Installation qualification for pure steam generator

Installation qualification for pure steam generator

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 

The tests shall be carried out at the customer’s place.

The verification of compliance to specifications as per vendor documents and to GMP requirements.

Confirmation that all design Documents, specifications, and test certificates are approved, available, and accurate.

Physical Inspection of the electrical hardware.

Mechanical inspection of the construction of the equipment.

RESPONSIBILITIES

Inspection

Customer or their authorized representatives are responsible for this IQ document

All documents shall be checked and approved by the customer or their authorized representatives.

Production personnel will perform this test.

CHECK POINTS & TESTING

Objective To check the documents required for the job as per the checklist.
Material  Documents list submitted in the FAT.
Method The submitted documents shall be checked for correct Document No., version No., date, and authorization details against the details submitted in the FAT Test form by the vendor
Acceptance Criteria The documents submitted shall be as specified in the list of reference documents.

LIST OF REFERENCE DOCUMENTS

Title Of Document Submittal Stage Document No.
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 FAT
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 Drawing No.
 G.A. Drawing SAT
P & I Diagram SAT
Wiring diagram SAT
Pneumatic Diagram SAT
Operation 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 to the vendor, 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 Certificate No.
Column Shell

14 SWG Sheet

ASTM A240M

GR316L

Condenser Shell

14 SWG Sheet

ASTM A240M

GR316L

Condenser Tubes

12.7 MM  OD X 1 MM Thk. Tube

 SA213 TP316L
Preheater Shell

3” OD X 16 SWG Pipe

AISI 304
Preheater Tubes

12.7 MM  OD X 1 MM  Thk. Tube

 SA213 TP316L
Sampling Pre heater Shell

3” OD X 16 SWG Pipe

AISI 304
Sampling Preheater Tubes

¾” OD X 16 SWG Pipe

SA 249 TP 316L
Separator Fabrication

20 SWG SHEET

ASTM A240M

GR316L

 
Pure steam Outlet :

2” X 1.65mm Pipe

ASME BPE 316L
Pure Steam Sampling line

0.5” X 1.65 mm Thk. Tube

ASME BPE 316L
Interconnecting pipe line& WFI outlet line:0.5”X1.65mm ASME BPE 316L
Purified water in and out line:0.5” X1.65mm ASME BPE 316L
Preheater assembly to condenser sensor bowl line:1” X1.65mm ASME BPE 316L
Steam line: 1.5” NB X SCH 10 AISI 304
 
MINI TC Gasket SILICON
1/2” T/C Gasket SILICON
1” T/C Gasket SILICON
2” T/C Gasket SILICON
3” T/C Gasket SILICON

 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.

BOUGHT OUT COMPONENTS

Component Make Certificate Type
MECHANICAL COMPONENTS
Feed Pump for feed water Grundfos Test Certificate
Flow  indicator Krohne Marshall Test Certificate
Non Return valve Alfa Laval Test Certificate
Pneumatic  valve Gemu Compliance Certificate
Sampling valve Crane Process Test Certificate
Diaphragm valve Crane Process Test Certificate
Steam Trap Spirax Test Certificate
Safety valve Spirax Test Certificate
Pressure Gauge for Pure Steam Waaree Calibration Certificate
Pressure Gauge for Boiler steam Waaree Calibration Certificate
Pressure Gauge for Feedwater Waaree Calibration Certificate
Ball Valve Shakti Test Certificate
Air  Pressure Regulator Festo Test Certificate
Globe Valve Shakti Test Certificate
Vent Filter Pall Test Certificate
Needle Valve Shakti Test Certificate–
ELECTRICAL COMPONENTS
PLC Allen Bradley Test Certificate
Display Allen Bradley Test Certificate
Conductivity meter Yokogawa Calibration Certificate
Conductivity sensor Yokogawa Calibration Certificate
Temperature Sensor Radix Calibration Certificate
Pressure switch Orion Test Certificate
Liquid level sensor on NCGR Pune Techtrol Test Certificate
Liquid level Sensor at Column E+H Calibration Certificate
Pressure Transmiter Jumo Complience Certificate
Temperature Transmitter Radix Calibration 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 The Vendor shall present Test certificates and Calibration certificates of the designated components (From the original manufacturer or a certified calibration laboratory) for verification.

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.

·National traceability certificate to be provided if committed in DR.

