XL 400 - downloads.german-pavilion.com€“ Turret change with upper and lower cam track and...
Transcript of XL 400 - downloads.german-pavilion.com€“ Turret change with upper and lower cam track and...
Pharmaceutical Rotary Presses
XL 400FT
The World‘s Most Flexible Tablet Press
XL 8
00
XL 4
00
XL 20
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XM 12
XL 10
0XP
1
KORSCH XL 400FT: 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
✓ Flexible Concept – Ultimate flexibility with single layer, multilayer (bi- and trilayer), and core- coating 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
XL 400FT
... 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 plat-form. The FT design offers an extreme improvement in ma-chine 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 modu-lar approach to permit the production of single-layer, bi-layer, tri-layer, and core-coated tablets on a single press. The com-plete 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 requi-res no hand tools, and all components are removed effort-lessly. The ejection cam and dosing cam are redesigned into simple modules that are installed with a single quick discon-nect. 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.
✓ 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
Automatic Turret Change
The XL 400FT features a large feeder for extended feeder dwell time – which permits precision tablet weight control at the highest press speeds. The fee-der can be easily dismounted, no hand tools are needed.
The new turret design permits the re-moval 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.
Noise Level
✓ Extremely quiet ≤ 75 dB(A)
✓ No Vibrations
✓ No product segregation
Fast Change Capability
No Hand Tools Required
Unique patented structural design that eliminates vibration to the head piece and base frame. The result is an ex-treme reduction in the operating noise level at the highest press speeds.
Lowest Noise and Vibration
Level Guaranteed
Removal of 13 components
Compression columns retract & Turret lift
Manual swing out of Turret
Turret transfer to the transport cart
5 min 2 min 2 min 1 min
Multi-Function Platform offers...
The KORSCH XL 400FT 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 400FT
offers the unique capability to be upgraded – at any time. A Multi-Function carrier plate permits this flexibility to be provi-
ded in the basic XL 400FT, 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 demand-oriented use.
Modular flexible base plate
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
Upper 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
Lower Cam Track Modules
✓ 100 kN for high precompression and main compression✓ 20 kN for precompression✓ 5 kN for tamping
Compression Roller Station Modules
✓ 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
Feeder Modules
The Modules
... Ultimate Flexibility.
XL 400FT Single-Layer Application✓ BBS, BB, B, D and D35 tools✓ 100 kN pre and main compression✓ Long filling length
Single-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
Bi-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
Tri-Layer Application
✓ Core module✓ 5 kN tamping force✓ 100 kN main compression✓ Module for core supply and placement✓ Convertible to bi-layer and single-layer
Core-Coating Application
Multi-Layer Applications
in a Modular Concept
Core-Coating Module
for Precise Placement
The new multi-functional Version XL 400FT 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 400FT MFP features a 20 kN pre compression station. The 20 kN tam-ping stations from the Multi-Layer versions can be used in single-layer mode as a pre compres-sion station after a quick change over.
The XL 400FT MFP 2C offers a core-coating ca-pability on the same equipment platform. Cores are controlled and monitored to achieve a per-fect central positioning. Furthermore a separate module permits the placement of preformed (e.g. extruded) solids with the core-coating technology.
Dedicated Single-Layer
Application
The XL 400FT 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 single-layer, bi-layer, tri-layer, and core-coated tablets.
