TABLE OF CONTENT

1. Objective
2. Scope
3. Responsibility (Client and manufacturer)
4. URS (User Requirement Specification)
5. Machine description
6. Technical specification of sub components/brought out items.
7. Specification of Automation.
8. Machine operation control through PLC
9. Details of power consumption
10. Material of construction of component
11. Test certificates/Inspection reports
12. Surface Area of the product contact parts
13. Brief Process Description
14. Safety-Interlocks/Alarms messages
15. Load calibration chart
16. Lubrication requirements
17. FAT procedure
18. Change control procedure
19. Appendix
1.0 OBJECTIVE:
To design, engineer, and supply the Cadmach CPD-II-37 station with Bi
Layer attachment as per cGMP and cGEP guidelines and to provide
assurance that the machine is manufactured as per the URS and it
complies with the Scope of Supply.
To prove that each operation proceeds as per the design specification and
the tolerances prescribed there in the document, are the same at utmost

transparency. Validation procedure is set for complete satisfaction of the

customer & building confidence of the user about the machine.

2.0 SCOPE:
The scope of this qualification document is limited to the Design
Qualification of Cadmach CPD-II-37 station with Bi Layer Attachment for
M/s USV Limited, in Daman. This qualification document is part of a
validation activity for the Cadmach CPD-II-37 station.
Qualification of support utilities is not within the scope of this qualification
document.
The equipment shall be used for compressing the powder into tablets.
The equipment shall operate under dust free environment and conditions
as per the GMP requirements.

3.0 RESPONSIBILITIES:
3.1 CLIENT:
3.1.1 To provide the URS for the equipment.
3.1.2 To perform the Factory Acceptance Test (FAT).
3.2 MANUFACTURER:
3.2.1 To design, engineer and provide the complete technical details of
the equipment pertaining to its design qualification viz.
3.2.1.a
3.2.1.b
their

Machine overview,
Specifications of the sub-components/ bought out items, and

make, model & quantity, and backup records/ brochures,

3.2.1.c Details of Utilities,
3.2.1.d Material of construction of all components
3.2.1.e Brief process description
3.2.1.f Safety features.
3.2.2 To facilitate the client for the Factory acceptance test of the
machine at their works/ site.
3.2.3 To confirm the safe delivery of the equipment to the user site.
3.2.4 To ensure that no un-authorized and / or unrecorded design
modifications shall take place. If at any point in time, any change is
desired in the mutually agreed design, Change control procedure
shall be followed and documented.

3.2.5 To ensure the proper installation and commissioning of the

equipment.
4.0

URS ( User Requirement Specification) :

Please refer attached Annexure

Requirement Specification.

No.

DQ/ANX/03

for

the

User

5.0 MACHINE DESCRIPTION

5.1 Process Equipment Description
The Cadmach CPD-II-37 station with Bi Layer Attachment, a double rotary
tablet press, is a versatile machine in the range of tabletting. It is also

incorporated
with
the
force-feeding
arrangement,
Lubrication
(Intermittent + Continuous), electromagnetic clutch and Programmable
Logic Controller. The Bi Layer attachment facilitates in producing twin
colour tablets.
Complete machine can be divided in following sub sections:
5.1.1 Powder feeding unit (LHS & RHS)
5.1.2 Powder Transfer unit (LHS & RHS)
5.1.3 Drive unit, Turret and Compression unit
5.1.4 Weight Dozer (LHS & RHS)
5.1.5 Hydraulic Power Pack Assembly.
5.1.6 Tablet discharge unit (LHS & RHS)

