CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
October , 2012
POWREX CORPORATION
OSAKA･TOKYO/JAPAN
G AT P. O . N O . 0 2 2 0 4 3 :
POWREX JOB NO.: 4-A-1051
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
N O TE S TO U S E RS
1 . B ef or e o p erat i n g t h i s m ac hi ne, yo u s h o ul d f i rs t t h or ou gh l y r ead
t hi s m an ual . Yo u m a y n ot u n der s ta nd al l of t he ex pl a na t i o ns t he
f i r st t i m e t hr ou g h, b ut b e on t h e l oo k out f or a n y s pe ci al
d i re ct i on s.
2 . Th i s m an ual contains i nst ru ct i on s f or t h e op er at i on, m ai nt en an ce,
a n d f a ul t f i n di n g of t h e s ys t em. I t sh ou l d be u se d i n c on j u n ct i on
w i t h t h e at tac h ed ma n uf a ct ure r' s m an ua l .
3 . I f a seri o us f a ul t s ho ul d oc cu r d uri ng o p er at i o n, an d/ or i f t he u ni t
i s m odi f i e d i n or de r t o ch a ng e t he i n i t i al o p erat i o nal p ur p ose,
c o ntac t GLATT AIR TECHNIQUES, INC.
4 . Spa r e parts sh o ul d be or d ere d f rom G L AT T AI R TE C H N I Q UE S,
I N C.
5 . Specifications an d eq ui pme nt ar e s u b jec t e d t o c h an ge w i t h o ut an y
o bl i ga t i o n o n t h e pa rt of t h e m an uf act u re r.
WARNING !!
C I RC UI T B R E AK E R , M O TO R S TAR TE R , DI S CO N NE C T SWI TC H et c.
FO R THI S M AC H I NE M US T B E P RO VI D E D WI TH LO CK O U T AN D / O R
TAG O U T EQ UI PM EN T I N AC C O R D AN C E WI TH O S H A.
M O VI NG PAR TS O F TH I S M AC H I N E M US T N O T B E TO U CHE D AT AN Y
TI M E DU RI NG M AC H I NE O PE R ATI O N.
FAI L U R E TO CO M P LY WI TH TH I S CO UL D RE S U LT I N S E RI O US
I NJ U RY O R D E ATH .
G AT P. O . N O . 0 2 2 0 4 3 :
POWREX JOB NO.: 4-A-1051
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
CO NTE NTS
1 . In t ro d u c ti o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2 . Sp e c i f i c a ti o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
3 . P re pa ra ti o n
3 .1 U n p a c k i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4 . L o c a ti o n a n d In s ta l l a ti o n
4 .1 L o c a ti o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4 .2 In s ta l l a ti o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0
4 .3 C o n n e c ti o n o f e l e c t ri c i t y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4 .4 C o n n e c ti o n o f p i p e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5 . Op e ra ti o n
5 .1 C h e c k o u t a n d s e t t i n g b e f o re o p e ra ti o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2
5 .2 N o -l o a d te s t o p e ra ti o n a n d c h e c k p o i n ts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 6
5 .3 L o a d o p e ra ti o n a n d p r o d u c t d i s c h a r g e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1
5 .4 W IP (W a s h - In -P l a c e ) C l e a n i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5
6 . Ma i n te n a n c e a n d C h e c k O u t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 7
6 .1 Ma i n b l a d e o i l s e a l re p l a c e m e n t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 7
6 .2 C ro s s - s c re w o i l s e a l re p l a c e m e n t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0
6 .3 D i s c h a rg e d u s t wi p e r (O - ri n g ) re p l a c e m e n t
f o r p r o d u c t d i s c h a rg e v a l ve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2
6 .4 Ma i n te n a n c e s c h e d u l e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5
6 .5 B u y - o u t pa rts l i s t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 7
7 . Me c h a n i c a l W a r ra n ti e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 9
G AT P. O . N O . 0 2 2 0 4 3 :
POWREX JOB NO.: 4-A-1051
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
CO NTE NTS
8 . D ra wi n g s

G E N E R A L A R R A N GE ME N T D R AW IN G : 1 2 V G0 8 5 0 -0 0 5 0 -0 1 - r3 . . . . . . . . . . . . . . 4 2

F L O OR E D GE D E TA IL : 1 2 V G0 8 5 0 - 0 0 5 0 -0 2 - r3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 3

D IS C H A R GE A S S E MB LY D R AW IN G : 1 2 V G 0 8 5 0 - 0 4 1 0 -0 0

C R OS S -S C R EW A S SE MB LY D R AW IN G : 1 2 V G0 8 5 0 -0 5 1 0 -0 0 A - r1 . . . . . . . . . . . 4 5

B L A D E A S S E MB LY D R AW IN G : 1 2 V G0 8 5 0 - 0 6 5 0 - 0 0 A . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 6

A IR _ E QU IP ME N T _ PA N E L _ A S S ' Y : 1 2 V G0 8 5 0 -0 8 1 0 - 0 6 . . . . . . . . . . . . . . . . . . . . . . . . . 4 7

A IR P IP IN G F L OW SH E E T : 1 2 V G0 8 5 0 - 0 8 1 0 -0 0 - r1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 8

E L E C T R IC A L W IR IN G : 1 2 V G 0 8 5 0 -8 4 0 0 -r 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 9
G AT P. O . N O . 0 2 2 0 4 3 :
.................... 44
POWREX JOB NO.: 4-A-1051
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
1. Introduction
"POW REX VERTICAL GRANULATOR", a high shear mixer-granulator, is mainly
used for mixing and wet granulation.
