NEW TECHNOLOGY
TABLET PRESS ES
Multi-Layer, MUPS, Direct Compression
Rieckermann OSD Seminar 2018
P R E S E N TAT I O N O U T L I N E
▪ The KORSCH Company
▪ New Design Tablet Presses
▪ Multi Layer Technology
▪ MUPS
▪ Direct Compression
COMPANY INTRODUCTION
▪ The specialist in tablet compression
technology
▪ Family owned
▪ Design, development, and production
solely in Berlin
▪ 250 employees
▪ > 100 tablet presses per year
I N N O VAT I O N S ▪ 90 M € turnover
MADE IN BERLIN ▪ More than 50 active patents
SINCE 1919 ▪ DIN EN ISO 9001:2008
I N T E R N AT I O N A L
KORSCH AG
KORSCH
America Inc.
KORSCH
Asia Pacific
INNOVATION CENTER AT A GLANCE
1 More than 600 customer visits / year
10 compression suites, 4 IPC labs and
2
a 100-seat auditorium
KORSCH specialists in pharmaceutical
3 technology and quality assurance at
your disposal
4 All machine models available
A Space to Advance Tableting
NEW DESIGN TABLET PRESSES
NEW DESIGN PRODUCTION TABLET
PRESSES
XL 4004 MFP XL 400 MFP XL 800
Flexible High-Speed Flexible High-Speed High-volume double
Single & Multi-Layer Single & Multi-Layer rotary tablet press
Production Production
TWO MACHINE MODELS…ONE COMMON VISION
1 XL 400 MFP
XL 400 MFP
▪ Flexible Single and Multi-
Flexible High-Speed Layer, High-Speed
Single & Multi-Layer Production
Production
2 XL 4004 MFP
▪ Flexible Single and Multi-
Layer, High-Speed
XL 4004 MFP
Production
Flexible High-Speed ▪ Highly Compact
Single & Multi-Layer
Production
Highly Compact
C O M M O N P L AT F O R M F O R E N H A N C E D C O M PAT I B I L I T Y
▪ Common major components
□ Turrets
□ Cam tracks
▪ Interchangeable spare parts
▪ Identical control systems and HMI environment
▪ Process equivalent design for direct product transfer
▪ Common procedures for setup, changeover, and turret exchange
AT A G L A N C E
▪ 29, 35, 44, 47 station turrets
▪ 5 kN max. tamping force
▪ 20 /100 kN max. precompression
▪ 100 kN max. main compression
▪ 120 RPM max. press speed
▪ Up to 338,400 tablets / hour
(single-layer)
▪ Up to 169,200 tablets / hour
(bi-layer)
▪ Up to 141,000 tablets / hour
(tri-layer)
T T W I N S TA L L AT I O N M I N I M I Z E S S PA C E I N G M P A R E A
▪ Multi-Function Column is placed through
the wall
▪ Electrical cabinet also mounted remotely
▪ True separation of white zone and grey
zone
▪ All service from grey zone with no
disturbance in white zone
▪ Conventional installation in the center of
the compression suite
Through-The-Wall Installation
SERVICE CONVENIENCE
▪ Machine Base:
□ Large access doors
□ Central connection for peripherals
□ Free of main drive, lube pump,
and major components
▪ Multi-Function Column
□ Superior access to major
components in the Multi-Function
Column for simplified
maintenance
MINIMAL NOISE AND VIBRATION
Special pneumatic system isolates all
1
vibration associated with compression
2 Very low noise emission < 80 dB(A)
Even at high compression forces and
3
high speed
Unique and Patented Design of the Carrier Plate
with Pneumatic Dampers
C A R R I E R P L AT E U N I Q U E A N D PAT E N T E D D E S I G N
Supports compression roller columns Supports main drive
Carrier Plate Self-Leveling with Special
Pneumatic Dampers
I S O L AT E D V I B R AT I O N
▪ No segregation of powder in the
feeding system which can occur
with machine vibration
▪ Reduction of machine wear
▪ No disturbance of the adjacent
equipment
MULTI LAYER C O N F I G U R AT I O N S
P R E - E N G I N E E R E D C A R R I E R P L AT E
Preconfigured positions for rapid
