Pharmaceutical Rotary Presses. PharmaPress 800. High Speed Double Rotary Press

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1 Pharmaceutical Rotary Presses PharmaPress 800 High Speed Double Rotary Press

2 Highest Output with... The KORSCH PharmaPress 800 is a high capacity, double sided tablet press for fully automated and unattended production of high volume products. The PharmaPress 800 technology has a proven track record of high-speed, three-shift production, offering superior performance and reliability. The PharmaPress 800 features modern GMP design and an isolated compression zone that permits the longest run durations and a fast cleaning and changeover capability. The PharmaPress 800 can be provided with a conversion kit for bi-layer tablet production to permit maximum flexibility. Advantages Maximum Output Double sided tablet press for high-speed, three-shift production Superior performance and reliability (Over 1 Mill. Tablets/Hour) Advanced composite cam course design and automatic punch lubrication system ensures the highest processing speeds Heavy tonnage, robust design (40kN Pre and 80kN Main Compression) Variable speed power feeder Flexible Concept Single-Layer or bi-layer tablet production mode Remote touch screen and electrical cabinet can be installed inside or outside of the compression room Higher GMP Standard Easy accessibility for cleaning and changeover Sealed compression zone Quick release component design Complete stainless steel package PharmaPress 800 Easy Set Up and Controls User friendly operator interface Reliable Siemens PLC control platform Full motorized machine adjustments Digital display for precision, accuracy and repeatability Electronic audit trail capability maintains batch history of machine adjustments and faults Press Force control system with proven PharmaControl 2i or 3i Software Full Documentation Full GMP compliance, documentation according to cgamp Comprehensive qualification and validation documentation

3 ... Robust and Reliable Technology The KORSCH PharmaPress 800 has a large pitch circle of 740 mm that guarantees smooth punch travel and long filling lengths - which insures superior output and precision tablet weight control. The modular construction of the PharmaPress 800, which prevents the migration of dust from the compression zone, insures extremely long run durations and more batches between major cleans. The proven composite cam course design extends cam life and tool life, and minimizes heat generation in the compression zone, even in a 24/7 continuous production operation. The long filling length of the PharmaPress 800 feeder increases feeder dwell time and insures superior tablet weight control at the highest press speeds. The PharmaPress 800 features a motorized adjustment of dosing, tablet thickness, and insertion depth - to permit a full product recipe capability. The product recipe function permits the storage of an unlimited number of products, and the recipe set-up capability greatly reduces set-up scrap. The multi-zone lubrication capability permits the optimal lubrication of the upper and lower punches independently. The 3-channel discharge chute offer a fail-safe design, and the capability to direct tablet samples to an automated tablet tester, to permit unattended operation. The module, PLC based control system, features a graphical and user-friendly touch-screen environment, and permits full compliance with 21 CFR Part 11. High Output for Single and Bi-Layer Tablets Single and Bi-Layer Application The PharmaPress 800 offers 40/80 kn compression capability for highest outputs over 1 Mill. Tablets/h (BB, BBS). The press can be prepared for bi-layer production and modified from single layer to a bi-layer execution with a conversion kit. The well proven KORSCH feeder design with long filling track guarantees superior tablet weight control and minimal product loss. Single layer capability 1 Mill. Tabl/h (EU B) Bi-layer capability 0.5 Mill. Tabl/h (EU B) 40 kn Precompression Force 80 kn Main Compression Force Short Cleaning time Short Change over time Bi-Layer Conversion Capability Instrumentation: Tamping Force (Bi-Layer only) Precompression Force Main Compression Force Ejection Force (optional) User Friendly Touch Screen Control KORSCH controls feature a user friendly 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 extremely 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. The HMI may be mounted on a swing arm at the machine or flush mounted in the wall of the compression suite. Automation KORSCH controls permit a modular approach to full automation, including: Press force control for automatic tablet weight control Single tablet rejection with reject log Product recipe storage and automatic set-up capability Interface to deduster and metal check for integrated logic control Interface to automated tablet tester with in-line measurement of tablet weight Interface to central SCADA system for remote monitoring or collection of production data Interface to overhead feed system or tablet collection system

4 PharmaPress Concept in Detail HMI Touch Screen User friendly environment Displays all parameters and alarms Motorized adjustments for precision and repeatability PharmaPr PharmaControl 2i/3i Press force control for automatic tablet weight control Reliable single Tablet rejection at all speeds 21 CFR Part 11 compliant Bi-layer Capability Conversion kit for bi-layer production available Automatic first layer sampling Easy Handling Quick release design for press tool installation Quick disconnect design for machine components No hand wheels, fully motorized machine adjustments Full accessibility to machine base simplifies service

