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3 Performa P Basic Machines: 4.1.2 Optional Features and Equipment (See Section 5.2)

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3 PERFORMA P BASIC MACHINES

One PERFORMA™ P rotary tablet press (See section 5.1 for


detailed description), including:
• Modular construction machine frame
• Stainless steel hexagonal machine housing with 3 windows
• Drive module with AC 3-phase motor with frequency inverter
and cooling unit
• Pharmaceutical compression zone, including:
− Exchangeable turret,featuring Exchangeable Die Disc (EDD)
− Complete upper cam
− Double rotary paddle feeder
− Scraper and powder recycling finger
− Ejection finger with pneumatic reject valve
− Light-weight tablet chute with two outlets
− Dust extraction nozzles designed for optimal dust extraction
− Set of pre-compression and main compression rollers
− Set of bottom cam tracks
− Top and bottom punch jamming detection
• Powder in-feed system
• Machine and punch lubrication systems
• PC/PLC-based control system Multi-Control 4 for fully
automatic machine and production control; 21CFR part11
compliant; featuring colour graphical interface
• Tool kit and calibration punches
• Comprehensive technical documentation

4.1.2 Optional Features and Equipment (See section 5.2)


m1 3 x Additional overfill cam
m2 3 x Powder hopper on top of the machine
m3 3 x “Constant Level” system
m5 1 x Agitator system for poor-flowing powders
m6 3 x Upper punch guides with exchangeable bushings and
keyways for shaped tooling; including keyways for lower punch
guidings
m8 3 x Tablet chute with sampling gate
m10 3 x Price supplement for closed feeder with slide-in wear
plate
m11 1 x Additional turret including upper & lower cam tracks
and EDD capability
m12 1 x Bi-layer kit, enabling bi-layer tablet production
m15 1 x Arm to lift turret / upper guide part from the machine
m17 2 x Trolley to hold and transport the turret
c1 3 x Compression force monitoring & Dual Control System
c3 3 x Equal porosity tabletting
c5 3 x Ejection force monitoring
c6 3 x Ethernet connection for remote diagnosis/maintenance
MC4
c20 3 x Weight re-calibration using Combi-Test
c22 3 x Combi-Test “Kraemer” – (Checkmaster)
p5 3 x PharmaTechnology deduster / metal checker COMBI
500 CE

5.0 SCOPE OF SUPPLY


5.1 PERFORMATM P
The Courtoy™ PERFORMATM P press is a single-sided rotary
tablet press, available for EU or
TSM tooling standard. Its technical characteristics for each type
of tooling are given in the
Technical Details table in Section 6 of this quotation.
5.1.1 The Machine Frame
• Combination of heavy cast iron frames and high-strength
steel tension rods for maximal
machine rigidity and vibration absorption.
• The upper cast iron parts are entirely nickel coated for
stainless protection.
• Four anti-vibration pads under the machine
• Provisions for crane lifting and slots for fork truck lifting
• Modular construction with 4 clearly separated and isolated
compartments:
(1) The drive module, containing main drive motor and
reduction gearbox, adjustment
motors, air compressor for pneumatic compensators, punch
lubrication system and
cooling unit. Electrical connection box at the back of the base
module
(2) The pharmaceutical compression zone, containing the
exchangeable turret including
the top cam, the compression rollers with guides, the lower cam
tracks, powder
feeder, tablet chute and dust extraction.
The compression zone is totally separated from the remainder
of the machine, while
removable guards made of FDA guideline compliant plastic
protect the rollers and
cam tracks from the powder.
(3) Electromechanical top module, containing drive motors for
feeder and the optional
“constant level” system, as well as the pre- and main
compression compensators.
The powder in-feed system is separated from this area and can
be easily removed
through a removable front panel.
(4) Electrical cabinet, containing the electrical and electronic
components, including the
PLC and PC, placed against the backside of the machine. This
way, a separate
electrical cabinet and cabling to the press are avoided. If
desired, the electrical
cabinet can be supplied separate from the machine, at extra
cost.
• The use of only two tensile rods allows for perfect accessibility
to the compression zone
once the three front doors are open.

