XP 1 XL 100 XM 12 XL 200 XL 400 XL 800 Pharmaceutical Rotary Presses XL 400 FT The World s Most Flexible Tablet Press
KORSCH XL 400 FT : Designed for... Advantages Fast and Easy Change Over Automatic turret change Minimized numbers of parts to dismantle No hand tools Turret change with upper and lower cam track and tooling Design Advantages New lightweight feeder weighs less than 12kg Long filling length for exceptional weight control Both feeder paddles have separate and independent speed adjustments Extreme accessibility to compression area Dust extraction is fully integrated in the lower turret shrouding, with quick disconnects TTW Technology: full separation of technical and GMP area Pneumatic carrier plate, self levelling XL 400 FT Flexible Concept Ultimate flexibility with single layer, multilayer (bi- and trilayer), and corecoating capability Pro version with integrated data collection for the development of 1, 2, 3 Layer and core coated tablets Easy Set Up and Controls User friendly operator interface Minimum numbers of screens for ease of use Reliable tablet rejection and layer sampling at all speeds Automatic weight control of each layer Comprehensive data collection and analysis capability Full Documentation Full GMP compliance, documentation according to cgamp with risk analysis available Comprehensive qualification and validation documentation Containment Solution WipCon solution available for potent applications
... Easy Handling The XL 400 has an impressive record of success and the FT design brings a new level of innovation to the XL 400 platform. The FT design offers an extreme improvement in machine changeover and turret exchange while preserving the major advantages of the XL 400, including exceptional output and precision tablet weight control. The FT design also adds a new dimension of flexibility to the XL 400, including a modular approach to permit the production of single-layer, bi-layer, tri-layer, and core-coated tablets on a single press. The complete compression zone of the XL 400 has been redesigned. The result is a streamlined design which requires the removal of only 13 components, by quick disconnect, to go from full production to turret removal. The disassembly process requires no hand tools, and all components are removed effortlessly. The ejection cam and dosing cam are redesigned into simple modules that are installed with a single quick disconnect. The dust extraction shrouds are ingeniously integrated to the covering of the lower cam section for easy removal and cleaning. A lightweight feeder design preserves the long filling length and precision weight control capability and can be easily removed and disassembled with no hand tools. Fast Change Capability No Hand Tools Required The XL 400 FT features a large feeder for extended feeder dwell time which permits precision tablet weight control at the highest press speeds. The feeder can be easily dismounted, no hand tools are needed. Automatic Turret Change Turret change in 10 minutes Change including all cams and press tools Turret change without hand tools New lightweight lifting arm Accurate turret placement on the service cart The new turret design permits the removal of the entire upper turret, lower turret, and press tools. A lightweight lifting arm is mounted on the internal lift device and the turret is staged for removal. A simple push-button triggers a safe, effortless, and automatic turret removal sequence to place the turret on the service/transport cart. The next clean turret may be automatically put in place once the machine is cleaned. The result is an expedited turret change sequence which is safe and reliable. 5 min 2 min 2 min 1 min Removal of 13 components Compression columns retract & Turret lift Manual swing out of Turret Turret transfer to the transport cart Lowest Noise and Vibration Level Guaranteed Unique patented structural design that eliminates vibration to the head piece and base frame. The result is an extreme reduction in the operating noise level at the highest press speeds. Noise Level Extremely quiet 75 db(a) No Vibrations No product segregation
