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

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

2 XL 800: Packed with Innovations: The largest member of the KORSCH family of rotary presses for the pharmaceutical industry, the KORSCH XL 800 was designed and developed for high-volume 24-hour production. This modular power pack is full of proprietary technology. 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 % 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. KORSCH XL 800 Technical Data Number of punch stations Number of compression stations Execution EU/TSM BBS BB B D D35 Main compression force max. Rolle 250 mm kn Precompression force variable max., Roll 250 mm kn Precompression force, alternative, Roll 110 mm kn Bi-layer-capability optional Yes Yes Yes Yes Yes Yes Tablet diameter (max.) mm Filling depths, single-layer max. mm Press speed min Tablet output, single-layer max. tabs/h Tablet output, bi-layer max. tabs/h Pitch circle diameter mm Height of the tablet max. mm 8,5 8,5 8,5 8,5 8,5 Machine dimensions mm/l x W x H x x Dimensions are identical for all versions Motor KW 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 regulations.

3 A New Dimension in Performance XL The multi-function column The 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 stations Four identical, completely enclosed compression roller columns. Pre and main compression force of 100 kn. Hydraulic retraction for cleaning and turret removal. Digital display of roll position on touch screen HMI. 3 The exchangeable turret New single-sided turret bearing assembly. Turret removal in 10 minutes. No validation/qualification necessary following turret change. 4 The drive system The frequency-controlled servomotor and the planetarygearbox 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 plate Central machine component with patented bearing system for smooth, vibration-free operation. 6 The head piece Self-supported construction. New window design with vibration damping elements. Impact resistant MAKROLON window construction. 7 Power feeder New, lightweight 2-chamber feeder design with frequency drive control. 8 The dust extraction system New dust extraction design minimizes material loss to 1%.

4 Convincing details... Adaptable: Modular design The 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 Head piece Material feed Automatic window Illumination Air intake Multi-function column Utility lines Hydraulic system for compression rollers Turret drive Control cabinet Operator interface Allen Bradley-PLC or SIEMENS SPS control Control unit PharmaControl Single tablet rejection Color touch screen operator interface 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 Printer interface Data storage for all data to permit seamless documentation Access openings Utilities for peripherals Base plate Height-adjustable feet Stainlesssteel base floor panels Peripherals Tablet deduster Metal-detection unit Tablet output Tablet collection system Tablet sampling unit Dust extraction unit

5 Versatile: Ultimate Flexibility Single-layer tablets Variant 1: XL 800 double rotary press with pre- and main compression force of 100 kn Variant 2: Pre-compression force 20 kn, main compression force of 100 kn WipCon Variant 7: Glovebox access to compression zone for product containment applications. 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. WIP Variant 6: XL 800 with wash-in-place capability Coated tablets Variant 5: Optional 3C package for the production of compression coated tablets. WIP

6 Revolutionary: The multi-function column This is the central assembly of the XL 800 and features welded-steel construction covered with stainless steel panels. 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

7 Flexible: The exchangeable turret The 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

8 The head piece enclosed by stainless steel panels inside and outside with optionally available with cellular lock Columnless: The head piece The head piece is mounted directly on the multi-function column. Self-supported columnless welded-steel construction guarantees optimum access to the compression compartment. The head piece supports three generously dimensioned MAKROLON windows that completely enclose 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. Identical: The compression roller stations The 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 adjustment, the press force sensors and the roll position measurement 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

9 Vibration-free: The base The base houses the vibration-control elements that support 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 dimensioned access openings with doors to the right, left and front. Two central units are provided for the connection of peripherals. Separate: The control cabinet The stainless steel cabinet contains all necessary controls and instrumentation as well as the menu-operated machine 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 screen The operator interface features a Siemens/WinCC or Allen-Bradley/WonderWare configuration. The touch screen permits comprehensive machine control, including password 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 compression room, or mounted in a swing arm on the head piece of the machine.

10 Many good reasons... Uncompromising: The new efficiency The 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 combination with the improvements in exchangeable turret technology, 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 Engineering KORSCH 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-thewall) 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. 1 KORSCH engineers offer customized, application specific support to insure peak performance and optimal processing parameters. 1. Technical area 2. Multi-function column 3. XL White GMP area 5. Control cabinet

11 Compliant: 21 CFR Part 11 Title 21, Code of Federal Regulations, Part 11, which establishes 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. Information on FDA 21 CFR Part 11 Electronic records / Electronic signatures Requirements KORSCH XL 800 Batch data management Access control Audit trail Access security Batch function Log-in function Complete audit trails Mandatory password changes Comprehensive: Customer Support & Services KORSCH offers an extensive customer support system on a global basis, including comprehensive programs for equipment installation, equipment qualification, training certification, and process optimization. KORSCH offers 24/7 technical 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 system for equipment design and development. The result is exceptional documentation which simplifies spare parts identification and order processing. i The KORSCH 24/7 Service Hotline: The KORSCH America Service Hotline: KORSCH-1 KORSCH representatives and KORSCH subsidiaries are present in over 40 countries worldwide.

12 KORSCH After Sales Support OEM Spare Parts Non OEM spare parts may seem inexpensive, but in the end, they are more costly. KORSCH OEM spares are manufactured 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. Service / Maintenance Service from KORSCH ensures safe and reliable performance of your coater, it will help to minimise down time, maintain 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. Training Comprehensive training certification programs 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. KORSCH 24/7 Service Hotline: berlin@korsch.de KORSCH AG Breitenbachstraße Berlin Deutschland/Germany Tel Fax berlin@korsch.de KORSCH America Inc. 18 Bristol Drive South Easton, MA 02375, USA Tel Fax sales@korschamerica.com Hotline: KORSCH-1 KORSCH Asia Pacific German Centre Suite 4190 Jl. Kapt. Subijanto No Tangerang-BSD Indonesien / Indonesia Tel Fax roestel@korsch.de KORSCH Schweiz GmbH Holdermattstrasse 11 P.O. Box Trimbach Schweiz/Switzerland Tel Fax gauer@korsch.de KORSCH UK Tel. +44 (0) Fax +44 (0) Mobile: +44 (0) avery@korsch.de KORSCH France Tel. +33 (0) Mobile: +33 (0) balfin@korsch.de /2010