5.1.2 The Machine Housing


• Hexagonal machine housing in stainless steel 304 with 3
large plexiglass windows (front,
left and right) to give excellent accessibility all around the
machine.
• The windows are supported by gas springs, to maintain the
necessary pressure on the
window seals.
• The housing stands on its own feet on the floor independent
from the machine frame. There
is only a soft packing seal between machine frame and
machine housing, NO fixed
connection. This construction considerably reduces vibrations
and noise, even at high
compression forces and high speeds.
• Machine housing sealed against the floor and with sealed
stainless steel roof panel.
• All windows are interlocked.

5.1.3 The Drive Module


• Main motor and worm gear reduction box in bottom of the
base module for maximal
vibration suppression.
• AC 3-phase motor with frequency control for a wide speed
range; can be stopped by braking
and restarted at any speed. Frequency control including
overload protection.
• Special zero-play worm wheel gearbox, to reduce noise and
to provide constant speed
without ripple.
• Drive belt between gearbox and main shaft prevents heat
transfer from gearbox to die table.
• Vertical spindle rotating on oversized conical bearings,
holding the turret.
• Acooling unit, based on air ventilation, in the machine base
improves heat evacuation to the
outside of the machine.

5.1.4 The Pharmaceutical Compression Zone


• Turret including one (1) Exchangeable Die Disc (EDD) of
choice: an EDD for conventional
dies (EDD-CD) or an EDD for the innovative Die Shells (EDD-
DS)
• Complete upper cam, mounted on the turret
• Double rotary paddle feeder with independent drives and with
tool-free disassembly
• Magnetically mounted scraper and powder recycling finger
• Ejection finger with pneumatic reject valve
• Low friction, light weighted tablet chute with two outlets (good
and reject) for maximum
flexibility. A sampling flap and outlet is available as an option.
• Well positioned dust extraction nozzles, designed for optimal
dust extraction. The nozzles
are connected to the principal dust extraction connection at the
top of the machine. The
principal connection is equipped with an underpressure
monitoring device for the dust
extraction system. A pressure sensor, located near the external
connection point for the
dust extraction, measures the underpressure in the outflow of
air and dust. In the Multi-
Control 4 software, an upper and lower underpressure limit can
be set. Whenever the
underpressure goes outside the specified band, an alarm is
generated and the machine will
stop production.
• The punch guides are equipped with specially designed
double-lip seals to prevent dust
migration into the guides and oil spots on the tablets.
• The turret is easily exchangeable, using a simple and
removable lifting arm. The
disconnection and removal of the turret is guided step by step
by the Multi-Control 4 control
system.
• The turret can be opened using the same lifting arm, enabling
simple and quick manual
exchange of the Exchangeable Die Disc (EDD).
• Minimal number of parts inside the compression zone.
• One set of pre-compression rollers
• One set of main compression rollers
• Bottom cam tracks
• High torque teeth coupling between the turret and the central
spindle
• Top and bottom punch jamming detection
• Ejection cam height regulation
• Fill cam height regulation
5.1.5 Powder in-feed
Powder is fed into the tablet press through a tube made of FDA
guideline compliant plastic,
featuring a DN 80 tri-clamp connection, on top of the machine.
As an option, the Constant Level
system can be installed or, alternatively – for poorly flowing
powders – the agitator system.
5.1.6 The Turret
• Forged steel for maximal strength (NO cast iron as this is too
brittle and breaks easily when
punch jamming occurs or a die is tightened too hard).
• Three parts: (1) lower punch guide section, (2) Exchangeable
Die Disc section, and (3)
upper punch guide section.
• Entirely nickel-plated for stainless protection.
• Working surface of the die table: hard chromium plated and
ground, giving a flat stainless
and very hard surface for an ideal action of scrapers and
minimal powder loss.
• Spring-loaded lower punch brakes for uniform filling
5.1.7 The Compression Cycle
THE FILL
OVERFILL
• Overfilling is done under the first paddle of the double rotary
feeder = filling paddle.
• Standard delivered: one overfill cam of choice: 8, 10, 12, 14,
16, 18 or 19 (max in case of B
& BB tooling) or 20 (max in case of D tooling).
• Automatic identification of the installed overfill cam and
saved as product parameter.
• Easily removable cam for removal of lower punches.
• The overfill cam can be removed and installed without
removing any of the lower punches.

