Image 005

Document No.
stQ 18960
*,.rcrrc I NSTALLATION QUALI FICATION Rev No. 0
Page 1t70
SYSTEM IDENTIFICATION
Customer
ccL Machins type Rotary tablet preas
LABORATORIES
Machine Serial No sr 18960 Machine Model MRC-3't S
Manufacturer
Approval Signatur€s , Dates
Job Title Name Signature Date
Written by QA M.J.Yoon Po- 2018.11.02
Reviewed by QA J.H Kim

t 2014.11.02
Approved by QA D.H Kim /laorl{- 201A.11.O2
Customer
Approval Sigmtures , Dates
Job Title Name Signature Date
L
e
U,ru;rUotnoJ \lr(@' -o2-l
EL L,roit !" I
Reviewed by
L
f Lh.,,n; vha.^
,hin ;61"'r^ t/^tn 2 o2
in**
e* Fdlhtu- Qwrrl"
0r'Nzwo,,.- tdtt
r./ LT-el-zol
I
o
Approved by { 'J
Tho Copvriqht and tho Non-Oisclosure.
Notice of Copyright: This public€tion, including all portions hereof, is copyrighted by Sejong Pharmatech Co., Ltd and is
protected by the copyright laws of the Republic of Korea and/or other relevant laws respecling
proprietary rights. No part of this publication an portion or in full or in any modilied fofm shall not be
reproduced, transmitted, transfened or re-distributed in any form or by any means, electronic or
mechanical or otherwise, including photocopying, recording or use in any information storage and
retrieval system without written permission from Sejong Pharmatech Co., Ltd. such unauthorjzed
reproduction, transfer or use may be a violation of criminal and civil law.
Non-Oisclosure : lt shall not be disclosed any part ofthe publication, in part or in fullto their parts by all means, without
or ssion of the t
sJaDF(0) Seiong Pharmatech

Document No. stQ 18960
#,.rcrlE I NSTALLATION QUALIFICATION Rev No. 0
Page 2t70
I A TABLE OF CONTENTS I
t. TNTRODUCTTON-------------- Page 3
2. PURPOSE ---- Page 3
3. SCOPE OF OUAL|F|CATION ------- Page 4
4. APPROACH Page 4
5. EQUIPMENT DESCRIPTION ------- Page 5
6. QUALIFICATIONMETHODOLOGY Page 6
7. IQ PROTOCOL Page 7
Page 9
7-2 User Requirement Specification Page l2

7.3 Drawings Page 14
7.4 lnspection ot Critical , Non-Critical Devices ------.---- Page 16
7.5 List of product contact and insp€ction of materials ----- Page 50
7.6 Calibrationprocedure<Option> Page 52
7.7 Period of change lubricants Page 55
7.8 Lbt of Spa]? parls & Tool box <Option> -------- Page 59
7.9 Othe6 Page 64

--------
8. CHANGE CONTROTL Page 66
9. PENDTNG L|ST
------------ Page 68
--
HISTORY OF THE DOCUMENT --------- Page 70
sJoDF(0) Sejong Pharmatech

Document No. sro 18960
gE.,g:l,G I NSTALLATION QUALI FICATION Rev No- 0
Page 3t70
t. INTRODUCTION
1.1 General Description
1.'l lQ protocol is written for the Installation Qualification of Rotary tablet press supplied to the customer.
1.1.2 Rotary tablet press e3 supplied a powder from feeder produces to the die makes the tablet from the powder
through comple33ing force with upper and lower compr€$ing tools.
1. t.3 Rotary tablet press can be divided tor checking wtth follouing 8 components.
1. Weight rail part (Filling cam)
2. Transmission pert
3. Mechanical feeder part
4. Discharge part
5. Upper pre & main pressure roll part
6. Lower pre & main pressure roll part
7. Control panel part
E. Option parl <Option>
1-1-4 Machine frame is made ofthe FCD45 castjron, and outsidc and insido turface are hairline-polished to STS3O4.
Each of the 4 doors is made of Acryl. Upper part of the equipments is plated with Aluminum.
1.2 Validation Sequence

1.2.1 lQ i8 verified with following 9 stepc afror locating tha machine ln tlE proper position with enough space;
1. Serviceslnstallation
2. User Requiremont Specltication
3. Drawings
a. lnspection ot Critical , Non.cildcal Deviceg
5. List of product contact and ln3pectlon of matllrLb
6. Calibration procedurc <Optlon>
7. Period of chango lubricant3
8. List of Spare parts & Tool box <Option>
9. Others
2. PURPOSE
lQ procedure is to bc verified through analyzing critical parameters and inspected lhe design if the machine is
designed for the production of tablet qualified during the installation of Rotary tablet press.
SJQDF(O) Seiong Pharmatech

Document No, stQ 18950
#,.rcr,tr I NSTALLATION QUALI FICATION Rev No- 0
Page 4170
3. SCOPE OF QUALIFICATION
3.1 validation range for Rotary tablet press is prescribed within following test items:
Item Validation ltem Testing No
Services lnstallation MRC-tQ{0741

User Requirement Specification MRC-rQ-007-02
Drawings MRC-tQ-007-03
lnspection of Critical / Non4ritical Devices MRC"tQ-007-04

IQ
List of product contact and inspection of materials trtRc-tQ{07-05
Protocol
Calibration procedur€ <Option> MRC-tQ{07.06
Period of change lubricant MRC-tQ-007-07
List of Spare parts & Tool box <Option> MRC-tO-00748
Others MRC-tQ-00749
4. APPROCH
4.1 A progress course
4.1.1 lQ validation procedure is preceded by customer,
4.1.2 lQ validation should be carried out by responsible peEonnel from Q/A departrnenl Technical team and
Production department (customer)
4.'1.3 lQ report is acknowledged finally by Production manag€r in customer after conlirmed by Technical team and
Production department and Q,lA department in customer according to URS.
4.2 Certificates Check

Before the validation procedur€, measure ent inatument should bG checked which is installed in Rotary tablet
press especially if measurcment instument b celibrated properly.
4.3 T6ting Service

4.3.1 lQ validation procedure rhould be pedomed by responsible personnol and deparEnent.
(ex,, QM, engineering, QA.)
4.3.2 lQ validation will be proceeded underthe co-work with customer Q/A dept. for the installation problem of the Rotary
tablet press
sJoDF(0) Seiong Pharmatech

Document No. slQ r8960
#,.rct?E I NSTALLATION QUALI FICATION Rev No. 0
Page 5170
4.4 lnstruments
All of measuring equipments for the Rotary tablet press has been calibrated before the test.
ln case that SEJONG Pharmatech can not supply equipments, customer should prepare instead. ln this case,
related Certificates are required.
lnstrument Using Certificate No Replaces date
T^rh"".Ptr,L rYewlwLrntaf o{ Lf/4 CL.OL8 lf-ol - 2bu)
5. EQUIPMENT OESCRIPTION
5.1 General Description
SPECIFICATION
Main power ,r00V 50H2, 3Ph
Numbers of stations 31
Max. Output (TAB/H) 186,000

Revolution of disk (rpm) 15-100
Round (O)
Max tablet diameter (mm)
Shape (mm) 25
irax tablet thickness (mm) 8.5

CAM B 4.5 - 10
Filling depth (mm) CAM C 8.5 - 14
CAM D 12.5 - 18
Upper punch insert (mm) 16

Max pre- pressure (kg f) 10,000
[[ax main p]€ssure (kg 0 10,000

Die type D
Punch type EU-D, TSM-D

Power of main motor ll Kw (1sHp)

Document No. srQ 18960
*,twlE I NSTALLATION QUALIFICATION Rev No.
Page
0
6t70
6 QUALIFICATION METHODOLOGY
lQ validation is preceded by following steps. Each protocol and test procedures are confirmed with dated
signature. On the process of the lQ, demanded certificates or Reterence data should be included and attached
in the report. And if there are calibration of equipments and measuring equipments missed, it must be re-
calibration again.
6.'l lQ Protocol
Write out protocol by the 3.1 evaluated ilem, and give test method. ln cas€ of unnecessary insp€ction according to
the machine specification, related items might be omitted through chocklng N/A in related column, but in case of
adding additional items requested by customer, those arc written by hand in appendix tormat.
6.2 lnstallation Qualifi cation Test Method

Test method of reported protocol is prescribed and evaluated about tho eccaptability through Acceptance criteria
and actual result. Depending on the necessity, reference documents al€ attached for evaluation's basis.
6.3 Reporting lQ rcsults

lQ report is written, revierved and approved by the customer.
sJQDF(0) Sejong PhaImatech

Oocument No. srQ 'r 8960
#.rcrtG I NSTALLATION QUALI FICATION Rev No. 0
Page 7 t70
7. IQ PROTOCOL
No. Content Ref. No. lO
Services lnstallation
I MRC-lQ-007-Ol
Check the other equipments for the operation, and demanded other equipments.
User Requirement Sp€c'

MRC.tQ-007-02
Check that the customer's requirement is adapted to the machine.
Drawings
3 MRC-tQ-007{3
Check the installed drawing, inspect of the completed and suitable ca36.
lnspection of Critical / Non€ritical Oevices

MRC-tQ-007-O/r
Write a component device importance of the machine, and Critical Parl List.
4-1 Weight rail part (Filling cam) irRc-tQ-007-04-01
4-2 Transmission part MRC-tQ-007-04-02
4 4-3 Uechanical fe€der fnrl r{Rc-tQ-007-04-03
44 Discharge part ltlRC-lQ-007-04-0rl
4-5 Upper pre & main preasure roll.part MRC-tO.007-04-05
4-6 Lower pre & main pressure rcll part mRc.lQ-007-04-06
4-7 Control panel palt tttRc-lQ-@7-04-07
4-8 Option part <Option> MRC-tO-007-(x-08
List of Product Contact and lnspsction of eGrials

5 MRC-tQ{07{)5
Make a list of the contact surfaca parts, and check the material is suitable.
Calibration Procedure <Option>

6 MRC-tO-007{6
Record of the attached measuring instruments, or calibrale the measuring
instruments and record the detail,
sJQDF(0) Sejong Pharmatech

Document No srQ 18960
ge.rcr|tr I NSTALLATION QUALI FICATION Rev No 0
Page st70
No. Content Ref. No. lQ
Period of change lubricants

7 MRC-tQ-007-07
Check the interval of oil and grease inrection or replacement.
List of Spare Parts & Tool box <Option>

MRC-rO-007-08
Check the condition and quantities of the spare parts & Tool box
OtheIs
o MRC-tQ.007-09
lf it needs confirmation of inspection and other points, it should do a test.
Change control
10 tttRc-tQ{08
Check the unexpected part which is nec6sary to imptove or re-fomed.
Pending List
'11 MRC-tQ{09
Wrile doryn and check lhe deviation during lQ procedure.

SE.WE INSTALLATION QUALI FICATION Rev No. 0
Page 9t70
7-1 Services lnstallation
Test Report No: MRC.IQ{o7Oi
All necessary facility for Rofary tablet press 3ystem should be checked if there is any
Purpose problem for the operation. All preparation for the production should be checked and
ready in advance.
1. Check equipments and electrical parts stand to install in the room a machine.
2. Check olher service utility is ready to install and use.

Test Method
1) 400v 3Ph
1. Main pol er source: 4{l0vt10%

Acceptance Criteria
SJODF(O) Seiong Pharmetech

Document No. sto 18960
getfflE I NSTALLATION QUALI FICATION Rev No. 0
Page 10t70
7.1.1 Phase voltage check
U
A
V*t
w
4oz votl
U w
/
4o> \/otf

#,.rcrlE I NSTALLATION QUAL! FICATION Rev No. 0
Page 11 t70
lnspection ltems Criterion
Power source /oovil0%
RECOMMENDATION
(|
Final Evaluation Yryr/ Noo N/A o
checked by
:Jauu
Date t1 .6>. tq
Approved by Date t7 . oL. tl.

#,.rcylE I NSTALLATION QUALI FICATION Rev No. 0
Page 12170
7-2 UserRequirementSpecification
Test Report No: MRC-lQ{07{r2
URS should b€ check whether it is adapted to system, and accompanied with nomal
Purpose
operation.
Test Method Check the contents of URS.
c
r
,.
Acceptance Criteria The on the URS.

