Installation qualification for purified water generation system

Installation qualification for purified water generation system

  • Purpose
  •  The purpose of this protocol is to provide an outline for the inspection of the system for static attributes to verify that:
  • Each installed sub-component complies with the engineering design and system data sheets/specifications.
  • The system is installed according to the design specifications and the manufacturer’s recommendations
  • The system meets the current Good Manufacturing Practice (cGMP) requirements and all other regulatory obligations.
  • No unauthorized or unrecorded modifications have taken place.
  • Standard Operating Procedures have been identified and listed.
  • All critical instrumentation has been identified for calibration of the equipment.
  • All supporting utilities are properly connected.
  • All peripherals and electrical are properly connected.
  • All safety features are accounted for.
  • All installation testing reports wherever available are maintained on file.
  • SCOPE
  • This Installation Qualification Protocol shall be performed on the Purified Water Generation System.This protocol defines the methods and documentation that shall be used to evaluate the said system for installation in accordance with the manufacturer’s and specifications and intended use. Successful completion of this protocol shall verify that this system meets the specified requirement
  • Installation checks shall be performed to document that the Purified Water Generation is installed with proper supporting services/utilities and components.
  • All documentation, including manufacturer’s cut sheets, weld reports, etc. for the components described in this protocol shall be verified for availability.
  • Any exceptional conditions encountered during the qualification studies shall be identified for review. Exceptional conditions shall be investigated and the appropriate course of action (justification, correction, re-qualification) determined. All data shall be documented.
  • KEY WORDS & GLOSSARY:
AbbreviationDescription
URSUser Required Specification
FRSFunctional Required Specification
cGMPCurrent Good Manufacturing Practice
QAQuality Assurance
USPUnited States Pharmacopoeia
WHOWorld Health Organization
ROHPRO High Pressure Pump
CIPFPCIP Feed Pump
SMBSSodium Meta bisulfate
ADSAntiscalent dosing System
pHCpH Correction
CFCartridge Filter
ROReverse Osmosis
EDIElectro-Deionization
CIPCleaning In Place
PpmMg/Ltrs OR Parts Per Million
NTUNeblometric Turbidity Unit
MWCOMolecular Weight Cut-Off
CFU/mlColony Forming Unit per ml
TSSTotal Suspended Solids
TDSTotal Dissolved Solids
TOCTotal Organic Carbon
TVCTotal Viable Count
TBCTotal Bacterial Count
TCTri Clover
P&IDProcess Flow & Instrumentation Diagram
LPHLiters Per Hour
PGPressure Gauge
RMRotameter
LLSLow Level Switch
PLCProgrammable Logical Controls
MMIManual Machine Interface
ORPOxidation Reduction Potential
CICConductivity Indicator cum Controller
HPSHigh Pressure Switch
LPSLow Pressure Switch
MOCMaterial Of Construction
CPVCChlorinated Poly-Vinyl Chloride
SSStainless Steel
PPPoly-Propylene
FRPFiber Reinforced Plastic
HDPEHigh Density Poly Ethylene
HOSHeight Of Shell
HPSHydroPure Systems
ZCHLZydus Cadila Healthcare Limited
  • INTRODUCTION TO THE SYSTEM
  • The system under consideration would be producing water of required quality.
  • TREATED WATER QUALITY
  • STAGE WISE TREATED WATER QUALITY AFTER RO:
  • (On basis of maximum feed water limiting condition)
Sr. No.Water ParameterOutlet of Multi Grade FilterOutlet of SoftenerOutlet of RO Pass IOutlet of RO Pass II
1pH6 to 8.56 to 8.5 5 – 6 5 – 6
2TSS< 5 ppm< 5 ppmNilNil
3TDS/ Conductivity1920 us/cm1920 us/cm200 us/cm25 us/cm
    4Total Hardness

(in ppm)

350 ppmLess than 5 ppmNilNil
5SDI< 33.0 maxNilNil
6TOC1000 ppb1000 ppb500 ppb200 ppb
7TVC1000 CFU/ml1000 CFU/ml100 CFU/ml50 CFU/ml
  • TREATED WATER QUALITY AFTER UF : ( as per ‘Design Limits’)
  • (PURIFIED WATER AS PER USP 39 std.)
Sr.

No.

Water Parameters USP 39Action

Limit

Alert LimitDesign

Limit

1.Conductivity1.25 µs/cm1.0 µs/cm0.8 µs/cm0.7 µs/cm
2.TOC in PPB500 ppb300 ppb200 ppb100 ppb
3.TVC / TBC

Microbial Count

100 CFU/ml90 CFU/ml70 CFU/ml40 CFU/ml
  • Note: With the change in the incoming water parameters, the treated water quantity & quality may get affected at different stages of the plant.
Sr. No.TYPE OF WATERINTENDED USE
1Purified WaterFor Different User Points
  • The details of the contractors assigned for supply, erection and commissioning of the system is as shown below:
Sr. No.Nature of JobName & Address of Contractor
1.Purified Water Generation

Design, Planning, Supply of system, Erection, Commissioning, Instrumentation & Documentation.