Multi-Function Platform offers... The KORSCH XL 400 FT offers flexible tabletting technology to produce single-layer, bi-layer, tri-layer, and core-coated tablets. The KORSCH Multi-Function Platform is a patented, modular, design concept that permits the flexible placement of feeders and compression stations on a preconfigured carrier plate, to facilitate the production of single-layer, bi-layer, tri-layer, and core-coated tablets on the same tablet press. The XL 400 FT offers the unique capability to be upgraded at any time. A Multi-Function carrier plate permits this flexibility to be provided in the basic XL 400 FT, with the opportunity to use these conversion modules in the future. The conversion between single-layer, bi-layer, tri-layer, and core-coater configurations may be done easily in the field, without the assistance of KORSCH service personnel. The control system configures itself for each operating mode at the push of a button. The result is the highest flexibility for an unlimited demandoriented use. The Modules Compression Roller Station Modules Modular flexible base plate Feeder Modules 100 kn for high precompression and main compression 20 kn for precompression 5 kn for tamping Small Feeder: 140 mm for multi-layer and core-coating configurations (less filling per layer) Standard Feeder: 330 mm for single and bi-layer configurations Long Feeder: 455 mm for single-layer configuration and material with poor flow Upper Cam Track Modules Lower Cam Track Modules Single-Layer, Pre 100 kn, Main 100 kn Single-Layer, Pre 20 kn, Main 100 kn Bi-Layer, Tamping 5 kn, Pre 20 kn, Main 100 kn Tri-Layer, Tamping L1 5 kn, Tamping L2 5 kn, Main 100 kn Modular compression room Single-Layer, Pre 100 kn, Main 100 kn Single-Layer, Pre 20 kn, Main 100 kn Bi-Layer, Tamping 5 kn, Pre 20 kn, Main 100 kn Tri-Layer, Tamping L1 5 kn, Tamping L2 5 kn, Main 100 kn
... Ultimate Flexibility. Dedicated Single-Layer Application The XL 400 FT is specifically designed to produce single-layer tablets with optimized feeders for long filling lengths. An upgrade for multi-layer production is not possible in this case. The flexible MFP Execution of the machine offers product specific adaptations including singlelayer, bi-layer, tri-layer, and core-coated tablets. Single-Layer Application XL 400 FT Single-Layer Application BBS, BB, B, D and D35 tools 100 kn pre and main compression Long filling length XL 400 FT MFP Application 100 kn main compression 20 kn or 100 kn precompression 2 or 3 chamber feeders Long filling length Single Multi-Layer Applications in a Modular Concept The new multi-functional Version XL 400 FT MFP permits the production of single-layer tablets and a future retrofit option to produce bi-layer, three-layer, and core-coated tablets. Different feeder sizes can be used in both the single-layer and the multi-layer application to guaranty a better filling or to combine with pre compression and tamping options. 5 kn or 20 kn tamping stations are located between the different layers (2L, 3L, before and after the core placement in the 2C version). The base model for the XL 400 FT MFP features a 20 kn pre compression station. The 20 kn tamping stations from the Multi-Layer versions can be used in single-layer mode as a pre compression station after a quick change over. Bi-Layer Application BBS, BB, B and D tools Flexible single and bi-layer 2nd feeder retractable Automatic first layer sampling 100 kn main compression 20 kn or 100 kn pre compression 5 kn or 20 kn tamping station Optional 1 or 2 chamber feeders Automatic layer weight control Quick change over time from bi-layer to single-layer Tri-Layer Application BBS, BB, B and D tools 2nd and 3rd feeder retractable Automatic layer sampling Automatic layer weight control 5 kn or 20 kn tamping stations 100 kn main compression Convertible to single-layer Bi-Layer Tri-Layer Core-Coating Module for Precise Placement The XL 400 FT MFP 2C offers a core-coating capability on the same equipment platform. Cores are controlled and monitored to achieve a perfect central positioning. Furthermore a separate module permits the placement of preformed (e.g. extruded) solids with the core-coating technology. Core-Coating Application Core module 5 kn tamping force 100 kn main compression Module for core supply and placement Convertible to bi-layer and single-layer Corecoating
The XL 400 FT Concept in Detail Improved Headpiece Optimized windows for maximum accessibility Reinforced windows High light intensity for better viewing Less maintenance through long life LED lights XL 4 Controls Reliable single-tablet rejection at all speeds Retracting feeder permits layer sampling at production speeds Color touch panel Control System Siemens or Allen-Bradley Low Noise Level / Carrier Plate Pneumatic carrier plate support Self levelling Absolute lowest noise level and vibration Automatic lock for transport Multi-Functional Column Houses main drive, hydraulics, lubrication system, and utility connections Permits TTW installation - complete separation technical area from GMP area (TTW=Through The Wall) No heat transfer to compression zone
Cam Track 00 FT Dwell bar design extends dwell time between pre and main compression Optimized cam tracks Optimized fill cam for long filling time Automatic Turret Change Automatic change With upper and lower cams and press tools Requires only 13 parts to be disassembled No hand tools Light turret removal arm Dust extraction shrouds integrated in lower cam track covering High-Capacity Feeder 12 kg lightweight design Very long filling track for fast and even die filling Minimized material loss through closed sealing Independent speed and direction control of each paddle Easy and quick disconnect Easy Maintenance Access Large access openings in the base Additional base access to feeder motors Unique access to compression area, NO corner columns Major machine components mounted in the multi-function column
