Installation qualification for WFI generation plant

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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