Document No, srQ l8960
#,tctrlE INSTALLATION QUALI FICATION Rev No. 0
Page 13t70
AWC TYPE
DUST COLLECTOR -'- I ea
Customer,s Requilement DE DUSTER -'- I ea
FAI rQ, OQ \--'' I copy
MANUAL w.-- 2 copy
RECOMMENDATION
Final Evaluation Yeaz- Noo N/A o
Checked by t><A,tt Date l1 . oL. t1.

s=
Approved by Date
tq '02'lq'

gE.WE I NSTALLATION QUALIFICATION Rev No 0
Page 14 t70
7.3 Drawings
Test Report No: URC-|Q407{3
Purpose Check of the irctalled drawing, then insp€ct ol the corrcctn€s.
'1. lnspect of the following drawing, then compare them with completed contenL
'l) Layout
2) Air Diagram
Test Method
3) Oil Lubrication
4) P&rD
5) Elect c wiring schematic
l. All ot Itre drawing must bo accord with content condition

Acceptance Criteria cse ol r€vision of the drawing.
2. Thero must be slgn in
sJoDF(0) Serong Pharmatech

Oocument No. sto 18960
#,tctrtc INSTALLATION QUALI FICATION Rev No. 0
Page 15 t70
AVAILABLE
lnspection ltems (YES/NO)
COMMENTS
Layout Yi-q &"rri,

Air Diagram Lonp lr
YES &A
Oil Lubrication
YEt9 L.cmfl*)
P&ID
YES b\7t,tt
Electric wiring schematic
YE-9 t-anVlud
RECOiIIMENDATION
L DRAWING : Manual <CH.8 DRAWNGS> att ched.
Final Evaluation Yel.s/ Notr N/A o
Checked by \,
.\14Lv\ Date t1 . 02. /?.
Approved by
t# Date
fr oz' t?
INSTALLATION QUALI FICATION Rev No. 0
Page 16r70
7.4 lnsp€ction of Critical / Non-Critical Dovices

7.4.1 Weight Rail part (Filling cam)
Test Report No: MRC-lQ{0744{1
1. Check the specification and the quantity Rail part

Test Method
A.
L
Acceptance Criteria 'r. The Rail part should be accord with the list.
r
) \

se.rcrlr; I NSTALLATION QUALI FICATION ReY No. 0
Page 17 t70
I) FILLING DEPTH
DIE
o
FILLING DEPTH
a changeable
MID DISK
LOWER PUNCH

Oocument No. srQ 18960
#,.E:IG I NSTALLATION QUALI FICATION Rev No. 0
Page 18t70
7-4.1-1 Filling CAM range and quantity
Result
Pa rt Detection Oistance Quantity
Yes No N/A
4.5 - 10mm 1 ,-/ tr tr
Filling CAM 8.5 - l4mm 1 ,d tr tr
12.5.18 mm I ,r' o a
7.4.1.2 Lower Tight Load cell
Result
Part Item S pec itication
Yes No N/A
Supplier S CELL
Model s8107-500K
Lower Tight Load cell \.r' c
Quantity 1
SIN 180s010
7 .4.1 .3 Servo Motor
Result
Part Item Specification
Yes No N/A
Supplier oirRoN
Servo Motor Model R88it-K40030T-S2 ,/ o tr
Quantity 1
7.4.1.4 Servo Gear
Result
Pa rt Item Specification
Yes No N/A
Supplier MTW
Servo Gear Model 40 (0.4Kw) / o tr
Quantity I
sJaDF(0) Sejong Pharmatech

Document No. stQ 't 8960
#.rcrrc I NSTALLATION QUALI FICATION Rev No. 0
Page 19/70
Standard of the parts Accordance with the Specification and the quantity
RECOMiIENDATION
Final Evaluation Yeqgl No r- N,/A :

Checked by
c>(otr,"
Oate t1 .e^fi.
Approved by
rffi Date
/? ' a'n

#,.g:lc I NSTALLATION QUALI FICATION Rev No.
Page
0
20170
7.4.2 TransmissionPart
Test Report No: MRC-1Q407{4{2
Test irethod
l. Check the specification and the quantity of Transmission Part
1. The specification and the quantity of Transmission Part should be accord with
Acceptance Criteria
the list.

Document No. slQ 18950
I NSTALLATION QUALI FIGATION Rev No, 0
Page 21 t70
REDUCER SIGHT GLASS
IN
L SUPPLY HOSE
r]
t
SUITABLE LEVEL LINE
N PLUG
OIL OUT
c
7.4.2.1 Worm reducer
Result
Yes No N/A
Supplier NAWOOTEC
Model RA61
Worm Reducer ,./ o a
Quantity 1
Serial No 't809152
sJooF(0) Sejong Pharmatech

Document No. stQ '18960
*tcrlE I NSTALLATION QUALI FICATION Rev No.
Page 22170
0
7.4.2.2 Main motor
Result
Part Item Specilication
Yes No N/A
Supplier HYUN DAI
Model No. HS1635R202E
Power ll Kw
Main Motor t/ o tr
Power source 220l380V / 60Hz
Quantity 1
Serial No 16J056D03-077-BGX
7.4-2.3 V-belt
Result
Part Specification Quantity Supplier
Yes No N/A
V-belt B-40' 4 DONG IL 'r./ o tr
7.4.2-1 A.W.C Encoder
Supplier
Part Specilication Quantity
Yes No N/A
Supplier OMRON
A.W.C Encoder Model E6C3-CWZ3XH ,'./ tr E
Quantity 1
sJaDF(o) Sejong Pharmatech

sEffiI INSTALLATION QUALI FICATION Rev No.
Page 23t70
0
7.4.2.5 Limit switch
Supplier
Part Specification Quantity
Yes No N/A
Supplier KOINO
Limit switch Model KLO3

A t/ 0 o
Quantity 1
7.4.2.6 Cooler Temperature Sensor
Supplier
Part Specification Quantity
Yes No N/A
Supplier
II woN
Cooler Temperature
Sensor Model IBL
,r'
Quanlity
I
I 1

#,.,f,}:IG INSTALLATION QUALI FICATION Rev No. 0
Page 24170
lnspection ltems Crilerion
Standard of the parls Accordance with the Specilication and the quantity
RECOMMENDATION
Final Evaluation Ywn Noo N/A o
Checked by
l\ Date t1 . 02. t7.
Approved by Date
t"f 6L l7
Document No. slo t8960
sesrE) I NSTALLATION QUALIFICATION Rev No.
Page 25t70
0
7.4.3 Mechanical Feeder Part
Test Repofi No: MRC-lQ{0744{r3
1. Check the specification and the quantity I Feeder Part

Test Method
^t
V
'1. The the Feeder Part should be accord
Acceptance Criteria
with the
: \
4
sJaDF(0) Serong Pharmatech

se.rc,,?E I NSTALLATION QUALI FICATION Rev No. 0
Page 26170
7.4-3-1 Feeder Motor
Result
Pa rt Item Specilication
Yes No N/A
Supplier NORD gear Pte Ltd
Feeder Motor Model sK80s,4 ,,/ D tr
Quantity 1
7-4.3-2 Feeder Gear
Result
Part Item Sp€citication
Yes No N/A
Supplier NORD gear fte Ltd

Feeder Gear irodel sK tsMttxovF - 80 sr4 t/ o tr
Ouantity 1
7.4.3.3 Powder sensor
Result
Yes No N/A
Supplier CARLO
Powder sensor Model EC3Ol6NPAPL

F tr tr
Quantity 1
7.4.3.4 Door sensor
Result
Part Item Specirication
Yes No N/A
Supplier TELEMECANIQUE
xcs-2c7902
Door gensor Model
xcs-zct
V o tr
,|
Quantity

*.rcyrc INSTALLATION QUALIFICATION ReY No. 0
Page 27 t70
RECOMMENDATION
Final Evaluation Y*d/ No! N/A o
Checked by
&ttn Date /"1 .ot. t7.
Approved by Date
t1 6L.t?
sJooF(0) Seiong Pharmatech
#.WE I NSTALLATION QUAL! FICATION Rev No. 0
Page 28t70
7.4.4 Discharge Part
Test Report No: MRC-lQ{r07O4{r4
Test Method
l. Check the specification and the quantity of Part
Acceptance Criteria l. The specification and the quantity should be accord with the lisl

Documenl No. slQ 18960
#,torltr INSTALLATION QUALI F]CATION Rev No. 0
Page 29170
7.4.4.1 Rotary Actuator
Result
Yes No N/A
Supplier FESTO
Rotary Actuator Model DSR-10-180-P ,/ tr o
Quantity 2
7.4.4-2 Solenoid valve
Result
Pa,1. Specification Quantity Suppli6r
Yes No N/A
Solenoid valve RDS3130 2 TPC / tr tr
7.4.4-3 Scraper sensor
Result
Part Item Spacification
Yes No N/A
Supplier oirRoN
Scraper sensor tlodel E2E.X2tttEl tr' o tr
Ouantity 1
7.4-4.4 A.W.C Solenoid valve
Result
Yes No N/A
Supplier MAC
A.W.C
Solenoid valve
Model 35A-AEA-DDAA.l BA 'tr B
,l
Quantity

sffi,
Documenl No. sro 18950
I NSTALLATION QUAL! F!CATION Rev No- 0
Page 30170
7-4.1-S Regulator
Result
Pa rt Specification Quanlity Supplier
Yes No N/A
Regulator 82019-2C-P 2 CKD \r' o
7 -4-1.6 Ejection Force Load cell
Result
Pa rl Item S pec iflcation
Yeg No l{/A
Supplier
Model
MS CELL
ut
II
Ejection Force
Load cell
Quantity
I 1
6 o tr
S/N
- )
a
-
sJQOF(0) Seiong Pharmatech

#,.rc,?E I NSTALLATION QUALI FICAT!ON Rev No. 0
Page 31 t70
Standard of the parts Accordance with lhe Specification and the quantity
RECOMMENDATION
Final Evaluation Yeld' Noc N/A e
v. /1 . o2-. t7.
Checked by
law Date
Approved by Date
n .
6L. )7.

sE.WE I NSTALLATION QUALIFICATION Rev No. 0
Page 321 70
7.4.5 Upper pr€ & main pressure roll Part
Test Report No: MRC-lQ{r07-04{5
Test Method
l. Check the specification and the quantity pre & main pressure roll Part
Y
1. The the & main pressure roll Part should be
Acceptance Criteria
accord
s
c qb=
4

#,tc,,?tr I NSTALLATION QUALIFICATION Rev No. 0
Page 33t70
7-4.5.1 Counter sensor
Result
Yes No N/A
Supplier OMRON
Counter sensor Model E2E.X2ME1 tr tr

^./
Quantity 1
7.4.5.2 Servo Molor
Result
Yes No N/A
Supplier OMRON
Servo Motor Model R88t{-K40030T-S2 w' tr
Quantity 2
7.4,5,3 Servo Gear
Result
Yes No N'A
Supplier MTW
Servo Gear tulodel 40 (0.4Kw) g tr tr
Quantity 2
7.4-5.4 Upper tight Load cell
Result
Part Item Specitication
Yes No N/A
Supplier MS CELL
Model sB107-500K
Upper tight Load cell
Quantity 1
'\r' tr o
s/N 1805005

#.rctrtc I NSTALLATION QUALIFIGATION Rev No. 0
Page 34170
7.4.5.5 Upper safety rail sensor
Result
Yes No N/A
Supplier AUTONICS
Upper safety rail
sen30r
Model
Quantity
PRCM12-2DN
1
r 6 tr tr
sJQDF(0) Seiong Pharmatech

Document No stQ 18960
#,'CI?E I NSTALLATION QUALIFICATION Rev No. 0
Page 35/70
lnsp€ction ltems Criterion
RECOMMENDATION
Final Evaluation Yfi.n Noo N/A
N-r' oL.
Checked by
,<atl\ Date /7 )7 .
Approved by Date
11 '62' t?
sJooF(0) Seiong Pharmatech
se.rcylE I NSTALLATION QUALI F!CATION Rev No. 0
Page 36/70
7.4.6 Lower pre & main pressure roll Part
Test Report No : MRC-|Q-007-04.06
Test Method l. Check the specification and the pne & main prcssure roll Part
V
1. The the & main presaure roll Part should be
Acceptance criteria
l.

#tcylE INSTALLATION QUALIFICATION Rev No.
Page
0
37 170
7.4.6-1 Servo Motor
Result
Part Item Sp€cification
Yes No N/A
Supplier OMRON
Servo Motor Model R88M-K40030T-S2 I o o
Quantity 2
7.4.6.2 Servo Gear
Result
Part Item Sp€cification
Yes No N/A
Supplier MTW
Servo Gear Model a0 (0.4Kw) tr o
Ouantity
7.4.6.3 Pre, Main Load cell
Result
Part Specification S'N quantity Supplier
Yes No N/A
SM600S-20T (Pre) 1808030 '1 iIS CELL \)/' tr o
Pre, Main Load cell
SM500S-20T (main) 180802s 1 MS CELL tr tr
7.4.6.4 Lower Change rail senror
Result
Yes No N/A
Supplier AUTONICS
Lol .er Change rail
sensor Uodel PRO8.I.5DN \,r tr tr
,|
Quantity

Document No- srQ r8960
#.,tr,/:IG I NSTALLAT!ON QUALI FICAT]ON ReY No. 0
Page 38r70
lnsp€ction ltems Criterion
Standard of the parts Accordance with the Specilication and the quantity
RECOMMENOATION
Final Evaluation ves{ Noo N/A n
ChGcked by
( Wz- Date
2c '02.11
Approved by Date ZO . 6>. t1.