  • RO High Pressure Pump
  • ORP Analyzer and pH sensor along with auto Dumping Valve
  • 5 – Micron Cartridge Filter
  • pH Correction System
  • Antiscalent Dosing System
  • SMBS Dosing System
  • FIRST PASS REVERSE OSMOSIS (HOT WATER SANITIZABLE) SYSTEM:
  • Softener Unit
  • Multi Grade Filter
  • Raw Water Pumps
  • Pre Sodium Hypo Chlorite Dosing System
  • PRE TREATMENT: (3800 LPH)
  • PRETREATMENT & PURIFIED WATER GENERATION SYSTEM:
  • SCHEME: 
  • The Fully Automated PLC based Purified Water Generation system generate 2 m3/hr. of Purified water as Per USP 39 Standards.
  •  SYSTEM DESCRIPTION
  • Reverse Osmosis Membranes along with High Pressure Housing
  • Conductivity Meter with Alarm
  • SECOND PASS REVERSE OSMOSIS (HOT WATER SANITIZABLE) SYSTEM:
  • RO High Pressure Pump
  • Reverse Osmosis Membranes along with High Pressure Housing
  • Conductivity meter with Alarm
  • POST TREATMENT:
  • Hot Water Sanitizable Electro – Deionization Unit
  • Conductivity meter with Alarm
  • SYSTEM DESCRIPTION:
  • Raw water before Raw Water Tank is dosed with Sodium Hypochlorite 1 – 2 ppm. Raw water feed pump will feed raw water from the raw water storage tank to Multi Grade Filter @ 7000 LPH.
  • Multi Grade Filter is a vertical down flow vessel containing pure graded silex quartz as a filtering media. The vessel is fabricated in FRP. The water generated at the outlet of Multi Grade Filter will have suspended solids less than 5 ppm. Multi Grade Filter is provided with Manual Backwash. We have provided manual ball valves of for change over from normal operation to Backwash operation.
  • (Note that the inlet suspended solid load should not be more than 50 ppm).
  • The water from Multi Grade Filter is passed through Softener. Hardness after softener is  less than 5 ppm. Soft Water after Softener unit is fed to Purified Water Generation System.
  • Sodium Metabisulphite (Na2S2O5) is then dosed in the chlorinated water to neutralize the free chlorine (excess chlorine) present in the filtered water.
  • Antiscalent Dosing System is then dosed in the soft water to avoid scale formation on the RO Membranes.
  • pH Correction Dosing System is provided to adjust the feed pH of  RO feed water as 6.5 – 8.5. The treated water is then passed through 5 micron Cartridge Filter to trap the suspended solids. This will avoid chocking of RO membranes due to suspended solids.
  • ORP Analyzer is provided so as to check the absence/presence of chlorine in the feed water to the RO System. If free chlorine is sensed in the feed water it will give an indication on the panel & open the dumping valve and dump the high ORP water for 300 secs. & Even if the ORP value is not below the set point it will trip the system.
  • This soft water is then fed to the Reverse Osmosis First pass System by means of a High Pressure Vertical multistage Pump with SS 304 wettable parts of M/s. Grundfos, Denmark. The First pass Reverse Osmosis System will generate 2700 liters/hr water with an overall recovery of 70 %. The generated water will have total dissolved solids less than 150 ppm. The semi-permeable reverse osmosis membrane has molecular weight cut off less than 150 MWCO. The Reveres Osmosis membrane acts as positive barrier to remove dissolved solids, organic compounds & bacteria.
  • The Reverse Osmosis System consists of thin film composite type Reverse Osmosis membrane of DOW. The material of construction of the RO membrane is Polyamide. The RO membrane is housed in the High Pressure SS 316L Wettable Parts Housing having TC end connection.
  • The outlet water of RO pass one is feed to RO pass two system. The Second pass Reverse Osmosis System will generate 2200 liters/hr of water with an overall recovery of 80%. The generated water will have total dissolved solids less than 15-20 ppm.
  • The Reverse Osmosis System consists of thin film composite type Reverse Osmosis membrane of DOW. The material of construction of the RO membrane is Polyamide. The RO membrane is housed in the High Pressure SS 316L Wettable Parts Housing having TC end connection.
  • The Permeate water from RO system will be fed to the Electro Deionization Unit (EDI) having designed capacity of 2000 LPH. The EDI system has a recovery of 90%.
  • The water generated from the outlet of EDI will be as per USP 39 Standards for Purified Water.
  • PURIFIED WATER GENERATION SYSTEM                                                                                    
  • CHECKS ON SYSTEM
  • Installation checks on system should be carried out based on design data of the system provided by the Vendor and the User Requirement Specifications.
  • System checks should include
  • cGMP compliance
  • Whether the system follows basic engineering design standards
  • Whether the system fulfills general safety standards
  • Whether the system fulfills other regulatory obligations (if any)
  • Such installation checks is a continuous exercise which shall begin right from the time the project is initiated and this protocol defines the specifications procedure summarizes the checks done from time to time.
  • When the contractor claims that all the installation of the system has been completed from his side, the qualification team shall conduct the final installation checks and report thereby.
    • Engineer responsible for Water Treatment Plant
    • Manager-Engineering
    • Head-Operations
    • Head – QA
  • The qualification team shall comprise of the following:
  • The final check on each System shall be recorded in the following format and any deviation from the specifications/design must be noted down in the Deviation Form:
  • INSTALLATION CHECKLIST
    Sr. No.Acceptance CriteriaYes / NoChecked ByDate