5.1.1 Powder Feeding Unit (LHS & RHS) :

This comprises of the following
5.1.1.a Hopper with Butterfly valve (LHS & RHS)
5.1.1.b Powder level sensor (LHS & RHS)
5.1.1.a Hopper with Butterfly valve (LHS & RHS)
An SS 316 L Hopper of capacity 18 Liters rests on top of the machine
which holds the powder in it and delivers to the feeding assembly through
a butterfly valve which controls the flow of the powder between the
Hopper and the Feeding assembly. It comprises of a flap, which can be
operated using a knob. In case of Bi Layer tablets, both the hoppers shall
contain different colour powder/granules.
5.1.1.b Powder Level Sensor (LHS & RHS): - This is set on a sight glass fit
to the hopper. The setting is done using two adjustable nuts. As soon as

the powder in the hopper drops down the level, the sensor senses the
same and gives the respective signal to the PLC and stops the machine.
5.1.2 Powder Transfer Unit: This comprises of the following
5.1.2.a Inlet Connector (LHS & RHS)
5.1.2 b Force Feeder Assembly (LHS & RHS)
5.1.2.a Inlet Connector (LHS & RHS)
It is a SS 316 L connector, which links the Hopper and the Force feeder.

5.1.2.b Force Feeder Assembly (LHS & RHS)

It comprises of
5.1.2.b.i Force Feeder
5.1.2.b.ii Tail over die, scrappers and feeder
5.1.2.b.iii Nozzle outlet for suction.
5.1.2.b.i. Force Feeder
The force feeder has two counter rotating paddles of SS 316 L, driven by
reduction gearbox and variable frequency AC drive motor. The pressing
material enters the feeder in the middle between the two paddles. With
the feeder in the MANUAL MODE, the force feeder is operated for initial
filling prior to rotating the machine and in AUTO MODE; the force feeder
will run along with the machine. While machine is in production, always
put the feeder in AUTO MODE.
5.1.2.b.ii Tail over die, scrappers and feeder
The tail over die is an essential feature of the high-speed tablet press.
The function of the tail over die is to keep the filled die covered until the
last moment before the upper punch enters the die. Failure to keep the
die covered will result in granules spilling out of the die with subsequent
variation of the tablet weight. The tail over die is fitted freely over the
turret die table and is pressed against the die table by spring action.
Ensure that the bottom surface of the tail over die rests flat and matches
with the die table.

The spring-loaded scrappers are inserted in the scrapper support bracket

and tail over die respectively. The springs press the scrappers against the
turret die table to scrap off. the tabletting powder

5.1.2.b.iii Nozzle outlet for suction

This comprises of a PVC pipe that is connected to the dust extraction unit.
The powder dust coming from the preceding feeder is completely sucked
thereby avoiding mixing of granules & reduce the dust generation.
5.1.3 Drive unit, Turret and Compression Unit
5.1.3.a Drive unit
A main motor of 7.5 HP drives a very high reduction gearbox unit using an
electromagnetic clutch and a timing belt. The gearbox unit consists of a
Phosphorus bronze (SAE65) worm wheel and a Worm shaft of SAE 8620
(with case hardening having 58 62 HRC). The worm wheel shaft holds
the Pinion. The turret has an internal helical ring, which meshes externally
to the pinion. The rotation of the pinion is responsible for turret motion.
Thus, CPD II 37 stations is purely eccentric drive.
N.B.: - The rotation of CPD-II-37 station is clockwise.
5.1.3. b Turret
This tool holding body is a 3 piece structure having the center die table of
SS 316 L and the Upper and Lower piece of Cast iron of grade FG-260.
The upper piece holds the upper punches, which rests on the upper cam
tracks with the cam plate. Similarly, the lower piece holds the lower
punches that travel on the lower cam tracks and dozer. The Dies lie in the
die cavities provided in the die table with the help of die locking screw
assembly. The lower punches are secured using punch holding device
comprising of brake plug, anti-turning spring strip and button head screw.
5.1.3.c Compression Unit
This comprises of
5.1.3.c.i Upper Main Pressure Roll Assembly (Front and Rear)
5.1.3.c.ii Lower Main Pressure Roll Assembly (Front and Rear)
5.1.3.c.iii Upper Punch Penetration Assembly (Main Front & Rear)

5.1.3.c.iv

Tablet Thickness Assembly (Main - Front and Rear)