The machine characteristics are as follows.
(1) Driving
The frequency inverter driven motors can vary the revolution of the main blade and
the cross-screw.
(2) Binder addition system
The machine is equipped with one (1) binder port at the lid for spraying binder to
the filled powder materials in the product bowl for granulation.
(3) Clearance
The clearance between the back face of mai n blade and the product bowl bottom is
accurately adjusted within Powrex standard.
(4) Air seal
Air seals are provided for the main blade and the cross-screw to prevent any
foreign material from invading into these areas.
1
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
2. Specifications
1)
Model:
FM-VG-600
2)
Serial No.:
12VG0850
3)
Working capacities
A) Nominal working capacity:
B)
Effective working capacity:
600-liter
360-liter
4)
5)
6)
2
Construction materials
A) Powder contacting parts
a) Metal parts:
b) Seals (o-ring, oil seal and gasket)
b-1) Oil seal for main blade:
b-2) Oil seal for cross-screw:
b-3) Gasket for lid:
b-4) O-ring for discharge
flange:
Note: Japanese food grade
B) Non-contacting parts
a) External surface of product bowl:
b) Jacket plate:
c) Frame (support-frame):
d) Top covering plate
(diamond plate) for frame:
Finish:
A) Stainless steel parts:
B) Top covering plate:
C) Frame:
mild steel
Utilities
A) Electricity:
B) Electrical code:
C) Dry & clean compressed air:
SUS316 stainless steel [JIS]
F.K.M. (so-called “Viton”)
F.K.M. (so-called “Viton”)
Silicone (sponge-type)
Silicone (solid-type)
SUS304 stainless steel [JIS]
SUS304 stainless steel [JIS]
Mild steel (carbon steel) [JIS]
SUS304 stainless steel [JIS]
320 grit Buffing finish
Pickling finish (acid cl eaning)
Rust preventive paint coating on
AC 460 V, 60 Hz, Three-phase
Explosion proof rating
750 N liter/min at 0.6 MPa
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
7)
Drive motors:
A) Main blade:
B) Cross-screw:
C)
Lubrication pump:
8)
Gear reducer:
9)
Nominal variable speed range of blades:
A) Main blade:
B) Cross-screw:
Totally-enclosed Fan-cooled
explosion-type
75 kW (100 HP), 4-Pole,
AC 460 V, 60 Hz,
3-Phase
Torque transmitter
To be procured and supplied by GAT
Totally-enclosed Fan-cooled
Explosion-type
22 / 11 kW (30 / 15 HP),
2 / 4-Pole, AC 460 V,
60 Hz, 3-phase
To be procured and supplied by
GAT
Totally-enclosed Fan-cooled
explosion-type
0.4 kW (0.5 HP), 4-Pole,
AC 460 V, 60 Hz, 3-phase
To be procured and supplied by GAT
PVA9040R2-RRT,
Reduction ratio 1/6.3
Approx. 28 - 280 min - 1 with a
frequency inverter
Approx. 3,600 / 1,800 min - 1 with a
Frequency Pole change
Note: Frequency inverters are mounted on a control panel manufactured by GAT.
3
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
10) Type of blades:
A)
Main blade:
a) Type:
B)
b) The clearance between the blade and
the inner-surface of product bowl:
Cross-screw:
a) Type:
Cross Screw
b) Sealing between chopper and
lock nut:
b) Special Motor Cover
11)
Product bowl
A) Type:
a) Non-ASME pressure vessel code:
b) Temperature range for heating
or cooling:
c) Jacket water inlet/outlet:
B) Product temperature sensor port:
C) Jacket water piping:
D)
Discharge:
a) Port:
b) Discharge port special design
c) Discharge Chute special design
4
Standard "Z" blade in one-piece
with the standard 35 deg. Angle
design
POW REX standard
Ten (10)-straight-knife edged
plate type
Included as option: Set of U-type
POM gasket
W ith full jacket for cooling or
heating
(Thermal insulation excluded)
Max. operating pressure :0.19MPa
5 - 60 deg. C
NPT 1/2”
1 pce.
One (1) each for Inlet and Outlet
(Thermal insulation excluded)
Pneumatic cylinder type
discharge valve
One (1) pce. of port: 150A ferrule
connection (Japanese standard)
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
12) Lid
A) Type:
B) Attachments:
a) Exhaust air filter:
b) Exhaust air filter port:
c) Material charge port:
d) Binder port:
e) Dust Collection Hoods
C) Lid mechanical lock:
13) Drive shaft sealing methods:
A)
Main blade:
B)
Cross-screw:
14) Instrument:
A) Resistance temperature detector:
B) Proximity switch:
5
Flat type with spring balance
One (1) pce. of hood for exhaust air
filter
Exhaust air filter is procured by
Customer
Custom design, with 200A ferrule
connection (Japanese standard)
One (1) pce. of material charge
port: 250A ferrule connection
(Japanese standard)
Hinged Open/Close charge port with
proximity SW
One (1) pce. of binder port:
2S ferrule connection
(Japanese standard)
Special Design (Same as CN 933313)
Manual stopper, 2 positions
(approx. 45 deg. & approx. 90 deg.)