     

    1.0Verify that the ‘As Built’ drawings are complete and represent the design concept.
    2.0Verify that there is sufficient room for servicing provided.
    3.0Verify that all piping and electrical connections has been done according to the approved drawing.
    4.0All access parts are examined and clear of debris.
    5.0Walking access parts to roof mounted equipment provided.
    6.0Required electrical connections are properly wired. 

     

    7.0Wiring diagram is glued or kept inside the pocket provided inside control panel.
    8.0Equipment identification nameplate is visible.
    9.0Units are installed on Skid and secured in place as per manufacturer recommendations.
    10.0Verified that major components are securely anchored and protected from shock. 

     

    11.0Does installation report have any deficiencies?
    12.0If yes are they rectified?
    13.0Are all safety features accounted?

    ­­­­­­­­­­­­

     

  • GENERAL CHECKS ON THE SYSTEM:
    Sr.

    No.

    Specified Characteristics/

    Acceptance Criteria

    Actual Details

    (Yes / No)

    Checked by/ Date
    1PRE TREATMENT: (3800 LPH)

    ·        Pre Sodium Hypo Chlorite Dosing System

    ·        Raw Water Pumps

    ·        Multi Grade Filter

    ·        Softener Unit

      
    2FIRST PASS REVERSE OSMOSIS (HOT WATER SANITIZABLE) SYSTEM:

    • SMBS Dosing System
    • Antiscalent Dosing System
    • pH Correction System
    • 5 – Micron Cartridge Filter
    • ORP Analyzer and pH sensor along with auto Dumping Valve
    • RO High Pressure Pump
    • Reverse Osmosis Membranes along with High Pressure Housing
    • Conductivity Meter with Alarm

     

    Sr.

    No.

    Specified Characteristics/

    Acceptance Criteria

    Actual Details

    (Yes / No)

    Checked by/ Date
    3SECOND PASS REVERSE OSMOSIS (HOT WATER SANITIZABLE) SYSTEM:

    • RO High Pressure Pump
    • Reverse Osmosis Membranes along with High Pressure Housing
    • Conductivity meter with Alarm
    4POST TREATMENT:

    ·Water Sanitizable Electro – Deionization Unit

    ·onductivity meter with Alarm

    Comments:

  • Verified By:
  • MAJOR EQUIPMENTS OF PRETREATMENT & PURIFIED WATER GENERATION SYSTEM:
  • PRE SODIUM HYPOCHLORITE DOSING SYSTEM
    DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
    QuantityOne
    TypePositive Displacement Pump
    Pump Capacity0.4 to 4 LPH
    Max. Working Pressure5.5 kg/cm2
    MOC of Dosing TankHDPE
    Dosing Tank50 Liters Provided
    Low Level SwitchProvided
    MakeMilton Roy
    ModelUC 11

     

    Observation

     

     

     Yes / No

     

    Checked By

     

    Sign &  Date

     Properly Installed and  Supported   

    Comments:

  •  Verified By: 
  • RAW WATER PUMPS (1W + 1SB):
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityTwo (1W + 1SB)
TypeHorizontal Multistage pump
Flow rate7 m3/hr (7000 liter/hr)
Head35 mWC
Material of ConstructionSS 304
MakeNanfang

 

Observation  Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  •  Verified By:

MULTI GRADE FILTER:

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityOne
Flow rate7 m3/hr
Max. Working Pressure3.5 kg/cm2
Max. Pressure Drop0.5 kg/cm2
Diameter600 mm
Height1800 mm
Specific Velocity of Filtration25 m/hr.
Back Wash Time Required10-15 min.
Filter mediaPure Graded Silex Quartz

of 1.5 to 2 mm Particle size

Valve TypeBall valve
MOC of Pressure VesselFiber Reinforced Plastic (FRP)
Make of  Pressure VesselM/s. Wave Cyber, USA / Pentair
Frontal Pipe Size38.1 mm

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Pressure gauge100 mm Dial ( Inlet /Outlet)
MOC PipingUPVC
Make of PipingFIP
MOC of ValvesUPVC
Make of ValvesFIP
Inlet, Outlet, Drain Connection1.5” BSPF union ends

 

Observation

 

 

 Yes / No

 

Checked By

 

Sign &  Date

 Properly Installed and  Supported   
  • Comments: 
  • Verified By:

SOFTENER

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityOne
TypeVertical Up Flow
Flow rate3.8 m3/hr
Max. Working Pressure4 kg/cm2
Max. Pressure Drop0.5 kg/cm2
Diameter600 mm
Height on straight1800 mm
Regeneration Time Required20-30 min.

