Installation qualification for purified water generation system
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 system for installation by the manufacturer’s 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 shall be verified for availability, including manufacturer’s cut sheets, weld reports, etc. for the components described in this protocol.
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.
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.
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:
(Based on maximum feed water limiting condition)
| Water Parameter | Outlet of Multi-Grade Filter | Outlet of Softener | The outlet of RO Pass I | The outlet of RO Pass II |
| pH | 6 to 8.5 | 6 to 8.5 | 5 – 6 | 5 – 6 |
| TSS | < 5 ppm | < 5 ppm | Nil | Nil |
| TDS/ Conductivity | 1920 us/cm | 1920 us/cm | 200 us/cm | 25 us/cm |
| Total Hardness (in ppm) | 350 ppm | Less than 5 ppm | Nil | Nil |
| SDI | < 3 | 3.0 max | Nil | Nil |
| TOC | 1000 ppb | 1000 ppb | 500 ppb | 200 ppb |
| 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.)
| Water Parameters | USP | Action Limit | Alert Limit | Design Limit |
| Conductivity | 1.25 µs/cm | 1.0 µs/cm | 0.8 µs/cm | 0.7 µs/cm |
| TOC in PPB | 500 ppb | 300 ppb | 200 ppb | 100 ppb |
| 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 be 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 the supply, erection, and commissioning of the system are as shown below:
| Nature of Job | Name & Address of Contractor |
| 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
- Antiscalant 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 generates 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 the Raw Water Tank is dosed with Sodium Hypochlorite 1 – 2 ppm. The 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 downflow vessel containing pure graded silex quartz as a filtering media. The vessel is fabricated in FRP. The water generated at the outlet of the Multi Grade Filter will have suspended solids of less than 5 ppm. Multi Grade Filter is provided with Manual Backwash. We have provided manual ball valves for the changeover from normal operation to Backwash operation.
(Note that the inlet suspended solid load should not be more than 50 ppm).
The water from the grade Filter is passed through the Softener. Hardness after softener is less than 5 ppm. Soft Water after the Softener unit is fed to the 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.
Antiscalant 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 a 5 5-micron Cartridge Filter to trap the suspended solids. This will avoid choking of RO membranes due to suspended solids.
ORP Analyzer is provided 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 employing 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 of less than 150 ppm. The semi-permeable reverse osmosis membrane has a molecular weight cut off less than 150 MWCO. The Reveres Osmosis membrane acts as a positive barrier to remove dissolved solids, organic compounds & bacteria.
The Reverse Osmosis System consists of a 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 fed to RO pass two systems. 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 a 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 the RO system will be fed to the Electro Deionization Unit (EDI) having a 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 the 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 are a continuous exercise that shall begin right from the time the project is initiated and this protocol defines the specifications procedure and 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:
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 –Acceptance Criteria
Verify that the ‘As Built’ drawings are complete and represent the design concept.
Verify that there is sufficient room for servicing provided.
Verify that all piping and electrical connections have been done according to the approved drawing.
All-access parts are examined and cleared of debris.
Walking access parts to roof-mounted equipment are provided.
Required electrical connections are properly wired.
The wiring diagram is glued or kept inside the pocket provided inside the control panel.
The equipment identification nameplate is visible.
Units are installed on the Skid and secured in place as per manufacturer recommendations.
Verified that major components are securely anchored and protected from shock.
Does the installation report have any deficiencies?
If yes are they rectified?
Are all safety features accounted for?
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
- Antiscalant 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
MAJOR EQUIPMENT OF PRETREATMENT & PURIFIED WATER GENERATION SYSTEM:
PRE SODIUM HYPOCHLORITE DOSING SYSTEM
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
| Flow rate | 7 m3/hr (7000 liter/hr) |
| Head | 35 mW |
| Material of Construction | SS 304 |
| Make | Nanfang |
MULTIGRADE FILTER:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
| 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 |
| 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 |
ANTISCALANT DOSING SYSTEM:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
REVERSE OSMOSIS HOUSING:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 the 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 are a continuous exercise that shall begin right from the time the project is initiated and this protocol defines the specifications procedure and 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.