#,.W8 INSTALLATION QUALI FICATION Rev No.
Page
0
39'70
7.4.7 Control panel Part
Test Report No : MRC-IQ-007-04-07
1. Check the specification and the quantity of Control panel Part

Test Method
.
V
1. The specification and the qua Part should be accord with the
Acceptance Criteria
list.
^r"A
,r,/
,
Y
a
I
sJoDF(0) Serong Pharmatech

#tcylE I NSTALLATION QUALI FICATION Rev No-
Page 40t70
0
7.4.7.1 Op panel
Result
Yes No N/A
Key switch X84-BG2

(Control poYver)
'I SCHNEIDER vd' tr D
=ZB4BG2+ZB2-aE1O1(21
Push button switch xB4-BAl311
2 SCHNEIDER L
(START) =ZB4BA131+ZBE-101
Push button switch xB4-842321
(sroP) 2 SCHNEIDER wa" tr o
=ZB4BA232+ZBE-101
Push button switch xB4-BA3'1
(rNcH) =ZB4BA3+ZBE.101
2 SCHNEIDER vq' tr
Push button switch xB4.BA55

(RESET) =ZB4BA5+ZBE-1 0l +ZBE-102
1 SCHNEIDER V,s' C tr
xB4.BS844
E.M.G switch 2 SCHNEIDER \D' o tr
=ZB4BS,U4+ZB2-BE1 02(2')
7.4.7.2 Touch screen
Result
Yes No NIA
Supplier Pro - face

Touch scl€en Model PS4700 o tr
Quantity 1
7.4.7.3 lnveter
Result
Part S pec ification Quantity Supplier
Yes No N/A
FR-A840-t'tK-t
lnverter <lNVl> 1 Mitsubishi ,.{ tr o
SIN : A8364X
lnverter <lNV2>
FR-E740-0.75K
S/N r 884591
1 Mitsubishi n tr o

*,HE I NSTALLATION QUALIFICATION Rev No.
Page 41 170
0
7-4-7-4 Control panel
Result
Yes No N/A
EMG switch zBE-102(21 1 SCHNEIDER / tr
CAM SWITCH v4 / 80A 1 SCHNEIDER ,"/ tr tr
NFB <NFB1> C60N/C63A+ vigi c60 1 SCHNEIOER \.r' tr
NFB <NF82> c60N/c404 1 SCHNEIOER Lf tr tr
NFB <NF83> c5oNtc10A ,|

SCHNEIDER td' o tr
NFB <NFB4> c60N/c6A I SCHNEIDER 0 tr

"rd'
NFB <NFBs> c60N,c16A 2P 1 SCHNEIOER g' tr
NFB <NFB5> c60N/c25A 2P 1 SCHNEIDER Ld' o
NFB <NFB7> C60NrC10A 2P+Yigi c60 1 SCHNEIDER ry' tr
Noise tilter <lNF> NFM.2lOS 1 SAM IL / tr
Noise filter <3NF> NFZ-4040SG 1 SAM IL \/ o
Power supply <PS2> sSJX-G10024C 1 OMRON \8," tr tr
Power supply <PS1> SSJX-Gl5O2,tc I OMRON ,,^'

Relay <K0r-K25> MY4N 25 OMRON t tr
Relay socket <K01-K25> RXZE 2Mfi4il 25 SCHNEIDER t/ tr
Servo Driver <AMPI-AMP6> R88D.KN04H-ML2 5 OMRON tr tr
Magnetic contactor <MCl> LCt.D126 /BD 1 SCHNEIDER \,p' tr tr
Thermal relay <ilCl> LR3D126 (5.5-6A) 1 SCHNEIDER .\F' tr tr
Transformer<TR> BHTB-DQlKTU I BUM HAN \9'' .] tr
Air pressure slw MPS-P37R.NCA 1 CONVUM D tr

"d'

Setc,:lE !NSTALLATION QUALI FICATION Rev No 0
Page 42t70
7.4.7.5 PLC
Result
Yes No N/A
PLC POWER cJlw-PA202 1 OMRON ,.r a tr
CPU UNIT CJ2M.CPUI4 1 OMRON tr D

^ri
INPUT UNIT cJlwJD23t I OMRON ttd tr tr
HIGH SPEED COUNTER UNIT cJlw-tDPo1 1 OMRON G D
OUTPUT UNIT cJtw.oD23'l ,|

OMRON t{ tr o
ANALOG INPUT UNIT cJrW.ADoSt-v'l 1 owrRoN \n tr
ANALOG OUTPUT UNIT cJtw-DAo41 1 otrtRoN ,n' tr tr
POSITION CONTROL UNIT cJlW-NCF7t 1 OMRON v{ tr n
7.4.7.6 PRTNT
Result
Part Spe6ification Quantity Supplier
Yes No N/A
PRINT Laseriet pro M'102W 1 HP \,t tr
UPS 5P 1150GR ,|
EATON ,/ tr tr

ge.,tr}:tc I NSTALLATION QUALI FICATION Rev No. 0
Page 43170
Standard of the part3 Accordance with the Specification and the quantity
RECOMMENDATION
Final Evaluation YeV//' NoE
Checked by
*nr+, Date -?o. DL. t1.
Approved by
, ./1A. ,) Date
2-b 'dL' I

3erctrlE I NSTALLATION QUALI FICATION Rev No. 0
Page 44t70
7.4.4 OPTION PART <Option>

7.4.8.1 DUST COLLECTOR CHECK
Test Report No: MRC-lQ.O07-044841
Verify the specification, standard and assemble of the parts for the Dust collector
Purpose
And supply information for the maintenance.
Test Method
l. Check the specification of the parE at the Dust collector
1. The specification and quentity of the installed parts at the Dust collector should be
Acceptance Criteria
same rYith the list.

seffil I NSTALLATION QUALI F!CATION Rev No.
Page 45170
0
7.4.8.1.1 DustCollector
Result
Part Item Specitication
Yes No N/A
Supplier SEJONG (OHM)
Dust Collector
Model
Voltage
Quantity
ovc.22Bs
400V / 50Hz I
I
tr
I I
tr tr
&
r
a

#,,tr,,1c INSTALLATION QUAL!F!CATION Rev No. 0
Page 46t70
ln3pection ltems Criterion
Standard of the parts Accordance rvith the Specification and the quantity
RECOMMENOATION
Final Evaluation YesSy' Notr NIA o
Checked by
c*dLN Date t7 . oL. t7.
Approved by Oate
1l'6L't7'
#,.W8 I NSTALLATION QUALI FICATION Rev No. 0
Page 47 170
7.4.8.2 DE DUSTER CHECK
Test Report No: MRC-|Q{07-04{8{2
Verify the specification, standard and assemblo of the parts for the De duster
Purpose
And supply information for the maintenance.
1. Check the specitication of the perts at the De du3ter.

Test Method
1. The sp€cilication and quantjty of the installed parB at the De duster should be same
Acceptance Criteria
Yvith ttl. list

Document No. sto18960
serryrE) I NSTALLATION QUALI FICATION Rev No.
Page 48t70
0
7.4.8.2.1 Regulator
Result
Part Specificalion Quantity Supplier
Yes No N/A
Regulator SAw2000 (lMPa) 1 MC n tr D
7.4.A.2.2 Regulator Control board

Result
Pa rt Specification Quantity Supplier
Yes No N/A
Control board FD.34 1

/ JIN SUNG
I td" tr tr
(,
<7
g
4

#JC,:|E I NSTALLATION QUALI FICATION Rev No. 0
Page 49t70
RECOMMENDATION
Final Evaluation Yesg/ No. N/A n
Checked by
<tth Date lll . o> .t1 .
Approved by Date
n .62 .n
*,.rcrlE I NSTALLATION QUALIFICAT!ON Rev No. 0
Page 50/70
7.5 List of Product Contact and lnspection of Materials
Test Report No: MRC-1Q40745
All of product contact parts should be checked if there is no problem product quality
Purpose
under the condition of User Required Specilicaton.
1. Check the list for the product contact pattt and the parts
Test ethod
2. Check the certificate for the w'itbn list
1. Product contacl parts matadal should be accord with the material ot construction
Acceptance Criteria
certific.ia (IOC)-
sJoDF(o) Sejong Pharmatech

#tfflE I NSTALLATION QUALIFICATION Rev No. 0
Page 51 170
Result
lnspection ltem Material
Certification No.
(Product Code(Name))
Yes No N'A
Powder tank STS316L I 41 203-RC0't PN-00025-0001 -d' o o
Feeder 4606r (AL606r ) 2014.05-29 ,,/ o tr
Feeder impeller 4606'r(AL606r) 2014-05-29 w' tr 0
Scra per c2680P.1/2H(BS) 1/r1216-576 \y o o
Turret GCD(FCr)4s) 20141029-2 \,s' o o
Discharge scraper 4L6061 /rco531C02 vd^ tr o
Discharge chute sTs316L 141201-ARNE{80-001 o o

-d'
Powder tank gasket SILICONE sH5160U \-d o o
Acryl connecting pip€ ACRYLIC MMA/EA tn o
Zero clearance pad PET 1100 \F' o tr
RECOii|MENDATION
l. Sudace Area sheet attached
2. Material certificate attached.
Final Evaluation Yeld' Nor NIA a
Checked by
&;^ Date 2o - o)-. t1.
Approved by
#_ Date
,4 .6>- ry
( ( (
OJ
Mlll Test Certificae No./ilBA{fl.!. : 14t2Ot-RCOt pN.00@S.0Ot 1
Dab ol issur/Itgtlrl;
Selh : POSCO ^lE Su sce Finish/tt Bof +a,: IO.2B
Doc., 10, 2Or4
irrflufaslure,: POSCO AST PO No./+eut : 0tSr3O4O9B

(I Ordar No./>{lel HQ : 01S13E4096
Contmodlty :
: SHINKWANG CORPORATIoI STS CR Ap COIL
: SHINKWAT\,G CORPORAIoN
,*fi
t t'* : AsrM{24oMi'l6L
--]-d.Fff
r-tErrlr clcrtc, Compodtbn/iqt'E (t)
o
PlodLd l&. OlidnY I lrr.- ,. . ,eE
t
tu Sia,rl+ ,Httrr t+9' E* r{aEt q fr, 0rl a CAl'rP 5 O ill c!ta
{lcl N
E IIRE
IC
t"l
s
B a5 Il gt ,a5
t - aub r.( (o.o) -. I : 1554
- )U hrinrrl - Brru&niTn.irnl
:'OrCrTCd -. 1!.514 (trl
"Gonlldr.l"' rq,ra (tt
i
I
I
i
i
!
I
-r: To. M Mdrlc3: lotnn tefi lna oltb, rd lbBo lpxihslio'r

'ltalts Te31. IrlraciEt lr.,s!r.r.d, G.{. L.rlgnr : 60rn(fudrrld4.
02*.r$r€l
'Or*.bn-LrtrliA.l{r! IOENTICAL TO ORIGINAL COPY
e SEJONG PHARi,{ATECH
t! .F
F H^r E edor C2tg+qtE g Eajtl EIlr, gr,tl + 9-Pq
14
'POWDER TANK H,it5tsrt ^', ^t !0lqE 9ac <\ ?€'r.r.
fl.Ea^t{ed 9ir(dE2!rr)l
i:
E
POSCO ASI
ASl
dr3.
g,tvetor fo :
Sao.l .r.DorE. tnn-n6u. ,nefl.Sl. XyuigkiDo. l6ts. . t^B€. t ) cardol tr!.lrr l.rh! l'rlotr l( rn. J 1l
ffid
a
tr)
o
( ( (
Ia
.E
::c! n:r
itr
:r
!r
*t! \t
r€
a^164^1 rout t{iN E co,trD 4 )l .E 3rl {rtE e 21& r+.209 83t rtqEE)
^l
(l nspectlon Certificate ) BCIIB TEI : 031-366-t285.428f / rN(;0t1-356-Q87
E No {{ I EE s.
ERNFI(lTT
fi€MPEn)
LOI No
(SIANDAnO) srl
.o 0 AIB
20r4.05.29 A6061 I6
o
N
4C053 rC02 x50 6701 gLIP! PI.ATE m14.11.05,
N 1.+Eiq(oRoERspEq
2.7144 A 1 (MrcHrftrcrr pRopERIl.q
+4 s il 0t EI IS YS TL se
+e*4 20.0 t2n 9000
{ORDER sPTq MAX x9o610ll e4fl
a{ufl lln
SP€C 166r P i
16 65rl
t1.0mm tlOmm b+{{qo.
.F (Ar-towANc0
qe{
o.x HtN
2li( dlg eI4 g
N c84 eei lttg* rtrg
4ao 6CTUAU 105 261 2l q4.
acruru
:NE 3. s t € E tcHEutcAl, coMposmo, 4,EgSIt
(TINA! DTCISIO}I)
E si fe BE
Cu Mn Mg C( Zn I At-
&!.AX 0.8 0? 0.1

SP€C 0.t5 12 0.lt 025 0.15 REM
(e$
t/tN 0.,1 01s
Efq
0.8 0.01
ox
q6{
0.770 0.111 0.266 ot2t 0,998 02, 0!0{ 0.01t 97.389
87i clolrll tq {e!s

{7i
^}s
E{galY
fls H^
;8IL .FEEDER
,FEEDER IMPELLER ,orrrriicr.r ro onrc,lLli copv
SEJONG PHARMATECH
( ( (
cu$roEE ES $voosulrc HETAL