5 ess 800 Compression Rollers 40kN precompression guarantees material de-airation 80kN main compression capability 300mm main compression roller diameter Independent adjustment of insertion depth and tablet thickness Hydraulic form overload system High Capacity Feeder 3 chamber variable speed feeder Long filling length for precision weight control Recirculation channel maximizes production yields GMP / Cleanability Ergonomic design Smooth interior and exterior surfaces Wear resistant, maintenance free seals Discharge Chute 2-channel discharge chute with fail safe mode Sampling channel for tablet tester

6 Control System Standard PLC Controls Platform Operator LOGIN with password Digital display and keypad adjustment of all machine parameters Product recipe capability for storage and automatic set-up for an unlimited number of products Real time display of individual press forces by punch station Real time trending of precompression and main compression force Integration of Pharmacheck Tablet Sampling System for automatic testing of tablet weight Automatic calibration of press force amplifiers Electronic audit trail of all machine alarms Electronic audit trail of all machine adjustments Comprehensive report capability for batch end reports including tablet weight, tablet thickness, tablet hardness, event log, alarm history, press force trending, and product recipe report Press Force Control System with single tablet rejection capability KORSCH controls are based on standard PLC design, offering a SIEMENS PLC platform. The result is an extremely robust and reliable system which can be supported on-site. We do not use black box software modules or customized components that require an KORSCH specialist to repair. The use of a standard PLC system offers a level of self-sufficiency which is required for multi-shift production environments. KORSCH also use a standard touch screen interface (WinCC) which is operating on a Windows XP platform. A simple ETHERNET connection permits full network connectivity. Press Force Control Highest reliability through proven control software Precompression Force Display Main Compression Force Display Single Forces Display Press Force Trending and Storage Single Tablet Rejection System The PharmaPress 800 can be configured with an integrated press force control system (PharmaControl 2i or 3i) that provides closed loop control of the dosing cam, based on the average press force. The press force module can also be configured with the single tablet rejection system, which can reject an individual tablet from a known punch station at all operating speeds. KORSCH utilize a patented KORSCH FUZZY LOGIC algorithm for the press force control system that provides a faster and more precise response to any deviation in the press force value. The result is superior tablet weight control at even the highest press speeds.

7 Turnkey Commissioning Support In addition to the full validation documentation package, KORSCH offer 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 offer training certification documentation to confirm the competency of the training program attendees. We also offer a process optimization support program to improve output, tablet quality, and production yields. Validation Documentation 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 KORSCH PharmaPress 800 Technical Data Number of Punch Stations Number of compression stations Tool Excution EU/TSM BBS BB B D Main Compression Force kn Precompression Force kn Tablet Diameter max. mm Filling Depths max. mm Press Speed, Single-Layer min -1 (max.) Tablet Output, Single-Layer (max.) tabl/h Press Speed, Bi-Layer min -1 (max.) Tablet Output, Bi-Layer (max.) tabl/h Pitch Circle Diameter mm Tablet Thickness max. mm 8,5 8,5 8,5 8,5 Upper Punch Insertion Depth mm Machine Dimensions mm/l x W x H 1320 x 1230 x Dimensions are identical for all versions Net weight of the machine kg approx Electrical Load kva Technical modifications reserved. The PHARMAPRESS 8oo 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 presses have the CE certificate and have been tested accordingly.

8 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. KORSCH Standard Service Preventative Maintenance/Calibration Full inspection of operating condition Functional test of all machine components Condition report with detailed maintenance recommendation Process Optimization Support Training Comprehensive training certification programs to establish internal experts and insure self-sufficient operation. Training can be conducted at your premises or in the new KORSCH TRAINING CENTER. Training modules include: Equipment Operation Equipment Maintenance (mechanical, electrical & software) KORSCH 24/7 Service Hotline: KORSCH AG Breitenbachstraße Berlin Deutschland/Germany Tel Fax [email protected] KORSCH America Inc. 18 Bristol Drive South Easton, MA 02375, USA Tel Fax [email protected] Hotline: KORSCH-1 KORSCH Asia Pacific Toll Boulevard Block E-21 BSD Tangerang Indonesien Phone: Fax: [email protected] KORSCH Schweiz GmbH Holdermattstrasse 5 P.O. Box Trimbach Schweiz/Switzerland Tel Fax [email protected] KORSCH UK Tel. +44 (0) Fax +44 (0) Mobile: +44 (0) [email protected] KORSCH France Tel. +33 (0) Mobile: +33 (0) [email protected] /2009