Air-purge type with variable-area
flow meter
Air-purge type with variable-area
flow meter
One (1) pce. for product temperature
One (1) pce. for jacket water
temperature
To be procured and supplied by GAT
One (1) pce. at the lid,
Stopping operation of main blade and
cross-screw while the lid is opened.
One (1) pce. at the discharge flange,
Stopping operation of main blade and
cross-screw
while the discharge flange is opened.
One (1) pce. at the charge port,
Stopping operation of main blade and
cross-screw while the charge port is
opened.
To be procured and supplied by GAT
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
15) Frame (support frame):
A) Type:
Six (6) pcs. of rubber pads
B) Major components mounted at the
frame:
One (1) set of pneumatic equipment
C) Thru-the-Floor Design
D) Diamond Plate
E) Expansion Flame Size Special Design (Same as CN 933313)
16) Spare parts:
A) Main blade oil seal:
C) Cross-screw oil seal:
D) Lid gasket:
E) Discharge cylinder o-ring:
F) Discharge flange o-ring:
6
Two (2) pcs. made of so-called “Viton”
[F.K.M.]
One (1) pce. made of so-called “Viton”
[F.K.M.]
One (1) pce. made of silicone,
sponge-type
One (1) pce. made of silicone
One (1) pce.made of silicone
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
Fig. 2-1
EXTERNAL VIEW
7
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
3. Preparation
3.1 Unpacking
(1) Unpack the export packing case.
(2) Take out VG-600.
(3) Take out the other components/parts contained within the case.
(4) Ensure that the machine has been received damage free.
(5) Damage to the machine may occur due to mishandling during shipment from
Japan to the customer ’s installation site .
CAUTION !!
IF ANY DAMAGE IS FOUND, CONTACT GLATT AIR TECHNIQUES, INC.
IMMEDIATELY.
DO NOT LEAVE ANY PARTS OR COMPONENTS IN THE CASE AND ITS
INNER CARTON BOX(ES).
8
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
4. Location and installation
To optimize the performance of the machine, installation should be done in accordance
with the following elements including location, electrical wiring and compressed air
piping.
4.1 Location
9
1)
This machine is designed for an indoor location.
2)
Installation site must be flat ground and/or flat structure, which have a sufficient
strength to endure the dynam ic load.
3)
The machine must be arranged with adequate working space for the safe
operation and maintenance.
4)
Decide the best position for the machine.
5)
Allow enough clearance to open and/or remove the maintenance doors if
applicable.
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
4.2 Installation
WARNING !!
THE SLINGS SHALL HAVE ENOUGH LOAD CAPACITIES TO
LIFT THE MACHINE. THE MACHINE WEIGHT IS 4,650 KG
APPROXIMATELY.
CONFIRM THE MACHINE BALANCE TO LIFT THE MACHINE
BEFORE LIFTING THE MACHINE UP HIGHER.
PRIOR TO LIFTING THE MACHINE, CHECK THAT THERE IS
SUFFICIENT WORKING SPACE AROUND THE MACHINE.
KEEP ALL UNNECESSARY PERSONNEL AWAY FROM THE
MACHINE WHILE LIFTING THE MACHINE.
1)
Fit sealant back up in insert frame. (cf. Fig.4-1)
2)
Screw four (4) eyebolts into the thread holes on the frame.
3)
Engage lifting slings (having enough load capacities against the machine
weight) to the eyebolts.
4)
Ensure to protect the machine surfaces by applying cloth pads between the
slings and the machine surfaces.
5)
Lift the machine up slightly to adjust horizontal balance.
6)
Slowly, lift and move the machine to the place to be installed.
7)
Avoid fast moving while lifting the machine.
8)
Slowly, place the machine onto the platform.
9)
To install the unit, assembly the parts according to Fig.4-1. Adjust the level of
machine by combination of SIM plate.
10) Fix the machine to the platform tightly and rigidly with the bolts and nuts.
11) Remove the lifting slings and cloth pads on the machine.
12) Remove four (4) eyebolts.
13) According to Fig.3-2, fit cover where eyebolts were placed.
10
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
14) Fill in clearance between VG frame and Insert Frame with sealing.
ｄ
ｂ
ｅ
ｃ
ａ
ｂ
ｄ
ｂ
ｃ
ａ
ｄ
ｅ
Fig.4-1 INSTRUCTION DRAWING
11
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
Ａ
Ａ
ｆ
ｆ
ｇ
ｇ
Ａ
Ａ
Cross-section surface
Fig.4-2
12
THREAD HOLE COVER
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
4.3 Connection of electricity
1)
Before commencing with the installation, carry out the following tests:
a) Continuity test of cables
b) Insulation resistant test
2)
The electric wire/cable shall be connected to the connecting joints as terminal plates.
