Installation qualification for WFI generation plant
Customer or their authorized representatives are responsible for this SAT document.
All documents shall be checked and approved by QA or their authorized representatives.
Production personnel will perform this test.
OBJECTIVE
To confirm, by physical inspection and testing, that the fabrication and assembly of the equipment and any auxiliary support systems, conform to the Design parameters as per the Design Review,
SCOPE OF THIS DOCUMENT
The tests shall be carried out at customer’s place.
The verification of compliance to specifications as per DQ documents and GMP requirements
Shall be done by:
Physical Inspection of the electrical hardware.
Confirmation that all design Documents, specifications, and test certificates are approved, available, and accurate.
Mechanical inspection of the construction of the equipment.
CHECK POINTS & TESTING
LIST OF REFERENCE DOCUMENTS
Objective: To check the documents required for the job as per the checklist.
Material: Documents list submitted in the SAT.
Method: The submitted documents shall be checked for correct Document No., version No., date, and authorization details against the details submitted in the SAT Test form by the vendor.
Acceptance Criteria: The documents submitted shall be as specified in the list of reference documents.
| Title Of Document | Submittal Stage |
| List of the reference drawings | SAT |
| Material history chart with Test Certificates | SAT |
| Bought – out components | SAT |
| Components certification & calibration. | SAT |
| Dimensional report | SAT |
| Surface finish report | SAT |
LIST OF REFERENCE DRAWINGS
Objective: To check the reference drawing required for a job against the list mentioned below.
Material: Approved drawings list submitted in the SAT
Method: The submitted Drawings shall be checked for correct Drawings No., version No., date, and authorization details against the details submitted in the FAT Test form by the vendor. Record all the data on Form.
Acceptance Criteria: The drawings submitted shall be as specified in the list of reference drawings.
| Title Of Drawing | Submittal Stage |
| G.A.Drawing | SAT |
| P & I Diagram | SAT |
| Wiring Diagram | SAT |
| Pneumatic diagram | SAT |
| PLC Logic Diagram | SAT |
MATERIAL HISTORY CHART
Objective: To prove that the materials used for the construction of components are as per the DR specification/ Approved drawing.
Material: Material test certificates.
Method: The submitted certificates shall be checked for correct material usage against the details submitted in the DQ , by the vendor
Acceptance criteria: The certificates shall prove that the materials used for the construction of components are as per the approved specifications.
MATERIAL HISTORY CHART
| Part Description & Size | Acceptance Criteria |
| Material | |
| Column Fabrication 5” OD X 10 SWG | AISI 316L |
| Condenser Fabrication 4” OD x 14 SWG | AISI 316L |
| Condenser Tubes 12.7 MM OD X 1 MM Thk. | SA 213 TP 316L |
| Separator Fabrication 20 SWG Sheet | SA 240 TP 316L |
| F.W & C.W Cooler Fabrication 12 SWG Sheet | SA 240 TP 316L |
| Feed Water Cooler & Cooling water cooler Tubes 12.7 MM OD X 1 MM Thk. | SA 213 TP 316L |
| PIPELINES | |
| WFI Line:1.5”X1.6 5mm | ASME BPE 316L |
| Column to feed water cooler line:1.5” X1.65mm | ASME BPE 316L |
| Purified Water line:0.5”X1.65mm | ASME BPE 316L |
| Cooler Air vent line, ,0.5” X 1.65mm Thk | ASME BPE 316L |
| Feed water / cooling water Line& Interconnecting line, 0.5”x1.65mm | ASME BPE 316L |
| Cooling water line:0.5”X1.65mm | ASME BPE 316L |
| Plant steam line, 1.5 ” NB X SCH10 Pipe | AISI 304 |
| GASKETS | |
| MINI T/C Gasket | Silicone |
| 1/2” T/C Gasket | Silicone |
| 1” T/C Gasket | Silicone |
BOUGHT–OUT COMPONENTS
Objective: To prove that the bought-out components used for the construction of the equipment are as per the approved specifications.
Material: Bought Out components specification sheets (From the original manufacturer)
Method: Inspect the installed component. Compare the Quality Certificate of the component the make, Model No. and other specifications with the approved specifications.