5.1.3.c.i Upper Main Pressure Roll Assembly (Front & Rear)

It comprises of a Roll Center, Pressure Roll and Pressure Roll Pin. The Roll
Center holds the Pressure Roll and is locked using External Circlips. The
rotation of the Roll is taken care by 02 No. cylindrical roller bearing (NJ310).
5.1.3.c.ii. Lower Main Pressure Roll Assembly (Front & Rear)
It comprises of a Roll Center, Pressure Roll and Pressure Roll Pin. The Roll
Center holds the Pressure Roll and is locked using External Circlips.The
rotation of the Roll is taken care by 02 Nos. cylindrical roller bearing (NJ2310).
5.1.3.c.iii Upper Punch Penetration Assembly (Main Front & Rear)
This is the assembly, which is responsible for the entry height of the
upper punch in the die. Whenever the wheel of upper punch penetration
is rotated, the entire upper pressure assembly with the carrier along with
the lower pressure assembly is moved up and down. Always care needs to
be taken to set the upper punch penetration initially and only then the
thickness.
5.1.3.c.iv Tablet Thickness Assembly (Main Front & Rear)
This is the assembly, which is responsible in deciding the tablet thickness.
The upward and downward movement of the lower pressure carrier
assembly varies the thickness.
5.1.4 Weight Dozer (LHS and RHS)
This assembly is responsible for adjusting the weight of the tablet by
varying the depth of fill. The depth of fill is adjusted by the upward and
downward movement of the weight adjusting head through a dozer
adjusting screw with the help of dial.
5.1.5 Hydraulic Power Pack Assembly
This system controls the safety overload mechanism, which governs the
maximum pressure, level, at which particular tablets are being made. The
oil reservoir for this system is located in front corner within lower cabinet.

It can be accessed by removing the lower side guard (LH). The oil level in
the reservoir should be checked regularly through the oil level indicator.
5.1.6 Tablet discharge unit
This comprises of5.1.6.a Ejection Cam (LHS & RHS)
5.1.6.b Tablet take off plate assembly (LHS & RHS)
5.1.6.c
Tablet discharge chute (LHS & RHS).
5.1.6.a. Ejection Cam (LHS & RHS)
The lower punch glides on the ejection cam and ejects the tablet. The
height of the ejection cam needs to be set in such a way that the tip of
the lower punch is slightly above the die so as to avoid tablet-chipping
problem. In case of Bi Layer operation, the ejection cam and fill cam of
the LHS are removed. This is done to facilitate the filling of the second
layer on the initial layer.

5.1.6.b Tablet take off plate assembly (LHS & RHS)

As soon as the tablet is ejected out it strikes the tablet take off plate
assembly, which directs the tablet to the discharge chute. Care should be
taken so that the tip of the lower punch does not strike the tablet
scrapper assembly. In case of Bi Layer operation, this assembly is present
on the RHS feeder only as there is no ejection on LHS.
5.1.6.c Tablet discharge chute (LHS & RHS)
It is made of SS 316 L with acrylic cover. Tablets slide out through this
chute to the container. In case of Bi Layer operation, only one discharge
chute is present i.e., on the RHS.

6.0
Technical specification of sub components / bought-out
items.

7.0 Specification of Automation

Automation
A.C.Drive for Main Motor
A.C.Drive for Feeder Motor
PLC System
MMI Touch screen

Make
Mitsubishi
Mitsubishi
Mitsubishi
Mitsubishi

Specification
Type FR E 500 - 5.5 K Rating 7.5 HP, 3 Phase, 415 V
Type FR S 500 - 0.75 K Rating 1 HP, 3 Phase, 415 V
Type FX2N 48 MR + 2 AD + 2DA, 48 digital I / O 2 Analog I / O
Type F 940 GOT LWD 5.7 " Colour

Specification of programmable logic control systems :

Make : MITSUBHISHI, Catalogue No. FX2N - 48 MR - ES / UA
Number of Input/Output
Number of Input/Output
Line Power
Inrush current
Input circuit type
Output circuit type
Operating temperature
Storage temperature
Operating humidity
Vibration