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 Certificate No.
MECHANICAL COMPONENTS
Feed Pump(CRN 3 -12)At the inlet of the feed water to PSG (MP1) Grundfos
Variable area indicator(KM25-P)100 – 1000 LPHAt discharge side of Feed pump (FI1) Krohne Marshall
Pneumatic  valve (DN 15 )At column purging water line (PNA1) Gemu
Pneumatic  valve (DN 15 / DN 20) At discharge of Feed Pump (PND3) Gemu
Pneumatic Valve (DN 15) At Feed Water In gas cooler (PND1) Gemu
Globe valve At the inlet of the plant steam (GV1) Shakti
Non-return valve (DN 25 )At Pure Steam Sampling Line (NRV1) Alfa Laval
Non-return valve (DN 25) At vacuum break line of GRC (NRV2) Alfa Laval
Diaphragm valve (DN 15 ) At Feed Water Inlet to PSG Line (DP1) Gemu
Diaphragm valve (DN 15 )At feed water inlet (DP2) Gemu
Air regulator At the Inlet of the compressed air (APR1) Festo
Steam Trap BPT-21,15 NB At First column air vent line (ST2) Spirax
Steam Trap BPT-21,15 NB At Plant Steam Condensate Drain of PH1(ST3) Spirax
Steam Trap FT-14CI-10 (c), 15 NB At Boiler Steam Condensate line of first condenser (ST1) Spirax
Safety valve SV11 75-125 PSI At inlet of the plant steam line (SV1) Spirax
Pressure Gauge (0-16 Kg/cm2 )At plant steam line (PG1) Waaree
Pressure Gauge (0-16 Kg/cm2 )At discharge side of feed pump (PG2) Waaree
Pressure Gauge( 0-7 Kg/Cm2 )At pure steam line (PG3) Waaree
Manual ball valve ½”At plant steam condensate drain through steam trap (BV2) Shakti
Manual ball valve ½”At plant steam condensate drain bypass to steam trap (BV1) Shakti
Manual ball-valve ½”At the steam inlet to preheater (BV3) Shakti
2 Way Pneumatic valve “NO” Type( DN 15) For gas removal column drain (PNANO) Gemu
Pneumatic Valve (DN 15) At gas removal column to gas cooler (PNA2) Gemu
Disposable Vacuum break Filter (KA1PFRP1 )At top of GRC (VF1) Pall
Plate-type Heat Exchanger For drain cooling (PHE1) Swep International
Manual ball-valve (½”)At the pure steam sample-taking line (BV4) Shakti
Pneumatic ValveDN 25At the cooling water of heat exchanger PNA3) Burket
Needle valve ½” At the sampling preheater line for conductivity (NV1) Shakti
Diaphragm valve( DN 25) At the  sample taking line (DP3) Gemu
ELECTRICAL COMPONENTS
PLC:

 

1762IR4

1766LX32BA

Allen Bradley
DISPLAY: Allen Bradley
Conductivity Meter Yokogawa
Conductivity sensor At the inlet of the machine (CS1) Yokogawa
Conductivity Sensor At Pure Steam Condensate Sampling Point (CS2) Yokogawa
Temperature sensor (-50 to 200o C) Boiler steam line (TS1) Radix
Temperature sensor (-50 to 200o C) Pure Steam Line (TS2) Radix
Temperature sensor (-50 to 200o C) Pure Steam Line Radix
Pressure Transmitter( -1 to 5 Bar G )Pure Steam Line (PT1) Jumo
Pressure Switch (0.5 -7.0 Bar) At air pressure Line (PS1) Orion
Pressure Switch (0.5 -7.0 Bar) Pure steam Line (PS2) Orion
Pressure Switch (0.2-2.6Bar) at the inlet side of feed water (PS3) Orion
Pressure Switch (1-15 Bar) For GRC to PH2 (PS4) Orion
Liquid  Level  Sensor (FLT-20H )On column (LS1) E+H

DIMENSIONAL MEASUREMENTS

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.

UTILITY CONNECTIONS CHECKS

HEIGHT (H), LENGTH (L), WIDTH (W)

OVERALL DIMENSIONS:

DIMENSION CHECKS

CHECK DIMENSION AGAINST GA DRAWING.

DIMENSIONAL MEASUREMENTS

Parameter Value from Drawing (mm) Actual Value (mm)
 Overall height   H
 Overall Width   W
 Overall Depth   D
Pure Steam Outlet Height

UTILITY CONNECTION POINTS CHECKS

Boiler Steam to PSG 1.5 ” ASA 150 # Flange
Compressed air inlet ½” BSP FEMALE THD.
Header Drain 1.5” BSP FEMALE THD.
Drain Header Air Vent 1” BSP FEMALE THD.
Pure steam outlet 2” TRICLOVER
Feed water Inlet 1” TRICLOVER

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.

 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 ( PASS/ FAIL)
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:

Pharma More Jobs and post Please click here

About Pharma Editor

Check Also

Unlocking Success with User Requirement Specification: Coating Machine URS

Unlocking Success with User Requirement Specification: Coating Machine URS In any project or system development, …