Superior Controls Control Concept Standard PLC Controls Platform User friendly graphical environment TFT Color Touch Screen for Machine and Controls Touch Screen-SCADA with Windows platform (WinCC or Intouch) Machine Control Siemens or Allen-Bradley Compression Force Control PharmaControl with Fuzzy Logic In-process control with PharmaCheck 3+ tablet tester Single-Tablet Rejection fully synchronized at all speeds Maintenance Manager Data Storage on USB Stick Full Network Connectivity KORSCH controls are based on a standard PLC design, offering both a SIEMENS S7 and Allen-Bradley ControlLogix platform. The result is an extremely robust and reliable system which can be supported on-site. KORSCH does not use black box software modules or customized components that require a KORSCH specialist to repair. KORSCH also uses a standard touch screen interface (WinCC or wonderware) which is operating on a Windows XP platform. A simple ETHERNET connection permits full network connectivity. Full Compliance 21CFR Part 11 Compliance KORSCH controls are fully compliant with 21 CFR Part 11 and offer the following features: Password Login with Four Access Levels Electronic Audit Trail of All Machine Adjustments (Event Log) Electronic Audit Trail of All Machine Faults (Alarm Log) Electronic Audit Trail of All Tablet Rejects (Reject Log) Version Control on Product Recipe Parameters Batch Reports in Secure PDF File Format Optional Network Integration for Central Batch Report Management Electronic audit trails permit full compliance with 21 CFR Part 11, and they also offer extremely valuable information about the production process. The Event Log tracks every adjustment that is made to the machine by date, time, parameter, initial value, and final value. This report permits the entire batch event log to be evaluated in chronological order or organized by event type. The Alarm Log offers a detailed report on all faults that cause the press to stop over the course of the batch and is organized in chronological order or grouped by alarm type. The Reject Log maintains a record of each and every tablet that was rejected over the course of the batch by punch station and permits the press to be stopped automatically based on excessive rejects.
Automation and Validation User Friendly Touch Screen Control Automation KORSCH controls feature a userfriendly touch screen with a graphic presentation of key parameters. The entire operation of the press may be monitored from a single screen. The control screens are well organized and clearly presented and offer an intuitive interface for operators of all skill levels. A multi-language capability permits the HMI language to be selected with the touch of a button. Peripheral equipment includes tablet deduster, metal detector, dust extraction system, and PharmaCheck are also be controlled by the touch screen. The HMI may be mounted on a swing arm at the machine or flush mounted in the wall of the compression suite. Simple and User-Friendly Environment KORSCH Simple controls and permit Self a Explaining modular approach Menues to full Minimum automation, Number including: of Control Screens for EASE of use Press Integrated force control PharmaControl for automatic tablet 3 Compression weight Force control Control System Single Upgrade tablet rejection to Weight with reject Control log with Product PharmaCheck recipe storage 3 and and automatic additional set-up Software capability Modules Interface Permits to deduster Compliance and metal with check 21 for CFR Part 11 integrated Comprehensive logic control Validation Support Interface to automated tablet tester with in-line measurement of tablet weight, thickness, and hardness Interface to central SCADA system for remote monitoring or collection of production data Interface to overhead feed system, containment valve, or tablet collection system Validation Documentation and Turnkey Commissioning Support Good Documented Product (GDP) In addition to the full validation documentation package, KORSCH offers a turnkey commissioning support program. The commissioning program consists of the machine installation, calibration, execution of the validation protocols, and the full training certification program. The training certification program includes training modules on machine operation and maintenance. KORSCH offers training certification documentation to confirm the competency of the training program attendees. KORSCH also offers a process optimization support program to improve output, tablet quality, and production yields. KORSCH controls are supported by a comprehensive validation documentation package, as follows: Full Validation Documentation IQ, CQ, OQ Protocols Functional Requirements Specification System Design Specification Product Contact Parts Specification Lubrication Specification Spare Parts List Electrical Schematics Mechanical Assembly Drawings Operation and Service Manuals