3)
Ensure there is no miss connecting.
CAUTION !!
LOOSE CONNECTION CAUSES FIRE
INDICATION.
AND/OR FALSE DATA
4.4 Connection of piping
1)
According to Fig.4-3 and Fig.4-4, connect air tube to terminal plate behind cross
screw motor cover.
2)
Connect the compressed air pipes and/or hoses.
3)
Connect the inlet and outlet pipes to the jacket.
4)
Ensure there is no miss piping.
CAUTION !!
THE COMPRESSED AIR MUST BE DRY, CLEAN, OIL FREE AND
WITHOUT DUST.
13
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
Ａ
３
５
１
２
４
Ａ
View
Fig.4-3 AIR TUBE CONNECTION
14
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
１
３
２
４
５
Fig.4-4 AIR PIPING FLOW SHEET
15
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
5. Operation
5.1 Check out and setting before operation
The following procedure must be applied to start the operation.
5.1.1
1)
2)
Check the V-belt for the main blade drive
Check that the V-belts for the main blade motor are properly tightened.
Make sure the V-sheaves (pulleys) rotate smoothly by hand without any
abnormality.
5.1.2
Check the gear reducer for the main blade drive
1) Check the filling quantity and condition of the lubrication oil.
2) For the part names and those details, refer to the attached instruction manual
issued by the supplier.
5.1.3
1)
2)
Check on lid operation
Release lid clamps and ensure the lid opens and closes smoothly.
Confirm the locking functions of the lid at 45 deg. Opening and 90 deg.
Opening.
WARNING !!
MAKE SURE THE POWER SWITCHES FOR BOTH THE MAIN BLADE
AND THE CROSS-SCREWS ARE OFF.
MAKE SURE THAT ALL THE CONNECTIONS AND FITTINGS
CONNECTED TO THE PORTS/FITTINGS/DEVICES ON THE LID
SHALL BE DISCONNECTED.
ENSURE THAT ALL OF CLAMPS ARE UNLOCKED BEFORE OPENING
THE LID.
MAKE SURE NO PERSON IS STANDING IN THE DIRECTION OF THE LID
OPENING.
MAKE SURE NOTHING IS PLACED ON THE LID.
16
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
5.1.4
Check the conditions of the main blade and the cross-screw inside the product bowl
1)
Loosen the lock nuts and move the main blade assembly and cross-screw assembly.
2)
Check for abnormalities in the oil seal conditions of the main blade and the cross-screw.
3)
After the completion of the oil seal condition checks, reset the main blade
assembly and the cross-screw assembly.
4)
Ensure no looseness of the both lock nuts of the main blade assembly and the
cross-screw assembly.
5)
Ensure the rotating directions of the main blade and the cross-screw while
jogging (inching) the main blade or the cross-screw.
The correct rotating direction:
Main blade:
Counterclock wise direction while viewing from
the lock nut (top) of main blade.
Cross-screw:
Clockwise direction while viewin g from the
lock nut (top) of cross-screw.
CAUTION !!
BE CAREFUL NOT TO SCRATCH THE INSIDE OF THE PRODUCT
BOWL.
ENSURE THAT NOTHING IS LEFT INSIDE THE PRODUCT BOWL.
17
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
5.1.5 Check on discharge valve operation
1)
2)
3)
Ensure that the discharge valve is closed and the discharge port flange locking
clamp is locked completely.
Check that the discharge valve comes into exact contact with the product bowl
discharge port.
Ensure the smooth open and close operations of the discharge valve with its
pneumatic cylinder.
CAUTION !!
THE DISCHARGE PORT FLANGE MUST BE OPENED AND
CLOSED ONLY WHEN THE DISCHARGE VALVE IS FULLY
OPENED.
DO NOT OPEN OR CLOSE THE DISCHARGE PORT FLANGE
WHEN THE DISCHARGE VALVE IS CLOSED.
THE DISCHARGE PORT FLANGE SHALL BE SECURELY LOCKED
BY THE LOCKING CLAMP WHILE THE DISCHARGE VALVE
CLOSING. DO NOT RELEASE THE LOCKING CLAMP.
WARNING !!
DO NOT PUT YOUR HANDS AND/OR FINGERS INSIDE THE
PRODUCT BOWL THROUGH THE DISCHARGE PORT WHILE THE
MACHINE RUNNING OR STOPPING, TO AVOID ANY SERIOUS
INJURIES.
18
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
5.1.6
1)
2)
3)
Check setting of compressed air supply
Confirm the User ’s primary (dry, clean and oil-free) compressed air supply
pressure at 0.4 - 0.6 MPa.
Set the seal air pressure at 0.03 - 0.05 MPa by adjusting the regulator.
Be sure that there is no air leakage from any of the piping or the piping
connections inside the frame.
Check and confirm in accordance with following procedures.
START
Compressed air supply
Filter regulator
Yes
0.4-0.6 MPa
No
Regulate the valve
Pilot regulator
0.03-0.05 MPa
No
Regulate the valve
READY
19
Yes
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
5.2 No-load test operation and check points
Check that electrical connecting has been connected securely, and turn the power
switch ON.