Shock Resistance
Agency certification
Terminal screw torque

24 Inputs
24 outputs
100 - 240 V AC 50/60 HZ
0.2 A
24 DC sink / source
MR - ES / UL (Relay output)
o
o
O
o
+ 0 to 55O c ( + 32 F to 131 F ) Ambient
o
o
O
o
- 20 C to +70 C( -4 F to +158 F) Ambient
5 % to 95 % relative humidity ( Non- condensing)
Operating : 10 to 57 Hz, 0.035 mm. Hlaf
2
Amplitude - 57 to 150 Hz. 4.9 n / sec -->
acceleration
2
EN 68 - 2- 27, 11 MS, 147 m/sec -->acceleration.
CE, UL / cUL, UL 508. CE complaint for all
applicable directives.
0.3 to 0.6 Nm I.e. 3 to 6 Kgf - cm

8.0 Machine operation control through PLC

Switch on the mains, `Welcome screen will be displayed
Enter valid password, `Main menu screen will be displayed
Three levels of password will be provided as follows:
a) Operator Level
b) Supervisor Level
c) Manager Level
Press machine control touch button, detailed `Machine control menu
screen will be displayed
Press turret control touch button, detailed `Turret control menu screen
will be displayed
Press feeder control touch button, detailed `Feeder control menu
screen will be displayed
Press compaction force touch button, detailed `Compaction force
menu screen will be displayed
Press lubrication control touch button, detailed `Lubrication control
menu screen will be displayed

Press machine status touch button, detailed `Machine status-1 menu

screen will be displayed
Press recipe management touch button, `Recipe password screen will
be displayed
Press batch data touch button, detailed `Batch data menu screen will
be displayed
Press technical data touch button, detailed `Technical data menu
screen will be displayed
More detail about machine operation control through PLC is as per the
attached Working Instruction Manual of PLC Touch Screen.
Note: Separate Instruction Manual is attached as annexure
9.0

Details of power consumption

Motor
Main
Voltage
Hp
Amperage

Feeder (R.H.)
Voltage
Hp
Amperage

Feeder (L.H.)
Voltage
Hp
Amperage

Power pack

Voltage

Hp
Amperage

Rated
specification
415
7.5
14.5

415
0.25
0.58

415
0.25
0.58

415
1
1.8

Total power consumption for main machine: 9 Kw

10. 0 Material of Construction of component

Description
Turret
a) Upper /
piece
b) Die table
Pressure Roll
Worm Shaft

Location
Upper cabinet
Lower
Roll Carrier
Main
drive
Gear Box
Main
drive
Gear Box

Worm Shaft

Feeder drive
Gear Box
Feeder Gear
Box
Upper
Cabinet
Feeder
housing
Roof
Near die table
Lower cabinet

Paddle for force

feeder
Hopper
Discharge chute
Lower guards

11.0

FG-260
SS 316 L

Worm Wheel
(Main Drive)

Worm Wheel
(Feeder Drive)
Feeder housing

MOC

Test certificates / Inspection reports.

OHNS
SAE 8620 with
case hardening
having
58-62
HRC
Phosphorus
Bronze
(SAE65)
Mild Steel
Phosphorus
Bronze
Gun Metal
SS 316L
SS 316L
SS 316L
SS 304

S.NO.

DESCRIPTION

11.1
11.2
11.3
11.4
11.5
11.6
11.7
11.8
11.9
11.1
11.1
11.12
11.13
11.14
11.15
11.16
11.17
11.18
11.19
11.20
11.21
11.22
11.23
11.24
11.25
11.26
11.27
11.28
11.29
11.30
11.31
11.32
11.33