CHECKS ON VALVES
| Location of Valve | Size | Type | M.O.C. |
| Before Raw Water Tank | 32 mm | Actuated Valve (NC) | SS 304 |
| ORP dump valve | 25 mm | Actuated Valve (NC) | SS 304 |
| RO-I Reject line (Auto Flushing) | 20 mm | Actuated Valve (NC) | SS 304 |
| RO-I Conductivity dump valve | 20 mm | Actuated Valve (NC) | SS 304 |
| RO-II Reject line (Auto Flushing) | 20 mm | Actuated Valve (NC) | SS 304 |
| RO-II Conductivity dump valve | 20 mm | Actuated Valve (NC) | SS 304 |
| Suction line of RWP-01 | 1.5” NB | Manual Ball Valve | SS 304 |
| Discharge line of RWP-01 | 1.25” NB | Manual Ball Valve | SS 304 |
| Suction line of RWP-02 | 1.5” NB | Manual Ball Valve | SS 304 |
| Discharge line of RWP-02 | 1.25” NB | Manual Ball Valve | SS 304 |
| MGF Inlet | d40DN32 | Manual Ball Valve | UPVC |
| MGF outlet | d40DN32 | Manual Ball Valve | UPVC |
| MGF back wash inlet | d40DN32 | Manual Ball Valve | UPVC |
| MGF back wash outlet | d40DN32 | Manual Ball Valve | UPVC |
| MGF drain | d40DN32 | Manual Ball Valve | UPVC |
| Softener-01 Inlet | d40DN32 | Manual Ball Valve | UPVC |
| Softener-01 Outlet | d40DN32 | Manual Ball Valve | UPVC |
| Softener-01 power water | d25DN20 | Manual Ball Valve | UPVC |
| Softener-01 brine injection | d40DN32 | Manual Ball Valve | UPVC |
| Softener-01 slow Rinse outlet | d40DN32 | Manual Ball Valve | UPVC |
| Softener-01 Fast Rinse outlet | d40DN32 | Manual Ball Valve | UPVC |
| Diversion line | d40DN32 | Manual Ball Valve | UPVC |
| Discharge ROHP-01 | 25 mm | Manual Ball Valve | SS 304 |
| Discharge ROHP-02 | 25 mm | Manual Ball Valve | SS 304 |
| Discharge line of Raw Water Pump – 01 | 1.25” | Non-Return Valve | SS 304 |
| Discharge line of Raw Water Pump – 02 | 1.25” | Non-Return Valve | SS 304 |
| Conc. Inlet EDI | DN 20 | Diaphragm Valve | SS 316 |
| CIP Tank drain valve | DN 20 | Diaphragm Valve | SS 316 |
| CIP Suction Valve | DN 20 | Diaphragm Valve | SS 316 |
| CIP Discharge Valve | DN 20 | Diaphragm Valve | SS 316 |
| ORP needle valve | ¼ ” | Needle valve | SS 304 |
| Reject line RO-01 | 20 mm | Needle Valve | SS 304 |
| Reject line RO-02 | 20 mm | Needle Valve | SS 304 |
| After NaOCl-01 Dosing System | 8 NB | Sampling Valve | SS 304 |
| Inlet of Multi-Grade Filter | 8 NB | Sampling Valve | SS 304 |
| Outlet of Multi-Grade Filter | 8 NB | Sampling Valve | SS 304 |
| Outlet of Softener-01 | 8 NB | Sampling Valve | SS 304 |
| After the SMBS dosing system | 8 NB | Sampling Valve | SS 316 |
| After the ADS dosing system | 8 NB | Sampling Valve | SS 316 |
| After the pHC dosing system | 8 NB | Sampling Valve | SS 316 |
| After the 5-micron Cartridge Filter | 8 NB | Sampling Valve | SS 316 |
| After RO pass-I | 8 NB | Sampling Valve | SS 316 |
| After RO pass-II | 8 NB | Sampling Valve | SS 316 |
| 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.
