Protocol No.： 一吖754/2022-23 S.K.

PHARMA MACHINERY PVT LTD

s.K.PHARMA MAc…NERY PW LTD

QUALI刊 ASSURANCE DEPARTMENT

Protocol No. 一吖754/2022-z3 Date ： 18.08.2022

Model No. MV-2000 L

Equipment ID No. SKPMPL/RHB/MW754/2022一23

Location UMBERGAON

PROTOCOL APPROVAL sHEET

DEPARTMENT NAME s一GNATURE DATE

Engineering

Production

Qua‖ty Assurance

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 TABLE OF CONTENTS

PURPOSE .................................................................................................................. w
RESPONSIBILITIES ..................................................................................................... w
REQUALIFICATI0N .................................................................................................... w
MACHINE DESCRIPTION ............................................................................................ 鼻
EQUIPMENT IDENTIFICATION .................................................................................... 驿
EQUIPMENT LOCATION ............................................................................................. 霸
INSTALLATION QUALIFICATION PROCEDURE ............................................................. …
TECHNICAL SPECIFICATIONs OF EQUIPMENT′S .......................................................... m
ooooo EQUIPMENT COMPONENTS ...................................................................................... m
ob MATERIAL OF CONSTRUmON ................................................................................ H 。、
Hb IDENTIFICATION OF COMPONENTS FOR CALIBRATION ............................................ H 黜
Nb VERIFICATION FOR INSTALLATION .......................................................................... H 黜
wb METHOD FOR CHECKING THE LEVEuNG OF THE EQUIPMENT AND ALIGNMENT ....... H 黜
pb DRAWINGS ............................................................................................................. H 阗
…b DEHCIENCY （IF ANY） AND CORREC寸WE ACTION REPORT.......................................... H 阗
mb ACCEPTANCE CRITERIA ........................................................................................... H 阗
黜 o REMARKS （IF ANY） .................................................................................................. H 阗
阗b SUMMARY.............................................................................................................. H o
o） b CONCLUSION .......................................................................................................... H u）
ob POST-APPROVAL SIGNATURES ................................................................................ H “>
Hb LIST OF ABBREVIATIONS ......................................................................................... H 也
Nb APPENDIX ............................................................................................................... N o

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 Lo PURPosE
1.1 The purpose of this protocol is to provide an outline for the InSta‖ation Qua‖fiCation of
Equipment for Static attributes to Ver询 that ：一
1，1.1 Each insta‖ed sub Component Comp"es With the engineering design and equipment data
sheets/ specifications， agreed upon With the manufacturer.
1，1.z A‖ supporting utilities are connected.
1.1.3 A‖ critical instruments have been identified for calibration.
1，1.4 The equipment is insta‖ed as per the laid down specifications.
1.1.5 No unauthoriZed or unrecorded modifications have taken place.
1，1.6 Required testing reports are available.
1，1，7 Standard Operating Procedures （SOPs） have been identified and listed.

2-0 REsPoNslBluTlEs
2-1 The validation group Comprising of a representative from each of the fo‖oWing departments sha"
be responsible for the overa‖ compliance With this protocol.
2-1.1 Project Depa枕ment
2-1.2 Engineering Department
z-1-3 Production Depa忱ment
2-1.4 Quality Assurance Department
z.2 The Projects and Engineering Department sha" be responsible for checking proper insta‖ation
and recording installation data as per the procedure outlined in this protocol.
2.3 The Quality Assurance Department sha" be responsible for the final review of the Qualification
Documents and its compliance to meet the acceptance criteria of the Insta‖ation Qualification
Protocol.
2.4 The summary repo忱 sha" be approved by the head of Project， Engineering， Production and
Quality Assurance.

3.o REQUAL旧CATmN
3-1 Insta‖ation Qua1ification to be re 一 qualified on：
3.1.1 Replacement of major component of the equipment With a neW component。
3，1.2 Any major modification in the existing equipment.
3，1.3 Shi代ing of the equipment from one 1ocation to another.

