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Installation qualification for puriffied 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 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:
Abbreviation Description

 

URS User Required Specification
FRS Functional Required Specification
cGMP Current Good Manufacturing Practice
QA Quality Assurance
USP United States Pharmacopoeia
WHO World Health Organization
ROHP RO High Pressure Pump
CIPFP CIP Feed Pump
SMBS Sodium Meta bisulfate
ADS Antiscalent dosing System
pHC pH Correction
CF Cartridge Filter
RO Reverse Osmosis
EDI Electro-Deionization
CIP Cleaning In Place
Ppm Mg/Ltrs OR Parts Per Million
NTU Neblometric Turbidity Unit
MWCO Molecular Weight Cut-Off
CFU/ml Colony Forming Unit per ml
TSS Total Suspended Solids
TDS Total Dissolved Solids
TOC Total Organic Carbon
TVC Total Viable Count
TBC Total Bacterial Count
TC Tri Clover
P&ID Process Flow & Instrumentation Diagram
LPH Liters Per Hour
PG Pressure Gauge
RM Rotameter
LLS Low Level Switch
PLC Programmable Logical Controls
MMI Manual Machine Interface
ORP Oxidation Reduction Potential
CIC Conductivity Indicator cum Controller
HPS High Pressure Switch
LPS Low Pressure Switch
MOC Material Of Construction
CPVC Chlorinated Poly-Vinyl Chloride
SS Stainless Steel
PP Poly-Propylene
FRP Fiber Reinforced Plastic
HDPE High Density Poly Ethylene
HOS Height Of Shell
HPS HydroPure Systems
ZCHL Zydus 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 Parameter Outlet of Multi Grade Filter Outlet of Softener Outlet of RO Pass I Outlet of RO Pass II
1 pH 6 to 8.5 6 to 8.5  5 – 6  5 – 6
2 TSS < 5 ppm < 5 ppm Nil Nil
3 TDS/ Conductivity 1920 us/cm 1920 us/cm 200 us/cm 25 us/cm
    4 Total Hardness

(in ppm)

350 ppm Less than 5 ppm Nil Nil
5 SDI < 3 3.0 max Nil Nil
6 TOC 1000 ppb 1000 ppb 500 ppb 200 ppb
7 TVC 1000 CFU/ml 1000 CFU/ml 100 CFU/ml 50 CFU/ml
  • TREATED WATER QUALITY AFTER UF : ( as per ‘Design Limits’)
  • (PURIFIED WATER AS PER USP 39 std.)
Sr.

No.

Water Parameters USP 39 Action

Limit

Alert Limit Design

Limit

1. Conductivity 1.25 µs/cm 1.0 µs/cm 0.8 µs/cm 0.7 µs/cm
2. TOC in PPB 500 ppb 300 ppb 200 ppb 100 ppb
3. TVC / TBC

Microbial Count

100 CFU/ml 90 CFU/ml 70 CFU/ml 40 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 WATER INTENDED USE
1 Purified Water For 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 Job Name & 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 Criteria Yes / No Checked By Date

     

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

     

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

     

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

    ­­­­­­­­­­­­

     

  • GENERAL CHECKS ON THE SYSTEM:
    Sr.

    No.

    Specified Characteristics/

    Acceptance Criteria

    Actual Details

    (Yes / No)

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

    ·        Pre Sodium Hypo Chlorite Dosing System

    ·        Raw Water Pumps

    ·        Multi Grade Filter

    ·        Softener Unit

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

    • RO High Pressure Pump
    • Reverse Osmosis Membranes along with High Pressure Housing
    • Conductivity meter with Alarm
    4 POST 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/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
    Quantity One
    Type Positive Displacement Pump
    Pump Capacity 0.4 to 4 LPH
    Max. Working Pressure 5.5 kg/cm2
    MOC of Dosing Tank HDPE
    Dosing Tank 50 Liters Provided
    Low Level Switch Provided
    Make Milton Roy
    Model UC 11

     

    Observation

     

     

     Yes / No

     

    Checked By

     

    Sign &  Date

     Properly Installed and  Supported      

    Comments:

  •  Verified By: 
  • RAW WATER PUMPS (1W + 1SB):
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity Two (1W + 1SB)
Type Horizontal Multistage pump
Flow rate 7 m3/hr (7000 liter/hr)
Head 35 mWC
Material of Construction SS 304
Make Nanfang

 

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

MULTI GRADE FILTER:

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity One
Flow rate 7 m3/hr
Max. Working Pressure 3.5 kg/cm2
Max. Pressure Drop 0.5 kg/cm2
Diameter 600 mm
Height 1800 mm
Specific Velocity of Filtration 25 m/hr.
Back Wash Time Required 10-15 min.
Filter media Pure Graded Silex Quartz

of 1.5 to 2 mm Particle size

Valve Type Ball valve
MOC of Pressure Vessel Fiber Reinforced Plastic (FRP)
Make of  Pressure Vessel M/s. Wave Cyber, USA / Pentair
Frontal Pipe Size 38.1 mm

 

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Pressure gauge 100 mm Dial ( Inlet /Outlet)
MOC Piping UPVC
Make of Piping FIP
MOC of Valves UPVC
Make of Valves FIP
Inlet, Outlet, Drain Connection 1.5” BSPF union ends

 

Observation

 

 

 Yes / No

 

Checked By

 

Sign &  Date

 Properly Installed and  Supported      
  • Comments: 
  • Verified By:

SOFTENER

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity One
Type Vertical Up Flow
Flow rate 3.8 m3/hr
Max. Working Pressure 4 kg/cm2
Max. Pressure Drop 0.5 kg/cm2
Diameter 600 mm
Height on straight 1800 mm
Regeneration Time Required 20-30 min.

 

Fast Rinse 5-10 Minutes
Resin Quantity 450 ltrs
Make of Resin M/s. Lenxess
Model of Resin  C 249
Regenerator (NaCl) 72 Kgs.
Reg. Tank Capacity 300 lts.
MOC of Reg .tank HDPE

 

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
MOC of  Softener Fiber Reinforced Plastic (FRP)
Make of  Vessel M/s. Wave Cyber, USA / Pentair
Frontal Pipe Size 38.1 mm
Valve Ball valve
Pressure gauge 100 mm Dial ( Inlet /Outlet )
Frontal Piping UPVC
Make of Piping FIP
Make of Valves FIP
Observation   Yes / No  Checked By  Sign &  Date
Properly Installed and  Supported       
  • Comments:
  • Verified By:
  • SODIUM META BISULPHITE DOSING SYSTEM:
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity One
Type Positive Displacement Pump
Pump Capacity 0.4 to 4 LPH
Max. Working Pressure 5.5 kg/cm2
MOC of Dosing Tank SS 304
Dosing Tank 25 Liters Provided
Low Level Switch Provided
Make Milton Roy
Model UC 11

 

Observation  Yes / No Checked By  Sign &  Date
 Properly Installed and  Supported      
  • Comments:
  • Verified By:
  • ANTISCALENT DOSING SYSTEM:
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity One
Type Positive Displacement Pump
Pump Capacity 0.4 to 4 LPH
Max. Working Pressure 5.5 kg/cm2
MOC of Dosing Tank SS 304
Dosing Tank 25 Liters Provided
Low Level Switch Provided
Make Milton Roy
Model UC 11

 

Observation   Yes / No  Checked By  Sign &  Date
 Properly Installed and  Supported      
  • Comment:
  • Verified By: 
  • pH CORRECTION DOSING SYSTEM
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity One
Type Positive Displacement Pump
Pump Capacity 0.4 to 4 LPH
Max. Working Pressure 5.5 kg/cm2
MOC of Dosing Tank SS 304
Dosing Tank 25 Liters Provided
Low Level Switch Provided
Make Milton Roy
Model UC 11
pH Correction Chemical NaOH or Na2CO3

 

Observation  Yes / No  Checked By  Sign &  Date
Properly Installed and  Supported       
  • Comments:
  • Verified By:
  • MICRON CARTRIDGE FILTER
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
No. of Unit One
Type of Cartridge Spun Bounded Type
Rating 5 micron
Flow rate 3800 LPH
No. of Cartridge 2 nos. 20” long
MOC of Cartridge Housing SS 304
MOC of Cartridge PP ( Polypropylene)
Make of Cartridge Kumar/Pratham
 Make of Housing HydroPure Systems
  Surface Finish of Housing Internally – < 0.4 Ra

Externally – mirror up to 180 grit

Type of Filter Double open end filter

 

Observation   Yes / No  Checked By  Sign &  Date
 Properly Installed and  Supported      
  • Comments:
  • Verified By: 
  • REVERSE OSMOSIS HIGH PRESSURE PUMP-I:
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity One
Type Vertical Multistage Pump
Flow rate 3.8m3/hr (3800 LPH)
Pressure 12kg /cm2
Material of Construction SS 304 wettable parts
Voltage Requirement 415 volts
Make Grundfos

 

Observation

 