After the trial checks are done according to the following procedure, start the no-load
test operation.
5.2.1
1)
2)
Checking the main blade rotating direction
Jog (inch) the main blade, and check that it is rotating counterclockwise viewing from
the lock nut (top).
If the rotating direction is not correct, change the wiring connection.
5.2.2 Checking the cross-screw rotating direction
1)
2)
Jog (inch) the cross-screw, and check that it is rotating clockwise viewing from the
lock nut (top).
If the rotating direction is not correct, change the wiring connection.
CAUTION !!
REVERSE ROTATING DIRECTION CAUSES LOOSENING THE LOCK
NUT FOR THE MAIN BLADE AND/OR THE CROSS-SCREW.
THE LOOSENED LOCK NUTS LEAD COMING OFF ITSELF AND
DAMAGING THE PRODUCT BOWL WALL, THE MAIN BLADE AND
THE CROSS-SCREW.
20
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
5.2.3
Checking the discharge valve operation
1)
Ensure the discharge valve is closed and the clamp is locked.
2)
Ensure the smooth action of the discharge valve with the pneumatic cylinder.
3)
Ensure the smooth open/close actions of the discharge port flange.
4)
Check that the valve comes into exact contact with the discharge port of the
product bowl.
CAUTION !!
WHILE THE DISCHARGE VALVE IS CLOSED, DO NOT RELEASE
THE LOCK OF THE DISCHARGE PORT FLANGE OTHER THAN
REQUIRED.
5.2.4
1)
Check the temperature indicator whether it indicates correctly.
5.2.5
21
Checking the temperature indication
Checking the pneumatic valve operations of air seals by compr essed air for
the main blade and the cross-screw
1)
Check and adjust the supply pressure in the range from 0.4 - 0.6 MPa.
2)
Check that the air seal valve opens when the main blade and/or the cross-screw is
ON in the normal operation mode.
3)
At this time, re-check that the gauge of regulator for air seal setting indicates
0.03 - 0.05 MPa.
4)
Check again the airflow.
5)
The above pressure should be reached with the airflow.
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
5.2.6
22
No-load operation
1)
Ensure that the main blade and the cross -screw set for low speed start
operation with all lid clamps locked.
2)
Check that no abnormal noise or vibration from any part of the machine is
found.
1)
Check high-speed operation of the main blade and/or the cross -screw in the
same manner.
2)
Stop the operation after 20 - 30 minutes of continuous operation of the main
blade and/or the cross-screw.
5)
Release the lid clamp locks, and open the lid according to step above.
6)
Check that no abnormal condition is found, such as loose lock nuts for the main
blade and the cross-screw, or scratches caused by contact of the product bowl
and the discharge valve with the main blade.
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
START
Confirm the lid clamp and the discharge clamp locked.
Confirm operation ready.
Run the main blade and the cross-screw.
Confirm no abnormal noise or
no irregular vibration.
No
Yes
Confirm run for 20 -30 minutes.
STOP
Stop the main blade and the cross-screw.
FINISH
23
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
WARNING !!
MAKE SURE THAT THE STARTING SWITCHES OF THE MAIN
BLADE AND THE CROSS-SCREW ARE LOCKED OFF, BEFORE
OPENING THE LID.
MAKE SURE TO CHECK ALL CLAMPS ARE UNLOCKED, PRIOR
OPENING THE LID.
ALL THE CONNECTIONS AND FITTINGS CONNECTED TO THE PORTS/
FITTINGS/DEVISES
ON
THE
LID
SHALL
BE
COMPLETELY
DISCONNECTED BEFORE OPENING THE LID.
MAKE SURE NOTHING IS LEFT INSIDE THE PRODUCT BOWL
BEFORE CLOSING THE LID.
WHILE THE LID IS OPENED AND THE AIR PRESSURE IS
LOWERED, THE MAIN BLADE AND THE CROSS-SCREW CAN NOT
BE ROTATED DUE TO INTERLOCK.
24
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
5.3 Load operation and product discharge
This machine is a wet type mixing granulator:
It adds a proper amount of binder while powdery materials are being mixed, thus
forming solidified granules.
The material and binder ratio is one of the important factors for bringing the
performance of this machine to its full capacity.
Since the amount of material, main blade & cross-screw speed, operation time and binder
addition are the other major factors, it is important to predetermine these items before
starting the regular operation.
5.3.1
25
Before operation
1)
The main blade and the cross-screw must be securely m ounted.
2)
Be sure that the main blade and the cross-screw are not loose and nothing abnormal is
on them.
3)
Check that all the clamps for the lid and the discharge port flange are locked at the closing
positions, and also the discharge valve is closed.
4)
Check that the exhaust air filter is securely set.
5)
Be sure all the connections/fittings are correctly connected tightly.
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
5.3.2
Load operation
The following steps are general procedures. It shall be established by the user.
26
1)
Charge the materials into the product bowl through the material charge port or
by opening the lid.
2)
If several kinds of materials are charged, the bulkiest one should be charged first
and the bulkier one next.
3)
W ith the main blade and cross-screw switches ON, the mixing operation will begin.
4)
W hile carefully checking the movement of materials within the product bowl,
adjust the rotation speed of the main blade and the cross-screw, if required.