^laE!l3a
SHEEI ilo. r4fl18 - 610 CERNFfCATE OF TEST ?13-3 WonC-Dono oinmr-ALAnlm -(Itv
oal? zqrr- r?-rB Xfl,nonl-Oo KOEEI
s spEolFrcAnot{ ir FrI: &r-{0r -0rt0
Ks O 52Ot EQ[QElflH (es) IEt4Ljfl:!6m
modlty & ?.mper ' Chomlc.l Compocl0on (tn wt't)
c?680P - 1l2H
t{i P Zn
Cu Pb Fe
8pec.
Mn 6{ 00 REM
0{mension(ol
LDt n O. trlar 68 00 0.05 0.0s REU
81 - 1671 -2 3.00 x '100.00 x '1200 64.54{ 0.008 0 008 0,004 .FEM
6drerlcd Tost
Adcls 9zo(m) Plecod
To0ollo Ylstd Ehcfilcd Appetlanco Wolghl
ElonoBIoi lhrdne3s IlGndino
stuglt' Sfiomth (s) Hvo,a
Cooductlv,lv
t03l 0(G)
Tlrlctnest widrh tenolh (H,od 0l/d, ftlAcs)
Speo
Mln - 0.08 - 0.00 -0 355 28 85 100 '
Lot rlo. t\,tax + 0.08 + 0.80 + I0 440 t45 RlrI=1
Br- 16?7 -2 2.S96 400.00 r200 38s 39.0 118.0 GOOD GOOD
_ cor
I&
Roma (: Wo ieDby corflfy that tbove nutodsl
l8otod lO Comdy lrlth ttrD specltlcaflOn.
t.r beon
Tolal wds[t(XGl
44
Yll000.{2 roi02 YO$UNO $ETAL &,,Ud,
.SCRAPER
I O: I'JCEeIJJ
ag16- 9 'AS 06rE Froml
^luc4^l( IEST REPORT )
t S (Regort No') ; 20141029-2 ,tq?4 6,,'

q q (Company Nane) : *{t}9 [rAm HlI( mrAt di'L:- ,
^! azlE tlr.^l *ebi4.+4 445-8e

il45.E9 Hagrln-ri, Yangchon-ew, Cimgo-i '
gl d (Cmnditv) I l,PPtR 019(
'
Gyconggi'do f,orea
TtL : 031)963-8098
: 03r)983-8066
4 tl (ilateriat)
(Dstc)
GCD
(FCD45)
2014.8,20
tr'AX
^lggrl
r. Eg/d*(i)
(Clrun i ca I CtrrDos it ior) EIA
rh P S llg
si
0.4 0.08 0.02 0,09

2,7
SPEC
fax f,ax Uar Iax lsx
NO l{in
2.62 0.25 0 0.006 0 u2
1 3.56
II I
- ,71fri44d
(tlechan i cal Proger i ies) tsl 3
H^ROilESS
T.S
(tl
Y.s
d
EI
$ EI HB
r40 -
HRC ks
450 280 t0
SPEC 270
I litn
NO tlin
18.4 I 160
J
46S
II I
3. BEla4al (li croscoD l c,
- - -
4, ul3 (Remarks )
(TURRET) L
"DiSK
SEJONG PHARI,{ATECH
d B6a18AS: 01 fEag 998 eiA gNtis Ut-i\{: uro Jl SE:atr ba_I]l_rl@

( ( (
u3[r@fl8t
IoYs llr lorla Llrlhd uf.r,lal
Ll
fto)l
1, lol9ll-ro,
S.dJl.
:
lGr$, b(c.
+@l 2269
.lrfg,
lm F8 i r@ nl 6EO
lnspect ion Cer t i f lcate
u'E i e{.r01t
@Em
otlll|taEn to ralat da aet
otruE PffiIIB Srlrolful 6mmr r mrl

{{E6 00r {06in0t E ,t +l.l.
,tu[I9s. tulllE rt8! tr0G{ l0r Ut/I IIDIX t80llr
tlE( r IUl'z ( [/d I (rl ( ! ) (r I ( !a I
I
)
lllrY TM g{E fiD$ I8SII{ $x 6.m t.2$.m 5,6a.O

ls.m
tlr
rII {,s0,0
1,24?.Q0
ffil f a.ml 1.20.m t,6r.dl ,ctur. b.arZ. 1,60.@ s.ffi.s
0f{rc|I sl Fe o th k tt Zn Ii Ead Iot&l lt p iLr 0ito8 t0i
trGlltdr 1
lrl ux 0.8 0.m 0.o 0.16 t,a 0.t 0.6 0. t60 0.6 0
ul 0.o 0.r5 0.o 0,01
/dull" 0. tto 0iql 0.26 1.q2, 0.9 0.2{l 0.sr 0.0{r 0.m 0.otr s7,s 0.I 0.I
!I1TN ET BES u,T 0lA 6 PIIfi FIEO

f,tofl rtoII grEr5
I b ) (hl I I
UI
IIII
l0n$t 3.0$ l,t4,l I
Ellrts
p.o.uffi Jn Dtt sfl? IU f,Bluf,i t u4 4tlt

E rBI CArfi mI BI3 l0lBlA rElS lr€ 0El0B'e lPslf lcr,lo6 NIiC/rL TO ORIC lL COPY I
SEJONG PHARI,
.DISCHARGE SCRAPER
( ( (
ru
1
o_
poe co
AST Mill Test Certificate/3 At=E Al
c€rti1lcat6 No.rSglAl E
t&
g 1141201-ARNE-08&O0'
of lssuerElg Glli:oec.. 11, 2014
Surfaca Fl')i$rE E U ?A:NO.28
Ord6r NoJI qr E A:GUS0228530 PO No.r+eEE:GUs0228530
Supplier/+E Il; Cammodity/EB :STS CR COIL
c0
m o
TU
0l
v{.bhr
I
Lft.lhrE El Al E lli!r- orrilrd cdrpce..llll qd e{trl
r! Prdud Nu cll.. Ef H.atl{o YS !,t T8 EL ntr
tu Size/fl+ ,ltit I (fr) {$} /es CgMnPc C, l{i C! llo x
t'r EIE UE +g (tql Ee![! I
-{3-3-{{ -2-2.t.2{
:
F r!, 62a 1!!4 350 l? 1658 10(: A 2t2
2,,219,,c Iovraorrazg I 3.{52 sY8m12 T ,t2 !04 5lt 7t.0 L 0
I
I 27l 630 ta 7t,7
"' Slb l6ul i t a5, I le)
- HEAT INEATU ll,':l;;",,. TEAT nEtT llhl 1( 40 c ouEr{cfill{o
* 6ddr TOLl I nLa I h)
- Grrn T.lt. I t.'2 ( EI
.T: tl:ftfidb,B: m.brbl har b-n ao.ndDa ftr bm!

'd ' Tadb T..1. oirsd|m : T.tn5vrtal. GauF Lrhgm : 50lt!(RadrryuL?1,
YP iddh : 0.2r an d
' (rLldl - Ltdlr An.lF& DENTICAL TO OR!G .;AL COPY
L! . chemrl oofitotidoo urdt .*1r100, i t1rl0oo, {rtil0lD0, {irl/! 0o0E
F-
rl
SEJONG PHARhTATECH
|..
.OISCHARGE CHUTE 'r d#59^lct cze Etll l8t + tlglx.
,a3E! /\lt ^t eldal0tst
SArCgll ll I^l {elt 2S' I E E + ,1€ U r1.
E Slrrrlyor To:
&
x x @i @ o!AITY laaul,.rae ra^l
tft POSCO AST ,003, SEONGKOK.OONG, DAN\A'ON.GU, ANSAN.SI, ICAJ}IGKI{)O, KOREA
E
ru
ffit
The Best Fine
Ch€mical Company
Material Safetv Data Sheet
Total Paqe : 5
Versron : 1 .1
Revision Date : 2A11105102
SH5160U Silicone rubber
Section 1 - Product and company identification
MANUFACTURER'S NAME
KCC Corporatron EMERGENCY TELEPHONE NO.
11-4, Daejuk-Rl, Daesan-Eup, Seosan-Sl, 82-4r -660-8700
Chungnanr-do, Korea INFOBMATION TELEPHONE NO
82-,r1-660-8700
PRODUCT CLASS DATE OF PBEPARATION
Silicone compound May. A2, 2411
TRADE NAME & PRODUCT CODE

SH516OU
Section 2 - Composition of inoredients
ING REDIENT SOBRIOUET CAS NO. PEBCENT

BY WEIGHT
Dimethyl, methyl vinyl siloxane, Polyalkylalkenylsiloxane 68083-18- 1 60-70
dimelhyl vinyl terminated
Silicon Dioxide Silca 7631-86-9 20- 30
Others 1-10
Section 3- Hazards ldentification
Routes of exposure
Exposure may be by inhalation. skin. eye contact. To minimize exposure. ventilat on and
personal protective equrpment is recommended. Avo d breathing vapor or mrst.
Ar'oid corlact ,/,{/irl- e/es. sl. n, and clolhrrg.
Short term & LonO t€rm otfects
- Short term eflecls -
No data
- Long term elfects _
No data
Section 4 - First Aid Measures
After inhalation
Remove from exposure area to fresh air mmed ately, Perlorm artif cial resp ralion il necessary.
Keep person warm and at rest. Gel medrcai attention immed ately.
Afler contact with the eyes
Wash eyes rmmedatelywith laroe amounls of water occasionally liftng upperand loYver lds.
until no evidence of chem cal rema ns(at least 15-20 minutes)
Gel med cal attent on rmmediately.
lrDENTrCrrL TO OR!G:riAL COPY

SEJONG PHART{ATECH
,POWDER TANK GASKET
Page 1 ol 5
ffi,
The Besl Fine
Chemical Company
Tolal Pase : 5
Bevision Dale : 2O11/05102
SH51 60U Silicone rubber
After contact with the skin

Rernove contarninated clolhing and shoes immed ately. Launder belore re-use.
Wash aifected area thoroughly with soap and water until no evrdence ol chemical
rema ns(at least 15-20 minutes). Gel med cal attention immediately.
After swallow
Extrehe cate must be used to prevent aspiration, Do not nduce vomitinO,
Sloltly dilute with 1-2 Olasses of lrater or milk. Get medical altention immediately.
Others
This prod!ct contarns Methylpolysiloxanes which can Oenerate Formaldehyde
at approxrmalely 300'F and above. n atmospheres which contain oxygen.
Formaldehyde is a skin and respiratory sensiti2er. eye and throat irritant, acute toxicant,
and potentral cancer hazard.
Section 5 - Fire Fiohtino Measures
Extinouishing media
Regular loam, Carbon Dioxide. Dry Che,n cal
Special the fightino procedures

Move conta ner lrom iire area if you can do it withoul aisk. Avoid breathing toxic vapors
Keep upvlrnd. Full protective equrpmenl nclud ng self-contained breathing apparat!s
should be used.
ivater spray may be rellective. lf rvaler s used. tog nozzles are preferabie.
lvater may be !sed to cool closed containers to prevent pressure build-up and possrble
auloignition or explosron $hen exposed to extreme heat.
Unusual fire and explosion hazards

Closed contarners may explode(due to the bu ld-up ol pressure) when exposed to
ex t reme hea1.
Section 6 - Accidental reiease measures
STEPS TO BE TAKEN IN CASE MAIEBIALS IS BELEASED OR SPILLED

Not appled due to sold.
Section 7 - Handlino and Storaoe
Handling
Wear eye proteclron dev ce and protective glove when handlrng this product-
May cause a cur ng drflicully wrth amrne. sulfur, organophosphate compound,
and organomelall c compolnd.
Storage
Store in a cool and dry place. Avo d direct sunl ght
Store container r a well vent ilated place.
iDENTICAL TO ORIG:TiAL COPY

SEJONG PHARMATECH
Page 2 of 5
reD
The Best Fine
Total Page : 5
Chemical Company Versron : 1.1
Bevision Date : 2A11105102
Section I- Exposure conlrols and personal protection squipment
EXPOSURE LIMITS
Maximum airborne concentratrons at the workplace:
not applicable
EXPOSUFE IN THE WORK PLACE LIMITED AND CONTROLLED
GENERAL PBOTECTION AND HYGIENE MEASURES
Observe slandard rndustrial hygiene practrces Ior the handling ol chemrcal substances. Do not
eal or drink when handling.
PERSONAL PROTECTION EOUIPMENT RESPIRATORY PROTECTION
Not necessary under usual conditions. lf aerosols occur during use, the followinO breathing
proteclion is recommended: tine dusl mask P2.
HAND PROTECTION
Reaommendation: Protect ve gloves made of butyl rubber , nitrile rubber protective gloves .
EYE PROTECTION
Becorrrrendaron: lrghl titrrg Drolecrive goOgles .
EXPOSURE TO THE ENVIRONMENT LIMITED AND CONTROLLED
Prevent mater al from entering surface waters and soil.
FUBTHER INFORMATION FOR SYSTEM DESIGN AND ENGINEERING MEASURES
Observe inlormation in section 7. ln case of aerosol formation special protective measures are
required (exhausting by suction, respfatory protection). ll the product is used with a
catalyst and crosslnker, the lollowing rreasures are recommended: Vapours/aerosols should be
exhausted directly at place ol lormation.
Section I- P ical and Chemical ProDerties
APPEARANCE : Transparent
ODOR:Oderless
SPEC{FIC GRAVITY (H,O=r) r 1.r 5-1.1S
BOltlNG POINT("F) : Not applicable
FLASH POINT : Not appticabte
EVAPORATION RATE(VS.n-BUAc) : Neslisible
PH VALUE I None known
SOLUBILITY IN WATER : Inso|ub|e
VAPOR DENSITY(VS.AlR) : Neslisible
LOW EXPLOSIVE LIMIT(LEL) : No data
UPPER EXPLOSIVE LII\,4IT(IJEL) : No data
AUTOIGNITION TEI\.IPEBATURE : No data
llDEltiIlCril TO ORIG:l.AL COPY I
I srroruc pnanr,rnrccH I
Page 3 ol 5
@,
Th6 B6st Fina
Ch6mical Company
Total Paos : 5
Version : 1 .1
Revision Date : 2011/05102
Saction 10 - Stability and Reactivity
Stability : stable under normal conditaons of use.

