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:
| 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 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 |
| 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:
PRE TREATMENT: (3800 LPH)
Pre Sodium Hypo Chlorite Dosing System
Raw Water Pumps
Multi Grade Filter
Softener Unit
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
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:
Water Sanitizable Electro – Deionization Unit
Conductivity meter with Alarm
Verified By:
MAJOR EQUIPMENTS OF PRETREATMENT & PURIFIED WATER GENERATION SYSTEM:
PRE SODIUM HYPOCHLORITE DOSING SYSTEM
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
RAW WATER PUMPS (1W + 1SB):
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Type | Horizontal Multistage pump |
| Flow rate | 7 m3/hr (7000 liter/hr) |
| Head | 35 mWC |
| Material of Construction | SS 304 |
| Make | Nanfang |
MULTI GRADE FILTER:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
| 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 |
SOFTENER
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 liters |
| 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 |
| 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 |
SODIUM META BISULPHITE DOSING SYSTEM:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
ANTISCALENT DOSING SYSTEM:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 DOSING SYSTEM
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
MICRON CARTRIDGE FILTER
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 | Hydro Pure Systems |
| Surface Finish of Housing | Internally – < 0.4 Ra
Externally – mirror up to 180 grit |
| Type of Filter | Double open end filter |
REVERSE OSMOSIS HIGH PRESSURE PUMP-I:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
REVERSE OSMOSIS MEMBRANES:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Size of Membrane | 8” Dia. & 40” Long |
| Type of Membrane | Thin Film Composite |
| Type of Sanitization | Hot water Sanitizable |
| Materia ofConstruction | 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 |
REVERSE OSMOSIS HOUSING:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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. |
REVERSE OSMOSIS HIGH PRESSURE PUMP-II:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
REVERSE OSMOSIS MEMBRANES
Location: Within the RO Housing
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
REVERSE OSMOSIS HOUSING:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
ELECTRO DEIONIZATION UNIT:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
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 |
CIP TANK
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
CIP FEED PUMP
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
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. |
| 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. |
| 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. |
| 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 |
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 |
| 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 |
PRESSURE GAUGES
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
PRESSURE GUAGES:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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. |
PRESSURE GUAGES:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
ROTAMETER:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
| 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) |
FLOW INDICATOR TOTALIZER
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Model | FT-650 |
| Line Size | 38 mm |
| Type | Turbine Type |
| End Connection | Threaded |
| Location | Outlet of Softeners |
FLOATY LEVEL SWITCH:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Make | Innovative Technologies |
| Type | Floaty type |
| MOC | PVC |
| LOCATION | Raw Water Tank |
LOW LEVEL SWITCH:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
FLOW SWITCHES:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Make | Dag Process |
| MOC | SS 316 |
| Size | 1.5” |
| Location | Raw Water inlet line |
ORP SENSOR TRANSMITTER & CONTROLLER
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Make | Forbes Marshall |
| Range | +1000 to – 1000 mV |
| End Connection | 1” TC end connection |
| MOC of Electrode | Glass |
| Location | Inlet of RO pass – I |
CONDUCTIVITY SENSOR TRANSMITTER & CONTROLLER
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
CONDUCTIVITY SENSOR TRANSMITTER & CONTROLLER:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
HIGH PRESSURE SWITCH
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
LOW PRESSURE SWITCH:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
LEVEL SWITCH for CIP Tank:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Make | Mahalaxmi |
| Model | SMT-16M 3” TC-AH |
| MOC | SS 316 |
| Location | CIP Tank |
TEMPERATURE INDICATOR & TRANSMITTER
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
CONTROL VALVES
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Make | Avcon |
| Type | Y- type Pneumatic operated ON-OFF |
| MOC | SS Wettable Parts |
| End Connection | TC end |
| Size | As per valve schedule |
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)
FLOW DIVERTER VALVE
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Make | Kumar Process |
| MOC | SS 316L |
| End Connection | TC end |
| Size | 1” |
| Location | Outlet of EDI unit. |
SAMPLING VALVE:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Make | Kumar Process |
| Type | Milipore Design |
| Size | 8 NB |
| MOC | SS 316L |
| Location | RO-EDI Distribution Piping |
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.
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 |
| 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 |
ELECTRICAL CONTROL PANEL DETAILS
Acceptance Criteria:
| Sr. No. | Parameter | Acceptance Criteria |
| 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 |
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.