 

Fast Rinse5-10 Minutes
Resin Quantity450 ltrs
Make of ResinM/s. Lenxess
Model of Resin C 249
Regenerator (NaCl)72 Kgs.
Reg. Tank Capacity300 lts.
MOC of Reg .tankHDPE

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
MOC of  SoftenerFiber Reinforced Plastic (FRP)
Make of  VesselM/s. Wave Cyber, USA / Pentair
Frontal Pipe Size38.1 mm
ValveBall valve
Pressure gauge100 mm Dial ( Inlet /Outlet )
Frontal PipingUPVC
Make of PipingFIP
Make of ValvesFIP
Observation  Yes / No  Checked By Sign &  Date
Properly Installed and  Supported    
  • Comments:
  • Verified By:
  • SODIUM META BISULPHITE DOSING SYSTEM:
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityOne
TypePositive Displacement Pump
Pump Capacity0.4 to 4 LPH
Max. Working Pressure5.5 kg/cm2
MOC of Dosing TankSS 304
Dosing Tank25 Liters Provided
Low Level SwitchProvided
MakeMilton Roy
ModelUC 11

 

Observation Yes / No Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:
  • ANTISCALENT DOSING SYSTEM:
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityOne
TypePositive Displacement Pump
Pump Capacity0.4 to 4 LPH
Max. Working Pressure5.5 kg/cm2
MOC of Dosing TankSS 304
Dosing Tank25 Liters Provided
Low Level SwitchProvided
MakeMilton Roy
ModelUC 11

 

Observation  Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comment:
  • Verified By: 
  • pH CORRECTION DOSING SYSTEM
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityOne
TypePositive Displacement Pump
Pump Capacity0.4 to 4 LPH
Max. Working Pressure5.5 kg/cm2
MOC of Dosing TankSS 304
Dosing Tank25 Liters Provided
Low Level SwitchProvided
MakeMilton Roy
ModelUC 11
pH Correction ChemicalNaOH or Na2CO3

 

Observation Yes / No  Checked By Sign &  Date
Properly Installed and  Supported    
  • Comments:
  • Verified By:
  • MICRON CARTRIDGE FILTER
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
No. of UnitOne
Type of CartridgeSpun Bounded Type
Rating5 micron
Flow rate3800 LPH
No. of Cartridge2 nos. 20” long
MOC of Cartridge HousingSS 304
MOC of CartridgePP ( Polypropylene)
Make of CartridgeKumar/Pratham
 Make of HousingHydroPure Systems
  Surface Finish of HousingInternally – < 0.4 Ra

Externally – mirror up to 180 grit

Type of FilterDouble open end filter

 

Observation  Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By: 
  • REVERSE OSMOSIS HIGH PRESSURE PUMP-I:
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityOne
TypeVertical Multistage Pump
Flow rate3.8m3/hr (3800 LPH)
Pressure12kg /cm2
Material of ConstructionSS 304 wettable parts
Voltage Requirement415 volts
MakeGrundfos

 

Observation

 

 Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:
  •  REVERSE OSMOSIS MEMBRANES:
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
No. of Membrane4 Nos.
Size of Membrane8” Dia. & 40” Long
Type of MembraneThin Film Composite
Type of SanitizationHot water Sanitizable
Materia   of

Construction

Polyamide
Make of Membrane DOW
ModelHSRO-390FF
Operating Temperature450 C
Recovery70 %
Feed Water Flow Rate 3800 m3/hr
Permeate Flow Rate2700 m3/hr
Reject Water Flow Rate1100 m3/hr
Sanitization Temp.850 C

 

Observation

 

  Yes / No  Checked By Sign &  Date
Properly Installed and  Supported    
  • Comment:
  • Verified By:
  • REVERSE OSMOSIS HOUSING:
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign  &  Date
No. of Housingone
No of RO Membranes Housing 14 Nos
Make of HousingHydropure Systems
MOCSS 304
Diameter204 mm
Length4060  mm
Thickness2.5 mm
Surface Finish of RO HousingInternally – < 0.4 Ra

Externally – mirror up to 180 grit

Max. Flow Rate for housing4000 LPH
Permeate flow rate from RO Pass I2.7 m3/hr.         

 

ObservationYes / No Checked BySign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:
  •  REVERSE OSMOSIS HIGH PRESSURE PUMP-II:
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityOne
TypeVertical Multistage Pump
Flow rate2.7 m3/hr (2700 LPH)
Pressure9 kg/cm2
Material of ConstructionSS 316 wettable parts
Voltage Requirement415 volts
MakeGrundfos

 

Observation  Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:
  • REVERSE OSMOSIS MEMBRANES

Location: Within the RO Housing

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign  &  Date
No. of Membrane2 Nos.
Size of Membrane8” Dia. & 40” Long
Type of MembraneThin Film Composite
Type of sanitizationHot water
Temperature of sanitization850 C
Material of ConstructionPolyamide
Make of MembraneDOW.
ModelHSRO-390FF
Operating Temperature450 C
Recovery80-85 %
Feed Water Flow Rate2.7 m3/hr
Permeate Flow Rate2.2 m3/hr