FINAL FILL OR “DOSING”


• “Fill cam” or “dosing cam” is adjusted in vertical position
through the control system using
an electro-motor with high-precision control loop for accurate
tablet weight control
• Reduced slope and “adjustable flight retainers” for uniform
filling even at high speeds
• Integrated lower punch tight detection by spring-loaded
system and proximity switch
• Second “scraper” paddle of the feeder scrapes excess of
powder above the die away and
brings it back in the first chamber of the feeder.
• A re-circulation groove in the centre of the turret recovers
the powder that escapes
between the feeder and the die table surface. This recovered
powder is scooped out of the
groove and fed into the dies BEFORE they go under the feeder
= PRE-FILLING.
• Powder scraper and die closing plate (after the feeder) and
powder recuperation finger
(before the feeder) is maintained in contact with the die table
using magnets. This allows a
very simple design, easy for cleaning and installation.

THE PRECOMPRESSION
• 2 well-dimensioned hardened steel pre-compression rollers,
diameter 160 mm
• Lifetime lubricated sealed bearings and guidings
• Top roller mounted on the unique Courtoy™ Air
Compensator for constant precompression
force under extended dwell time.
• Pre-compression height adjustment by electro-motor and
encoder on lower roller. Closed
loop position control and adjustment through control system.
• Maximum pre-compression force of 10 kN: The air
compensator allows an extended dwell
time requiring a significantly lower force than any other system.
• Overload protection: The pneumatic system has greater
sensitivity to overload and
reacts faster to an overload situation than a hydraulic or
electro-mechanical protection
system.
THE MAIN COMPRESSION
• 2 well-dimensioned hardened steel main compression rollers,
diameter 160 mm
• Lifetime lubricated sealed bearings and guidings
• Top roller mounted on the unique Courtoy™ Air
Compensator; to be used for either
“constant thickness” tabletting or “constant force” tabletting.
(The latter is also called
“Equal Porosity Tabletting.) In case of constant force tabletting,
the dwell time is
considerably longer, often resulting in better quality tablets
and/or increased machine
output.
• Top punch penetration manually adjustable between 1 and
4 mm, by means of an
excenter axis.
• Tablet thickness adjustment by electro-motor and encoder
on lower roller. Closed loop
position control and adjustment through control system.
• Overload protection: The pneumatic system has greater
sensitivity to overload and
reacts faster to an overload situation than a hydraulic or
electro-mechanical protection
system.
• Maximum main compression force up to 80 kN in case of
constant thickness tabletting. In
case of constant force tabletting (i.e. Equal Porosity Tabletting),
the maximum compression
force is limited to 60 kN.
THE EJECTION
• Variable slope ejection cam for optimal ejection curve,
resulting in less capping problems.
• Exchangeable bronze wear plate
• Adjustable ejection height
• Ejection finger with integrated pneumatic reject valve for
out-of-tolerance tablets.
THE TABLET CHUTE
• Tablet chute in PU: food approved, easy to clean and light
weighted.
• Double channel tablet chute for good tablets and out-of-
tolerance tablets.
• Reject flap valve in good-tablet outlet for non-controlled
tablets: i.e. tablets produced in
manual mode and at machine start-up.
• An obstruction sensor is installed on the tablet chute cover,
detecting any blockage of the
tablet chute in the good-tablets outlet. The sensor is a robust
capacitive sensor, easy to
adjust and insensitive to dust accumulation in the tablet chute.
• Additional flap and outlet for automatic tablet sampling
available as an option.
THE TOP CAM
• One central piece in steel with 4 exchangeable wear parts in
bronze. This avoids replacing
the complete cam when certain parts are worn out due to
punch friction.
• Up-going and down-going acting cams are double-sided (=
act on both sides of the punch)
to minimise cam and tooling wear.
• The complete cam is mounted on bearings on the turret. A
spring loaded lever system
prevents the cam from rotating with the turret.
• Top punch tight detection: When the torque on the top cam
surpasses a pre-set value, the
spring loaded lever system will move. This is detected by a
proximity switch, generating the
appropriate alarm.
5.1.8 Machine Lubrication
• No open oil lubrication system by using the latest state of the
art dry and lifetime grease
lubrication systems
5.1.9 Punch Lubrication System
• Sophisticated punch lubrication system based on volumetric
dosage of oil quantity.
• Oil and compressed air are mixed in adjustable proportion and
conducted in a tube to the
point of lubrication, where they are ejected as an oil mist on
the punches.
• Accurate control on the oil volume per stroke of the micro-
pump
• Totally separated lubrication systems for upper and lower
punches, allowing independent
set-up
• Upper punches at 2 points: Punch body and punch head.
• Lower punches at 4 points: inside punch body, outside
punch body, punch head and
ejection cam.
• All lubrication points are mounted rigidly inside the cam tracks
and no position adjustment is
Needed
5.1.10 Other
• Tool kit for basic disassembling and cleaning operations
• Calibration punches for calibration of the different position
regulation units.
• Electrical wiring and software control for peripheral
equipment: tablet deduster, metal
detector and/or automatic tablet sampling system. Connectors
are nicely incorporated and
hidden behind a door.