Acceptance criteria: The verification shall prove that the bought-out components used for the construction of the equipment is as per the approved specifications.
| Component | Make | Certificate Type | |
| MECHANICAL COMPONENTS | |||
| Feed Pump | Grundfos | Compliance Certificate | |
| Cooling Pump | Grundfos | Compliance Certificate | |
| Non Return valve | Alfa Laval | Test Certificate | |
| Non Return valve | Valcon | Test Certificate | |
| Flow meter | George Fischer | Compliance Certificate | |
| Ball Valves | Shakti | Test Certificate | |
| Globe Valve | Shakti | Test Certificate | |
| Pneumatic valve | Gemu | Compliance Certificate | |
| Diaphragm Valve for Feed Pump | Crane (Saunders) | Test Certificate | |
| Pressure Gauge for Boiler Steam | Waaree | Calibration Certificate | |
| Pressure Gauge for Feed Water | Waaree | Calibration Certificate | |
| Steam trap | Spirax | Test Certificate | |
| Safety valve | Spirax | Test Certificate | |
| Sampling Valve | Pharmalab | Test Certificate | |
| Sanitary Dumping Valve | Ciparani | Test Certificate | |
| Needle valve | Shakti | Test Certificate | |
| Disposable Vent Filter | Pall | Test Certificate | |
| ELECTRICAL COMPONENTS | |||
| PLC | Allen Bradley | Test Certificate | |
| Display | Allen Bradley | Test Certificate | |
| Conductivity Converter | Yokogawa | Calibration Certificate | |
| Conductivity Sensor | Yokogawa | Calibration Certificate | |
| Pressure Switch at the inlet of the feed water pump | Orion | Test Certificate | |
| Pressure switch at the discharge side of a feed pump | Orion | Test Certificate | |
| Pressure switch at the suction side of cooling pump | Orion | Test Certificate | |
| Air Pressure Switch | Orion | Test Certificate | |
| Temperature sensor | Radix | Calibration Certificate | |
| Liquid Level Sensor | E+H | Compliance Certificate | |
COMPONENTS CERTIFICATION & CALIBRATION
Objective: To verify the Test certificates and Calibration certificates of the designated components.
Material: Test certificates and Calibration certificates of the designated components (From the original manufacturer or a certified calibration laboratory).
Method:·Check whether the certificate corresponds to the installed component.
Compare the make, Model No. and other specifications from the certificate with the specifications of the component and in the table below.
Check the accuracy of the certificate.
Acceptance criteria: The verification shall prove that the designated components used for the construction of the equipment are properly tested/calibrated.
COMPONENTS CERTIFICATION & CALIBRATION
| Component | Make | |
| MECHANICAL COMPONENTS | ||
| Feed water pump | Grundfos | |
| Cooling water pump | Grundfos | |
| Non-Return Valve for cooling air vent: DN25 (NRV1) | Alfa Laval | |
| Non-Return Valve at WFI rejection line: DN25 (NRV2) | Valcon | |
| Sampling Valve :DN15 (SM2,SM3,SM4) | Gemu | |
| WFI Sampling Valve: DN15(SM1) | Gemu | |
| Variable area flow meter discharge side of feed pump: 100-1000 LPH (FI1) | George Fischer | |
| Variable area flow meter discharge side of cooling pump: 100-1000 LPH (FI2) | George Fischer | |
| Pneumatic Valve for the last column purging line: DN15 (PNA1) | Gemu | |
| Pneumatic Valve at cooling water inlet line: DN15 (PNA2) | Gemu | |
| 2-Way Pneumatic valve (DN 25) At the cooling water of the heat exchanger(PNA3) | Gemu | |
| Pneumatic Valve at Feed water inlet line: DN15 (PND2) | Gemu | |
| Pneumatic Valve for cooler air vent: DN20 (PND1) | Gemu | |
| Diaphragm valve(DN 15)At feed water inlet (DP2) | Gemu | |
| Globe Valve at the inlet of Plant Steam: 40 MM (GV1) | Shakti | |
| Diaphragm valve at the outlet of feed pump: DN 15 | Gemu | |
| Air regulator At the Inlet of the compressed air (APR1) | Festo | |
| Steam Trap at first column air vent: BPT -21: 15NB (ST2) | Spirax | |
| Safety Valve at the inlet of plant steam line: ¾” (SV1) | Spirax | |