XL 400FT MFP Application✓ 100 kN main compression✓ 20 kN or 100 kN precompression✓ 2 or 3 chamber feeders✓ Long filling length
Single
Bi-Layer
Tri-Layer
Core-coating
The XL 400FT 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
Controls
Low Noise Level / Carrier Plate
✓ Pneumatic carrier plate support
✓ Self levelling✓ Absolute lowest noise
level and vibration✓ Automatic lock for transport
✓ Reliable single-tablet rejection at all speeds
✓ Retracting feeder permits layer sampling at produc-tion speeds
✓ Color touch panel✓ Control System Siemens
or Allen-Bradley
Multi-Functional Column
✓ Houses main drive, hydrau-lics, lubrication system,
and utility connections✓ Permits TTW installation
- complete separation tech-nical area from GMP area (TTW=Through The Wall)
✓ No heat transfer to com-pression zone
XL 400FT
Cam Track
✓ 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
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
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
XL 400FT
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 Adjust-
ments (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
✓ 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
Control Concept
Superior Controls
KORSCH controls are based on a standard PLC design, offering both a SIEMENS S7 and Allen-Bradley Con-trolLogix 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 inter-face (WinCC or wonderware) which is operating on a Windows XP platform.
A simple ETHERNET connection per-mits full network connectivity.
Standard PLC Controls
Platform
Electronic audit trails permit full com-pliance with 21 CFR Part 11, and they also offer extremely valuable informa-tion about the production process.The Event Log tracks every adjust-ment 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 evalu-ated in chronological order or orga-nized 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.
21CFR Part 11 Compliance Full Compliance
Automation and Validation
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 well organized and clearly presented and offer an intui-tive interface for operators of all skill levels. A multi-language capability per-mits 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 con-trolled 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.
User Friendly
Touch Screen Control
In addition to the full validation docu-mentation package, KORSCH offers a turnkey commissioning support pro-gram. The commissioning program consists of the machine installation, calibration, execution of the valida-tion 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 pro-gram attendees. KORSCH also offers a process optimization support program to improve output, tablet quality, and production yields.
Validation Documentation and
Turnkey Commissioning Support
✓ Simple and User-Friendly Environment✓ Simple and Self Explaining Menues✓ Minimum Number of Control Screens for EASE of use✓ Integrated PharmaControl 3 Compression
Force Control System✓ Upgrade to Weight Control with PharmaCheck 3 and additional Software
Modules✓ Permits Compliance with 21 CFR Part 11✓ Comprehensive Validation Support
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,
thickness, and hardness
✓ Interface to central SCADA system for re-
mote monitoring or collection of production
data
✓ Interface to overhead feed system, contain-
ment valve, or tablet collection system
KORSCH controls are supported by a compre-
hensive 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
Good Documented Product (GDP)
Containment Capability
Pro Capability
✓ 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/m3 > OEL > 0.1 µg/m3)
✓ Integrated negative pressure control system
with safe-change filters
✓ Integration with any containment valve
✓ Full turnkey installation
✓ Comprehensive validation documentation
✓ OEB3 execution (>10µg/m3) for minor contain-
ment requirements
✓ Integrated PharmaResearch® with data ac-
quisition / 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 develop-
ment, scale-up, and full production
✓ Permits fully documented process parameters
✓ Closes the loop between development and
production
The KORSCH XL 400 WipCon® offers a full wash-in-place and high-contain-ment capability which is suitable for any potent application, while retaining the flexibility of the machine to pro-duce 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 com-pression zone is fully prepared for the WIP environment. The material inlet and tablet discharge are prepared with tri-clamp connections and can be con-figured 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 require-ments.
Turnkey Containment
Solution
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 correla-tion with product development data for scale-up and process optimization. The PharmaReseach® works in com-bination with the PharmaControl® (automatic weight control) to provide the best of both worlds – a fully auto-mated tablet press control system with integrated data acquisition and analy-sis. Collected data may be exported to a central SQL server to permit compa-rison and correlation with other data sets from a remote workstation.
