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Installation qualification for WFI generation plant

  •  RESPONSIBILITES
  • Inspection 
  • 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 personal 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, conforms to the Design parameters as per the Design Review,
  • SCOPE OF THIS DOCUMENT
  • The tests shall be carried out at customer place.
  • The verification of compliance to specifications as per DQ documents and to 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.
  • ABBREVIATIONS
ABBREVIATIONS FULL FORM
PO Purchase Order
MOC Material Of Construction
PLC Programmable Logic Controller
RPM Rotations Per Minute
HP Horse Power
T/C Triclover
FAT Factory Acceptance Test
ASME American Society of Mechanical Engineers
MMI Man Machine Interface
DP Diaphragm
AV Air vent
PG Pressure Gauge
SV Safety Valve
STU Steam Trap Unit
  • CHECK POINTS & TESTING
  • LIST OF REFERENCE DOCUMENTS
Objective To check the documents required for job as per checklist.
Material  Documents list submitted in the SAT.
Method The submitted documents shall be checked for correct Documents 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.

 

Sr. No. Title Of Document Submittal Stage Document No. Remarks
1. List of the reference drawings SAT  

 

2. Material history chart with Test Certificates SAT  

 

3. Bought – out components SAT
4. Components certification & calibration. SAT  

 

5. Dimensional report SAT
6. Surface finish report SAT

 

Corrective action

In case of Non Compliance

 

 

 

 

Conclusions
  Performed By Checked By
Name
Signature
Date
  • LIST OF REFERENCE DRAWINGS
Objective To check reference drawing required for job against list mention 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 drawing.

 

Sr. No. Title Of Drawing Submittal Stage Drawing No. Rev. Remarks
1. G.A.Drawing SAT
2. P & I Diagram SAT
3. Wiring Diagram SAT
4. Pneumatic diagram SAT
5. PLC Logic Diagram SAT

 

Corrective action

In case of Non Compliance

 

 

 

Conclusions
  Performed By Checked By
Name
Signature
Date
  • MATERIAL HISTORY CHART
Objective To prove that the materials used for 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 construction of components are as per the approved specifications.
  • MATERIAL HISTORY CHART
Sr. No. Part Description & Size Acceptance Criteria Result Remarks
Material Certificate No.
1. Column Fabrication

5” OD X 10 SWG

AISI 316L
2. Condenser Fabrication

4” OD x 14 SWG

AISI 316L
3. Condenser Tubes

12.7 MM OD X 1 MM Thk.

SA 213 TP 316L
4. Separator Fabrication

20 SWG Sheet

SA 240 TP 316L
5. F.W & C.W Cooler Fabrication

12 SWG Sheet

SA 240 TP 316L
6. Feed Water  Cooler & Cooling water cooler Tubes

12.7 MM OD X 1 MM Thk.

SA 213 TP 316L
PIPE LINES
 1. WFI Line:1.5”X1.6 5mm ASME BPE 316L
 2. Column to feed water cooler line:1.5”X1.65mm ASME BPE 316L
 3. Purified Water line:0.5”X1.65mm ASME BPE 316L
 4. Cooler Air vent line, ,0.5” X 1.65mm Thk ASME BPE 316L
 5. Feed water / cooling water Line& Inter connecting line, 0.5”x1.65mm ASME BPE 316L
 6. Cooling  water line:0.5”X1.65mm ASME BPE 316L
 7. Plant steam line,

1.5 ” NB X SCH10 Pipe

AISI 304
GASKETS
 1. MINI T/C Gasket Silicone
 2. 1/2” T/C Gasket Silicone
 3. 1” T/C Gasket Silicone

 

Corrective action

In case of Non Compliance

 

 

 

Conclusions
  Performed By Checked By
Name
Signature
Date
  • BOUGHT – OUT COMPONENTS
Objective To prove that the Bought Out components used for 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 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 construction of the equipment is as per the approved specifications.