 

Observation Yes / No Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:
  • REVERSE OSMOSIS HOUSING:
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign   &  Date
No. of HousingOne
 Make of HousingHydroPure Systems
Material of ConstructionSS 316L
Diameter204 mm
 Length2040 mm
Thickness2.5 mm
Surface Finish of RO HousingInternally – < 0.4 Ra

Externally – mirror up to 180 grit

 Max Feed Flow rate3000 LPH

 

Observation Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  •  Verified By 
  • ELECTRO DEIONIZATION UNIT:
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign   &  Date
No. of UnitOne  
TypeHot Water Sanitizable  
 Model No.IP – LXM 24 – HI-3  
Minimum Flow rate1400 ltrs/hr  
Maximum Flow rate4200 Ltrs/hr  
 Normal Flow rate2800 ltrs/hr  
End Connection1” TC  
Operating Voltage DC150 – 250 V DC  
Maximum Voltage300 V  
Operating Current1 – 3 Amps  
Maximum Current5 – 6 Amps.  
Concentrate Flow rate(Reject)250 LPH

 

  
Pressure Drop across concentrate0.5 kg/cm2  
Max. Working Pressure2.5 kg/cm2  
Make of EDIM/s. Ion Pure EDI, USA  
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign   &  Date
Material of Construction of different parts
Dilute SpacerPolysulfone  
Concentrate SpacerPolysulfone  
End BlockPolypropylene  
Resin compartment O-rings                            FDA-grade silicon  
Anion exchange resin 1Styrene / DVB, strong base,

type I

  
Anion exchange resin 2Styrene / DVB, strong base,

type II

  
Cation exchange resinStyrene / DVB, strong acid  
Anion exchange membraneHeterogeneous PE/AER

 

  
Cation exchange membraneHeterogeneous PE/CER

 

  
AnodePlatinized Titanium  
CathodeSS 316  

 

ObservationYes / No            Checked BySign &  Date
 Properly Installed and  Supported   

Comments:

Verified By:

CIP TANK

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityOne  
MakeHydro pure
TypePlain Tank
Working Capacity200 Liters
Gross Capacity220 Liters
Tank Dia ID600 mm
Shell Height750 mm
Design Pressure & Tempe3.5 Kg/cm2 & 120oC
Design CodecGMP
Top & BottomTorispherical Dished end
M.O.C. of ShellSS 316 L
NozzlesTriclover end
Surface FinishInternally electro polished to <0.4 micron Ra

Externally buffed to mirror finish

 

ObservationYes / No Checked BySign &  Date
Properly Installed and  Supported   

Comments:

Verified By:

CIP FEED PUMP

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityOne
TypeHorizontal Multistage Pump
Flow rate2.5 m3/hr (2500 liter/hr)
Pressure2.9 kg / cm2
Material of ConstructionSS 316 wettable parts
Voltage Requirement3 Phase, 415 volts
MakeGrundfos

 

Observation Yes / No Checked BySign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified:

CHECKS ON PIPING & PIPE FITTINGS &VALVES

  • Installation checks on piping should be carried out based on design data of the system provided by the Vendor and the User Requirement Specifications.
  • System checks should include
  • cGMP compliance
  • Whether the system follows basic engineering design standards
  • Whether the system fulfills general safety standards
  • Whether the system fulfills other regulatory obligations (if any)
  • Such installation checks is a continuous exercise which shall begin right from the time the project is initiated and this protocol defines the specifications procedure summarizes the checks done from time to time.
  • When the contractor claims that all the installation of the system has been completed from his side, the qualification team shall conduct the final installation checks and report thereby.
  • The qualification team shall comprise of the following:
  • Engineer responsible for Water Treatment Plant
  • Manager – Engineering
  • Head – Operations
  • Head – QA
  • The final check on each System shall be recorded in the following format and any deviation from         the specifications/design must be noted down in the Deviation Form:
  • CHECKS ON VALVES

 

Sr NOLocation of ValveSizeTypeM.O.C.Remark
1Before Raw Water Tank32 mmActuated Valve (NC)SS 304
2ORP dump valve25 mmActuated Valve (NC)SS 304
3RO-I Reject line (Auto Flushing)20 mmActuated Valve (NC)SS 304
4RO-I Conductivity dump valve20 mmActuated Valve (NC)SS 304
5RO-II Reject line (Auto Flushing)20 mmActuated Valve (NC)SS 304
6RO-II Conductivity dump valve20 mmActuated Valve (NC)SS 304
7Suction line of RWP-011.5” NBManual Ball ValveSS 304
8Discharge line of RWP-011.25” NBManual Ball ValveSS 304
9Suction line of RWP-021.5” NBManual Ball ValveSS 304
10Discharge line of RWP-021.25” NBManual Ball ValveSS 304
11MGF Inletd40DN32Manual Ball ValveUPVC
12MGF outletd40DN32Manual Ball ValveUPVC
13MGF back wash inletd40DN32Manual Ball ValveUPVC