Integrated Data Acquisition
and Analysis
Technical Data
Number of punch stations 47 44 35 29 22
Press Tools EU/TSM BBS BB B D D35
Main Compression Force kN 100 100 100 100 100
Precompression Force
Bi-Layer / Single-Layer kN 20/100 20/100 20/100 20/100 20/100
Tablet Diameter (max.) mm 11 13 16 25 34
Filling Depths, Single-Layer (max.) mm 18 18 18 22 22
Filling Depths, Bi-Layer (max.) mm 0–3/3–7/7–10 – Dimensions are identical for all Versions
Press Speed, Single-Layer min-1 5–120 5–120 5–120 5–100 5–80
Press Speed, Bi-Layer min-1 5–60 5–60 5–60 5–50
Press Speed, Tri-Layer min-1 5–40 5–40 5–40 5–40
Tablet Output,
Single-Layer (max.) tabs/h 338.400 316.800 252.000 174.000 105.600
Tablet Output,
Bi-Layer max. tabs/h 169.200 158.400 126.000 87.000
Tablet Output,
Tri-Layer max. tabs/h 112.800 105.600 84.000 69.600
Pitch Circle Diameter mm 410 410 410 410 410
Tablet Thickness (max.) mm 8,5 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 3.700
Electrical Load KVA 18,5 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 400FT presses comply with applicable safety regula-
tions as well the guidelines applicable in the German chemical in-
dustry. They have been tested in accordance with EMV guidelines
and are delivered with required EC certificate.
KORSCH XL 400FT 1-/2-/3-Layer Technical Data
2C Core-coated tablets technical data on request
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 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.
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.
Pharmaceutical Rotary Presses
XM 12
Small-Scale Bi-Layer
Tablet Press
XL 8
00
XL 4
00
XL 20
0
XM 12
XL 10
0XP
1
The Machine Concept ...
XM 12
Advantages
✓ Flexible Concept – Bi-Layer execution with optional single-layer conversion kit – Exchangeable turret – Turret sizes for product development, scale-up, and mid-range production – Full production capability in a scale-up machine – Self-contained, fully portable design
✓ Fast and Easy Changeover – Internal turret lift device for extreme simplicity in turret removal and installation – Clean compression zone with quick-disconnect design
✓ Design Advantages – Small-scale bi-layer capability – Robust caster base permits full portability – Large touch screen flush mounted – Unique structural design eliminates vibration and
noise – Zero clearance feeder for maximum yield and optimal layer separation – Retractable second layer feeder for automatic first
layer sampling
✓ Full instrumentation – Tamping force – Pre/Main compression force – Ejection force
✓ Touch Screen Control – Press force control and single tablet rejection capability – Comprehensive data collection and analysis capability – Real time display and batch data documentation
✓ Containment Solution – WipCon® solution available for potent products
... for Small-Scale Bi-layer Applications
The KORSCH XM 12 Bi-Layer Tablet Press is a small-scale press which is ideal for product development, scale-up, clini-cal trials, and midrange production. The bi-layer execution, single-layer conversion kit, and exchangeable turret offer unprecedented flexibility.
The XM 12 Bi-Layer Tablet Press offers a new standard in GMP with extreme accessibility to the compression zone and a com-bination of quick disconnects and smooth surfaces that permit fast cleaning and changeover. The machine features a 5 kN tamping station, 40 kN precompression station, 80 kN main compression station, and a unique structural design that elimi-
nates vibration to the head piece and base frame. The result is an extreme reduction in the operating noise level.
The XM 12 Bi-Layer Tablet Press features a retractable second layer feeder that permits automated first layer sampling at pro-duction speeds. The first layer sampling capability also offers a hardening feature, in which the main compression station will automatically compress the first layer tablet for in-process measurement. The two feeders are zero clearance and are configured with an integrated dust extraction manifold, which cleans the die table and completely eliminates any potential for cross-contamination.