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 4-o MAc…NE DEscR一PT一oN
4-1 sa"ent Features：-

4.1.1 Eas‖Y deanabIe.

4.1.z A" contact part made of SS 316L and non-Contact part SS 304 material.
4.1.3 A" pipelineS are electro pO"Shed from inside and joints are easy open able and fitting a廿er
Cleaning.
4.1.4 Man Hoie opening to facilitate deaning at the time of product ChangeOVer
4.1.5 Variable Frequency Drive provided for Top Ent邝 Padd一er Agitator for di仟erent speed.

5.0 EQ…PMENT…ENT一F一cAT一oN
The subjected equipment is identified as
Model No. sKPMPL一 MV- 2000 L （Given by manufacturer）

Name of the Supplier S.K. Pharma MachineW Pvt. Ltd

60 EQUIPMENT LOCATION
sr. No. subject Remarks

1. Location

2. Location Code

3. Floor

4. Area

5. Room Name

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 7，0 INSTAL…TIoN QUA‖FICATIoN PROCEDURE
7.1 一n5tructi0ns：

7.1.1 Identi抨 the Critical Components of equipment and Veri抨 that the Components are
COmp一ying as per deSired specifications. Record the ObseWatiOns in the data sheet.
Check the MOC of the component. Record the obse…ation of the MOC in the data sheet.
Identi碲 the Ut‖ity Supp‖eS required for equipment operation. Veri押 that Utilities.
Identi坪 the critical instruments supp‖ed with the equipment or insta‖ed on the ut…ty
supply line. Veri坪 that instruments are as per the desired specifications. Review the
calibration status of the instruments Record the availability of the Calibration record
provided bv the supplier.
7，1.5 Check the installation of equipment：
7.1.5.1 To Veri抨 the location of installation as per the equipment layout.
7.1.5.z To veri抨 the proper assembly of the components as per the equipment drawings.
Record the insta‖ation location and verification of assembly in Test Data-
7.1.5.3 To check the leveling and alignment as per the procedure given. Record the
obseWation in the Data Sheet.
7.1-6 List the avai1able drawing and record the Ref. No. for their location /availability in the
format.
7.1-7 Record the Deficiency （if any） and report the Details of Action Taken.
7.z Note：
7.2.1 Record a‖ the observations against the respective specifications， mentioned in the specific
check points， （the specifications are extracted from the Purchase order / Manua1 /
Manufacturer′s Recommendations）.
7.z.2 WhereVer specifications are not mentioned， record the observations as per the statement
of the data sheet.
7.2.3 ln case of non-compliance， give the eXplanation/justificati0n in the deViation format.
7-2.4 When more than one unit of the same type exists， replicate the corresponding data sheet
to match and uniquely identi抨 each page.
7.z.5 ln case of multiple options； clearly identi种 the one， Which has been supplied.
7.2.6 The calibration certificates of the instruments sha" be traceable to National/International
standards.
7，2，7 Define a‖ technical terms and abbreViatiOns in the appendiX.

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 8.o TECHN一CAL sPEC一F一CAT一oNs OF EQ…PMENT′s
8.1 capaCiW：
1. Gross Volume 2400 L
2. Working Volume 2000 L

8，z vesse一：

DESCRIPTION DIAMETER（MM） HEIGHT（MM） T…CKNESS（MM） Moc

She" 1450 1300 6 SS 316L
Top Dish 1450 320 6 SS 316L
Bottom Dish 1450 320 6 SS 316L
surfaCe Finish Internal 一 Mechanical Mirror po‖Shed Ra go .5 pm-

8，3 jacket ：

Description Diameter（mm） Height（mm） Thickness（mm） MoC

She" 1510 1250 4 SS 304

8-4 Insu1ation and cladding：

Description Thickness（mm） MoC
insulation 50 Rock Wool
Cladding on Shel1 3 SS 304
Surface Finish External 一 Mechanical Matt po‖shed Ra SO .9 um.