 

Sr NOLocation of ValveSizeTypeM.O.C.Remark
14MGF back wash outletd40DN32Manual Ball ValveUPVC
15MGF draind40DN32Manual Ball ValveUPVC
16Softener-01 Inletd40DN32Manual Ball ValveUPVC
17Softener-01 Outletd40DN32Manual Ball ValveUPVC
18Softener-01 power waterd25DN20Manual Ball ValveUPVC
19Softener-01 brine injectiond40DN32Manual Ball ValveUPVC
20Softener-01 slow Rinse outletd40DN32Manual Ball ValveUPVC
21Softener-01 Fast Rinse outletd40DN32Manual Ball ValveUPVC
22Diversion lined40DN32Manual Ball ValveUPVC
23Discharge ROHP-0125 mmManual Ball ValveSS 304
24Discharge ROHP-0225 mmManual Ball ValveSS 304
25Discharge line of Raw Water Pump – 011.25”Non Return ValveSS 304
26Discharge line of Raw Water Pump – 021.25”Non Return ValveSS 304
27Conc. Inlet EDIDN 20Diaphragm ValveSS 316
28CIP Tank drain valveDN 20Daiphragm ValveSS 316

 

 

Sr NOLocation of ValveSizeTypeM.O.C.Remark
29CIP Suction ValveDN 20Daiphragm ValveSS 316
30CIP Discharge ValveDN 20Diaphragm ValveSS 316
31ORP needle valve¼ ”Needle valveSS 304
32Reject line RO-0120 mmNeedle ValveSS 304
33Reject line RO-0220 mmNeedle ValveSS 304
34After  NaOCl-01 Dosing System8 NBSampling ValveSS 304
35Inlet of Multi Grade Filter8 NBSampling ValveSS 304
36Outlet of Multi Grade Filter8 NBSampling ValveSS 304
37Outlet of Softener-018 NBSampling ValveSS 304
38After SMBS dosing system8 NBSampling ValveSS 316
39After ADS dosing system8 NBSampling ValveSS 316
40After pHC dosing system8 NBSampling ValveSS 316
41After 5-micron Cartridge Filter8 NBSampling ValveSS 316
42After RO pass-I8 NBSampling ValveSS 316
43After RO pass-II8 NBSampling ValveSS 316
44After EDI system8 NBSampling ValveSS 316
  • Verified By:
  • Comments:

 

  • CHECKS ON COMPONENTS & INSTRUMENTATION
  • Installation checks on components (this includes motors & pumps) & instrumentation should be carried out based on design data of the system provided by the Vendor and the User Requirements Specifications.
  • System checks should include
  • Engineer responsible for Water Treatment Plant
  • Manager – Engineering
  • Head – Operations
  • Head – QA
  • The final check on each System shall be recorded in the following format and any deviation from   the specifications / design must be noted down in the Deviation Form:
  • Instrument Details
  • PRESSURE GAUGES
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity03 No
MakeWaaree
Size of Gauge100 mm Dial
Range0 – 7 kg/cm2
End Connection3/8” BSP (M)
MOCSS Body with SS internals
Location1)Inlet of Multi Grade Filter

2) Outlet of Multi Grade Filter

3) Outlet of Softener

 

Observation

 

 Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:
  • PRESSURE GAUGES
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity03 No.
MakeWaaree
Size of Gauge63 mm Dial
Range0 – 7 kg/cm2
End Connection1/4” BSP (M)
MOCSS Body with SS internals
Damping LiquidGlycerin
Accuracy± 1.6 % of FS
Location1)Inlet of 5 micron

Cartridge Filter

2)Outlet of 5 micron

Cartridge Filter

3)Inlet line of EDI System

 

 

 

Observation  Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments: 
  • Verified By:

 

  • PRESSURE GUAGES:
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity04 No.
MakeWaaree
Size of Gauge63 mm Dial
Range0 –21 kg/cm2
End Connection¼” BSP (M)
MOCSS Body with SS internals
Damping LiquidGlycerin
Accuracy± 1.6 % of FS
LocationFOR TWO PASS RO-EDI

SYSTEM

1)Feed line of RO pass –I

2)Reject line of RO pass–I

3) Feed line of RO pass–II

4) Reject line of RO pass-II.