Main Drive Motor

Force Feeder Motor
Force Feeder Motor
Hyd.Power Pack Motor
AC Frequency Drive (Main Motor)
AC Frequency Drive (Feeder Motor)
PLC & MMI
Electromagnetic Clutch
Hyd.Accumulator
Hyd.PressureGuage
Lubrication Pump P.P.I
Pressure Sensor 100Bar
Power Level Sensor
Digital Volt meter
Digital Amp. Meter
M.O.C. of Turret
M.O.C. of Die Table SS 316L
M.O.C. of Pressure Roll
M.O.C. of Rubber Below
M.O.C. of Paddle SS 316L
M.O.C. of Hopper SS 316L
M.O.C. of Discharge Chute SS 316L
M.O.C. of Lower Guard
M.O.C. of Feeder Housing
M.O.C. of Worm Wheel (Main)
M.O.C. of Worm Wheel (Feeder)
M.O.C. of Worm Shaft (M.G.B.)
M.O.C. of Worm Shaft (F.G.B.)
Insp.Report of Main Gear Box
Insp.Report of F.F. Gear Box
Insp.Report of Adj. Dials
Test Certificate Of Surface Finish
Test Certificate Of PTFE Mat. For Tail
Over Die & Strip at Feeder
Test Certificate Of Hyd. Gear Pump
OP3003-CPSTB
Test Certificate Of Pressure SwitchIPS350-30
Test Certificate Of Check Valve
C06 S1-03
Test Certificate Of Directional
Operational Pressure Relief Valve-DPRH
06S4
Test Certificate Of Pilot Operated Check
Valve- CIM 06AB1-20

11.34
11.35
11.36
11.37

11.38

12.0

T.C.NO.& DATE

CERTIFICATE DETAILS

Dated 08/03/2004
Dated 13/12/2003
Dated 13/12/2003
Dated 15/03/2004
Dated 14/04/2004
Dated 14/04/2004
Dated 23/06/2004
Dated 20/09/2003
Dated 09/03/2004
817dated 09/03/2004
Dated 01/06/2004
--Dated 16/06/2004
Dated 16/06/2004
1209 dated 08/02/2004
W5010 dated 04/03/2004
2003016552 dated 11/8/03
2785 dated 30/01/2004
2698 dated 19/05/2004
2675 dated 17/05/2004
2697 dated 19/05/2004
2178 dated 22/04/2004
280 dated 19/01/2004
3098 dated 08/06/2004
3133 dated 10/06/2004
5525 dated o3/12/2003
W3405 dated 15/11/2003
Dated 14/06/2004
Dated 14/06/2004
Dated 10/06/2004
Dated 14/07/2004
922 dated 16/07/2004
--

M/s. Crompton Greaves

M/s. Bharat Bijlee Ltd
M/s. Bharat Bijlee Ltd
M/s. Crompton Greaves
M/s. Messung System Pvt. Ltd.,
M/s Messung Systems Pvt. Ltd.,
M/s. Messung System Pvt. Ltd.,
M/s. Golden Engg. Co.
M/s. EPE Process Filter
M/s. Sharon Engg.
M/s. Cenlub Industries Ltd.,
M/s. IFM Electronics
M/s. IFM Electronics
M/.s Enercon Systems Pvt. Ltd.,
M/s. Enercon Systems Pvt. Ltd.,
M/s. Fitcast Founders
M/s. Metalab Enterprise
M/s. Mahendra Ugine
M/s. Metalab Enterprise
M/s. Metalab Enterprise
M/s. Metalab Enterprise
M/s. Metalab Enterprise
M/s. Metalab Enterprise
M/s. Metalab Enterprise
M/s. Metalab Enterprise
M/s. Metalab Enterprise
M/s. Metalab Enterprise
M/s. Metalab Enterprise
M/s. Cadmach Machinery
M/s. Cadmach Machinery
M/s. Cadmach Machinery
M/s. Cadmach Machinery
M/s. CIEPT - Ahmedabad
M/s Dynamatic Techn.Ltd.

Dated 03/06/2004

M/s Polyhydron Pvt.Ltd.

Dated 22/06/2004

M/s Polyhydron Pvt.Ltd.

Dated 30/06/2004

M/s Polyhydron Pvt.Ltd.

