s，K.
PHARMA MACHINERY PVT LTD
QUALITY ASSURANCE DEPARTMENT
Protocol No. o吖754/202z一23 Date： 18，08，2022
Model No. MV一2000 L
Equipment ID No. SKPMPL/RH B/MV/754/2022-23
Location U M BERGAO N
PROTOCOL APPROVAL sHEET
DEPARTMENT NAME SlGNATuRE DATE
Engineering
PrOd uCtiOn
Quality Assurance
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Protocol No.： o吖754/20z2-23 S.K.PHARMA MACHINERY PVT LTD
TABLE OF CONTENTS
1.0 PURPOSE 3
z.o RESPONS一B一uT一Es 3
3.o REQUAL一F一cAT一oN 3
4.o MACHINE DEscR一PT一oN ................................................................................... 4
5.o OPERATI0NAL QUAUFlCATION PROCEDURE ..................................................... 4
6.0 TRA一N一NG 4
7，0 KEY FUNCTIONAuW......................................................................................... 5
8.o TEST DATA sHEET 5
9.0 DEFICIENcY （IF ANY） AND coRREcTIVE ACTION REPORT ................................... 7
10.o AccEPTANcE c…TE…A ..................................................................................... 7
11.o SUMMARY 8
12.o CONCLUSION 8
13.o PosT-APPRoVAL s一GNATUREs.......................................................................... 8
14.o LIST OF ABBREVIAT一oN ..................................................................................... 8
15-o APPEND一X LIST 9
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Protocol No.： o町754/2022-23 S.K.PHARMA MACHINERY PVT LTD
Lo PURPosE
1，1 The purpose of this protocol is ：一
1，1.1 To Veri抨 the operational attributes of the MANUFACTURING VEssEL 一
2000 L model
LLZ sKPMPL-MV-2000 L supplied by M/s. s.K. Pha「ma Machinery P耽. Ltd，
critical to seNe the intended purpose of the Equipment.
1.1-3 To establish the suitab…tY of the drah SOP prepared for the operation
of Equipment-
1.1.4 To document the observations for future reference.
2，0 REsPoNslBluTlEs
2-1 The Validation group comprising of a representative from each of the
fo‖oWing depa忱ments sha" be responsible for the overa‖ comp‖ance With
this protocol.
2.2-1 EngineeringDepa枕ment
2.2.2 Production Depa忱ment
2.2.3 Quality Assurance Depa眈ment
z.2，3.1 The Officer-Production and O仟icer-Engineering should be
responsible for checking proper operations and recording data as
per the procedure outlined in this protocol.
2.2，3-2 Executive 一Va"dation should co‖ect a‖ the test data and should
compile the results to make the repo忱s of qualification studies.
2.2.3，3 The Repo忱s should be checked by Manager-Engineering and
Manager-Plant.
2.2.3.4 The senior Manager 兴夏A， should fina‖y approVe the Va‖dation
Report.
3-0 REQUALlFlCATloN
3.1 operational Qualification to be re-qualified on：
3.1.1 Replacement of any major component / instrument-
3.1，z Major modification in the existing equipment.
3.1.3 During monitoring， if equipment is found to be ma一functioning.
3，1.4 Shi抚ing ofthe equipment from one location to another.
-，′二：："
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4-o MACHINE DEscR一PT一oN
4，1 sa"ent Features： 一
4.1.1 EaS‖Y c一eanab一e.
4-2.1 A‖ Contact pa枕 made of SS 316L and non-Contact pa忱 SS 304 material.
4.3，1 A‖ pipelineS are electro pO‖Shed from inside and joints are easy open
able and fitting after Cleaning.
4.4.1 Manh0一e opening to fac…tate cleaning at the time of product.
4.5.1 Variable Frequency Drive provided for T Top Entry Paddler AgitatOr for
di仟erent speed.
5.0 oPEMTIoNAL QUAuFICAnoN PRocEDURE
5.1 Pri0r to the Qualification test， the personnel shall be trained by the Engineer from
the supplier on the Operational features of the equipment / system. This training
sha" be recorded-
5.z The trained personnel sha" Carry out the Operational Qualification fO‖oWing the
procedures mentioned， for key functionality and safety Features. Record the
observations of Qualification test in test Data sheet.
5.3 RepO眈 the deficiency from the specified functiOn， if any.
6.o TRAlNlNG
6.1 Title： Operational Features of Manufacturing Vessel
Name of the Trainer（s）：
M/s. s，K. Pharma MachineW Pvt-Ltd
sr. No Name of the Trainee Employee Number signature
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Signature of the Trainer （s）：
Date：
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DOC-No. SKPMPL/Qua"ty/03 Page 4 of 9 ）
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7.o KEY FUNCT一oNAuW
7-1 Purpose：
7，1，1 The purpose of this procedure is to demonstrate that the control
panel and Other manua1 operations of Manufacturing Vessel （Tag
NO............. ）
Check a‖ the displays on the panel are identified.
Turn on the power from the electrical panel.
Set the control（s） on the panel.
Veri秤 functionality of each component on the control panel
against its specified functions.