5.2 OPTIONAL FEATURES AND EQUIPMENT


M.1 Additional overfill cam
The basic machine is delivered with one (1) standard overfill
cam (to be chosen by the
customer). This option includes for one (1) additional standard
overfill cam of choice.
M.2 Powder hopper on top of the machine
This option covers the supply of a powder hopper supported by
a ring, positioned on 4 poles on
the top frame. The hopper will be designed to fit the specific
installation requirement and
interface with the customer’s powder feeding system. The inlet
of the powder hopper can be
equipped with either a Mueller cap, or alternatively lay-flat
tubing, for dust-free connection with
the powder feeding system.
M.3 Controlled powder infeed: “Constant Level” system
The “Constant Level” system has the following features:
• A rotary dosing valve located in the top module, but separated
from this and easy accessible
via a front door, carries the powder column above the press.
The valve is driven by an
electro-motor
• Transparent tube connection to the feeder, with infra-red
powder level detector
• The level sensor controls the motor in such way to have a
constant powder level above the
feeder, resulting in constant & reduced powder pressure inside
the feeder. This is very
important to reach constant tablet weight at very high tabletting
speed.
• Totally TOOLFREE (dis)assembling
• The rotary valve can be used as shut-off valve
The “Constant Level” system combined with the double rotary
paddle feeder answers the feed
requirements of nearly all powders and granules while at the
same time being a simple
construction for easy maintenance and cleaning.
M.6 Upper punch guides with exchangeable bushings and
keyways for shaped tooling
+ lower punch guides with keyways
This option includes for exchangeable bushings for the upper
punches. Equipping the turret with
such exchangeable bushings can result in significant
maintenance cost savings: when the
guidings of the upper punches are worn out, only these
bushings need to be replaced,
eliminating the need to replace the entire turret. The bushings
are much lower in cost compared
to a new expensive entire turret.
These exchangeable bushings for the upper punches are
equipped with keyways for the upper
punches. This is necessary when shaped (i.e. non-round)
tablets need to be produced on the
machine.
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PERFORMA™ P with MC4 Control System Specifar S.A.
Athens, Greece
COUR10-05.1434/12 Page 22 of 35 GEA Pharma Systems -
Courtoy™
When selecting this option, the guidings for the lower punches
will also be equipped with
keyways, but they will not be equipped with exchangeable
bushings. Keyways in lower punch
guidings are necessary in case of round tablets with emboss
(or break line) on both upper and
lower face, whereby both embosses must have fixed orientation
relative to one another (e.g.
double break line).
IMPORTANT REMARK:
When this option is not selected, upper and lower punches with
keys cannot be used on the
machine!
M.8 Tablet chute with sampling gate
This tablet chute has an additional sampling channel in addition
to the ‘good tablets’ channel
and the ‘out-of-tolerance tablets’ channel. An additional
sampling flap directs the tablets to the
sampling outlet. As the diverter flap is controlled on a time
basis, a sample will contain a noncontrolled
number of tablets: a sample typically contains between 20 and
30 tablets. (Singlestation
sampling is available as an option.)
The sampling gate can be used for manual sampling (i.e.
samples are taken manually at the
sampling outlet) or automatic sampling (i.e. samples are
diverted to a tablet analyser for inprocess
control).
Just like the standard tablet chute, this tablet chute has a dust-
tight plexiglass cover.
M.10 Price supplement for closed feeder with slide-in wear
plate
This option includes for a feeder base plate with exchangeable
slide-in wear plate in foodapproved
"ketron" plastic material.
The support plate of the feeder is adjusted in such a way that
the wear plate is in contact with
the rotating die table, eliminating the opening between feeder
base plate and die table surface.
This set-up reduces the amount of powder that re-circulates
around the die table and reduces
the powder losses, resulting in an increased yield of the
compression process.
The wear plate has however a reduced life time depending on
the speed of the tablet press and
the physical characteristics of the powder to be compressed,
and needs to be replaced on a
regular time interval.
The slide-in wear plate is available with different sizes of the
powder opening, depending on
tablet dimensions.
