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 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 |