Dated 15/06/2004

M/s Polyhydron Pvt.Ltd.

Surface Area of the product contact parts.

Sr.
No.

Name of the part Product

contact
surface
area
in sq. cm /
piece

Hopper

3078

Total
quantity
used
in
the
machine
2

Total
product
contact
surface
area in sq.
cm
6156

Extension
for
80
2
160
hopper
3
Flap for flow control
63
2
126
4
Bellows portion
66
2
132
5
Inlet flange at bowl
256
2
512
6
Bowl
96
2
192
7
Feeder frame
561
2
1122
8
Paddle (First)
84
2
168
9
Paddle (Second)
119
2
238
10
Turret (Die table
1964
1
1964
only)
11
Tablet chute (Inner)
448
2
896
12
Tablet
chute
719
2
1438
(Outer)
TOTAL FOR
13104
MACHINE
N.B. The total product contact surface area of the parts of
CPD-II-37 station machine with Bi Layer attachment is
13104 sq. cm.

13.0

Brief Process Description.

13.1 Mono layer Operation

13.1.1 Force Feeding
The formulated powder in the hopper is pulled down using a Force
Feeding arrangement consisting of rotary force feeders. The advantage of
force feeder is, ensured die filling.
13.1.2 Compression
The lower punches, which always remain in the die, hold the powder that
is fed into the die, onto it. Further, due to the rotation of the turret, these
punches move on the dozer assembly where only required quantity of the
powder is held back and the rest is scrapped out. Punches then glide on
to pressure roll. At this stage the upper punch moves down the Upper
cam track Lowering, and then the pressure roll. Both the punches get

pressurized under the pressure rolls. At this instant, due to the heavy
compression force the tablet is formed. The excessive backpressure
generated in this process is absorbed by the hydraulic cylinder, which is
suspended onto the lower pressure roll carrier. After the tablet is formed
inside the die, it needs to be ejected out. The lower punch moves further
on to the ejection cam track and the tablet gets ejected out. At this stage,
the upper punch moves onto the Upper cam track Lifting and glides idly
on the upper cam piece. After the tablet is ejected out, the lower punch
moves in the lower cam track and comes beneath the feeder and the
cycle continues. In one revolution, there is double ejection of tablets.
Tablet output / revolution = No. of stations x 2

13.2 Bi Layer Operation

13.2.1 Force Feeding
In case of Bilayer operation, two hoppers on the either sides would
contain two different granules. The granules for the first layer are fed in
using right hand feeder while for the second layer, using the left hand
feeder.
13.2.2 Compression
The granules for the first layer are fed into the dies by the right hand
force feeder; the weight-adjusting cam regulates the correct amount.
Excess granules are ejected from the die cavity and rejected through the
excess power rejection slot. The material then passes between the front
pressure rolls where the granules are tamped by the upper and lower
punches. The degree of pressure applied should be just sufficient to
produce a sharp demarcation between layers without affecting the
bonding of the first and second layers. Adjusting the lower roll by the
tablet thickness control can regulate the degree of tamping. The lightly
compressed tablet, maintained at a height fixed by the amount of top
punch penetration at the first compression station, passes under the
second feeder and receives its second charge of granules. Again the
appropriate weight-adjusting cam controls the fill of granules and the
surplus granules are ejected from the die cavity and rejected through the
excess power rejection slot. But, it should be noted that the maximum

depth of fill is controlled by the amount of the upper punch entry at the
first compression. The dies, containing the two layers of material pass
between the final compression rolls, which are adjusted to give the
required final tablet hardness. The compressed tablet is ejected and
deflected down the take-off chute (R.H.)