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 8.5 NozZ一es：
NoZZLE
}
DESCR一PT一oN
一 SIZE （TC） \ MOC
on Top Dish
N01 ManhO一e With VieW Glass 450 mm SS 316L
N02 Light Glass 75mm SS 316L
N03 Compound Gauge 40 SS 316L
N04 VEnt F‖ter 40 SS 316L
N05 Vessel Safety Valve 25 SS 316L
N06 Vacuum Inlet 25 SS 316L
N07 Product Inlet 40 SS 316L
N08 Charging H0pper 50 SS 316L
N09 CIP Inlet （A，B） 50 SS 316L
N010 suction 一nlet 50 SS 316L
on Bottom Dish
N011 Vessel outlet 50 SS 316L
N012 Temperature Sensor 25 SS 316L
on Jacket
013 Jacket Inlet 40
Jacket Outlet 40
Jacket Safety ValVe/ PG 25
Jacket Vent 25

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 9-0 EQ…PMENT COMPONENTS
9.1 Top EntW Padd一e Agitator with scrapper Agitator Motor 一 1 NO.
Description specifications Yes/No checked Bv
Type 一nduCti0n motor
Motor Make HinduStan
Power Rating 10 HP/7.5 KW/415 V/50 HZ
Motor speed 1450 RPM
Motor Cover MOc SS 304
Location On Top Dish
一DE. Code TEPAM 10
Serial No- 20578163

9.z Vacuum Pump Motor一 1 No.

Description specifications Yes/No checked BY
Type induction motor
Motor Hindustan
Rated Power 10 HP/7-5 KW/380 V/50 HZ
Motor Speed 1450 RPM
Motor Cover MOC SS 304
Mounting MS 一 Epoxy Painted Stand
Location On Service area
一DE. Code VPM10
Serial No. 20608537

93 Vacuum Pump 一 1 No.

Description specifications Yes/No checked By
Type Water ring type
Make Vactech
Vacuum 710 mm of hg
CFM 220 m3/hr
MOC Cast iron With bronze impe‖er
Location service Area
一DE. Code VP10
Serial No. 22109765

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 9.4 Top EntW Padd一e Anchor with Scrapper Agitator Gear Box 一 1 No.
Description specifications Yes/No checked BY
Type He‖ca一 BeVeI
Gear BOX Make Bonfig"O‖
Speed 0 t0110 RPM
Ratio 13.1：1
一/P RPM 1450 RPM
o/P RPM 110 RPM
Location On Top Motor
一DE- Code TEPAGB10

Serial NO. 220000114381550001

9.5 Mechanical seal for Top EntrY Padd一e Anchor with scrapper Agitator 一 1 No.
Description specifications Yes/No checked By
Type Single Ca枕ridge
Make Leak proof engineering
Size 70 mm
seal face SiC/SiC
Location On Top Motor
一DE- Code MS…s70
serial NO” 22090816

9，6 Butte附Y Valve 一 1 No.

Description specifications Yes/No checked By
Type Pneumatic
Make sK
Size 50 TC
MOC ss 316L
Location Vessel Outlet
一DE， code PBFV25

9.7 Butte汁一y Valve 一 2 Nos.

Description specifications Yes/No checked By
Type Manual
Make SK
size 50 TC
MOC ss 316L
Location 1. suction 一n一et
2. Charging Hopper
lDE- Code PBFV25

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 9.8 Butterfly Valve 一 1 No.
Description specifications Yes/No checked BY
Type Pneumatic
Make SK
size 25 TC
M0c SS 315L
Location Vent F‖ter
一DE. Code PBFV25

9.9 Bu忱e跚y Valve 一 z Nos.

Description specifications Yes/No checked By
Type Pneumatic
Make SK
Size 40 TC
MOc SS 316L
Location 1- CIP 一n一et
2. Vacuum Inlet
lDE， Code PBFV4o

9.10 Ba" Valve 一 3 Nos.

Description specifications Yes/No checked By

Type Pneumatic
Make SK
Size 40 TC

MOC SS 304
Location 1. co0‖ng Water inlet
2. coo‖ng Water outlet
3. Jacket Drain
1DE， Code PBV40