1 installation of compression columns of
different sizes
Pre-configuration for the drive of all
2
possible feeder combinations
3 Plug and play approach
Total Flexibility for all Multi -Layer Formats
PRE-ENGINEERED HEAD PIECE
1 Different material feed openings
Different electrical connections for
2
compression modules
3 All necessary plugs available
Plug and Play Configuration
COMPRESSION ROLLER MODULES
100 kN MODULE 20 kN MODULE 5 kN MODULE
▪ Main Compression ▪ Precompression ▪ Tamping
▪ Precompression
Pneumatic Cushion Facilitates Transport on Carrier Plate
FEEDER MODULES
TWO–CHAMBER FEEDER SINGLE-CHAMBER FEEDER
▪ 294 mm filling length ▪ 124 mm filling length
▪ 2-paddles ▪ 1-paddle
▪ Single or multi-layer ▪ Multi-layer
B I - L AY E R
MODES
B I - L AY E R M O D E 2 . 1
▪ Layer 1:
□ 2-chamber feeder
□ 5 kN tamping station
▪ Layer 2:
□ 2-chamber feeder (retracting)
▪ 100 kN main compression
B I - L AY E R M O D E 2 . 2
▪ Layer 1:
□ 2-chamber feeder
□ 5 kN tamping
▪ Layer 2:
□ 1-chamber feeder (retracting)
▪ 20 kN precompression
▪ 100 kN main compression
B I - L AY E R M O D E 2 . 3
▪ Layer 1:
□ 1-chamber feeder
□ 5 kN tamping
▪ Layer 2:
□ 2-chamber feeder (retracting)
▪ 20 kN precompression
▪ 100 kN main compression
B I - L AY E R M O D E 2 . 4
▪ Layer 1:
□ 1-chamber feeder
□ 5 kN tamping
▪ Layer 2:
□ 1-chamber feeder (retracting)
▪ 100 kN precompression
▪ 100 kN main compression
T R I - L AY E R
MODES
T R I - L AY E R M O D E 3 . 1
▪ Layer 1:
□ 1-chamber feeder
□ 5 kN tamping
▪ Layer 2:
□ 1-chamber feeder (retracting)
□ 5 kN tamping
▪ Layer 3:
□ 1-chamber feeder (retracting)
▪ 100 kN main compression
PROCESS ADVANTAGES
Multi-Layer Modes
O P T I M A L L AY E R S E PA R AT I O N
▪ No cross-contamination:
□ No product re-circulation
□ Zero clearance feeders: seal
between feeder and die table
□ Dust extraction before each
feeder
▪ Tamping (low compression force)
to obtain an even surface and the
filling space for the next layer
□ Avoids layer separation
FEEDER BASE
Flexible
Feeder Seal Feeder
Drives
F O R C E F E E D E R M AT E R I A L C O N TA I N M E N T
Flexible Silicone Tube
PTFE Sealing
Plate
F U L LY A U T O M AT E D L AY E R S A M P L I N G
▪ Layer sampling on demand at production
speeds
▪ Hardening function: layers hard enough
to permit weighing
▪ Retracting feeder design
▪ Layer sampling with press force under
automatic control
O P T I M A L W E I G H T C O N T R O L O F L AY E R S
▪ Independent weight control of every layer for correct drug delivery profile
▪ Press force control system:
□ Monitoring of individual force at the tamping and final compression stations
□ Closed loop control of each layer weight
▪ Single tablet rejection based on layer tamping force and final compression
force with reject log
QUICK CHANGE OVER BETWEEN THE DIFFERENT
C O N F I G U R AT I O N S
▪ Quick change over “plug and
produce” modules
▪ Transition process to be
customer executed during normal
changeover
▪ Control system with auto setup
for each press configuration
MAXIMIZED YIELD IN EACH
MODE
▪ Tail over die and zero
clearance feeder
▪ Optimized integration of dust
extraction
▪ Individually adjustable dust
extraction nozzles
▪ Different materials for seals
depending on product
characteristics
▪ Different feeder paddles
configurations
XL 400 CC Configuration
▪ Tri-Layer Platform
▪ Core Delivery Module
Between Feeders
▪ 5 kN Tamping Station
▪ 100 kN Main Compression
Station
▪ First and Second Layer
Weigth Control