 Yes / No  Checked By  Sign &  Date
 Properly Installed and  Supported      
  • Comments:
  • Verified By:
  •  REVERSE OSMOSIS MEMBRANES:
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
No. of Membrane 4 Nos.
Size of Membrane 8” Dia. & 40” Long
Type of Membrane Thin Film Composite
Type of Sanitization Hot water Sanitizable
Materia   of

Construction

Polyamide
Make of Membrane  DOW
Model HSRO-390FF
Operating Temperature 450 C
Recovery 70 %
Feed Water Flow Rate  3800 m3/hr
Permeate Flow Rate 2700 m3/hr
Reject Water Flow Rate 1100 m3/hr
Sanitization Temp. 850 C

 

Observation

 

  Yes / No  Checked By  Sign &  Date
Properly Installed and  Supported       
  • Comment:
  • Verified By:
  • REVERSE OSMOSIS HOUSING:
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign  &  Date
No. of Housing one
No of RO Membranes Housing 1 4 Nos
Make of Housing Hydropure Systems
MOC SS 304
Diameter 204 mm
Length 4060  mm
Thickness 2.5 mm
Surface Finish of RO Housing Internally – < 0.4 Ra

Externally – mirror up to 180 grit

Max. Flow Rate for housing 4000 LPH
Permeate flow rate from RO Pass I 2.7 m3/hr.         

 

Observation Yes / No Checked By Sign &  Date
 Properly Installed and  Supported      
  • Comments:
  • Verified By:
  •  REVERSE OSMOSIS HIGH PRESSURE PUMP-II:
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity One
Type Vertical Multistage Pump
Flow rate 2.7 m3/hr (2700 LPH)
Pressure 9 kg/cm2
Material of Construction SS 316 wettable parts
Voltage Requirement 415 volts
Make Grundfos

 

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

Location: Within the RO Housing

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign  &  Date
No. of Membrane 2 Nos.
Size of Membrane 8” Dia. & 40” Long
Type of Membrane Thin Film Composite
Type of sanitization Hot water
Temperature of sanitization 850 C
Material of Construction Polyamide
Make of Membrane DOW.
Model HSRO-390FF
Operating Temperature 450 C
Recovery 80-85 %
Feed Water Flow Rate 2.7 m3/hr
Permeate Flow Rate 2.2 m3/hr

 

Observation  Yes / No Checked By  Sign &  Date
 Properly Installed and  Supported      
  • Comments:
  • Verified By:
  • REVERSE OSMOSIS HOUSING:
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign   &  Date
No. of Housing One
 Make of Housing HydroPure Systems
Material of Construction SS 316L
Diameter 204 mm
 Length 2040 mm
Thickness 2.5 mm
Surface Finish of RO Housing Internally – < 0.4 Ra

Externally – mirror up to 180 grit

 Max Feed Flow rate 3000 LPH

 

Observation  Yes / No  Checked By  Sign &  Date
 Properly Installed and  Supported      
  • Comments:
  •  Verified By 
  • ELECTRO DEIONIZATION UNIT:
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign   &  Date
No. of Unit One    
Type Hot Water Sanitizable    
 Model No. IP – LXM 24 – HI-3    
Minimum Flow rate 1400 ltrs/hr    
Maximum Flow rate 4200 Ltrs/hr    
 Normal Flow rate 2800 ltrs/hr    
End Connection 1” TC    
Operating Voltage DC 150 – 250 V DC    
Maximum Voltage 300 V    
Operating Current 1 – 3 Amps    
Maximum Current 5 – 6 Amps.    
Concentrate Flow rate(Reject) 250 LPH

 

   
Pressure Drop across concentrate 0.5 kg/cm2    
Max. Working Pressure 2.5 kg/cm2    
Make of EDI M/s. Ion Pure EDI, USA    
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign   &  Date
Material of Construction of different parts
Dilute Spacer Polysulfone    
Concentrate Spacer Polysulfone    
End Block Polypropylene    
Resin compartment O-rings                            FDA-grade silicon    
Anion exchange resin 1 Styrene / DVB, strong base,

type I

   
Anion exchange resin 2 Styrene / DVB, strong base,

type II

   
Cation exchange resin Styrene / DVB, strong acid    
Anion exchange membrane Heterogeneous PE/AER

 

   
Cation exchange membrane Heterogeneous PE/CER

 

   
Anode Platinized Titanium    
Cathode SS 316    

 

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

Comments:

Verified By:

CIP TANK

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity One    
Make Hydro pure
Type Plain Tank
Working Capacity 200 Liters
Gross Capacity 220 Liters
Tank Dia ID 600 mm
Shell Height 750 mm
Design Pressure & Tempe 3.5 Kg/cm2 & 120oC
Design Code cGMP
Top & Bottom Torispherical Dished end
M.O.C. of Shell SS 316 L
Nozzles Triclover end
Surface Finish Internally electro polished to <0.4 micron Ra

