Installation qualification for WFI generation plant

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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