 

Observation Yes / No Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:

 

  • PRESSURE GUAGES:
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
MakeWaaree
Size of Gauge63 mm Dial
Range0 –7 kg/cm2
End Connection¼” BSP (M)
MOCSS Body with SS internals
Damping LiquidGlycerin
Accuracy± 1.6 % of FS
LocationDischarge line of CIP Feed

Pump-1     

 

Observation Yes / No Checked BySign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:

 

  • ROTAMETER:

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity06 Nos. 
MakeGeorge Fischer 
End ConnectionTri Clover end 
TypeVariable Area 
ModelSK 
MOC of floatSS 316 
MOC of Measuring TubeSS 
 MOC of end connection Nylon 6 
Accuracy class 2.5 

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Location1) Inlet line of Multi Grade Filter (1000 – 10000 LPH)

2) Potable Water Line (500 – 5000 LPH)

3) RO First Pass reject line (200 – 2000 LPH)

4) RO Second Pass reject

line (100 – 1000 LPH)

5) EDI Feed line (400 – 4000 LPH)

6) Concentrate line of

EDI – I (30 – 300 LPH)    

 

 

Observation Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:

 

  • FLOW INDICATOR TOTALIZER

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity01 Nos.
MakeAster Technology
ModelFT-650
 Line Size38 mm
TypeTurbine Type
End ConnectionThreaded
LocationOutlet of Softeners

 

ObservationYes / No  Checked By Sign &  Date
Properly Installed and  Supported   
  •  Comments:
  •  Verified By:

 

  • FLOATY  LEVEL SWITCH:

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity01 Nos.
MakeInnovative Technologies
 TypeFloaty type
   MOC                      PVC
LOCATIONRaw Water Tank

 

Observation  Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  •  Comments:
  •  Verified By:

 

  • LOW LEVEL SWITCH:

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity05 Nos
MakeInnovative Technology
TypeMagnetic
   MOC                PP
Location1)NaOCl-01 Dosing Tank

2)Raw Water Tank

3)SMBS dosing system  

4)ADS dosing system

5)pH correction system

 

Observation Yes / No  Checked By Sign &  Date
Properly Installed and  Supported   
  •  Comments:
  •  Verified By:

 

  • FLOW SWITCHES:

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityOne  
MakeDag Process  
MOC             SS 316  
Size      1.5”
LocationRaw Water inlet line

 

Observation Yes / No Checked BySign &  Date
 Properly Installed and  Supported   
  • Comments: 
  • Verified By:

 

ORP SENSOR TRANSMITTER & CONTROLLER

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
QuantityOne
MakeForbes Marshall
 Range+1000 to – 1000 mV
End Connection 1” TC end connection
MOC of ElectrodeGlass
LocationInlet of RO pass – I

 

Observation  Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported    
  • Comments: 
  • Verified By:

 

  •  CONDUCTIVITY SENSOR TRANSMITTER & CONTROLLER
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity02 No
MakeEmerson
 Range0 – 200  µs/cm for First Pass Permeate

0 – 100  µs/cm for Second Pass Permeate

End Connection 1 ½” TC end connection.
 MOC                        SS  316 wettable parts
Location1) Outlet of RO pass – I

2) Outlet of RO pass – II

 

Observation Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:

 

  • CONDUCTIVITY SENSOR TRANSMITTER & CONTROLLER:

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity01 Nos  
MakeEmerson
Range0 – 10  µs/cm (EDI outlet)
End Connection1 ½” TC end connection
MOCSS  316 wettable parts
LocationOutlet of EDI system

 

Observation Yes / No  Checked By Sign &  Date
Properly Installed and  Supported   
  •  Comments:
  •  Verified By:

 

  • HIGH PRESSURE SWITCH
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity02 Nos  
MakeDanfoss
Range1 to 16 bar
End Connection3/8” BSP (M)
MOC SS wettable parts
TypeSeamless Bellow type pressure switch
Location1)Outlet of RO High Pressure – I

2)Outlet of RO High Pressure –II

 

Observation Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  •  Comments:
  •  Verified By:

 

6.3. B.10 LOW PRESSURE SWITCH:

(TAG NO:  LPS – 01 / 02 / 03)

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity03 No 
MakeDanfoss
Range0 to 3 bar
End Connection3/8” BSP (M)
MOCSS wettable parts
TypeSeamless Bellow type pressure switch
Location1) Inlet of RO High Pressure – I

2) Inlet of RO High Pressure – II

3) Inlet of EDI unit

 

Observation  Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:

 

  •  LEVEL SWITCH for CIP Tank:
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity01 No  
MakeMahalaxmi
ModelSMT-16M 3” TC-AH
MOCSS  316
LocationCIP Tank

 

Observation  Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  •  Verified By:

 

  • TEMPERATURE INDICATOR & TRANSMITTER
DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity01 No  
MakeWika
Wetted materialSS 316
Range0  to 2000 C
InputPT – 100 (RTD)
Accuracy+ / – 0.5% of F.S.
Ambient temp250 C
LocationCIP Feed Pump Discharge

 

Observation  Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:

 

CONTROL VALVES

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity06 Nos  
MakeAvcon
TypeY- type Pneumatic operated ON-OFF
MOCSS Wettable Parts
 End Connection TC end
SizeAs per valve schedule

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Location1) Raw Water Inlet line

2) Before RO High

Pressure – I (ORP Dump)

3) Reject line of RO

pass – I (Auto Rinse Valve)

4) Permeate line of RO

pass – I (CIC Dump)

5) Reject line of RO

pass – II (Auto Rinse Valve)

6) Permeate line of RO

pass – II (CIC Dump)

 

Observation Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  • Comments:
  • Verified By:

 

  • FLOW DIVERTER VALVE

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity01 No  
MakeKumar Process
MOCSS 316L
 End ConnectionTC end
Size1”
LocationOutlet of EDI unit.