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 |
| 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 (Size of Gauge -63 mm Dial)
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 microns Cartridge Filter 3)Inlet line of EDI System |
PRESSURE GAUGES: (Size of Gauge –63 mm Dial )
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 GAUGES: (Range –0 –7 kg/cm2 )
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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: (End Connection –Tri Clover end )
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
| 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
| PARAMETER | ACCEPTANCE CRITERIA |
| Line Size | 38 mm |
| Type | Turbine Type |
| End Connection | Threaded |
| Location | Outlet of Softeners |
FLOATY LEVEL SWITCH:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Type | Floaty type |
| MOC | PVC |
| LOCATION | Raw Water Tank |
LOW-LEVEL SWITCH:
| PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
| MOC | SS 316 |
| Size | 1.5” |
| Location | Raw Water inlet line |
ORP SENSOR TRANSMITTER & CONTROLLER
| PARAMETER | ACCEPTANCE CRITERIA |
| Range | +1000 to – 1000 mV |
| End Connection | 1” TC end connection |
| MOC of Electrode | Glass |
| Location | The inlet of RO pass – I |
CONDUCTIVITY SENSOR TRANSMITTER & CONTROLLER
| PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
| 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 |
| 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 |
| 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 |
| Model | SMT-16M 3” TC-AH |
| MOC | SS 316 |
| Location | CIP Tank |
TEMPERATURE INDICATOR & TRANSMITTER
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| 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 |
| Type | Y-type Pneumatic operated ON-OFF |
| MOC | SS Wettable Parts |
| End Connection | TC end |
| Size | As per the valve schedule |
Location
1) Raw Water Inlet line
2) Before RO High Pressure – I (ORP Dump)
3) Reject the line of RO pass – I (Auto Rinse Valve)
4) Permeate line of RO pass – I (CIC Dump)
5) Reject the line of RO pass – II (Auto Rinse Valve)
6) Permeate line of RO pass – II (CIC Dump)
FLOW DIVERTER VALVE
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| MOC | SS 316L |
| End Connection | TC end |
| Size | 1” |
| Location | Outlet of EDI unit. |
SAMPLING VALVE:
| DETAILS/ PARAMETER | ACCEPTANCE CRITERIA |
| Type | Millipore 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 the 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 are a continuous exercise that shall begin right from the time the project is initiated and this protocol defines the specifications procedure and 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.
Acceptance Criteria
- The pump should be mounted rigidly & properly on the skid.
- Non-return valves should be provided wherever necessary.
- Sampling valves should be provided between every two pieces of equipment or wherever necessary to provide isolation and targeting of problems.
- Straight piping runs should be supported at least every ten feet.
- A dosing point should be provided in the bottom portion of the pipe.
- All pipes shall be properly supported.
- All tanks and pumps must be completely self-drainable.
- The piping should have a 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 the 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 do not meet the acceptance criteria. Exception Report must be completed in the 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 based on documentation provided by the vendor. The list of documents (& drawings) to be verified for availability is as follows:
Specified Documents
- As-built Drawing
- Electrical Drawing
- Hydro Test Report
- Standard Operating Procedures
- Cleaning / Sanitization Procedures
- Passivation Report
- Calibration Certificates
- Components Test Certificates
- MOC Certificates
- Pump Performance Curve
- Guarantee / Warranty Certificate
- Welding Protocol / Certificate / Welding Log
- Surface Finishing Certificates
- Manufactures & Preventive Maintenance Manual
- PLC & MMI Certificates
- Spare Part List
ELECTRICAL CONTROL PANEL DETAILS
| Parameter | Acceptance Criteria |
| Operation | Electrically Operated |
| Dimension | As for suiting room dimensions, no strict specifications |
| Mounting | Base Mounted |
| Fabrication & Finish | 14-gauge sheet, Mat Finish |
| Alarm Systems | Provided as per the safety alarm list |
| Power Cables | Shall be of copper, 4 cores |
| Control Wiring | Shall be of copper, stranded, PVC insulated |
FINAL REPORT
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.
Report approval.
The Installation qualification report for the Purified Water Generation System is reviewed and complies/does not comply with requirements.