5)
If the material is mixed sufficiently, gradually add binder.
6)
Normally, the granulation is completed in a few minutes after the binder addition
is completed.
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
CAUTION !!
DURING THE OPERATION, WATCH FOR ABNORMAL SOUNDS
(NOISES), VIBRATION AND HEAT GENERATION.
STOP THE OPERATION IMMEDIATELY WHENEVER IRREGULAR
SOUNDS, VIBRATION, HEAT GENERATION AND SO ON IS
DETECTED.
ALWAYS TAKE NOTE OF THE MAIN BLADE AND THE
CROSS-SCREW LOAD VARIATIONS (POWER VALUE), AND
UNDERSTAND THE RELATIONSHIP BETWEEN THE CONTINUOUS
CONDITION ON THE MACHINE OPERATION AND THE LOAD.
THE CORRELATIVE RELATIONSHIP BETWEEN THE LOAD
FACTOR AND THE GRANULES BECOME ONE OF BAROMETER
FOR FUTURE OPERATION.
WARNING !!
FEED MATERIALS, BINDER AND OPERATING CONDITIONS MUST
BE CONDUCTED BY AN AUTHORIZED SPECIALIST OF THIS
MACHINE.
27
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
5.3.3
1)
Product discharge
Place an adequate container under the discharge port of the machine and open
the discharge valve.
a) The products should be discharged while running the main blade at low
speed.
b) As the amount of the product left in the product bowl decreases, increase the
main blade speed gradually to complete the discharging.
c) Also inch (jog) the cross-screw at low speed.
2)
After the product discharging is completed, open the lid.
a) Check the stickiness of the product.
b) Check the residues of the product in the product bowl.
c) Check scratches on the inner bottom and wall of the product bowl.
d) Check looseness of the lock nuts of the main blade and the cross-screw.
WARNING !!
ENSURE THAT THE STARTING SWITCHES OF THE MAIN BLADE
AND CROSS-SCREW ARE LOCKED OFF, BEFORE OPENING THE
LID.
ENSURE THAT ALL
OPENING THE LID.
OF
CLAMPS ARE UNLOCKED, PRIOR
ALL THE CONNECTIONS AND FITTINGS CONNECTED TO THE PORTS/
FITTINGS/DEVISES
ON
THE
LID
SHALL
BE
COMPLETELY
DISCONNECTED BEFORE OPENING THE LID.
ENSURE THAT NO PERSON IS STANDING IN THE DIRECTION OF THE
LID.
ENSURE THAT NOTHING IS PLACED ON THE LID.
28
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
6. Maintenance and check out
IMPORTANT !!
DISCONNECT ALL ELECTRICAL POWER SOURCE BEFORE
MAINTENANCE WORK.
AFTER MAINTENANCE AND CHECK OUT, THE MACHINE MUST
BETHOROUGHLY CLEANED OFF FOREIGN MATTER.
PRIOR TO REPLACING THE PARTS BELOW MENTI ONED, READ
AND UNDERSTAND ALL OF THE WARNINGS AND CAUTIONS
DESCRIBED IN THIS MANUAL.
6.1 Main blade oil seal replacement
Following procedures are for the main blade oil seal replacement.
For name of the parts and the detailed construction of the main blade seal unit, see Fig.
6-1.
29
1)
Remove the lock nut.
2)
Mount the lifting piece on the main blade.
3)
Slowly lift up the main blade by using the maintenance hoist.
4)
Check no powder invading.
In case of powder existing, check air seal circuit with adjusting seal air pressure.
5)
Remove four (4) fixing bolts for the bushing.
6)
Screw the two (2) of four (4) bolts above into two air blowout holes, which are
tapped differently.
7)
Pull up carefully the bushing and remove it.
8)
Take out the oil seals from under side of the bushing with use of a screwdriver. Pay
attention not to damage inside the bushing.
9)
W ipe up to clean all of removed parts and surroundings.
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
10) Check the oil seals visually and replace them, if they are worn.
11) Before setting, the oil seals periphery must be coated with grease in food grade.
12) Insert the oil seals into the bushing directing a spring to down ward.
13) Spread silicone grease between the oil seals.
14) Finishing the seal replacement, assemble the parts as they were. Assembling work
should be done in reverse order above.
15) After hand tightening the lock nut, knock knobs on the lock nut with a plastic
hammer within the toolbox.
16) Procedure above prevents loosening of the lock nut during operation.
CAUTION !!
WHILE REPLACING THE MAIN
CAREFUL ATTENTION BELOW.




30
BLADE
OIL SEALS,
PAY
DO NOT HIT ANYTHING AGAINST INSIDE OF THE PRODUCT
BOWL.
DO NOT DROP ANYTHING ON THE PRODUCT BOWL
BOTTOM.
DO NOT MAKE ANY SCRATCHES IN THE PRODUCT BOWL
WALL.
DO NOT DAMAGE THE LIP OF THE SEAL, IT CAUSES
SEALING PROBLEMS.
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
Fig. 6-1
31
MAIN BLADE UNIT
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
6.2 Cross-screw seal replacement
Following procedures are for replacing the cross-screw seal.