Externally buffed to mirror finish

 

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

Comments:

Verified By:

CIP FEED PUMP

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity One
Type Horizontal Multistage Pump
Flow rate 2.5 m3/hr (2500 liter/hr)
Pressure 2.9 kg / cm2
Material of Construction SS 316 wettable parts
Voltage Requirement 3 Phase, 415 volts
Make Grundfos

 

Observation  Yes / No Checked By Sign &  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 NO Location of Valve Size Type M.O.C. Remark
1 Before Raw Water Tank 32 mm Actuated Valve (NC) SS 304
2 ORP dump valve 25 mm Actuated Valve (NC) SS 304
3 RO-I Reject line (Auto Flushing) 20 mm Actuated Valve (NC) SS 304
4 RO-I Conductivity dump valve 20 mm Actuated Valve (NC) SS 304
5 RO-II Reject line (Auto Flushing) 20 mm Actuated Valve (NC) SS 304
6 RO-II Conductivity dump valve 20 mm Actuated Valve (NC) SS 304
7 Suction line of RWP-01 1.5” NB Manual Ball Valve SS 304
8 Discharge line of RWP-01 1.25” NB Manual Ball Valve SS 304
9 Suction line of RWP-02 1.5” NB Manual Ball Valve SS 304
10 Discharge line of RWP-02 1.25” NB Manual Ball Valve SS 304
11 MGF Inlet d40DN32 Manual Ball Valve UPVC
12 MGF outlet d40DN32 Manual Ball Valve UPVC
13 MGF back wash inlet d40DN32 Manual Ball Valve UPVC

 

Sr NO Location of Valve Size Type M.O.C. Remark
14 MGF back wash outlet d40DN32 Manual Ball Valve UPVC
15 MGF drain d40DN32 Manual Ball Valve UPVC
16 Softener-01 Inlet d40DN32 Manual Ball Valve UPVC
17 Softener-01 Outlet d40DN32 Manual Ball Valve UPVC
18 Softener-01 power water d25DN20 Manual Ball Valve UPVC
19 Softener-01 brine injection d40DN32 Manual Ball Valve UPVC
20 Softener-01 slow Rinse outlet d40DN32 Manual Ball Valve UPVC
21 Softener-01 Fast Rinse outlet d40DN32 Manual Ball Valve UPVC
22 Diversion line d40DN32 Manual Ball Valve UPVC
23 Discharge ROHP-01 25 mm Manual Ball Valve SS 304
24 Discharge ROHP-02 25 mm Manual Ball Valve SS 304
25 Discharge line of Raw Water Pump – 01 1.25” Non Return Valve SS 304
26 Discharge line of Raw Water Pump – 02 1.25” Non Return Valve SS 304
27 Conc. Inlet EDI DN 20 Diaphragm Valve SS 316
28 CIP Tank drain valve DN 20 Daiphragm Valve SS 316

 

 

Sr NO Location of Valve Size Type M.O.C. Remark
29 CIP Suction Valve DN 20 Daiphragm Valve SS 316
30 CIP Discharge Valve DN 20 Diaphragm Valve SS 316
31 ORP needle valve ¼ ” Needle valve SS 304
32 Reject line RO-01 20 mm Needle Valve SS 304
33 Reject line RO-02 20 mm Needle Valve SS 304
34 After  NaOCl-01 Dosing System 8 NB Sampling Valve SS 304
35 Inlet of Multi Grade Filter 8 NB Sampling Valve SS 304
36 Outlet of Multi Grade Filter 8 NB Sampling Valve SS 304
37 Outlet of Softener-01 8 NB Sampling Valve SS 304
38 After SMBS dosing system 8 NB Sampling Valve SS 316
39 After ADS dosing system 8 NB Sampling Valve SS 316
40 After pHC dosing system 8 NB Sampling Valve SS 316
41 After 5-micron Cartridge Filter 8 NB Sampling Valve SS 316
42 After RO pass-I 8 NB Sampling Valve SS 316
43 After RO pass-II 8 NB Sampling Valve SS 316
44 After EDI system 8 NB Sampling Valve SS 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/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 03 No
Make Waaree
Size of Gauge 100 mm Dial
Range 0 – 7 kg/cm2
End Connection 3/8” BSP (M)
MOC SS Body with SS internals
Location 1)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/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 03 No.
Make Waaree
Size of Gauge 63 mm Dial
Range 0 – 7 kg/cm2
End Connection 1/4” BSP (M)
MOC SS Body with SS internals
Damping Liquid Glycerin
Accuracy ± 1.6 % of FS
Location 1)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/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 04 No.
Make Waaree
Size of Gauge 63 mm Dial
Range 0 –21 kg/cm2
End Connection ¼” BSP (M)
MOC SS Body with SS internals
Damping Liquid Glycerin
Accuracy ± 1.6 % of FS
Location FOR 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/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Make Waaree
Size of Gauge 63 mm Dial
Range 0 –7 kg/cm2
End Connection ¼” BSP (M)
MOC SS Body with SS internals
Damping Liquid Glycerin
Accuracy ± 1.6 % of FS
Location Discharge line of CIP Feed