8.0 TEST DATA sHEET
sr， on HMI obseWati0n checked BY Verified BY
Test pa忱icu一ars Acceptance Criteria
No. Display （OK/NOT OK）
1. check the functi0ning of Top Padd一e AgitatOr Motor
Entry Padd一e Agitator Motor shou1d be run in CiOckWise
direction
2. Check the functiOning of Vacuum Pump Motor
Vacuum Pump Motor Should be run in C一OckWise
direction
3" Check the functioning of Vacuum Pump should be
Vacuum Pump run in C一ockWise direction
4. Check the functioning of Padd一e Agitator Gear box
Padd一e Agitator Gear Box Should be run in c一OckWise
direction
5. Check the functiOning of Mechanical Seal for Padd一e
Mechanical Seal for Paddle Agitator should not be
Agitator leakage during running
process or ideal position
6. Check the functioning of A" the Valve/Actuator
Pneumatic Butterfly Valve 50 should be open Or closed.
TC
Vessel Outlet
7. Check the functioning of A‖ the Valve/Actuator
Manual Butterfly Valve 50 TC should be open or closed.
1. suction 一n一et
2. Charging Hopper
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Protocol No.： o町754/z02z-23 S.K.PHARMA MACHINERY PVT LTD
sr. on HMI observation checked BY Verified BY
Test pa忧icu一ars Acceptance Criteria
No， Display （OK/NOT OK）
8- Check the functioning of A‖ the Valve/Actuator
Pneumatic Butte汁一Y Valve 25 Should be Open Or closed.
TC
1. Vent Filter
9. check the functioning of A" the Valve/Actuator
Pneumatic Butte湃一y Valve 40 should be open Or closed.
TC
1. ClP 一n一et
2. Vacuum 一n一et
10. Check the functiOning of A" the Valve/Actuator
Pneumatic Ba" Valve 40 TC Should be Open or closed.
1. C00‖ng Water In一et
2. COO‖ng Water Outlet
3. Jacket Drain
11. Check the functiOning of A" the Valve/Actuator
Pneumatic Angle seat Va1ve Should be open Or closed-
40 TC
1. COndensate
2. Bypass line
12. Check the functiOning of A‖ the Valve/Actuator
Pneumatic Angle seat Valve should be Open Or closed-
25 TC
1. Steam lnlet
2. COmpressed Air inlet
13. Check the functiOning of
Manual Angle seat Valve 25
TC
1. Steam lnlet
2. Bypass line
14. Check the functiOning of Showing actual
Temperature Sensor temperature
15. Check the functiOning of Light should glow ′ON′
Light Glass pressing on button
16. Check the functiOning of At Without pressure it
Compound Gauge should show Zero
17. Check the functioning of At Without pressure it
Pressure Gauge should show Zero
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Comment （if any）：
9.0 DEFICIENCY （IF ANY） AND CORRE盯WE ACTION REPORT
1f there is no deficienCY， then Write N. A.
Description of deficiency and date observed ：
Person， responsible for correctiVe action and date assigned：
CorrectiVe actions taken and date conducted：
conducted by： ApproVed By：
Date： Date ：
10.o AccEPTANcE cR一TERiA
1. Operational Qualification sha" be considered acceptable When a" the Conditions
specified in Various forms have been met.
2. Any deViation from the acceptance criteria of the specific check point sha" be
reported and decision should be taken for the rejection， replacement or
rectification of the equipment/component-
3. OQ Wi" be limited for Water & single batch trial.
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11-0 SUMMARY
check5 obSewations Remarks
Whether acceptance criteria of the protocol and Specific
Yes/No
check points are met.
12.0 CONCLUSION
MANUFACrURING VEssEL bearing Machine No. 754 一5 / IS Not qua‖坪ing the Operational Qualification
test as per the guideline described in this Protocol No. The Vesse1 （Tag No. ----------- ） can Be/ Not Be
tested for its Performance Qualification as per Protocol No. o硼754/2022-23，
13.0 PosT-APPRoVAL slGNATU REs
Name signature Date
（HoD- Production）
（HOD 一 Engineering）
（HOD 一 Qua"tY Assurance）
14.o LlsT OF ABBREWATlON
URS User Requirements Specification
CGMP Current Good Manufacturing Practices
DQ Design Qualification
FAT Factory Acceptance Test
HZ He忱Z
V Voltage
HP HOrsepOWer
KW K‖OWatt
RPM Revolutions per minute
P&一D Piping & Instrumentation Drawing
TC TricloVer
VFD Variable Frequency Drive
SKPMPL S_ K. Pharma Machinery P岫 Ltd
MV Manufacturing Vessel
PG Pressure Gauge
Max. Maximum
QTY Quantity
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15.o APPEND一X uST
15-1 Reference Documents
1- Manufacturer′S Manua1.
2. To be supplied With the 一nSta‖atiOn qualifiCati0n documents.
Sr， No. Description
1. Operational manuaL
2. Test Certificate of Components.
3- Material of construction ce忧…cateS.
15.2 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&1D/754/2022-23
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