For the name of the parts and the detailed construction of the cross-screw seal units,
see Fig. 6-2.
1)
Remove the lock nut with turning to clockwise.
2)
Pull out the cross-screw blades, collar and rotor.
3)
Check no powder invading into a sleeve.
In case of powder existing, check air seal circuit with adjusting seal air pressure.
4)
Remove four (4) lock bolts and screw two (2) of them into tapped holes for pulling
out.
5)
Pull out it.
6)
Push out the oil seal from behind the sleeve using a screwdriver. Pay attention
not to damage inside the sleeve.
7)
W ipe up to clean all the removed parts and surrounding.
8)
Check the oil seal visually and replace, if it is worn.
9)
Before setting the oil seal the periphery must be coated with grease in food
grade.
10) Insert the oil seal into the sleeve with directing its spring toward the product bowl
wall and spread silicone grease on lip of the oil seal.
11) W hen setting the sleeve, it should be put back straightly. Be careful not to
damage the lip.
12) Finishing replacement of the seal assembles the parts as they were.
Assembling work should be done in the reverse order above.
13) After hand tightening the lock nut, knock knobs on the lock nut using a plastic
hammer within the toolbox.
14) Procedure above prevents loosening of the lock nut during operation.
32
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
CAUTION !!
WHILE REPLACING THE CROSS-SCREW OIL SEAL, PAY CAREFUL
ATTENTION BELOW.





DO NOT HIT ANYTHING AGAINST INSIDE OF THE PRODUCT
BOWL.
DO NOT DROP ANYTHING ON THE PRODUCT BOWL
BOTTOM.
DO NOT MAKE ANY SCRATCHES IN THE PRODUCT BOWL
WALL.
DO NOT DAMAGE THE LIP OF THE SEAL, IT CAUSES
SEALING PROBLEM.
DO NOT DAMAGE INSIDE THE SLEEVE, IT CAUSES
SEALING PROBLEM.
Fig. 6-2
33
CROSS-SCREW UNIT
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
6.3 Discharge dust wiper replacement for product discharge valve
Following procedures are for replacing the discharge o-rings and
dust wiper.
For the part names and the detailed construction of the discharge unit, see Fig. 6-3.
1)
Open the discharge valve by pulling back the pneumatic cylinder fully.
2)
Unlock the clamp to open the discharge port flange.
3)
Open the discharge port flange fully and push out the valve .
4)
Loosen the Protector-1.
5)
Slide the Protector (1) towards the pneumatic cylinder until the valve lock nut
appears.
6)
Fix the valve on its hub by using a suitable wrench or adjustable wrench.
7)
Unlock the valve lock nut.
8)
Remove the spring pin.
9)
Unscrew and remove the valve from the pneumatic cylinder rod.
10) Pull out the Protector (2).
11)
Remove the three (3) fixing bolts on the Protector (2).
12)
Pull out the Protector (2).
13)
Check the dust wiper (O-ring) visually and replace it, if damaged.
14) Reassemble the parts as they were after completing the dust wiper (O-ring) replacement.
Assembly shall be done in reverse or der of the above.
34
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
CAUTIONS !!
PAY KEEN ATTENTIONS NOT TO GIVE ANY ROTATIONAL FORCE TO THE
PNEUMATIC CYLINDER ROD WHILE UNSCREW THE VALVE.
CAUTION !!
WHILE REPLACING THE DISCHARGE DUST WIPER, PAY CAREFUL
ATTENTION BELOW.
35

DO NOT RELEASE A CLAMP, BEFORE OPENING THE
DISCHARGE
VALVE
THOROUGHLY.
OR IT CAUSES
DAMAGING THE VALVE AND/OR THE VALVE SEAT.

DO NOT DAMAGE THE VALVE ON ITS CONTACTING
SURFACE TO PRODUCT BOWL. OR IT CAUSES TROUBLE LIKE
POWDER LEAKING AND/OR DEPOSITING.

DO NOT DAMAGE THE VALVE SEAT, IT CAUSES SEALING
PROBLEM.
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
Fig. 6-3
36
DISCHARGE UNIT
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
6.4
Maintenance schedule
The following servicing work must be carried out on the machine at the specified
period.
A. Daily (Every 8 hours)
No. Item
Method
1
2
3
Exhaust air
filter
Compressed
air pressure
Sealing
compressed
air pressure
Visual check
-No leak of powder
during operation
-No remove due to
powder blockage
Pressure gauge
W ithin 0.4-0.6MPa
Pressure gauge
W ithin 0.03-0.05MPa
Maintenance
- Fasten the
clamp.
- Wash
exhaust
filter.
Regulate the
valve.
Regulate the
valve.
Fasten
connection or
exchange
parts.
Fasten
connection or
exchange
parts.
4
Air leak
Air noise
No noise when
supply
5
Water leak
Visual check
No leak of water
6
Oil leak from
the gear
reducer
Visual check
No leak of oil
Call GAT.
Judgment
Maintenance
-No wear and tear at
lip
-Enough grease
-Exchange
the oil seal.
-Add grease.
-No wear and tear at
lip
-Enough grease
-Exchange
the oil seal.