13.2.2 Sampling
The weight of the layers can be checked whilst the machine is in
operation. To affect this the lower pressure roll of the first compression
station is mounted on an eccentric pin, which has a gear cut on one end.
This gear meshes with a rack mounted on the end of an air cylinder
piston rod. When a weight check of the first layer is required the selector
switch is put in ON condition. This actuates the air cylinder, which in
turn pushes the rack upwards, and thus rotates the eccentric pin. The
movement of the eccentric pin lifts the lower pressure roll and increases
the hardness of the first layer. Due to this increased hardness no bonding
between layers will take place during the final compression and the two
layers will separate on ejection.
Weight of the first layer can be obtained by direct weighing the first layer
sample and the weight of the second by subtraction the first layer sample
tablet weight from the total weight of the completed two-layered tablet.

14.0

Safety - Interlocks / Alarms messages.

Due to any of the following interlocking reasons the m/c will not start or
will stop immediately, if in operation. The m/c healthy messages will be
displayed in green colour while the interruption messages are displayed
in red colour.
S.N.
InterruptiveMessage
1
Turret motor overload

2
3
4
5
6
7
8
9

10

11

Action
a) Machine stops
immediately.

Cause
a)To check for resp. output
in thePLC
b)To check the tightness of
thetiming belt
c)To check for any one
phasefailure.
L.H. feeder motor overload a) Motor stops
Material clogging between
thepaddles.
b) Indication on MMI
R.H. feeder motor overload a) Motor stops
Material clogging between
thepaddles.
b) Indication on MMI
Emergency
push button M/ c does not start
Emergency push button
operated
being pressed.
M/ c guards open
M/ c will not start and will M/ c set in interlock mode.
stop if in motion.
Hydraulic motor overload
Indication on theMMI
PhaseFailure.
Lubrication oil level low
Indication on theMMI
Lubrication oil
reservoir
running short of oil.
Batch sizecompleted
M/ c will not start
Batch size being completed
and needs resetting.
R.H. Powder level is low
M/ c will not start. If in a) Hopper running out of
motion, it will stop after few powder.
revolutions.
b) Sensor disturbed Needs
re-setting.
L.H. Powder level is low
M/ c will not start. If in a) Hopper running out of
motion, it will stop after few powder.
revolutions.
b) Sensor disturbed Needs
re-setting.
Machine selected in manual M/ c
will
not
run
in It is used to fill up the
mode
continuousoperation.
feeders by jogging.

The following are the alarm functions. The alarm messages will be displayed in
red colour, and machine should not be run longer.

S.N.
AlarmMessage
Action
Cause
1 Guards selected in By-Pass Machines runs but with red- Not applicable
mode
indication in theMMI
2 Tablet countingproxy not in 1) Machines runs, but with Setting being disturbed.
position
red-indication in theMMI
2)No tablet counting.
3 Main set pressure (Front & Machine runs with excessive 1) Suspected for hydraulic
Rear) overload
vibration at lower roll carrier oil leakage.
2) Hydraulic pressure not
being set before starting the
machine.

15.0

Load calibration chart

Punch force depends upon tablet size, shape, product characteristics and
requirement of tablet hardness. The load on punches between two main
compression rolls is developed by a hydraulic system. It should be set
with the hydraulic system as required. The load on punches will be
displayed on the digital force indicator in KN.

Load on punches
between two main
press rolls in Tons
1
2
3
4
5
6
6.5
7
8
9
10

Digital force
Pressure gauge
indicator reading in reading in kg/sq. cm
kN
10
20
30
40
50
60
65
70
80
90
100

5.6
11.1
16.7
22.2
27.8
33.9
36.2
39
44.5
50
55.6

16.0

Lubrication requirements

Sr. No.