M.12 Bi-layer kit
This option includes all the mechanical parts required for bi-
layer tablet production:
• Two single-paddle feeders
• Second powder feeding and dosing system
• Tamping roll for first-layer compression, including force
measurement sensor
• Special-design powder scraper fingers
• Bi-layer dedicated upper and lower cam tracks, including one
overfill cam
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PERFORMA™ P with MC4 Control System Specifar S.A.
Athens, Greece
COUR10-05.1434/12 Page 23 of 35 GEA Pharma Systems -
Courtoy™
M.15 Lifting arm to remove the turret from the machine
The arm can be used to either lift the entire turret out of the
machine, or to swing out the upper
punch guide part, clearing the way for the EDD to be lifted out
manually.
M.17 Trolley to hold and transport the turret
Once the turret is removed from the machine, it can be
deposited onto this trolley for easy
transportation.
C.1 Compression force monitoring & Dual Control System
This option features a load cell under the lower main
compression roller – including the
necessary signal amplification and filtering – to measure the
force exerted by the compression
roller via the lower punch on the tablet during final
compression.
Compression force monitoring
The MC4 measures the peak values of all individual punches
and displays them in a colour bar
graph on the operator interface panel together with the
average, maximum, minimum and
standard deviation. This bar graph can be viewed by pressing
the corresponding software push
button on the operator interface panel.
It is possible to print all individual peak values of one complete
revolution of the turret by
pressing the appropriate button on the control system interface.
This is very useful in case the
numeric value of the peak force for each individual punch is
required.
Stop function
The average compression force is calculated on a user-defined
number of punches, varying
from 1 to 99.
The control system will monitor this average compression force
signal during production and
stop the press if the average force signal exceeds the upper or
lower tolerance limit, provided
such limits have been set and activated. The control system will
then display an appropriate
alarm message on the operator interface panel. The operator
defines the upper and lower
tolerance limits in the appropriate set-up screen.
Dual Control
The Dual Control System allows for an additional control loop to
maintain the tablet hardness as
constant as possible. The main compression height is adjusted
continuously and automatically,
with the aim to keep the average main compression force as
close as possible to the set value
introduced by the operator.
By maintaining the compression force as constant as possible,
irrespective of fluctuations in
tablet weight and granule characteristics and irrespective of
changes in punch length (due to
thermal expansion), the resulting tablet hardness will also
remain as close as possible to the
target value. However, the accuracy of this control loop and the
resulting hardness tolerance
depend on powder characteristics.
__________________________________________________
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PERFORMA™ P with MC4 Control System Specifar S.A.
Athens, Greece
COUR10-05.1434/12 Page 24 of 35 GEA Pharma Systems -
Courtoy™
When the Dual Control functionality is activated, it is also
possible to activate the Dual Tablet
Rejection function: tablets are then also rejected when their
individual main compression force
value is outside the pre-set rejection limits. These rejection
limits are part of the products recipe
parameter settings.
This Dual Tablet Rejection system offers greater security for
the tablet quality as tablets can
now be rejected from the good product stream for two
independent reasons:
1) Tablet weight is out of specification: a tablet is rejected
when its displacement on precompression
is outside the reject limits.
2) Tablet hardness is out of specification: a tablet is rejected
when its main compression
force is outside the reject limits.
Therefore, the Dual Control system offers:
1) Better process control: tablet weight and hardness are
continuously - and
independently from one another - monitored and controlled by 2
separate control loops
2) Better quality guarantee: tablets are only accepted if they
successfully pass TWO tests:
both pre-compression displacement and main compression
force have to be within
spec.
C.3 Equal porosity tabletting
This option includes for the possibility to work in "equal force
compression" mode (EFC) on the
main compression station, in addition to the conventional