Pump-1     

 

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

 

  • ROTAMETER:

 

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 06 Nos.  
Make George Fischer  
End Connection Tri Clover end  
Type Variable Area  
Model SK  
MOC of float SS 316  
MOC of Measuring Tube SS  
 MOC of end connection  Nylon 6  
Accuracy class  2.5  

 

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Location 1) 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/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 01 Nos.
Make Aster Technology
Model FT-650
 Line Size 38 mm
Type Turbine Type
End Connection Threaded
Location Outlet of Softeners

 

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

 

  • FLOATY  LEVEL SWITCH:

 

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 01 Nos.
Make Innovative Technologies
 Type Floaty type
   MOC                       PVC
LOCATION Raw Water Tank

 

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

 

  • LOW LEVEL SWITCH:

 

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 05 Nos
Make Innovative Technology
Type Magnetic
   MOC                 PP
Location 1)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/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity One    
Make Dag Process    
MOC              SS 316    
Size       1.5”
Location Raw Water inlet line

 

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

 

ORP SENSOR TRANSMITTER & CONTROLLER

 

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity One
Make Forbes Marshall
 Range +1000 to – 1000 mV
End Connection  1” TC end connection
MOC of Electrode Glass
Location Inlet of RO pass – I

 

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

 

  •  CONDUCTIVITY SENSOR TRANSMITTER & CONTROLLER
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 02 No
Make Emerson
 Range 0 – 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
Location 1) 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/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 01 Nos    
Make Emerson
Range 0 – 10  µs/cm (EDI outlet)
End Connection 1 ½” TC end connection
MOC SS  316 wettable parts
Location Outlet of EDI system

 

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

 

  • HIGH PRESSURE SWITCH
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 02 Nos    
Make Danfoss
Range 1 to 16 bar
End Connection 3/8” BSP (M)
MOC  SS wettable parts
Type Seamless Bellow type pressure switch
Location 1)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/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 03 No  
Make Danfoss
Range 0 to 3 bar
End Connection 3/8” BSP (M)
MOC SS wettable parts
Type Seamless Bellow type pressure switch
Location 1) 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/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 01 No    
Make Mahalaxmi
Model SMT-16M 3” TC-AH
MOC SS  316
Location CIP Tank

 

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

 

  • TEMPERATURE INDICATOR & TRANSMITTER
DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 01 No    
Make Wika
Wetted material SS 316
Range 0  to 2000 C
Input PT – 100 (RTD)
Accuracy + / – 0.5% of F.S.
Ambient temp 250 C
Location CIP Feed Pump Discharge

 

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

 

CONTROL VALVES

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 06 Nos    
Make Avcon
Type Y- type Pneumatic operated ON-OFF
MOC SS Wettable Parts
 End Connection  TC end
Size As per valve schedule

 

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Location 1) 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/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 01 No    
Make Kumar Process
MOC SS 316L
 End Connection TC end
Size 1”
Location Outlet of EDI unit.

 

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

 

  • SAMPLING VALVE:

 

DETAILS/ PARAMETER ACCEPTANCE CRITERIA ACTUAL READING Sign &  Date
Quantity 07 Nos  
Make Kumar Process
Type Milipore Design
Size 8 NB
MOC SS 316L
Location RO-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. Description Corrective Action Observed by Approved 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 Documents Provided

Yes / No

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

 

  • ELECTRICAL CONTROL PANEL DETAILS
  • Acceptance Criteria:
Sr. No. Parameter Acceptance Criteria Checked by
1 Operation Electrically Operated
2 Dimension As suiting room dimensions, no strict specifications
3 Mounting Base Mounted
4 Fabrication & Finish 14-gauge sheet, Mat Finish
6 Alarm Systems Provided as per the safety alarm list
7 Power Cables Shall be of copper, 4 cores
8 Control 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

 

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