-Add grease.
Adequate oil level
Add oil.
No dirt
Exchange oil.
B. Monthly (Every 200 hours)
No. Item
Method
Visual check by
Oil seal for the disassembling
1
main blade
the main blade
assembly
Visual check by
Oil seal for the disassembling
2
cross-screw
the cross-screw
assembly
Lubricant oil
3
amount for the Visual check
gear reducer
Lubricant oil
condition for
4
Visual check
the gear
reducer
37
Judgment
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
C. Annual (Every 2,500 hours)
No. Item
Method
O-ring for the
1
Visual check
main blade
O-ring for the
2
Visual check
cross-screw
Dust wiper
for the
3
Visual check
discharge
cylinder
4
Lid gasket
Visual check
Judgment
No damage
No damage
Maintenance
Exchange the
o-ring.
Exchange the
o-ring.
No damage
Exchange the
dust wiper.
No damage
Exchange the
gasket.
D. Others
We recommend checking below accordingly.
No. Item
Method
Judgment
-No irregular sound
Motor for the
-Visual check
1
-No abnormal heat-up
main blade
-Thermometer
-No vibration
-No irregular sound
Motor for the
-Visual check
2
-No abnormal heat-up
cross-screw
-Thermometer
-No vibration
Motor for the
lubricant
-No irregular sound
-Visual check
3
circulation
-No abnormal heat-up
-Thermometer
pump of the
-No vibration
gear reducer
4
38
Bearing for the
cross-screw
-Visual check
-Thermometer
-No irregular sound
-No abnormal heat-up
Maintenance
Call GAT.
Call GAT.
Call GAT.
Exchange
bearings.
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
6.5
Buy-out parts list
a: Main Blade
Item
Description
Oil seal
TC 130 x 160 x 14
O-ring
Material
Maker
POWREX
Q’ty
Part No. equipped
Viton
11126
2
G-260
Silicone
98260
1
O-ring
P-100
Silicone
92100
1
O-ring
P-18
Silicone
92018
4
b: Cross-screw
Oil seal
TC 50 x 68 x 9
Viton
11226
1
Gasket
50 / 65 x 5
ＰＯＭ
-
1
O-ring
G-110
Silicone
98110
1
O-ring
G-105
Silicone
98105
1
O-ring
G-50
Silicone
98050
2
Flange unit
UCFC211
-
12426
2
c: Discharge
O-ring
G-40
Silicone
98040
1
O-ring
P-130
Silicone
92130
1
O-ring
G-200
Silicone
98200
1
O-ring
P-210
Silicone
92210
1
O-ring
P-40
Silicone
92040
1
Guideless cylinder
GLC-00-63-215-N-FL163768
-
CKD
32122
1
Speed controller
AS2301F-02-08-S
-
SMC
-
2
-
1
d: Lid
Lid gasket (O-ring)
39
16×13×2720L
Silicone
Sponge
-type
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
f: Pneumatic Parts
Filter
F4000-15-W-T
-
CKD
-
1
Filter regulator
AW40-04DE
-
SMC
-
1
Pilot regulator
R3000-10-W-T
-
CKD
-
2
Air operate valve
NAB1-10-D
-
CKD
-
4
Air operate valve
4KB221-08
-
CKD
-
1
The following parts have been supplied as spare parts.
a)
b)
c)
d)
40
Two
One
One
One
(2)
(1)
(1)
(1)
pcs.
pce.
pce.
pce.
of
of
of
of
oil seals for the main blade (TC 130 x 160 x 14)
oil seal for the cross-screw (TC 50 x 68 x 9)
o-ring for the discharge cylinder (P-130)
o-ring for the discharge flange (P-175)
CUSTOMER: Novartis Pharmaceuticals Corp
SERIAL NO.: 12VG0850
7. Warranty
The vendor undertakes upon written request of the purchaser to settle, to repair or replace
at the vendor's own discretion as quickly as possible, a damage/trouble or any parts
exhibiting deficiencies due to faulty m aterial, bad design or poor workmanship, whenever
it is evidently originated from the design or the fabrication of the machine.
The warranty period is for 12 months after the shipment from Powrex Corporation.
Replaced parts shall become the vendor's property.
Exempted from the Warranty
1. The quality, finish, appearance, fineness and any other losses damage and/or trouble
caused by the mixing/granulation products and materials.
2. Secondary loss, resulting from the machine damage/trouble.
3. Any damage/trouble beyond the principal obligation of the machine use.
4. Any damage/trouble resulting from any modifications and/or a change in usage of the
machine taken by any other parties except the vendor and/or its representative.
5. Any damage/trouble resulting from failure not to follow the operating instructions and/or
improper handling of the machine.
6. Any damage/trouble resulting from the utilities at the purchaser's site, including power
source, compressed air, cooling water and/or others.
7. Consumable parts.
8. Equipment, devices, parts and components supplied (to us [Powrex]) by Glatt Air Techniques,
Inc.
9. Equipment, devices, parts and components designed, selected, produced and/or supplied (to
the customer) by Glatt Air Techniques, Inc.
10. Any damage/trouble resulting from natural calamity.
11. Act of God.
- CONCLUDED -
41