Conditions to avold : None.
Mat€rials to avoid : No data
Ha2ardou6 docompositlon products : No data
Hazardous potyrn€rization : will nol occur under normal conditaons
Soction 11 - Toxicolooical lntormation
Eftects of exposute : Not applied
Acute lox city dala I No data
ACUTE TOXICITY DATA :
LD501mo/ko. Oral-ral) LC50(oom/4h. lnh-rat)
Polydim ethylsiloxane
Fumed silica Unknown Unknown
Others
Section 12 - EnMronmenlal lnlormation
AIR
Thrs product rs a h ch molecular weight liqu d polymer which has a very low vapour pressure
i<l mm Hg)- As a result il s unlikely to become an atmospheric contam nant unless
generaled as an aerosol.
WATER
Th s product has a very low water solub lty (< I00 ppb). As it has a specilc gravrty ot < 1. I
d scharged to waler. rl wrll lnrlially fornr a sudace film- As the product is non volatile and has a
h gh bind ng a{t nrty lor padrculate matter, rt wrll adsorb io part culates and sediment oul-
SO IL
ll d scharged to surJace waler. lhrs product will bind to sedrment. lf discharged in elfluenl 1o a
wasle water trealment plant, the product rs remov6d from the aqueous phase by blnding to
sewaoe sludoe. ll the sewage slLrdoe rs subsequently spread on soil, the silicone product is
expected to deOrade.
DEGRADATION
No specific inlormation is available on this Droduct, but analogy with polydimethylsiloxane
suooests that it will deorade in the sorl, initially via an abiotic mechanism to lorm smaller
molecules. These rn lurn are eilher biodegraded in soil or volatilized into the air where they
are broken down in the presence of sunlight. Due to the very low water solubility of this
product. standard OECD protocols lor ready and inherent biodegradability are not suitable for
measurinO the biod6gradability of this product.
ENVI RONI\,IENTAL EFFECTS

TOXICITY TO WATEFI ORGANISi'S
Based on analooy to similar malerials this product is expected to exhibit low toxicity to aquatic
organism s.
Drscharoe treatment, or disposal may be sublecl to nat onal, slate, or local laws.
NTlCriL TO ORIG COPY

SEJONG PHARIT
Page 4 ol 5
reD
The 86st Fine
Tolal paoe : 5
Ch6mical Company Vercion:L]
Bevision Dale : 2O11 /A5/02
SH51 60U Silicone rubb€r
Section 13 - Disposal Considerations
Discharoe, treatment, or d sposal may be subject to national. state, or local laws-
Section 14 - Transport lnformation
US Depa.tmenl of Transportation(DOT)
Shippjno name : not applicable

Hazard class : Not DOT regulated
lD number : None
Packino group i None
labels : not appl icable
Section 15 - R6oulatory lnformation
The lall ror occupational safety and health in Korea: seotion S, 41

The lan lor hazardous chenical substances in Xorea
Other lnternational ReOUlations

Chem rcal lnventor res
illlTl : All components are listed on EIICS or its erefipt rule.
KECL:All ingredrents lsted, exeipt or notified.
IECSC: All ingredients I sted or exerpt.
EINECS: All ingredients lisled or exempt.
TSCA : Nol determined
DSL:Not delermined.
AICS:Nol determ rned.
PICCS:Not determ ined
Section 16 - Other lnlormation
The data orven here rs based on our current knowledOe and experience. The purpose of lhrs safety data
to describe the products rn terms of their safety requirements.
The data does not siOnity any warranty with regard to the products' properties.
t! L ILJ o
Page 5 ol o
Lucite
% lnternational
SAFETY DATA SHEET
,|
IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE
COMPANYi UNDERTAKING
PRODUCT NAI\,1E ELVACITE@ ACRYLIC RESIN - POLY(IVMAJEA) BASED
Produci Description Polymer based on l\.lethyl methacrylate and Ethyl acrylate.

This dala sheet covers the following grades: ELVACITE@ 2010, 202'1E, 2685, 3001, 3003,
3007, 3008, 3009, 3010, 4045.
CAS No 009010-88-2
Recommended uses and restrictions on use Manufacture of inks, parnts and varnishes.
Manufacturer Lucite lnternational Canada 1nc..2795 Slough Street. Mississauga, ON L4T 1G2
Tel. (905) 673-3345 Faxr (905)673-1459
msdsrnfo@lucite.com
Emergency Phone No 1-800-424-9300 (Transport Emergency)
1 -877-886-2143 (Medical Emergency)
2. HAZARDS IDENTIFIGATION
Hazard classification Combustible dust

Signal wo.d Warning
Hazard statement(s) lVay form combustible dusl concentmtions in air.
Other hazards Low toxicity under normal conditions of handling and use.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Chemical idenlity of the substance Poly(N.,!ethyl methacrylate/Ethyl acrylate)

CAS No, 009010-88-2
Substances in the product which may present a health or environmental hazard, or which have been assigned occupational exposure limits,
are detailed below.
Substance identity CAS No.

No classifiable hazardous inOredjent(s)
4. FIRST AID MEASURES
Description of first aid measures

lnhalation lF INHALED: Remove victim to fresh air and keep al rest in a position comfortable for
breathing.
Skin Contact lF ON SKIN: Wash with plenty of soap and water. lf skin initation or rash occurs: cel medical
atlention.
Eye Contacl lF lN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if
presenl and easy to do. Continue rinsing.
lngestion Do not induce vomiting. Rinse moulh. Obtain medical attention if ill effects occur.
N,lost important symptoms and effecls, both acute and delayed

Not applicable.
lndication of any immediate medical attention and special treatment needed

None necessary.
iDENTICAL TO ORIGII.]AL COPY

-ACRYLIC CONNECTOR PIPE SEJONG PHART{ATECH
ELVACITEeACRYLTC RESrN POLyIMMIL/EA) aASEO Oale: 03-Seplember 2o13
Pagel/ 5
5. FIRE.FIGHTINGMEASURES
Suitable extinguishing media Water spray, foam, dry powder or COr.

Unsuitable Exlinguishing Media Oo not use water jet.
Special hazards arising iom the subslance Combustible but not readily igniied. By analogy with similar materials, the product may
or mixtuae decompose if heated to temperatures above 392"F (200"C). Cohbustion or thermal
decomposition willevotue toxic, iritant and flammabie vapors.
Special protective equipmenl and A self contained breathing apparaius and su able protective ctothing should be wom in fi.e
precautions for fire fighters conditions.
6. ACCIDENTAL RELEASE MEASURES
Methods and matenals for containment and Caut,on - spillages may be slippery. Sweep up and shovel into waste drums or plastic bags
cleaning up Wash the spillage area with water.
7. HANDLINGANDSTORAGE
HANDLING Producl as suppliedi Avoid contact with eyes. Avoid prolonged skin contact. Unlikely to
represent a dust hazard under normal handling conditions.
Process Ha2ards The product may be suitable for a wide range ol industrial applications and therefore it is
impossible to make detailed rscommendations regarding all process hazards. Thermal
processing requircs adequale ventilation lo remove any monomer decomposition products,
and L/se of anerl afnosphere may be required in some processes to safely decompose the
resin when il is used as a tinder. Arry thermal processing must consider the time-
temperature decoftposition of the resin. lf the product is to be used in applicalions for which
the hazards are not fully underst@d it is recommended to consult the supplier before use.
STORAGE Acrylic polyrners are supplied in either bags or bulk containers. Keep containers in a clean,
cool and dry area away from heal sources- Natural ventilation is adequate.
Slorage Temperature Ambient.

lncompatible malerials None known
8. EXPOSURE CONTROLS'PERSONAL PROTECTION
Control parameters
Substance CAS No. OSHA PEL ACGIH ACGIH Co.npany Sld. Company
STEL srd.
STEL
Particulates (Total dust) Not
rable established
The folloriring values apply to substances
which may be evolved during thermal
sl
Methyl methacrylate 000080 62-6 100 ppm 50 ppm 100 ppm 50 ppm 100 ppm
410 mg/m' (205 mgr'm') (410 mg/m')
SEN
Elhyl acrylate 000140-88-5 Nol Not 50 ppm 100 ppm
established established
Appropiate engineering controls Do not eat, drink or smoke at the work place. Provide adequate ventilalion, including
appropriale local extraction, to ensure that the occupational exposure limit is not exceeded.
Consideration should be given lo the work procedures involved and lhe potential extent of
exposure as they may deteamine whether a higher level of proteclion is required.
lndividual protection measures, such as personal protective equipment (PPE)
Eye/face protection
NTICAL TO ORIG:I,I LC r'

€LVAC TEOACRYLIC RES N POTYIMMIJI SEJONG PHARIJAT ECt
Wear eye/face protection. Safety spectacles/goggles/full face shield
Skin p.otection
Not normally required
Respiratory protection
i A suitable dust mask or dust respirator with filter type P may be appropriate. ln the unlikely event of formatioo of
particularly high levels of dust a self contajned breathing apparatus may be appropriate.
9. PHYSICAL AND CHEMICAL PROPERTIES
Form Beads.
Color.
Odour Typically methacrylate
pH (Value) Not available.
Boiling Point ('C) Not applicable.
Flash pojnt ('C) 300
Relative Evaporation Rate (Ether = l) Not applicable.
Flammable Limits Not applicable
Vapour pressure (Pascal) Not applicable.
Vapor Density (Air=1) Not applicable.
Specifi. Gravity 1.18
Solubility (Water) Neglr9ible.
Sol'.rbility (Other) Not available.
Partition coefflcient {n-Octanol,\^/ater) Not applicable-
Viscosity (mPa. s) Not available.
Explosive Properlies Not applicable.
Oxidisrng Properties Not applicable.
10. STABILITY AND REACTIVITY
Ha2ardous Roaclions None known,

Conditions lo avoid Keep away hom heat.
Materials to avod None known.
Hazardous Decomposition Produc(s) Methylmethacrylate, Ethyl acrylate, Carbon dloxrde. Carbon monoxrde
11. TOXICOLOGICAL INFORMATION
Acute toxicity
lngestion Low oral loxicity.
lnhalation Unllkely to be hazardous by inhalation-
Skin Contact Unlikely to cause skin initation.

Contains greater than 0.1olo residual (lrethyl methacrylate, Ethyl acrylate). Ouring normal
handling this will not constitule a hazard. lf the polymer matrix is destroyed e.g. when the
produat is dissolved in organic solvent, chemical residues will be released from the polymer
matrix. Under these conditions, they may produce an allergic reaclion in persons already
sensilised.
Skrn sensrtrzalron data
Eye Contact Dust may cause lrritation

Repeated exposure toxicity
Chronic exposure Ihis type of malerial has been in use for many years with no evidence of adverse effects.
ELVACITE@ACRYLCRESIN. POIYIMMA,/EA ..- IJAL COPY

qTECH
CHEt\,1lCALS IARC NTP OSHA ACGIH
NONE
12. ECOLOGICALINFORMATION
Ecotoxicrty The product is predicted to have low toxicity to aquatic organisms.

Persrstence and degradability The product is non-biodegradable in soil. There is no evidence of degradation in soil and
waler.
Bioaccumulative potential The product has low potentialfor bioaccumulation.
Mobalrty the product is predicted to have low mobility in soil.
Other adverse efiects
13. DISPOSALCONSIDERATIONS
The wasle is considered to be non hazardous. Clean scrap may be reprocessed. lncineration may be used to recover energy value. l\ray be
disposed of by landfill in accordance with local regulations. Certain packages are retumable. Please consult your local omce for further
details. Ensure that all packaging is disposed of safely.
14. TRANSPORT INFORMATION
Not Classified as Dangerous for Transport.
Transport in bulk according to Annex ll of Not applicable.