"equal thickness compression" mode
(ETC).
When working in ETC mode, the upper and lower compression
rollers are fixed in position
during the compression. All tablets are then compressed to the
same (i.e. "equal") thickness,
while the peak compression force will vary with the weight of
the tablets: a heavier tablet will
require a higher compression force; a lighter tablet will require a
lower compression force.
These variations in peak compression force are typically within
a band of +/-20% for weight
variations within the acceptable weight tolerance limits. This
results in important variations in
porosity and density from tablet to tablet, and consequently
significant variations in tablet
hardness and disintegration time. Moreover, the thickness of
the tablets will not be exactly equal
due to differences in punch length and slight differences in
machine deformation as a result of
the variations in peak compression force.
When compressing tablets in EFC mode, the same (i.e. equal)
peak compression force is
exerted on each individual tablet, independent of the weight of
the tablet and the length of the
punch. As a result, the variability in tablet weight and punch
length does not induce variability in
tablet density & porosity, but only a limited variability in tablet
thickness. As the tablet porosity is
equal for all tablets, the hardness and disintegration time will
show significantly less variability
within a sample and between different samples of the same
batch. Moreover, when working in
EFC mode, the compression dwell time is longer compared to
the ETC mode. This results in a
better de-aeration of the powder bed and a better inter-
particulate bonding. Consequently, a
higher tensile strength is achieved for a given machine speed,
or a higher machine speed can
be achieved for a specific required tablet hardness.
__________________________________________________
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PERFORMA™ P with MC4 Control System Specifar S.A.
Athens, Greece
COUR10-05.1434/12 Page 25 of 35 GEA Pharma Systems -
Courtoy™
EFC is a novel compression method made possible on
Courtoy™ tablet presses thanks to the
air compensator system on the main compression station, and
offers better process control and
higher consistency in tablet quality aspects (hardness,
disintegration time, etc.).
Note: the maximum main compression force is limited to 60 kN
when working in EFC mode.
C.5 Ejection force monitoring
This option features a load cell under one of the two supports of
the ejection cam – including the
necessary signal amplification and filtering – measuring the
force exerted by the lower punches
on the front end of the ejection cam.
The control system (Multi-Control 4) will monitor this ejection
force signal during production and
stop the press when a preset limit is exceeded. The control
system will then display an
appropriate alarm message on the operator interface panel.
This system cannot measure the individual ejection force for
each tablet, as the load cell is only
supporting part of the ejection cam and several punches are in
contact with the ejection cam at
any moment. This feature is therefore intended as a sensitive
system to detect jamming of the
bottom punches in their guiding and/or increasing resistance by
the compressed tablets against
ejection from the dies. By detecting an increase of the overall
and average ejection force, this
system provides an effective protection of the cam tracks and
compression tooling.
C.6 Ethernet connection for remote software diagnosis &
maintenance
This option includes for a ethernet connection installed on the
machine to allow GEA Pharma
Systems - Courtoy™ engineers to perform software trouble
shooting and software maintenance
remotely. The price quoted includes one year’s support by GEA
Pharma Systems - Courtoy™
software engineers, who will be available for remote software
trouble-shooting and maintenance
during GEA Pharma Systems - Courtoy™ office hours.
C.20 Automatic weight correction using data feedback
from Combi-Test
This option includes for the software module (including
validation and testing) for automatic
tablet weight correction by re-calibration of the primary control
loop.
This re-calibration is based on the average tablet weight, fed
back by the Combi-test (optional),
and is done by re-adjusting the pre-compression height and the
die fill depth according to the
difference between actual and nominal tablet weight.
IMPORTANT NOTE: As re-calibration is done by adjusting the
PRE-compression height, the
FINAL compression height is NEVER changed. As a result,
final tablet thickness remains
