800 - EquipNet · XL 800: Packed with Innovations: The largest member of the KORSCH family of...
Pharmaceutical Rotary Presses
XL 800
The modular powerhouse
for maximum performance
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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
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☎ 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.