| Ball Valve for 1st column drain: ½” (BV1) | Shakti | |
| Ball Valve for plant steam condensate drain bypass to steam strap: ½” (BV3) | Shakti | |
| Ball valve at Plant steam condensate drain through the first column: ½” (BV2) | Shakti | |
| Needle valve at cooling water line: ½” (NV1) | Shakti | |
| Sanitary Dumping Valve: DN40 (DV1) | Ciparani | |
| Pressure Gauge for plant steam line :0-16 Kg/cm² (PG1) | Waaree | |
| Sanitary Pressure Gauge Glycerin filled at the discharge side of the feed pump 0-16 Kg/cm² (PG2) | Waaree | |
| Disposable Vent Filter at Cooler air vent line | Pall | |
| Steam Trap FT-14CI-10 (c), 15 NB At Boiler Steam Condensate line (ST1) | Spirax | |
| Plate-type heat exchanger For drain cooling (PHE1) | Swep International | |
| ELECTRICAL COMPONENTS | ||
| PLC | 1766L32BXBA | Allen Bradley |
| Conductivity Sensor at the inlet of feed pump (CS1) | Yokogawa | |
| Conductivity Sensor at the WFI line(CS2) | Yokogawa | |
| Temperature Sensor (-50o C to 200o C) For third column (TS6) | Radix | |
| Temperature Sensor (-50o C to 200o C) At the WFI water outlet line (TS2) | Radix | |
| Temperature Sensor (-50o C to 200o C) At the Boiler steam inlet line (TS1) | Radix | |
| Temperature Sensor (-50o C to 200o C) At the cooling water outlet line (TS3) | Radix | |
| Temperature Sensor( -50o C to 200o C) For first column (TS4) | Radix | |
| Temperature Sensor (-50o C to 200o C) For second column (TS5) | Radix | |
| Temperature Sensor (-50o C to 200o C) For last column (TS7) | Radix | |
| Temperature Sensor (-50o C to 200o C) At the drain cooling (TS8) | Radix | |
| Air Pressure Switch: 0.5 to 7 Bar (PS1) | Orion | |
| Sanitary Pressure Switch at the discharge side of the feed pump: 1 to 15 Bar (PS2) | Orion | |
| Sanitary Pressure Switch at the inlet of Feed water pump: 0.2 to 2.6 Bar (PS3) | Orion | |
| Pressure switch at the suction side of cooling pump: 0.2 to 2.6 Bar (PS5) | Orion | |
| Liquid level sensor for the first column (LS1) | E+H | |
| Liquid level sensor for the last column (LS2) | E+H | |
DIMENSIONAL CHECKS
Objective: Dimension check against Approved GA Drawings.
Instruments: Measure Tape 0-3000mm, Vernier Caliper 0- 300 mm,
Method: Direct measurement of Overall dimensions and connection Points. Install the plant in a suitable place. Measure the indicated dimensions and fill in the dimension report.
Acceptance Criteria: All the measured dimensions shall be within the dimensional tolerances.
DIMENSIONAL MEASUREMENTS
| Parameter |
| Overall Width W |
| Overall Depth D |
| WFI Outlet Height |
UTILITY CONNECTION POINTS CHECKS
| Description | Value from GA Drawing (mm) |
| Feed water Inlet | 1” TRICLOVER |
| Cooling water Inlet | 1” TRICLOVER |
| Compressed air inlet | ½” BSPT (F) THD |
| WFI outlet | 1” TRICLOVER TO SUIT 1.5” OD TUBE |
| Header Drain | 1.5” BSP (F) Thd. |
| Header air vent | 1” BSP (F) Thd. |
SURFACE FINISH TESTS
Objective: To check the surface finish of the surface of the plant and to verify against the approved drawing requirement.
Instruments: Verification of documents submitted by a vendor
Acceptance Criteria: All the surfaces tested shall meet the requirements.
PLC INPUT OUTPUT CHECK
Objective: To check the Input Output and to verify against the wiring diagram requirement.
Method: Check the input output against the wiring diagram visually during operation. Results shall be recorded.
Acceptance Criteria: All the Input and output shall meet the requirements.
| TEST TO BE CARRIED OUT & PROCEDURE | ACCEPTANCE CRITERION |
| Check the input-output against the wiring diagram visually during operation. | All the Input and output shall meet the requirements. |
SUMMARY REPORT
Summary of the results obtained during IQ:
Significant deviations observed during IQ:
Conclusions:
INSTALLATION QUALIFICATION REPORT APPROVAL
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