Containment Capability Turnkey Containment Solution Wash in place (Wip) and high-containment (Con) capable Ergonomic glove port placement based on mock-up study Supports highest containment requirement of OEB 5 (1 µg/m 3 > OEL > 0.1 µg/m 3 ) Integrated negative pressure control system with safe-change filters Integration with any containment valve Full turnkey installation Comprehensive validation documentation OEB3 execution (>10µg/m 3 ) for minor containment requirements The KORSCH XL 400 WipCon offers a full wash-in-place and high-containment capability which is suitable for any potent application, while retaining the flexibility of the machine to produce single-layer, multi-layer, or core coated tablets. The XL 400 WipCon offers ergonomic placement of glove ports and an RTP port to permit the contained transfer of press tools, hand tools, and machine parts. The compression zone is fully prepared for the WIP environment. The material inlet and tablet discharge are prepared with tri-clamp connections and can be configured with any type of containment valve, based on the OEL requirements of the application. The WIP sequence is fully automated and recipe driven to support cleaning validation requirements. Pro Capability Integrated Data Acquisition and Analysis Integrated PharmaResearch with data acquisition / analysis for product development, scale-up, and clinical production Integrated PharmaControl with automatic tablet weight control and single tablet rejection Superior flexibility for use in product development, scale-up, and full production Permits fully documented process parameters Closes the loop between development and production The Pro Capability offers the unique feature of adding the integrated PharmaResearch in the same HMI. The PharmaResearch system permits a comprehensive data acquisition and analysis capability to permit correlation with product development data for scale-up and process optimization. The PharmaReseach works in combination with the PharmaControl (automatic weight control) to provide the best of both worlds a fully automated tablet press control system with integrated data acquisition and analysis. Collected data may be exported to a central SQL server to permit comparison and correlation with other data sets from a remote workstation.
Technical Data KORSCH XL 400 FT 1-/2-/3-Layer Technical Data Number of punch stations 47 44 35 29 Press Tools EU/TSM BBS BB B D Main Compression Force kn 100 100 100 100 Precompression Force Bi-Layer / Single-Layer kn 20/100 20/100 20/100 20/100 Tablet Diameter (max.) mm 11 13 16 25 Filling Depths, Single-Layer (max.) mm 18 18 18 22 Filling Depths, Bi-Layer (max.) mm 5 10 Dimensions are identical for all Versions Press Speed, Single-Layer min -1 5 120 5 120 5 120 5 100 Press Speed, Bi-Layer min -1 5 60 5 60 5 60 5 50 Press Speed, Tri-Layer min -1 5 50 5 50 5 50 5 40 Tablet Output, Single-Layer (max.) tabs/h 338.400 316.800 252.000 174.000 Tablet Output, Bi-Layer max. tabs/h 169.200 158.400 126.000 87.000 Tablet Output, Tri-Layer max. tabs/h 141.000 132.000 105.000 69.600 Pitch Circle Diameter mm 410 410 410 410 Tablet Thickness (max.) mm 8,5 8,5 8,5 8,5 Machine Dimensions mm/l x W x H 1.582 x 947 x 2.153 Dimensions are identical for all Versions Net Weight of the Machine kg 3.700 3.700 3.700 3.700 Electrical Load KVA 18,5 18,5 18,5 18,5 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. KORSCH XL 400 FT presses comply with applicable safety regulations as well the guidelines applicable in the German chemical industry. They have been tested in accordance with EMV guidelines and are delivered with required EC certificate. 2C Core-coated tablets technical data on request
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 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. 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: +49 30 43576-300 E-Mail: berlin@korsch.de KORSCH AG Breitenbachstraße 1 13509 Berlin Deutschland/Germany Tel. +49 30 43576-0 Fax +49 30 43576-350 E-Mail: berlin@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 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: roestel@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 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 KORSCH France Tel. +33 (0)4 72 71 48 34 Mobile: +33 (0)6 31 10 79 96 E-Mail: balfin@korsch.de www.korsch.de 97000410 05/2010