MARPOLT3TS and the IBC Code
Ship type
Pollution category
Reportable Quantity (RO)
TOG Class
TMD Packing Group
.15. REGULATORYINFORfulATION
Nol Classified as Dangerous for Supply/Use
US Federal Regulations
SARA 302 - Extremely Hazardous
Substances
SARA 3'13 - Toxic Chemicals NON E
US State Regulations
Califomia SUBSTANCES KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER Ethyl
acrylate
Canadian Regulations
WHMIS Classitication NONE
NFPA Rating
Health 0
Flammability 1
Reactivity 0
NPCA-HNilS Rating NTICAL TO ORiGIITAL COPY

SEJONG PHARMATECH
ELVACITE€ ACRYLIC RESIN, POLYiMMA'EA] AASEO Dar6: 03 -S€pr@ber 2013

Pag€:4 / 5
Health 0
Flammability 1
Reactivity 0
EU regulations
16, OTHER INFORMATION
The following sections contain revisions or 1, 2, 3, 4, 5. 6, 7, 8, 9, 10, 1 't, 't2, '13, 14, 15, 16
new stalementsl
Date of preparation: 6 -November- 2009
lnventory Status
European Union To the besl of ou. knowledge all chemicals in this product comply with REACH regulations.
United Staies (TSCA) Listed in TSCA
Canada (DSUNDSL) Listed in DSL
Japan (ENCS) Listed in ENCS
Philippines (PICCS) Lrsted rn PICCS
Australia (AICS) Lrsied rn AICS
South Korea (KECI) Listed in KECI
China (IECSC) Listed in IECSC
LEGEND
Noler Nol all of the following are necessarily contained in this Safety Data Sheet:
ELVACITE@ is the Registered Trade Mark of companies within the Lucite lnternational Limited Group of companies
MEDICAL USE: CAUTION: DO NOT USE lN l\,lEDICAL APPLICATIONS INVOLVING IMPLANTATION lN THE HUMAN BODY.
Lucite lnternational lnc. has performed no clinicaltesting on the use ofthis product in any medical application. Lucite lnlernational lnc. has no
data to support the use ofthis product in any medical application. This product was not designed or manufactured for use in implantation in
the human body or in contact with internal body fluids or tissues. Lucite Intemalional lnc. has neither sought, nor received, approval from any
.egulatory agency for the use ofthis product in implantation in the huftan body or in coniact with internal body fluids or t6sues.
It s the responsibility of the end-product manufacturer to identify all market and use-specific regulations and to ensure compliance with lhese
regulations.
Subject to the exclusions and limitations sel out below the lnformation contained in this publication or as otherwise supplied to the user is
believed to be accurate and has been given in good farth. lt is for the User to use the lnformation conlained in this publication or as
otherwise supplied to the User with care and satisfy itself of the suitability ofthe product for their intended use and the applicabilfty of the
advice given. Except to the extent that exclusion is prevented by applicable law Lucite lnternational lnc. gives no wafianty as to the fltness of
the product for any particular purpose and any implied warranty or condilion (statutory or otherwise) is excluded and accepts no liability for
loss or damage (other than that arising from death or personal injury caused by defective product, if proved), resulling from reliance on this
information. Freedom under Patents, Copyright and Designs cannoi be assumed.
COPY
)H
ELVACTTE@ACRYL C RESIN PO|YIMMA/EA) EASED Dare: 03 Seplember 2013

Page:51 5
u QUADRANT
I,NGINEERIN6 PLA5TIC PRODUCT'
I,IATERIAL SAFETY DATA SHEET
MSDS# 1100
SECTION 1
QUADRANT EPP
212 O EAI RMONT AVENUE TELEPHONE NUMBERS:
P. O. BOX 14235 PRODUCT INFORMATION (Quadrant EPP )
READING, PA. 79672-4235 610-320-6600
TRANSPORTATION EMERGENCY {CHEMTREC)
800-424-9300
MATERIAI, I DENT I FICAT I ON
PRODUCT NAME: ERTALyIE PET*P, NATITRAI AllD BLACtr

CHEMICAI NAME: POLYEEIIYLEI{E TEREPHTHALATE (PEl)
CAS No.: 25038-59-9 (BASE PoL:uER)
PRODUCT USE: ENGINEERING TI{ERMOPLASTIC SIOCK SHAPE FOR SUBSEoUENT

FABRICArION.
TSCA INVENTORY STATUS: AI.I. REPORTABLE INGREDIENTS ARE LISTED IN THE
TSCA CHEMICAI, ST'BSTANCE INVENTORI.
SECTION 2
HAZARDOUS INGRED]ENTS (ADDITIVES NOT HAZARDOUS BY 29 CFR 1910.1200)
I DENTITY CAS + CONCENTRATION TV], (TWA)

NA NA NA NA
SECTION 3
HEALTH HAZARD DATA
ACUTE OR IMMEDIATE EFFECTS: ROUTES OF ENTRY AND SYSTEMS
INGESTION: NOT A PROBABLE ROLTIIE OF EXPOSURE.

SKIN: MOLTEN PET CAUSES THERMAL BtRNS.
EYE : MECEANICAI, IRRITATION ONLI.
INHALATION: SITAPES NOT RESPIR,ABLE.
DENTICAL TO ORIGiNAL COPY

TZERO CLEARANCE PAD SEJONG PHARMATECH
MSDS #1100 Quadrant EPP Page 2
SECIION 4
EMERGENCY FIRST AID

IF EXPOSED TO FUUES FROM OVERIIE:ATING, MOVE TO FRESH AIR. CONSULT A
PHYSTCIA!{ IF SIMPTOMS PERSIST.
9'ASH SKIN WITII SOAP AND PLENTY OF TATER.
ELUSH EYES }IITII IIATER. CONSULT A PHYSICIAN IF SIUPTOMS PERSIST.
IF MOLEEN POLYMER CONTACTS SKIN, COOL RAPIDLY VIITH COLD WATER. DO NOT
ATTEITPT TO PEEL POLIMER FROM SKIN. OBTAIN MEDICAL ATTENTION TO THERI'IAr.
BURN.
CHRONIC EFFECTS: NONE KNOWN.
MEDICAL CONDITIONS GENERA],LY AGGRAVATED BY THIS MATERIAI,: NONE KNOI{N
SECTION 5
FIRE AND EXPLOSION HAZARD DATA
FLASH IGNITION TEMPERATURE: 652 E. / 350 C. METHoD: ASTM D-1929

UNUSUAL FIRE, EXPLOSION HAZARDS: NONE KNOWN.
HAZARDOUS COMBUSTION PRODUCTS: AT TEMPERATT,RES ABOVE

562 E./35O C.. HE A\/r EUMTNG, CARBON DIOXIDE AND CARBON MONOXTDE WILL
occuR.
SPECIAL FIRE FIGHTING INSTRUCTICNS: FIRE FTGHTERS AND OTHERS EXPOSED
TO PRODUCTS OF COMBUSTTON SHOT'LD IIEJAR FU1L PROIECTIVE CLOTHING
INCLT'DING SELF-CONTAINED BRE,ATEING APPARATUS. FIRE FIGHTING EQUI PMENT
SIIOULD BE THOROUGHLY DECONTEMTNATED AFTER USE.
EXTIN-GUISHING MEDIA: WATER SPRAY OR ANY CLASS A EXTINGUISHING AGENT
Phys r ca I health Hazards:

DUST MAY FORM EXPLOSI\,E MIXTURES WI9II AIR. AVOID DUST FORIIIATION Al{D
CONTROL IGIIITION SOURCES. ALL PI.ASTIC DUST PARTICLES SUSPENDED IN AIR
ARE COMBUSTIBLE AND MAY BE EXPLOSIVE. KEEP AI{AY FROM HEAT, SPARKS.
FLAME, AND OTHER IGNITION SOI'RCES. PREVENT DUST ACCUMUI,ATIONS AND
DUST CLOUDS. EIr{PLOY GROUNDING, VANTING, AND EXPLOSM RELIEF
PROVISIONS IN ACCORDANCE WITH ACCEPTED ENGINEERING PRACTICES AND NFPA
PROVISIONS IN ANY PROCESS CAPABLE OF GENER,ATING DUST AND/OR STATIC
ELECTRICITY. EXPLOSION HAZARDS APPIY ONLY TO DUSTS, NOT GRANUI.AR
EORMS OF TIIIS PRODUCT. SEE ALSO SPECIAL PRECAUTIONS SECTION BELOI.I.
IIDENTTCAL TO ORTG|NAL COPY

I SEJONG PHART{ATECH
SECTION 6
ACCIDENTAL RELEASES
SPILL OR RELEASE: CLEAN UP BY VACI,I,MING OR WET SWEEPING TO MINIMIZE

DUST EXPOSI'RE.
SECTION 7
S?ORAGE CONDIT IONS
DRY STORAGE. KEEP CONTAINERS CLOSED TO ION .
ON
PROTECTlON INFORMATTON
EYE: SAFETY TO PARTICULATE MATTER EROM

ENTERING EYES WHI OR
SKIN: PROTECTIVE EANDLING HOT POLIMER. AISO,

LONG SLEEVE IF IIANDLINGMOLTEN POLYMER.
VENT I LAT l ON : T AII EQUI PMENT TO KEEP

PARTICUI,ATES LIMIT FOR NUISANCE DUSTS .
RESPIRATOR: NONE ING, IF VENTILAIION IS ADEQUATE.
iDENTICAL TO ORIGINAL COPY

SEJONG PHARMATECH
MSOS #1100 Quadrant EPP Page 4
SECTION 9
PHYSICAL/CHEMICAL DATA
APPEARANCE: STOCK SHAPE !,lAY BE ROD, PI.ATE , TUBE, OR STRIP FORM.
ODoR: ESSENTIALLY ODoRLESS.

MELTTNG POrNT: 225-260 C. / /t37-500 F.
SOLUBILITY IN WATER: INSOLI,BLE
VOLATILE CONTENT ?: (1t
SPECIFIC GRAVITY: 1.33-1.43
Precautions Eor Repair & Maintenance Of Contaminated Equipment:

Eliminate ignitlon sources:
TRANSFER FROM STORAGE WITH A MINIMUM AMOT'IIT OF DUSTING. GROT'ND AI.L
TR,ANSFER, BLENDING, AND DUST COLLECTING EQUIPI,IENT TO PREVENT STATIC
SPARKS IN ACCORDANCE VIITH NFPA 70 'NATIONAT ELECIRIC CODEZ. REVIEW
AND COMPLY WITH AI.L RELEVANT NFPA PROVISIONS, INCLI'DING BUT NOT
LIMITED TO NFPA 481I AND NFPA 654 REI.ATED TO COMBUSTIBLE DUST EAZARDS.
REMOVE ALL IG!{ITION SOITRCES FROM IIIATERIAL EANDLING, TRANSFER, AND
PROCESSING AREAS }IHERE DUST I.IAT BE PRESENT. LOCAI EXHAUST VENTILAEION
SHOULD BE PROVIDED IN WORK AREA.
SECTION 10
HAZARDOUS REACT IVI TY
STAB1],ITY AT ROOM TEMPERATURE: STABLE.

MATERIALS TO AVOID: STRONG OXIDENIS AND BASES.
CONDITIONS TO AVOID: NONE KNOllN.
DENTICAL TO ORIG:I.;AL COPY

SEJONG PHARMATECH
SECTION 11
\./ TOXICOLOGICAL INFORMAT T ON
CHRoNIC TOXICITY: ERTALYIE PET-P DOES NoT APPEAR To PossEss ANY

TOXICOLGICAI PROPERTIES.
MEDICAL CONDITTONS PRONE TO AGGRAVATION BY EXPOSURE: INEAI,ATION OF
FUMES FROM GROT'ND PELLETS CAN IRRITATE THE NOSE AND THROAT.
CARC]NOGENIC]TY : NONE KNOflN.
sEcTroN 12
ECOLOGICAL TNEORMATTON
AQUATIC TOXTCTTY: TOXICITY IS EXPECTED TO BE LOW BASED ON INSOLUBILITI

OF POLIMER IN WATER.
SECTION 13
DISPOSAL
}IASTE DISPOSAL: RECYCLING IS ENCOT,R,AGED, LANDFILL OR INCINER,ATION IN

COMPLIANCE TIITH FEDERAI, STATE, AI{D LOCAL REGULATIONS.
SECTION 14
TRANS PORT INFORMATION
DOT HAZARD C],ASS: NA
SHI PPING NAME: NA
IDENTICAL TO ORlcir',iAL COPY

SEJONG PHARMATECH
SECTION 15A
REGUI,ATORY INFORT.IATION
SECTION 313 SUPPLIER NOTI FICATION:

(SARA TITLE III_TOXIC CHEMICALS ],1ST)
THIS PRODUCT CONTAINS NO KNOWN TOXIC CHEMICALS SUBJECT TO THE

REPORTTNG REQUIREMENTS OF SECTTON 313 OF THE EMERGENCY PI.ANNING AND
COMMI'NI TY RIGHT-TO-KNO}I ACT OF 1985 AI{D 40 CER 372.
STATE RIGHT TO KNOW LAWS
NO SUBSTANCES ON THE STATE HAZARDOUS LIST, FOR THE STATES TNDICATED
BELOW, ARE USED IN THE MANUFACTT'RE OF PRODUCTS ON THIS MATERIAI. SAFETY
DATA SHEET, WITH THE EXCEPTIONS INDICATED. IIHILE I{E DO NOT
SPECIEICAILY AI,IALYZE THESE PRODUCTS, OR THE RAW I.TATERIAJ,S USED IN
THEIR MANUFACTURE, EOR SUBSTANCES ON VARIOUS STATE EAZARDOUS
SUBSTANCES LTSTS, TO TI{E BEST OF OI.,R KNOiILEDGE TIIE PRODUCTS ON THIS
MATERIAL SAFETY DATA SHEET CONTAIN NO SUCH SUBSTANCES EXCEPT FOR THOSE
SPECTFICA',LY LISTED BELOT| :
PENNSYLVANIA:
SUBSTANCES ON THE PENNSYLVANIA HAZARDOUS SUBSTANCES IIST PRESENT AT A