9.11 Angle Seat Valve 一 2 Nos.

Description specifications Yes/No checked By
Type Pneumatic
Make AVcon
Size 40 TC
MOC ASTM A351 CF8
Location 1. condensate
2. Bypass line
lDE. Code PASV40
serial No. 22PVA005769， ZZPVA005770

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 9.12 Angle seat Valve 一 2 Nos-
Description specifications Yes/No checked By
Type Pneumatic
Make AVC0n
Size 25 TC
MoC ASTM A351 CF8
Location 1- Steam Inlet
2. COmpreSSed Air inIet
一DE. Code PAsV25
Serial No- 22PVE028035， 22PVE028034

9.13 Angle seat Valve 一 2 Nos.

Description specifications Yes/No checked BY
Type Manual
Make MaScOn
Size DN 25
MoC SS 316
Location 1. Steam Inlet
2. Bypass line
IDE. Code PASV25
Serial No. A-8527， A一8528

9-14 Non Return Valve 一 1 No.

Description specifications Yes/No checked By
Type Spring Type
Make SK
Size 40 TC
M0c Brass
Location On Vacuum Pump
一DE. Code NRV40

9.15 solenoid Valve 一 1 No.

Description specifications Yes/No checked By

Make SK
Size 1/2" BSP

Operating Voltage 24 V Dc
Moc Brass
Location On Vacuum Pump
一DE. Code SV-1

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 9.16 Steam Trap 一 1 No.
Description specifications Yes/No checked BY
Type Float Type
Make Forbes Marsha‖
Size 25 NB
MOC ls 210 GR FG260 CAST 一RON
Location On Condensate
一DE. code ST25
Serial No. 1210165298

9，17 steam Trap 一 3 Nos.

Description specifications Yes/No checked By
Type Thermodynamic
Make ForbeS Marsha‖
Size 15 NB
M0c ASTM A743 GR CA4o
Location 1. Steam 一n一et
2. COo‖ng Water in一et
3- 0n Condensate
一DE. Code ST15
Serial No- 1221505323， 1221502325， 1221502316

9，18 Vessel safety Valve 一 1 No.

Description specifications Yes/N。 checked By
Type Spring loaded
Make MasCon
Size DN 25X25
Moc SS 316L
Set pressure 1.2 bar
Location Vessel Top Dish
一DE. Code VSV25
Serial No. B一8248

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 9.19Jacket Safety Valve 一 1 No.
Description specifications Yes/N0 checked By
Type Spring loaded
Make MaScon
size DN 25X25
MOc SS 316L
Set pressure 3.2 bar
Location On Jacket
一DE. Code JSV25
Serial NO. B-8249

9.20 Tempe rature sensor 一 1 No

Description specifications Yes/No checked BY

Type PT 100， RTD
Make Radix

Range -50 to 250 。C

MoC SS 316L
Location On Bottom DiSh
一DE. Code Ts一1

Serial NO- 321034298

9.21 Light Glass 一 1 No.

Description specifications Yes/No checked BY
Make Prompt
Voltage 230 V AC
Location On Top Dish
lDE， Code LG

9.22 Man Hole with View Glass With Wiper 一 1 No.

Description specifications Yes/No checked BY
Make SK
size 450mm
View Glass size 125mm
Location on Top Dish
MOC SS 316L
lDE， Code MH450

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 9.23 Compound Gauge 一 1 No.
Description specifications Yes/No checked BY
Type Diaph「agm
Make SK
Size 砂100 mm + 40 TC
Range 一1 To 9 BAR

MOC SS 316L
Location On Top DiSh
一DE. Code CG-100
Serial No. PG220801360002

9，z4 Charging Hopper一 1 No.

Description specifications Yes/No checked By
Make SK
Size 50 TC
Capacity 5 Ltrs
MOC SS 316L
Location On Top Dish
一DE. code CH5

9.25 Pressure Gauge 一 1 No.

Description specifications Yes/No checked BY
Type Diaphragm
Make SK
Size 砂100 mm 十 40 TC
Range 0 to 7 Bar
MOC SS 316L
Location On Jacket
iDE. Code PG-100
Serial No. PG220801360001

9-26 Vent Fi 一ter Housing 一 1 No.