▪ Nominal Output 30,000 to
50,000 Tablets Per Hour
Core Coating Technology
CORE-PLACEMENT TECHNOLOGY
E Q U I P M E N T L AY O U T
SPECIAL TECHNOLOGY
MICROCH IP -IN -TA B LE T TEC H N OLOGY
M I C R O C H I P - I N - TA B L E T T E C H N O L O G Y
DELIVERY METHODS
Direct Placement
IEM Placement in Active Tablet
XL 400 MFP with IEM Module
Indirect Placement
IEM Placement in Placebo Tablet
Placement of Placebo Tablet Core in
Final Active Tablet
XL 400 MFP with IEM Module
XL 400 MFP with 2C Module
MIC R OC H IP -IN -TABLET TEC H N OLOGY
SYSTEM COMPONENTS
▪ XL 400 MFP Tablet Press
1 ▪ Portable HMI Cabinet
2 ▪ IEM Reel Feeder
3 ▪ IEM Delivery Module
MICROCHIP-IN-TABLET TECHNOLOGY
XL 400 MFP with IEM Module
MUPS
(MULTIPLE UNIT PELLET(PARTICULATE) SYSTEM)
MUPS Design:
MUPS
(MULTIPLE UNIT PELLET(PARTICULATE) SYSTEM)
MUPS Design:
MUPS
(MULTIPLE UNIT PELLET(PARTICULATE) SYSTEM)
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
Problems of MUPS Production
• Powder-Particle Segregation
• Unequal Powder-Particle Flow
• Particle Damage
• Unequal Distribution of the Particles in the Tablet
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
VARIABLE GRAVITY FEEDER
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
Rotational Orientation against Particle Shifting in the Die
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
Nexium (esomeprazole magnesium ) Heartburn Protection
Target the Capsule and the Tablet should be bioequivalent
Important most of the pellets are not broken
Distribution is not a real issue
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
Solution:
Achieved with a special filling system of round not
to the die table reaching paddles, a proper coating of
the pellets (Colorcon, Evonic etc.) (thicker but elastic
polymeric coat) and damping (cushion) additives in
the formulation (porous or soft compressed
pellets) or powder excipients (cellulose,
lactose etc.). Mix Ratio 1:3 or 1:4 is
regarded optimum here and a low
compaction force pre 1-3 kN main
up to 7,5 kN
MUPS
(MULTIPLE UNIT PELLET (PARTICULATE) SYSTEM)
Design Factors:
DIRECT COMPRESSION
Problems in the Production with Direct Compression
• Insufficient Flowing from Hopper to Feeder
• Bad Filling of the Dies
• High Product Loss
• Insufficent Hardness
• Capping of the Tablets
T Y P I C A L P R O B L E M S I N T H E TA B L E T P R O D U C T I O N
Tablet weight deviation
Solutions:
-Dosing wheel
E X C E L L E N T W E I G H T U N I F O R M I T Y AT H I G H S P E E D S
1 Extended filling length (294 mm)
Minimum material loss: seal between
2
feeder and die table
3 Multiple feeder paddles design available
Longest Feeder Dwell Time in the Single -Sided
Machine Market
EXTENDED FEEDER FILLING LENGTH
F E E D E R PA D D L E D E S I G N
FEEDER BASE
Flexible
Feeder Seal Feeder
Drives
F O R C E F E E D E R M AT E R I A L C O N TA I N M E N T
Flexible Silicone Tube
PTFE Sealing
Plate
EXTENDED DWELL TIME (VERSION 1.1)
▪ Adjustable upper and lower
compression dwell bar between
pre and main compression
▪ Extend compression dwell time
▪ Permit higher tablet hardness at
high speeds and for direct
compression
▪ Extremely effective for difficult
products and for direct
compression
SUPERIOR YIELDS
1 Long feeder fill length
2 Tail-over-die and zero-clearance feeder
3 Feeder height adjustment (option)
4 Optimized integration of dust extraction
Target Yield: 98 - 99%
KORSCH AG | Breitenbachstr. 1 | 13509 Berlin | Germany | +49 (0)30 435 76 0 |
[email protected] | www.korsch.com