CONCENTRATION OE 1% OR MORE: NONE XNq*I.
SUBSTANCES ON THE PENNSYIVANIA SPECIAI HAZARDOUS SUBSTANCES LIST

PRESENT AT A CONCENTRATION OF 0.011 OR MORE: NONE KNovlN.
CATI FORNIA PROPOSITION 65:

SUBSTANCES KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER: NONE
KNOI{N .
SUBSTANCES KNOI,IN TO THE STATE OF CAIIFORNIA TO CAUSE BIRTH DEFECTS OR

OTHER REPRODUCTIVE HARM: NONE XNONN.
SECTTON 158
LABELING INFORT{ATION
HEAI.TH 0
EI,AMMABILITY l-
REACTIVITY 0
PPE A
#ACUTE TCHRONIC
I(TICAL TO ORIG AL COPY

SEJONG PHARI.. \TECH
SECTION 15
MISCELLANEOUS INFORMATlON
Reviewed by: Michael Yohn
Issued: 18 -october-2 012

Supersedes: Eebruary 02, 2012
The information set forth herein has been gathere rom standard re ference
materials and/or supplier test data and is, to owledge and
belief of Quadrant EPP, accurate and reliable. tion is offered
sol"e ly fo r your consideration, inves tigati on tion, and it is
not sug9e sted or guaranteed that the hazar d cau t s or procedures
ment i oned are the onl-y ones that exist. Qu a EP kes no warranties,
expr essed or implied, with respect to the u information or the
use of th e specific material identified he e ination with any
other material or process, and AS sno sp ity therefor.
NA= Not appl i cabl e

NE= Not established.
> : New or revised inf ecti when">"appearsinthe
left margin. a
END OF MSDS
IDENTICN.L TO ORIGINAL COPY

SEJONG PHARMATECH
PRODUCT CONTACT SURFACE AREAS CHECK SHEET
setc,i?i6 for MRC-s
I Product Contact Surface Areas Check
No. lnspection ltem Material Surface Area(mm2)
POWDER HOPPER STS3I6L
1 404309.7
)
L-
l
l
T-15@5-6-l T s?6.5? I -rj,J.cfi'n-t
fi
FEEDER A506r(4L6061)
(i
fi-iJ-65rr7s--l 195950.7
,.
.t,
.\"7 72|8 I
FEEDER IMPELLER 46061 (AL6O6r)
3 r06014.6
1;
i,.'.
c2680P-rr2H(BS),
SCRAPER(INLEI OUTLET)
STS315L, TEFLON
)
4 19033.7
2736 l I040 1444 5
(,
\
c
fsr6or.l
\
l
\
-r33as
1t3 Sejong Pharmatech

#.,r,:rtr for MRC.S
No. lnspection ltem Material Surface Area(mm2)
TURRET(OrSK) GCO(FCr)4s)
5 148593
'i G
148593
DISCHARGE SCRAPER 606'l (AL6061)
6 7963.8
r 's', I
DISCHARGE STS316L
7 96024.5
o
(r-
I
fr6o745-l
POWTER TANK GASKET sHsr60u(slLlcoNE)
8 16274
t627B
213 Sejong Pharmatech

#tcr,tr for RC-S
No lnspection ltem Material Surface Arca(mm2)
ACRYL CONNECTOR PIPE MMA/EA(ACRYLIC)
9 2'1205.4
ZERO CLEARANCE PAD PET
10 1127.3
TOTAL 1015501.1 mm'
3t3 Seiong Pharmatech

#.,(,,:ttr I NSTALLATION QUALIFICATION Rev No. 0
Page 53t70
7.6.1 Calibration procedure List
Unit , Certificate Calibration Result

No Item Serial No Supplier
Model No. date Yes No N/A
1 o o
2 tr tr tr
I tr tr tr
4 o tr tr
5 tr tr tr
6 tr o tr
7 tr
o o
10 tr D tr

Oocument No. stQ 18960
#.rcrlE I NSTALLATION QUALIF!CATION Rev No. 0
Page 54110
Calibration check<Option> Refer to Calibration certificate
RECOMMENDATION
1. Callbrauon certificate is attached.
Final Evaluation Yes o Nor N/A a
Checked by Date
Approved by Date

CAL I BRAT I ON CERTI F I CATE
20 r B-05-29
MODEL : s8107-500K
Serial Number : t805005
WIRING COLOR CODE

Bated Load : 500 kg
Bed +lnput
Rated Output :
2.16 White - ln put
Zero Balance : -0.0011 Green +Signal
Combined Error : 0.03 "/.R.O. Blue -Signal

Non-Reoeatability : 0.02 7.R. O. Black Shield
Creep(30mln) : 0.03 %R.O.

Compensated Temp. Range :
-r0c- 40t
Operating Temp. Range : 80 1)
Thermal Zero Shift : 0.02 %R.O./10C
Thermal SENS Shilt : 0.015 7.R.O./t 0t)
Input Resistance : 206. I
Output Resistance : 35r a
, 14- 1g-7369L-
lnsulation Resistance : 2000 rro@50Vdc
:fit^g E $#- ,
Salety Overload :
t5 DC or AC
150 %R. L.
.'' ,;; ,te+ eeg $W ''
-'!'lt?Jli
x c 0ll =- =- ---
==
CELL DIVISION
CAL I BRAT I ON CERTI F I CATE
201 B-06-04
tvlODEL s8107-500K
Serial Number 1 80501 1
WIRING COLOR CODE

Bated Load : 500 ko Red r ln put
Rated Output : 2.168 mV/V White - ln put

Green +Signal
Zero Balance : 0.0027 mV/V
Blue -Signal
Combined Error : 0.03 %8.o.
Black Shield
Non-RePeatability : 0.02 %R.o.
creep(3omin) : 0.03 v"R.o.
Compensated TemP. Range : -1oc- 40c
Operating TemP.Range : -20c- 80t
Thermal Zero Shilt 0.02 %R.O./101r
:
Thermal SENS Shilt : 0.015 %R.O./10c

lnput Flesistance : 395 a )14- 13-7369 r
Output Resistance : 351 A ,.ioll^€ EBe.l
lnsulation Resistance : 2000 ro@sovdc
15 ::-:.jqr.l tllc-l? EBE 140-11
Max Exciation : DC or AC
Safety overload : 150 %R.1. : r.E0ll
CELL DIVI SION

CAL I BRAT I ON CERT I F I CATE
20 r 8-06-04
MODEL : sBl07-500K
Serial Number : r805010
WIRING COLOR CODE

Rated Load : 500 kg
Red i ln put
Rated Output : 2.17 4 White -lnput
Zero Balance '.
0.0129 Green +Signal
Combined ErroI : 0.03 $R.O. Blue -Signal

Black Shield
Non-Bepeatability : 0.02 %R.O.
Creep(30min) : 0.03 9',.8.O.

Compensated TemP. Flanoe :
-10c- 40c
Operating Temp. Range : -20c - 80t
Thermal Zero Shift i 0.02 %R.O./10c
Thermal SENS Shift : 0.015 %R.O./10c
lnput Resistance : 395 I
Output Resistance
c g e'l :
: 351 Sl
lnsulatlon Resistance : 2000 to@50Vdc : rollag

Max Exciation : 15 DC or AC
:.:' -'1\l tll'-l+ EBE 110-'11
Safety Overload : 150 %R. L. g'-gir:il:i
i,i.E0[
CELL DIVISION
CAL I BRATION CERTI F I CATE
201 8-08- 1 3
MODEL si/600s-207
Serial Number 1808030
WIRING COLOR CODE

Rated Load I 20000 kg
Fed +lnput
Rated Output i 1.9999 put
White - ln
Zero Balance :
Combined Error :
0.1 %R.O. Blue -Signal
Non-Repeatability : 0.05 y"H.o. Black Shield
Creep(30min) : 0.03 %R.O.
Compgnsated Temp. Range :
-10t- 40D
Operating Temp. Range :
-20t- 80c
Thermal Zero Shift :
0.025 %R.O./l0c
Thermal SENS Shilt 0.0 t5 %R.O./10C
lnput Besistance
:
,14-13-7 3697
' ilrl -\,1J! x{ "&#r
: 700
Output Fesistance :
700 g t_d -€i--
lnsulation Resistance -r,, - 11 ctl.l+
: 2000 rP@50Vdc l EB5*0. 11
't5 DC or AC
Salety Overload '.
150 %R.1.
C BY:
CELL DIVISION
CAL I BRATI ON CERT I F I CATE
2018 08-13
MODEL : sI/600s-207
Serial Number : r 808025
WIFING COLOF CODE

Rated Load : 20000 kg
Red +lnput
Rated Output :
2.0023 White lnput
Zero Balance '.
Combined Enor : 0.1 %R.O. Blu e -Signal
Non- Repeatability i 0.05 %R.O. Black Shield
Creep(30min) : 0.03 %R.O.

Compensated Temp. Range : -l0r- 40c
Operating Temp.Range : -20c- 80c
Thermal Zero Shift : 0.025 %R.O./ I0 C
Thermal SENS Shift : 0.01 5 %R.O./ l0t
Input Resistance : 700 a )14-13-736q4,
Output Resistance
lnsulation Resistance
:
:
700 a
2000 Io@50Vdc
:';011^g I1 gf4.\
Max Exciation : t5 DC or AC
:r-J ;11t rflE-l? EBE ltFii. .
Satety Overload : 150 %H. L. i.'x.E[ll
E ED
D CELL DIVISION
sE} I NSTALLATION QUALI FICATION Rev l{o.
Page
0
55r70
7-7 Period of change lubricantg
Test Report No: mRC-lQOo7{r7
'1. Check the specilication and the quantity of lubricants part

Test Method
A.
1. The
4
the
! lubricants part should be accord with
Acceptance Criteria
the list.
c
0

#.rcylE I NSTALLATION QUAL! FICATION Rev No.
Page 56170
7.7.1 LubricationChart
Item Supplier Product

rso Vis cst@ Vis cst@ Viacosity Flash Fire Pour
Grade 40t r 00t lndex Point Point Point
Ff,I FLUID RO 46
Cycle pump 420'F 435'F
FUCHS 46 49.09 7.21 106 -181)
(Upper track) (Old type: (2t5.st) (223.8t)
GERALYN RO46)
Visco3ity
Items Supplier Oil type Items Remark
lndex
OiIALA 52 G 220
lnitial third month
after installation and
Worm gear box
SHELL
(Old typc: OiIALA 220)
tso vG220 every six month
Appror.6.5,
(Reducer) KSt{ 2127
(8-10H operating /
(uachine tool slide way
dav)
lubricant)
FM GERASE CLEAR 2
Upper pressure roll FUCHS lnject every 30 days
(Old typo: GERALYN AXC2)
LorYer pressure roll

GADUS 52 t r60L 2
SHELL (old type: DARINA R2) ln ect every 30 days KSM 1230
Vertical shaft (Rolling bea.lng grease)

gE.rcrrc I NSTALLATION QUALI FICATION Rev No. 0
Page 57 t70
7.7.2 Oil pump
Result
Pa Item Specification
Yes No N/A
Supplier HAN SUNG
Oil pump Model HMGP.3O3M ./ o
Quantity
,|
l--
7.7.3 Solenoid valve
Result
Parl iilodel
-\ -/ a
Quantity Supplier
Yes No N/A
Solenoid valve vxE2320A-02-5G1€ 2 sMc wl tr o
sJaDF(o) Sejong Pharmatech

Oocument No. stQ 't 8950
sE> INSTALLAT!ON QUALI FICAT!ON Rev No.
Page
0
58/70
RECOMi,lENDATION
0
g
s
c
a
Final Evaluation Yeaa/ Nor N/A o
Fz-
Checked by
&,t1" Date en. & .t1-
Approved by
ffi Date
20 'aL' t1'
sJQDF(0) Seionq Pharmatech

3E.WE INSTALLAT!ON QUALI FICATION Rev No. 0
Page 52170
7.6 CalibrationProcedure<Option>
Test Report No : MRc-lQ-007-06
Purpose Check the calibration required rcgulators with tha list
1. Check the calibration list and the part3 it those are accord vvith the list and certificatB.
Test ttlethod
2. Check the calibration tag on the calibrated part3.
l. Serial number on lhe calibratod items should b€ accord with the serial number in the
cerllflcate.
Acceptance Criteria 2. Callbration tag 3hould ba at{rchGd on the calibration r€qui]€d items.
3. Calibrrdon Epo.t should hav€ the standard format as the ofticial documenl
SJODF(O) Sejong Pharmatech

*,.rcrlE INSTALLATION QUALI FICATION Rev No, 0
Page 59/70
7.8 List of Spare Parts & Tool box <Option>
Test Report No: MRC-IQ{07{8
Sparc parts or required tools for the maintenance ahould be checked for proper rcaction in
Purpose
case ot the trouble.
'1. Spar€ parB E Tool box status should be checlred lf tfio3€ are ob8ewed following approval
boundary.
Test Method
2. Sparc parB & Tool box qu.ntlty E.t.tu 3hould b€ checked.
1. Spalr parE & Tool box should bo lndicated tollowing dstails.

l)Code 2)lt m 3) Sp.clfication 'l) Quantity
Acceptance Criteria
2. All of Bp.re parts & Tool bor should be pcsiblo to b€ purchaaed.

