Pharmaceutical Rotary Presses

XL 400FT

The World‘s Most Flexible Tablet Press

XL 8

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XL 4

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XL 20

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XM 12

XL 10

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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

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 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: berlin@korsch.de

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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: berlin@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

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: sales@korschamerica.com

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: avery@korsch.de

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 France

Tel. +33 (0)4 72 71 48 34

Mobile: +33 (0)6 31 10 79 96

E-Mail: balfin@korsch.de

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.