Description specifications Yes/No checked By
Type Cartridge
Housing Make SK
Size 5" long + 25 TC
MiCr0n Rating 0.Z Micr0n
Cartridge Make Kumar
Cartridge MOC Polypropylene
Location On Top Dish
一DE. Code VF25

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 9，27 spray Ba" 一 2 Nos，
Description specifications Yes/No checked By
Type Dynamic
Make Atu一
Cover ra nge 360。
Min.PreSS.Reqd 2 Bar
Location On Top DiSh
IDE. Code DSB-1

9.28 Proximity Sensor 一 1 No.

Description specifications Yes/No checked BY
Make SK
Location For Man Hole
IDE. Code Ps一1

9，29 Electrical control Panel

sR. No CONTENT RATING MAKE QW.

1. Variable Frequency Drive （VFD）
SCHN日DER
A. PADDLE AG丨TATOR 10 HP 1

2. PLC & HM一 （10”） 24 V DC SCHNEIDER 1

3。 R一Y-B lndicat0r 24 V DC SCHNEIDER 3
4。 3 PHASE McB
A. PADDLE AGITATOR 一 3 pole 25AMP
B. 24 V Dc Control 一 1 Pole 2AMP SIEMENS
4
c. 230 V control 一 1 Pole 2AMP
D. Vessel Light 一 1 Pole 2AMP

5- MPcB 14-20AMP S一EMENS 1

6. contactor with overload Relay
SIEMENS 1
A. VAcUUM PUMP 32AMP
7. sMPs SINGLE PHASE LUBI 1
8. Power distribution module 24 V DC SHAVISON 1
9. Fan with F"ter SK 1
10. Emergency switch SIEMENS 1
11. control Key SIEMENS 1
12. Hooter Cey0ne 1
13. Main supply switch THREE PHASE SALZER 1

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 930 Ut…W Details
Sr. No UT…TY REQ…RMENTs
ELE酊'R忙AL
A. PHASE 3 PHASE
1. B. VOLTAGE 380 V
C. FREQUENCY 50 Hz
D. POWER P
Z. STEAM R
3. PUR旧ED WATER R
4. cOouNG WATER R
5. coMPREssED AIR R
6. VACUUM of Hg

1o.0 MATER一AL OF coNsTRUcT一oN

sr. No. coMPoNENT DESCRIPTION MoC
1， Vessel She" SS 316L
2. Vessel Top DiSh SS 316L
3. Vessel Bottom Dish SS 316L
4- Vessel Legs SS 304
5. Jacket SS 304
6. Insulation Rock Wool
7. Cladding ss 304
8. Gaskets silicone （Food Grade）/TsE/BsE
9. ManhOle SS 316L
10. Charging Hopper SS 316L
11. Compound Gauge SS 316L
12. Dynamic Spray Ba" SS 316L
13. Butterfly Valve SS 316L
14. Vessel Safety Valve SS 316L
15- Jacket Safety Va1ve ss 316L
16- Temperature Sensor SS 316L
17- Ba‖ Valve Ss 304
18. Angle seat Valve ASTM A351 CF8
19. Pressure Gauge ss 316L
Steam Trap ls 210 GR FG260 CAST lRON
20.
ASTM A743 GR CA40

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Protocol No-： 一吖754/2022-23 S.K.PHARMA MACHINERY PVT LTD

11-0IDENTIFICATIoN oF COMPONENTS FOR cA‖BRATIoN

11.1 一n the MANUFACTURING VEssEL 一 2000 L the fO‖OWing components needs Ca‖bration- They Sha"
be Calibrated during/ before insta‖atiOn of the equipment at the Site：
Sr. No The components are as fo"ows specifications observations
1. Temperature Sensor
2. Compound Gauge
3. Pressure Gauge