setffG ! NSTALLATION QUALI F!CATION Rev No.
Page
0
60/70
7-8.1 Spare part3
Result
Code Item Specification Quantity
Yes No N/A
328234024 PIN IN&OUT BOLT 15 \,n tr
623104027-00 TAPER PIN @15'551 16 a/' tr o
62310-0015-02 SET SCREW @10'2OL t6 O,// o tr
623104023-00 UPPER PUNCH BELLOWS D-Type 16 \f o o
32823-0030 LOWER PUNCH DUST CAP D-Type 31 / C o
32827-0066 SCRAPER 145'15'10. 1 vE c tr
32A274009 POWDER TANK GASKET I vl tr
160k9(@22'2951),
723404037 GAS SPRING
STROKE 100mm
I \P. tr
71338-0018 V-BELT B-40 4 ,n tr
72111{505-00 BALL BEARING 69OODDU \P,. tr
721t 1{506-00 BALL BEARING 69O3DDU 4 \-d tr tr
72111450740 BALL BEARING 69O4DDU \2- tr o
72111{508-00 BALL BEARING 6905DOU \.n' o
721r r 45r6-00 PEEK BEARING #680s (PEEK) 1 L o
72241-OO12 SNAP RING s-20,(SHAFT) 3 ,rn o
72241.0008 SNAP RING s-10, (SHAFT) 1 \.2' tr
72428401740 TEFLON ROTARY LIP SEAL FRS-'t 15, 40'25.8, 4 rn tr
8r 310-0013 CONTROL RELAY MY4N DC24 (S) 3 vd D o
83410-0001 PROXIMITY SENSOR PRCMI2-2DN 2 t"/ tr
83410.0010 PROXIMITY SENSOR E2E-X2ME1(8mm),npn 2 t,n o tr
83430-0003 SENSOR EC30I6NPAPL-1 ,.r o
81213-0002 ilIAGNETIC CONTACTOR LCl -Or2(LC1-Dr 26-BD) 1 \F. tr o
85470-0005 N/O CONNECTOR zBE-101 4 w tr
85470-00't l N/C CONNECTOR zBE-'l02 4

"{ o tr

#,.rcrlE INSTALLATION QUALI FICATION Rev No. 0
Page 6t,70
7.8-2 Tool box
Result
Yes No N/A
741424898 FITTING PC @10-U8 ,|

v/' o D
741424899 FITTING PC @10'1t2 1 *r' o tr
74142-0958 FITTING PG @10'@8 1 v/' o tr
74'142.0959 FITTING PG @12-@10 1 o D

",'
74142-0964 FITTING PUL @10 3 q..' o tr
74142-0967 FITTING PUT @r0 2 t' tr
741424972 FITTING PY @r0 8,, L-l
77121-OOO2 ADJUSTABLE WRENCH 4 1

vt
77121-0003 ADJUSTABLE WRENCH 12" 1
\-d D
77121-OO11 SPANNER 24fim 1 wl o tr
77121-0014 THICKNESS GAUGE 1 ,-< D o
77',121-0016 T-WRENCH 6 1
rP" o o
77121-0019 SOCKET 24mm 1 \-B' tr D
7712'l -OO21 HEX WRENCH SET l.smm - lomm 1 vd- C tr
77',1214022 T-WRENCH it8 1 \-z'

,|
771214023 COMBINATION WRENCH 10,12,13,14,',17,1gmm v.e' tr o
77121{024 TORQUE WRENCH 500Kgf.cm 1 tr tr
77121-0026 SCREWDRIVE 6mm(+,-) 1 \P'/ o tr
771214027 HEXGON WRENCH 3/8"'8mm 1 ,.r' E o
771214031 RACHET HANOLE 1t2" 4725-10F 1 \rt- o tr
MX HEXA SOCKET l/2" 30mm 'l v.s? tr o

771214033
77121425640 SOCKET 3/4" 30mm I w{ o
771214069 RATCHET HANOLE 3,4" 60mm

,l
v"- D tr
77't31-0001 TOOL BOX 1 \,a- o
771314002 OIL GIJN 1 tr o D
Seiong Pharmatech
SJQDF(O)
*,rcrltr INSTALLAT]ON QUALI FICAT!ON Rev No.
Page
0
62t70
Result
Yes No N/A
77131-0003 GREASE GUN 1 \P/ o o
77131400/ GREASE RUBBER HOSE 1

\t'- o o
77't31-0005 LUBRICANT wD40 1 v,' o o
77't31{)006 NUMBERING LOCK I \,' C o
85730{001 CABLE TIE 270mm 30 a.,' tr tr
771214095 EXTENTION BAR 1t2" 75mm I vd tr o
75112-0107.00 PIPE 204(1m) ,|

tr g/' D
322514012 DIE HOLE CLEANER @50'45, (D.WPE) 1 o- o
32251-0080-00 DIE SETTING STICK @26'2601, (D-TYPE) 1 un D tr
32823-0032-01 DUST CAP JIG @40'20, (D-TYPE) I q,,/" o o
328234030 LOWER PUNCH DUST CAP D-Type 5 vr' o o
62310.0023-00 UPPER PUNCH BELLOWS D-Type 5 E-... o D
328234024 PIN IN&OUT BOLT \-v' o tr
62310-0027-00 TAPER PIN @1s's5L 5 \P. U
62310-0015{2 SET SCREW @10'201 @ )/' C o

#tcylE I NSTALLATION QUALI FICATION Rev No. 0
Page 53/70
lnspection ltems C terion
Spare parts<Option> Spare parts list is attached.
Tool Box Tool box list is attached.
RECOMMENDATION
Spare parts check Yes b/' Noo N/A o

Final Evaluation
Tool box check Yes gr,' Noo N/A o
Checked by Date )cr . o2. tl

Approved by Date
>.o -bjL . 11.

*,tw,tr INSTALLATION QUALI FICATION Rev No.
Page
0
62t70
Result
Code llem Specification Quantity
Yes No N/A
77r3r{003 GREASE GUN 1

V o
77'131400/ GREASE RUBBER HOSE 1

\./ o
77t31{005 LUBRICANT wD{0 I v/' o o
77131-0006 NUMBERING LOCK 1 o o
857304001 CABLE TIE 270mm 30 a.,' D tr
771214095 EXTENTION BAR 112" 75mm 1 @' o o
7 51124107 40 PIPE 20A(1m) 1 tr @/' tr
322514012 DIE HOLE CLEANER @50'/(i, (D-WPE)

,|
e,' tr
32251-0080-00 DIE SETTING STICK @26'260r- (O-TYPE) 1 \n o o
32823403241 DUST CAP JIG @40'20, (D-TYPE) 1 a,'- tr tr
328234030 LOWER PUNCH DUST CAP tlType v,' tr
623't0-0023-00 UPPER PUNCH BELLOWS D-Type 5 E./ D o
328234024 PIN IN&OUT BOLT 5 v/ o o
623't0-0027-00 TAPER PIN @r5-551 5 va-' tr D
62310-O015.02 SET SCREW @10'201 5 v.'/ o

Oocument No. stQ r8960
*,HE I NSTALLATION QUALI FICATION Rev No
Page
0
63r70
Spare parts<Option> Spare parts list is attached.
Tool Box Tool box list is attached.
RECOMMENDATION
Spare parts check Yes / No. N/A

Final Evaluation
Tool box check y*uz/ No N/A :
Checked by
I
Date !o . oz. (1.
Approved by Date
U'uL'l

#.rcrE I NSTALLAT!ON QUAL!FICATION Rev No.
Page
0
64t70
7.9 Others
Test Report No: MRC-1Q407{9
Purpose lf there is any additional check list required, additional inspection should be ananged.
1. The format of report should be followsd attached fomat.

Test Method 2. Additional check list should be d6cid6d thiough discussing the details between the
customer and lhe manufacturer-
Acceptance Criteria Agreed additional check list should b€ recorded and atlached
sJQOF(0) S€iong Pharmatech

seffil
I NSTALLAT!ON QUALI FICATION Rev No. 0
Page 65/70
RECOMMENDATION
€
.(
r
4
Final Evaluation Yes :l Notr NIA q,z-

Checked by Date
Approved by Date

Document No. sro 18950
3etfflc I NSTALLATION QUALIFICATION ReY No.
Page
0
56/70
8 CHANGE CONTROL
Test Report No: MRC-1Q408
ln case of unexpected matters or renovation required matters, the detail should be written
Purpose in the specified format of report and get the signature from Proiect team member. After
completing the report, it should be kept and managed in lQ protocol storage.
Test Method Rotary tablet press maior components and addit onal requiremenl
Unexpected matte6 / Renovation required matter is written and managed based on Chanqe
Acceptance Criteria control format.

#,.rcrlE I NSTALLATION QUALI FICATION Rev No. 0
Page 67 170
RECOMMENDATION
I
d
Final EYaluation Yes D Noo NlAa.-

Checked by Date
Approved by Oate

#.rcrltr I NSTALLATION QUALI F!CATION Rev No.
Page
0
68/70
9. PENDING LIST
Test Report No: MRC-lQ{09
Purpose Any deviation during lQ procedure 3hould be and checked.
Ouring lQ validation, the deviation it should be checked before OQ

Test Method validation.
(
a
Acceptance Criteria of the reaction should b€ recorded.

setctrlE I NSTALLATION QUALI FICATION Rev No. 0
Page 69r70
RECOMMENDATION
1. Others , Change control / Pending List format is attached
Final Evaluation Yes - No- NIAtt ''
Checked by Oate
ApproYed by Date

( ( (
Document No.
n Others E Change Control E Pending List

Action Result Remarks
No. Item
#.rcrlE I NSTALLATION QUALI FICATION Rev No. 0
Page 70 170
HISTORY OF THE DOCUMENT
Revision No Reason for the modificetion Date
0 Establish 2013.06.01
sJQDF(o) Sejong Pharmatech

Image 005

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Image 005

Uploaded by

Copyright:

Available Formats

Document No.

*,.rcrrc I NSTALLATION QUALI FICATION Rev No. 0

Machine Serial No sr 18960 Machine Model MRC-3't S

Written by QA M.J.Yoon Po- 2018.11.02

Reviewed by QA J.H Kim

Approved by QA D.H Kim /laorl{- 201A.11.O2

Tho Copvriqht and tho Non-Oisclosure.

sJaDF(0) Seiong Pharmatech

#,.rcrlE I NSTALLATION QUALIFICATION Rev No. 0

2. PURPOSE ---- Page 3

3. SCOPE OF OUAL|F|CATION ------- Page 4

5. EQUIPMENT DESCRIPTION ------- Page 5

7-2 User Requirement Specification Page l2

7.4 lnspection ot Critical , Non-Critical Devices ------.---- Page 16

7.5 List of product contact and insp€ction of materials ----- Page 50

7.6 Calibrationprocedure<Option> Page 52

7.7 Period of change lubricants Page 55

7.9 Othe6 Page 64

sJoDF(0) Sejong Pharmatech

gE.,g:l,G I NSTALLATION QUALI FICATION Rev No- 0

1.2 Validation Sequence

SJQDF(O) Seiong Pharmatech

#,.rcr,tr I NSTALLATION QUALI FICATION Rev No- 0

Item Validation ltem Testing No

Services lnstallation MRC-tQ{0741

lnspection of Critical / Non4ritical Devices MRC"tQ-007-04

List of Spare parts & Tool box <Option> MRC-tO-00748

4.2 Certificates Check

4.3 T6ting Service

sJoDF(0) Seiong Pharmatech

#,.rct?E I NSTALLATION QUALI FICATION Rev No. 0

lnstrument Using Certificate No Replaces date

T^rh"".Ptr,L rYewlwLrntaf o{ Lf/4 CL.OL8 lf-ol - 2bu)

Main power ,r00V 50H2, 3Ph

Max. Output (TAB/H) 186,000

irax tablet thickness (mm) 8.5

Upper punch insert (mm) 16

[[ax main p]€ssure (kg 0 10,000

Punch type EU-D, TSM-D

sJoDF(0) Sejong Pharmatech

*,twlE I NSTALLATION QUALIFICATION Rev No.

6.2 lnstallation Qualifi cation Test Method

6.3 Reporting lQ rcsults

sJQDF(0) Sejong PhaImatech

#.rcrtG I NSTALLATION QUALI FICATION Rev No. 0

No. Content Ref. No. lO

User Requirement Sp€c'

lnspection of Critical / Non€ritical Oevices

4-1 Weight rail part (Filling cam) irRc-tQ-007-04-01

4-2 Transmission part MRC-tQ-007-04-02

4 4-3 Uechanical fe€der fnrl r{Rc-tQ-007-04-03

44 Discharge part ltlRC-lQ-007-04-0rl

4-5 Upper pre & main preasure roll.part MRC-tO.007-04-05

4-6 Lower pre & main pressure rcll part mRc.lQ-007-04-06

4-7 Control panel palt tttRc-lQ-@7-04-07

4-8 Option part <Option> MRC-tO-007-(x-08

List of Product Contact and lnspsction of eGrials

Calibration Procedure <Option>

sJQDF(0) Sejong Pharmatech

ge.rcr|tr I NSTALLATION QUALI FICATION Rev No 0

No. Content Ref. No. lQ

Period of change lubricants

List of Spare Parts & Tool box <Option>