 

Sr. No. Component Make Certificate Type QTY.
MECHANICAL COMPONENTS
1. Feed Pump Grundfos Compliance Certificate 01 No.
2. Cooling Pump Grundfos Compliance Certificate 01 No.
3. Non Return valve Alfa Laval Test Certificate 01 Nos.
4. Non Return valve Valcon Test Certificate 01 Nos.
5. Flow meter George Fischer Compliance Certificate 02 Nos.
6. Ball Valves Shakti Test Certificate 03 Nos.
7. Globe Valve Shakti Test Certificate 01 No.
8. Pneumatic valve Gemu Compliance Certificate 04 Nos.
9. Diaphragm Valve for Feed Pump Crane (Saunders) Test Certificate 01 No.
10. Pressure Gauge for Boiler Steam Waaree Calibration Certificate 01 No.
11. Pressure Gauge for Feed Water Waaree Calibration Certificate 01 No.
12. Steam trap Spirax Test Certificate 02 Nos.
13. Safety valve Spirax Test Certificate 01 No.
14. Sampling Valve Pharmalab Test Certificate 05 Nos.
15. Sanitary Dumping Valve Ciparani Test Certificate 01 No.
16. Needle valve Shakti Test Certificate 01 No.
17. Disposable Vent Filter Pall Test Certificate 01 No.
ELECTRICAL COMPONENTS
PLC Allen Bradley Test Certificate 01 Set.
Display Allen Bradley Test Certificate 01 No.
Conductivity Converter Yokogawa Calibration Certificate 01 No.
Conductivity Sensor Yokogawa Calibration Certificate 02 Nos.
Pressure Switch at inlet of feed water pump Orion Test Certificate 01 No.
Pressure switch at discharge side of feed pump Orion Test Certificate 01 No.
Pressure switch at suction side of cooling pump Orion Test Certificate 01 No.
Air Pressure Switch Orion Test Certificate 01 No.
Temperature sensor Radix Calibration Certificate 03 Nos.
Liquid Level Sensor E+H Compliance Certificate 02 Nos.

 

Corrective action

In case of Non Compliance

Conclusions
  Performed By Checked By
Name    
Signature    
Date    
  • 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 from 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 construction of the equipment are properly tested / calibrated.

 

  • COMPONENTS CERTIFICATION & CALIBRATION 
Sr. No. Component Make Sr. No. / I.D. No Certificate No.
MECHANICAL COMPONENTS
1. Feed water pump Grundfos
2. Cooling water pump Grundfos
3. Non Return Valve for cooling air vent: DN25 (NRV1) Alfa Laval
4. Non Return Valve at WFI rejection line: DN25 (NRV2) Valcon
5. Sampling Valve :DN15 (SM2,SM3,SM4) Gemu
6. WFI Sampling Valve  : DN15(SM1) Gemu
7. Variable area flow meter discharge side of feed pump : 100-1000 LPH  (FI1) George Fischer
8. Variable area flow meter discharge side of cooling pump : 100-1000 LPH (FI2) George Fischer
9. Pneumatic Valve for last column  purging line: DN15 (PNA1) Gemu
10. Pneumatic Valve at cooling water inlet line : DN15 (PNA2) Gemu
11. 2 Way Pneumatic valve (DN 25) At the cooling water of heat exchanger(PNA3) Gemu
12. Pneumatic Valve at Feed water inlet line: DN15 (PND2) Gemu
13. Pneumatic Valve for cooler air vent :

DN20 (PND1)

Gemu
14. Diaphragm valve(DN 15)At feed water inlet (DP2) Gemu
15. Globe Valve at inlet of Plant Steam : 40 MM (GV1) Shakti
16. Diaphragm valve at outlet of  feed  pump:       DN 15 (DP1) Gemu
17. Air regulator At the Inlet of the compressed air (APR1) Festo
18. Steam Trap at first column air vent :

BPT -21: 15NB   (ST2)

Spirax
19. Safety Valve at inlet of plant steam line : ¾”  (SV1) Spirax
20. Ball Valve for 1st column drain: ½” (BV1) Shakti
21. Ball Valve for plant steam condensate drain  bypass to  steam strap: ½”  (BV3) Shakti
22. Ball valve at Plant steam condensate drain through first column: ½”  (BV2) Shakti
23. Needle valve at cooling water line: ½”  (NV1) Shakti
24. Sanitary Dumping Valve : DN40 (DV1) Ciparani
25. Pressure Gauge for plant steam line :

0-16 Kg/cm²  (PG1)

Waaree
26. Sanitary Pressure Gauge Glycerin filled  at discharge side of  feed pump