UNCHANGED and tablet hardness remains also CONSTANT
(as long as powder/granule
characteristics are unchanged). Therefore, on a Courtoy™
tablet press, there is NO need for
feed-back and re-correction of thickness and hardness.
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PERFORMA™ P with MC4 Control System Specifar S.A.
Athens, Greece
COUR10-05.1434/12 Page 26 of 35 GEA Pharma Systems -
Courtoy™
C.22 Combi-Test (KRAEMER)
• The Combi-Test system will take samples of tablets at
programmable time intervals by
means of an electromagnetic sampling gate in the tablet chute.
• Time interval between samples is set in the tablet press
control system. (In case of doublesided
or double-layer machine, side A and B will be sampled one
after the other.)
• Tablets are transported from the press to the Combi-Test by
means of a vacuum transport
system. This system is standard included in the scope of this
option.
• The Combi-Test can be installed on a table or on the floor
nearby the tablet press. The
flexible tablet transport tube has a maximum length of 5 m.
• The Combi-Test will measure the individual weight,
thickness and hardness values for a
pre-set number of tablets and send this data back to the tablet
press control system.
• Weight, thickness and hradness values are compared to the
standard “Pharmacopea” limits
– or customer in-house tolerance limits – and the press will be
stopped in case too many
tablets are out of T1 and/or T2 tolerance limits.
• Depending on the type of tablet press control system, the
individual weight-thicknesshardness
values, their mean value and standard deviation will be printed
or logged in the
batch report after each sampling cycle. In case of Multi-Control
3 control system, the data is
available in graphical format, including historical trending
graphs and distribution graphs.
The hardware used for the COMBI-TEST is the KRAEMER
CompuLab, model UTS CI:
♦ Modular tablet testing system for measuring weight,
thickness, diameter and hardness
♦ For use as table top or floor model on stand
♦ Including patented KRAEMER separating feeder
♦ Standard measuring range for weight 0 - 2,9 g, thickness 0-10
mm, diameter 0-30 mm,
hardness 3-300 N
♦ Operating and display panel for all four parameters, including
calibration features
♦ Configuration program for customer specific applications
♦ 2 interfaces RS232
♦ 2 network interfaces RS422/RS485
Including:
♦ 1 tester unit
♦ 2 waste bins Plexiglas
♦ 1 calibration set
♦ 1 operating manual
♦ 1 power cable
♦ 1 RS232 serial cable
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PERFORMA™ P with MC4 Control System Specifar S.A.
Athens, Greece
COUR10-05.1434/12 Page 27 of 35 GEA Pharma Systems -
Courtoy™
P.7 PharmaTechnology deduster / metal checker COMBI
500 CE
This option covers the supply of a deduster DV 500 combined
with a metal detector CEIA into
one frame.
Technical specifications:
- Uphill dedusting and vertical transporting via stepless
vibration
- Tablet entry by U profile 120 mm x 35 mm H with silicone lips
- Stainless steel 316L spiral with continuous TIG welding, made
of two pieces with quick
assembling & disassembling systems
- Central aspiration column with bottom stitching diameter 52
mm for dust extraction to
be connected on your dedusting installations
- Ten dust suction points (60 mm x 40 mm) connected with the
central aspiration column
- Lifting height: 630 mm
- Spiral made of two pieces with quick assembly system
- Tablet outlet by U profile 100 mm x 35 mm H
- Execution according to GMP standard and CE standard
- Very quick dismantling with tri-clamp
- Very short cleaning time
- All stainless steel 316 frame with integrated wiring into the
frame
- Stainless steel 304 electrical cabinet equipped with main
switch, speed variator and
diode.
- Total floor dimensions: 770 mm x 460mm
- Adjustable height between 715 mm – 815 mm from the floor
- 2 x 1 block of 25mm to be placed under the vibrating base to
get a higher adjustable
inlet height
Including :
Frame mounted on castors/Adaptation and metal detector
CEIA THS/PH21
- Construction all stainless steel 304 mirror finish
- Head opening dimension: 100 mm x 40 mm
- Electrical cabinet protection: IP 67
- Multi-language alpha numeric menu & bar graph display
- Power requested 230V 50/60Hz / 110V AC 60 Hz
- Accuracy : 0,5 mm stainless steel 316 ; 0,30 mm ferrous
steel ; 0,35 mm non-ferrous
steel (Please note: intrinsic accuracy depends on product
effect)
- 100-product memory
- LCD display
- Automatic adjustment of product effect
- RS 232 connector for printer.
- “Lift flap” rejection mechanism

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