12，oVER一F一cAT一oN FOR 一NsTAL…T一oN

12.1 Location and Assembly
Acceptance checked By verified BY
sr. No. Test Pa眈icu一ars observations
Yes/NO
1. Check that equipment has
been insta‖ed in the room
specified in Equipment Layout
2. Check that Components are
assembled as per the DQ/
Drawing

12.2 Leveling and Alignment

Leveling / Alignment source of checked By Verified By
sr. NO- Item Description
OK/NOT OK Verification
1. Ver询 Whether the equipment has
been aligned as specified in given
room layout drawing
2. Ver耐 the level of equipment
installed With help of leveling
instrument

checked BY Verified BY

13.0METHOD FOR CHEcKING THE LEVELING OF THE EQUIPMENT AND ALIGNMENT

13.1 Method for checking the Leveling of the Equipment
1. Using spirit Level Indicator
1.1 Place the spirit level indicator at di仟erent points On the machine frame.
1.2 Acceptance Criteria： The air bubble of the spirit level indicator sha" be obse…ed in the
center.

z. Using Water Level Indicator

2.1 Place transparent tube fi‖ed With Water of suitable length at Various corners. Compare
the levels of Water and align the equipment.
2.2 Acceptance Criteria： The Water level at both the locations should match With the
edgeS of those locations， if required should be repeated for Other edges of the
equipment on same plane.

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 14.0DRAWINGS
14.1 AttaCh a Copy of Or reference the location of a‖-「e一eVant drawing5 and "St below.
sr. No. Title Drawing No. Attached Yes/No
1. DQ Drawing
2. P&一D

15.oDEFIclENcY （IF ANY） AND coRRE盯IVE ACnON REPORT

lf there is no deficiencY， then Write
Description of deficiency and date observed ：

Person， responsible for correctiVe action and date assigned：

Correct1Ve actions taken and date conducted ：

conducted By： ApprOVed By ：

Date ： Date ：

16.0AccEPTANcE cRITERIA
1. Insta‖atiOn Qua‖ficati0n sha" be considered acceptabie When a‖ the conditions specified in
Various forms have been met.
2. Any deViati0n from the acceptance criteria of the specific check point sha" be reported and
decision should be taken for the rejecti0n， replacement or rectification of the
equipment/component.

17，oREMARKs （一F ANY）

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 18.osUMMARY
checks observations Remarks
Whether acceptance criteria ofthe protocol and
yes/No
Specific check points are met.

19.0coNcLUSIoN
MANUFACTURING VEssEL bearing Machine No. 754 ls / ls Not Qua‖抨ing the InSta‖ation

Qualification test as per the guideline described in this Protocol. Can Be / Not Be tested for its
Operational Qualification as per Protocol No. I吖754/2022-23.

20.o PosT-APPRoVAL slGNATUREs

Name signature Date

（HoD- Pmduction）

（HOD 一 Engineering）

（HOD 一 Qua‖ty Assurance）

21.ousT OF ABBREV一AT一oNs
URS User Requirements Specification
CGMP Current Good Manufacturing Practices
DQ Design Qualification
FAT Facto吖 Acceptance Test
HZ HertZ
V Voltage
HP HorsepoWer
KW KiloWatt
RPM Revolutions per minute
P&lD Piping & Instrumentation Drawing
TC TricloVer
VFD Variable Frequency Drive
sKPMPL S. K. Pharma MachineW PVt Ltd
MV Manufacturing Vessel
PG Pressure Gauge
Max- Maximum
oW Quantity

粳毽
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藿斌 <

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、铲
飙
[
 zz.oAPPEND一X
zz.1 Refe rence Documents

1. Manufacturer′s Manual
2. To be Supp‖ed With the InSta‖ati0n qualifiCati0n documents-
sr， No. Description
1. Operational manual.
2. Test Certificate of Components.
3. Material of Construction Ce忱1fiCateS.

22.2 Annexure List

sr. No. Description Annexure No.
1. Purchase Order LC

2. Equipment DQ Drawing SKPMPL/RHB/D硼MV/754/2022-23

3- Equipment P & ID Drawing SKPMPL/RHB/P&ID/754/2022-23

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