0-16 Kg/cm²  (PG2)

Waaree
27. Disposable Vent Filter at Cooler air vent line : KA1PFRP1 (VF1) Pall
28. Steam Trap FT-14CI-10 (c), 15 NB At Boiler Steam Condensate line (ST1) Spirax
29. Plate type heat exchanger For drain cooling (PHE1) Swep International
ELECTRICAL COMPONENTS
1. PLC

 

1766L32BXBA

1762 IR4

Allen Bradley
2. Display  :PVP 600 Allen Bradley
3. Conductivity Converter Yokogawa
4. Conductivity Sensor at inlet of feed pump (CS1) Yokogawa
5. Conductivity Sensor at the WFI line(CS2) Yokogawa
6. Temperature Sensor (-50o C to 200o C) For third column (TS6) Radix
7. Temperature Sensor (-50o C to 200o C) At the WFI water outlet line (TS2) Radix
8. Temperature Sensor (-50o C to 200o C) At the Boiler steam inlet line (TS1) Radix
9. Temperature Sensor (-50o C to 200o C) At the cooling water outlet line (TS3) Radix
10. Temperature Sensor( -50o C to 200o C) For first column (TS4) Radix
11. Temperature Sensor (-50o C to 200o C) For second column (TS5) Radix
12. Temperature Sensor (-50o C to 200o C) For last column (TS7) Radix
13. Temperature Sensor (-50o C to 200o C) At the drain cooling (TS8) Radix
14 Air Pressure Switch : 0.5 to 7 Bar (PS1) Orion
15 Sanitary Pressure Switch at the discharge side of feed pump : 1 to 15 Bar (PS2) Orion
16. Sanitary Pressure Switch at inlet of Feed water pump : 0.2 to 2.6 Bar (PS3) Orion
17 Pressure switch at suction side of cooling pump : 0.2 to 2.6 Bar (PS5) Orion
18. Liquid level sensor  for first column (LS1) E+H
19. Liquid level sensor for  last column (LS2) E+H

 

Corrective action

In case of Non Compliance

 

 

Conclusions
  Performed By Checked By
Name    
Signature    
Date    
  • 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, Connection Points.

Install the plant on the 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
Sr.

No.

Parameter Value from Approved G.A Drawing

(mm)

Value from As Built G.A Drawing

 (mm)

Conclusion
1  Overall Height   H
2  Overall Width   W
3  Overall Depth   D
4  WFI Outlet Height
  • UTILITY CONNECTION POINTS CHECKS
Sr.

No.

Description Value from GA Drawing

(mm)

Actual Value

(mm)

Corresponding /

Non corresponding

  1. Boiler steam inlet 1.5” ASA 150# FLANGE
  2. Feed water Inlet 1” TRICLOVER
  3. Cooling water Inlet  1” TRICLOVER
  4. Compressed air inlet ½” BSPT (F) THD
  5. WFI outlet 1” TRICLOVER TO SUIT 1.5” OD TUBE
 6. Header Drain 1.5” BSP (F) Thd.
 7. Header air vent 1” BSP (F) Thd.

 

Corrective action

In case of Non Compliance

 

 

Conclusions
  Performed By Checked By
Name    
Signature    
Date    
  • 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 vendor
Acceptance Criteria All the surfaces tested shall meet the requirements.

 

Corrective action

In case of Non Compliance

 

 

 

Conclusions
  Performed By Checked By
Name    
Signature    
Date    
  • PLC INPUT OUTPUT CHECK
Objective To check the Input Output and to verify against the wiring diagram requirement.
Method Check the input output against 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 RESULTS

( PASS/ FAIL)

WITH SIGN

Check the input output against wiring diagram visually during operation. All the Input and output shall meet the requirements.  

 

Corrective action

In case of Non Compliance

 

 

 

Conclusions
  Performed By Checked By
Name    
Signature    
Date    
  •  SUMMARY REPORT
  • Summary of  the results obtained during IQ: 
  • Significant deviations observed during IQ:
  • Conclusions:
  • INSTALLATION QUALIFICATION REPORT APPROVAL
    Department Name Signature Date
    FOR M/s. 
    Checked By
    Review By
    Approved BY
                 FOR M/s. 
    SERVICE

     

 

 

 

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