 

Observation Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   
  •  Comments:
  •  Verified By:

 

  • SAMPLING VALVE:

 

DETAILS/ PARAMETERACCEPTANCE CRITERIAACTUAL READINGSign &  Date
Quantity07 Nos 
MakeKumar Process
TypeMilipore Design
Size8 NB
MOCSS 316L
LocationRO-EDI Distribution Piping

 

Observation Yes / No  Checked By Sign &  Date
 Properly Installed and  Supported   

Comments:

Verified By:

 

  • CHECKS ON GENERAL ERECTION & INSTALLATION
  • Installation checks on general erection & installation should be based on following:
  • cGMP compliance
  • Whether the system follows basic engineering design standards
  • Whether the system fulfills general safety standards
  • Whether the system fulfills other regulatory obligations (if any)
  • Such installation checks is a continuous exercise which shall begin right from the time the project is initiated and this protocol defines the specifications procedure summarizes the checks done from time to time.
  • When the contractor claims that all the installation of the system has been completed from his side, the qualification team shall conduct the final installation checks and report thereby.
  • The qualification team shall comprise of the following:
  • Engineer responsible for Water Treatment Plant
  • Manager – Engineering
  • Head – Operations
  • Head – QA

    Acceptance Criteria                    

  • Pump should be mounted rigidly & properly on the skid.
  • Non-return valves should be provided wherever necessary.
  • Sampling valves should be provided between every 2 equipments or wherever necessary to provide isolation and targeting of problems.
  • Straight piping runs should be supported at least every ten feet.
  • Dosing point should be provided in the bottom portion of pipe.
  • All pipes shall be properly supported.
  • All tanks and pumps must be completely self-drainable.
  • The piping should have suitable self-draining gradient.
  • Result:
  • The final check shall be recorded in the following format and in case any Exception is found, the exact details of the location of Exception from the specifications/design must be noted down in the Exception Form:
  • EXCEPTION REPORT
  • If any of the studies carried out in the Installation Qualification test does not meet the acceptance criteria. Exception Report must be completed in below format.

Any corrective actions identified must be verified based on the investigation findings.

 

Sr. No.Point No.DescriptionCorrective ActionObserved byApproved by
  • Comments:
  • Verified By:

 

  • CHECKS ON DOCUMENTATION
  • The qualification team shall verify all system characteristics on the basis of documentation provided by the vendor.
  • The list of documents (& drawings) to be verified for availability is as follows:
Sr. No.Specified DocumentsProvided

Yes / No

Remarks
1As-built Drawing
2Electrical Drawing
3Hydro Test Report
4Standard Operating Procedures
5Cleaning / Sanitization Procedures
6Passivation Report
7Calibration Certificates
8Components Test Certificates
9MOC Certificates
10Pump Performance Curve
11Guarantee / Warranty Certificate
12Welding Protocol / Certificate / Welding Log
13Surface Finishing Certificates
14Manufactures & Preventive Maintenance Manual
15PLC & MMI Certificates
16Spare Part List
  •  Comments:
  •  Verified By:

 

  • ELECTRICAL CONTROL PANEL DETAILS
  • Acceptance Criteria:
Sr. No.ParameterAcceptance CriteriaChecked by
1OperationElectrically Operated
2DimensionAs suiting room dimensions, no strict specifications
3MountingBase Mounted
4Fabrication & Finish14-gauge sheet, Mat Finish
6Alarm SystemsProvided as per the safety alarm list
7Power CablesShall be of copper, 4 cores
8Control Wiring

 

Shall be of copper, stranded, PVC insulated
  • Comments:
  • Verified By:

 

  • FINAL REPORT
  • Summary
  • The systems have been tested with the specifications and
  • Found satisfactory / Not Satisfactory.
  • Analysis/Evaluation
  • cGMP Compliance and overall system: Acceptable / Not Acceptable.
  • Overall Dimension: Acceptable / Not Acceptable.
  • Overall Finishing: Acceptable / Not Acceptable.
  • Conclusion
  • Report approval.
  • The Installation qualification report for Purified Water Generation System is  reviewed and complies / does not comply with requirements.
Executed & Reviewed b
Sign / Date :—————

Name :——————–

        Validation -QA

 Sign / Date :—————

Name :——————–

            Engineerin

  • Comments:
  • We certify that the Installation qualification report for Purified Water Generation System is Accepted / Rejected.
Qualification Approval
Sign / Date : ___________________

Name :          ___________________

Engineering

Sign / Date :  ___________________

Name :           ___________________

Manufacturing

 Sign / Date : ___________________

 Name :          ___________________

Q A Head

 Sign / Date :  ___________________

 Name :           ___________________

Unit Head

 

About Pharma Editor

Check Also

VIAL WASHING MACHINE PQ PROTOCOL

VIAL WASHING MACHINE PQ PROTOCOL TABLE OF CONTENTS S. No. Description 1.0 Protocol approval 2.0 …