Description

Location

Duration

Lubricant
Hindustan
Shell make
Petroleummake

Reservoir
for Resides
main Fill asrequired Enklo - 68
Omala 220
continuous/ inter drive gearbox
mittent
within
lower
lubrication
cabinet.
system.
2
Main
drive Within
lower About
2000 Enklo - 68
Omala 220
Sr. No.
Description
Location
Duration
Lubricant
gearbox.
cabinet.
working hrs.
Hindustan
Shell make
3
Gear boxfor force Within
turret About
2000Pe
Enklo
- 6m
8ake
Omala 220
tro
le
u
m
6
Oil nipplesfor
feeder drive
zone
working hrs.
a. Tablet
Adjacent upper Apply with one Enklo 68
thickness control roll carrier
shot with oil
4
Oil drip cups
On
uppeg
run
Fillda
aily
srequired Enklo - 68
lowe
ring
cam
,
b. Guideblocks On
cab
inet top
Apply
with one Enklo 68
on
turre
t
g
ua
rd.
for bottomlink. within
upper shot with oil
5
Oil drip trays caB
eside
loweg
run
Fillda
aily
srequired Enklo - 68
bine
t s
rollrcarrier roll Apply one shot Enklo 68
c. Pivot pin at Uppe
upper roll carrier. carrier trunion with oil gun
daily

Grease nipples for

a. Bearing

Upper and Lower Apply one shot Servo gem 3

roll centres
with grease gun
once in a month
b. Bearing
Main drive gearbox Apply one shot Servo gem- 3
with grease gun
once in a month
Motor bearing
a. Main drive gear Apply
manually Servo gem 3
motor
after about 3000
b. Force feeder working hours.
drive motor
c. Hydraulic pump
motor
Power pack systemBesides bottomleg Fill as required
Enklo 32
oil reservoir
(rear L.H.) within
lower cabinet

Omala 220

Omala 220
Omala 220

Omala 220
Omala 220

Alvania RA grease

Alvania RA grease

Alvania RA grease

Tellus - 37

17. 0 FAT PROCEDURE

Factory Acceptance Test Procedure shall be as follows:
After the completion of erection work of the machine, client shall be
informed to perform the factory acceptance test (FAT)
Client shall perform the FAT at the manufacturer site and record all the
data in the prescribed FAT document as per the details given below:
1. Test Criteria
2. Design verification check list

3. Deficiency and corrective action report

4. Pre installation requirements
5. Final reports.

18.0

Change Control Procedure

Change in the agreed design shall be addressed through the well-defined

change control procedure.

19.0

QUALIFICATION DOCUMENT REPORT APPROVAL

19.1 Summary:

19.2 Certifications:

20.0

APPENDIX

20.1 List of Abbreviations.

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15

cGMP
cGEP
FAT
URS
PLC
SS
AC
HP
HRC
PB
RPM
mm
KN
V
Hz

Current Good Manufacturing Practices.

Current Good Engineering Practices
Factory Acceptance Test
User Requirement Specification
Programmable Logic Controller
Stainless Steel
Alternating Current
Horse Power
Rockwell Hardness
Phosphorus Bronze
Revolution Per Minute
Millimeter
Kilo Newton
Volt
Hertz

16
17
18
19
20
21
22
23
24
25
26
27
28
29

Amps
MS
DC
mA
W
C
F
Nm
KW
OHNS
Sq.cm
N.B.
Kg/Sq.cm
M/c

Amperes
Micro Switch
Direct Current
Milli Ampere
Watts
Degree Centigrade
Degree Fahrenheit
Newton-Meter
Kilo watts
Oil Hardened Non Shrinkage
Square centimeter
Nota Benni
Kilogramper square centimeter
Machine.

20.2 Reference documents

20.2.1 Manufacturers Brochure(s) / Manual(s)
To be supplied with the installation qualification documents.
a)
b)
c)
d)

Instruction and Maintenance Manual.

MOC Certificates
Test Reports
Inspection Reports

20.3 Annexure list

Sr.

Description

Annexure Number

No.
01
02
03
04
05
06

Equipment
Brochure
Purchase Order
URS
Scope of supply
FAT Report
Inspection Report

DQ/ANX/01
DQ/ANX/02
DQ/ANX/03
DQ/ANX/04
DQ/ANX/05
DQ/ANX/06

20.4 Drawing list

S.N.

Description

01

G.A. Drawing for CPD-II-37 station

with PLC system
Continuous and Intermittent
lubrication

02

Drawing
Number
DQ/ANX/07
DQ/ANX/08