Single-Layer Application
✓ Small-Scale Bi-Layer ✓ 5 kN First Layer Tamping Force✓ 40 kN Precompression Force✓ 80 kN Main Compression Force✓ Single-Layer Conversion Capability✓ Instrumentation: – Tamping Force – Precompression Force – Main Compression Force – Ejection Force
Bi-Layer Application
✓ Single Layer Conversion: – 30 Minute Conversion Time – High Speed Single-Layer Capa-
bility (120 RPM) – 40 kN Precompression Force – 80 kN Main Compression Force – Exchangeable Turret – Mix-Turret✓ Instrumentation: – Precompression Force – Main Compression Force – Ejection Force
The XM 12 features an exchangeable turret capability to permit a single ma-chine to run all press tool sizes to pro-vide maximum flexibility and versatility. An internal lift arm eliminates the cost and space requirement of a large exter-nal turret removal device. A single layer conversion kit adds yet another dimen-sion of flexibility.
Internal Turret Lift Device for
Extreme Simplicity in Turret
Removal and Installation
The XM 12 Concept in Detail
XM 12
PharmaControl®
Carrier Plate
Containment
✓ WipCon® Solution for Wash-in-Place and high-containment applications
✓ Unique floating structure design for dramatic noise reduction at all operating speeds
✓ Touch screen HMI for user friendly operation
✓ Integrated system for automatic layer weight control and single tablet rejection
✓ Clearly displays key para-meters and adjustments
✓ Fully compliant with 21 CFR Part 11✓ Retracting second layer
feeder for automated first layer sampling with
hardening option
PharmaResearch®
✓ Integrated data acquisition and analysis
✓ Full instrumentation for tamping force, precom-pression force, main
compression force, and ejection force
XM 12
New Feeder Design
Machine Base
✓ Self contained design✓ Robust caster base per-
mits full portability✓ Full accessibility to major
components simplifies service
✓ Low-volume feeder paddle option for product development with mini-mum material quantities
✓ Zero clearance feeder design for maximum
yields and layer separa-tion
Compression Zone
✓ Open access to compres-sion zone
✓ Quick disconnect design requires no tools
✓ Smooth surfaces for easy cleaning
Exchangeable Turret
✓ Turret sizes for product development, scale-up,
and mid-range production✓ Bi-layer execution with optional single-layer con-
version kit✓ Internal turret lift device
for extreme simplicity in turret removal and installa-tion
✓ Mixed turret offering D, B and BB press tools in a single turret
XM 12 ProSmall-Scale Bi-Layer Tablet Press and Comprehensive Data Analysis
✓ Integrated PharmaControl 3i✓ Pneumatic Single Tablet Sorting✓ Automatic Weight Control✓ Batch Data Recording / 21 CFR Part 11 Compliant✓ Integrated PharmaResearch®
✓ Extensive Data Acquisition and Analysis✓ Graphical Display of Forces and Displacement✓ Statistical Evaluation and Reporting✓ Complete Data Storage and Export
Faster Development
with Less Material
The KORSCH XM 12 Pro includes pro-duction style controls for clinical batch production and an integrated data collection and analysis capability for product development. The result is a comprehensive and user-friendly con-trol system that permits fully docu-mented clinical production, with the ability to collect and analyze data at any time. The XM 12 Pro offers an ex-pedited product development process using minimal material quantities and a streamlined clinical batch capability.
PharmaResearch®
Comprehensive Data
Acquisition and Analysis
PharmaResearch® is a Windows-based system that offers data acquisition and analysis for press force and punch dis-placement data. The system displays press force waveforms in real time and permits on-demand data collec-tion. The system can collect data lo-cally, or write the data to a networked SQL server for centralized data storage and analysis. The system can work with the following tablet press instru-mentation:✓ Precompression Force✓ Main Compression Force ✓ Ejection Force✓ Scrape-Off Force✓ Die-Wall Force✓ Punch Displacement
The data analysis is automatic and provides a statistical assessment of:✓ Peak Force✓ Area Under The Force-Time Curve✓ Contact Time✓ Rate of Force Application✓ Rate of Force Decay
Properties
✓ Free format graphic and statistical analysis to
allow the export of many data formats.
✓ Reports can be automatically generated in a varie-
ty of data formats with and without an electronic
signature.
✓ Charts can be dimensioned, comments added,
formatted and exported before being processed
in the MS Office world.
✓ Fingerprint recording during production. Overlay
Technology allows safe and quick recognition of
subsequent waveforms.
✓ Correlation Analysis to establish a “Knowledge
Database” that serves to easily compare the
properties of known and unknown ingredients.
The database enables the user to correlate mea-
suring values from the tableting process and
derived and externally recorded quantities (e.g.
tablet hardness, density, etc.).
✓ Compaction Analysis allows evaluations e.g.
Heckel plot, energy, work of compression, con-
tact time, compressibility.
✓ “Built-in” PAT function, i.e. the database is au-
tomatically filled with process data thereby hel-
ping to define and complete PAT requirement for
Knowledge Space and Design Space.
Optional
Product DevelopmentModule:
PharmaResearch®
Data Collection / Analysis
Optional
Clinical BatchModule:
PharmaControl® 3Automatic Weight Control
Machine Control Module (all Pro Machines)Secure Login, Parameter Adjustments, Display of Press Forces,
Event Log, Alarm Log, Product Recipe
The Pro CapabilityFull Compaction Studies With Limited Material Quantities in One HourFully Documented Clinical Batches with Event, Alarm, and Reject Logs
Number of Punch Stations 12/18 16/22 18/26 28
Number of Compression Stations 3 3 3 3
Tool Execution EU/IPT D B BB BBS
Main Compression Force kN 80 80 80 80
Precompression Force kN 40 40 40 40
Tamping Force kN 5 5 5 5
Tablet Diameter max. mm 25 16 13 11
Filling Depths max. mm 22 18 18 18
Max. Second Layer Insertion Depth mm 11 11 11 11
Press Speed Bi-Layer RPM 10–60 10–60 10–60 10–60
Output Bi-Layer Tablets/Hour 43.200 / 64.800 57.600 / 79.200 64.800 / 93.600 100.800
Press Speed Single Layer RPM 10–80 10–120 10–120 10–120
Output Single Layer Tablets/Hour 57.600 / 86.400 115.200 / 158.400 129.600 / 187.200 201.600
Pitch Circle Diameter mm 252 252 252 252
Tablet Thickness max. mm 8 8 8 8
Machine Dimensions mm / L x W x H 1.700 x 900 x 1.950 – Dimensions are identical for all versions
Net Weight of the Machine kg 2.500 2.500 2.500 2.500
Electrical Load kVA 5,5 5,5 5,5 5,5
KORSCH XM 12 Technical Data
Technical modifications reserved. The new KORSCH XM 12 is in accordance with the valid safety and accident prevention regulations and
with the regulations of the workmen´s compensation board of chemistry. The new KORSCH XM 12 has the CE certificate and has been tested
according to EMC regulations.
XM 12 WipCon® Development & Analysis
✓ Minimum space requirements, portable design
✓ Best cleaning / decontamination results for
product specific demands
✓ Optimized glove port configuration
✓ All types of make/break connections possible
✓ High containment range for lab scale and
medium size batches OEB 5 (1 μg/m³ > OEL >
0.1 μg/m³) with RTP transfer system
✓ Medium containment range for small production
batches OEB 4 (10 μg/m³ > OEL > 1 μg/m³) with
split valve connections
✓ Connection to Wip tablet deduster on same
containment level OEB 4 (10 μg/m³ > OEL >
1 μg/m³)
✓ Negative pressure control and safe-change filter
box attached or separate, depending on space
availability
High Containment for
Bi-Layer Compression
The KORSCH XM 12 WipCon® is an in-novative tablet press and offers a com-prehensive wash in place (OEB 3) and high containment (OEB 4,5) capability for highly hazardous products. There-fore, the KORSCH XM 12 WipCon® complements operator safety and operational excellence.
The XM 12 WipCon® can be fully in-strumented for the measurement of tamping force, precompression force, main compression force and ejec-tion force to permit product develop-ment parameters to be evaluated and stored.
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 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.
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.