Operational qualification purified water generation system

Operational qualification purified water generation system

  • The purpose of this protocol (OQ protocol) is to establish confidence that the Purified Water Generation System is capable of operating within these established limits and tolerances with following feature but not limited to:
  • The functional design specification to be address the permanent recording, visual indication, design / specification range, normal operating range, alert and alarm limits, and the functional interrelationship of each component within the system. All of these requirements to be verified during the OQ phase to ensure that they operate as planned, and that the requirements have been anticipated correctly.
  • The OQ is performed on systems, which may consist of facilities, utilities, and/or equipment; to verify operation within specified parameters. Execution of the OQ involves testing parameters that regulate the process or product quality. Verification of proper operation of controllers, indicators, recorders, alarms and interlocks, is performed and documented during the OQ testing.
  • This is the policy that a written protocol will be followed for the process of testing to ensure that Purified Water Generation System and its components operates as specified and within the anticipated range.
  • Why:
  • This document is to verify that all aspects of Purified Water Generation System operate as intended throughout all anticipated ranges. This document also defined the process of testing to ensure that individual components and systems operate as specified, and how that information is recorded.
  • What:
  • To demonstrate that the Purified Water Generation System performs reproducibly and consistently.
  • To document performance of the Purified Water Generation System for future
  • To assure that Purified Water Generation System is adequate to support for which system is intended.
  • To develop the SOP’s for start-up, operation, shut down and sanitisation of the Purified Water Generation System.
  • To document test procedures and criteria for acceptance.
  • To define parameters that should be reproducible.
  • To verify performance across full range of operation from minimal to maximal load, with special evaluation at upper and lower limits.
  • When:
  • This procedure will be followed after completion of installation qualification of Purified Water Generation System in the company. This document will also be followed at the time of installation or removal of any part in the existing Purified Water Generation System (RO-EDI) by following the change control management.
  • Re-qualification:
  • Operational Qualification to be re-qualified on:
  • Any major modification in the existing Purified Water Generation System since purchase, which can affect the quality of the product.
  • If there is change in the location of the Purified Water Generation System.
  • Responsibility:
  • The team for the Operational Qualification shall be comprised of head of the following functional area. The exact representation of each department has been stated in validation project responsibility matrix.
  • Engineering
  • Quality Assurance
  • Head Operations
  • Head Quality
  • The members of the project validation team, Representative of Manufacturer and Representative of Supplier, their responsibilities will be as follows:
Functional Area Responsibilities
Vendor -Pre review / approval of Operational Qualification Report
-Review / Approval of Final Operational Qualification Report-Review / Approval of change control procedure-Co-ordination / execution in testing
Engineering -Pre review / approval of Operational Qualification Report

-Review / Approval of Final Operational Qualification Report

-Co-ordination for engineering activity and to provide all utilities

Required for operation.
– Installation of system / equipment as per protocol.

-Co-ordination & execution of internal and external calibration

Program.

Quality Assurance -Draft / Approval of Operational Qualification Report

-Review / Approval of Final Operational Qualification Report

-Review and Approval of Change control if any and its impact on the quality of the product.

-Co-ordination & execution of Internal and External calibration

Program.

Head Operations -Pre review / approval of  Operational Qualification Report

-Review / Approval of Final Operational Qualification Report

Head Quality -Pre review / approval of Operational Qualification Report

-Review / Approval of Final Operational Qualification Report

  • (Note: Ensure that the rise of temperature during sanitization should not be more than 30 C per min.)
  • Carry out the Hot water sanitization of system at 80-850 C temperature.
  • Start the sanitization of Loop in auto mode.
  • Connect the RO II & EDI system with CIP system with flexible hose
  • RO-EDI SYSTEM
  • Sanitization is done when microbial growth occurs in RO & EDI System. Frequency of sanitization will be decided by QA department after 3 seasonal validation of the plant. In normal case frequency of sanitization is 15 days or month.
  • WHEN???
  • Sanitization is done to remove microbial growth from the system.
  • WHY???
  • SANITIZATION PROCEDURE:
  • The water generated from the outlet of EDI will be as per USP 34 Standards for Purified Water.
  •  The Permeate water from RO system will be fed to the Electro Deionization Unit (EDI) having designed capacity of 2000 LPH. The EDI system has a recovery of 90%.
  • The Reverse Osmosis System consists of thin film composite type Reverse Osmosis membrane of DOW. The material of construction of the RO membrane is Polyamide. The RO membrane is housed in the High Pressure SS 316L Wettable Parts Housing having TC end connection.
  • The outlet water of RO pass one is feed to RO pass two system. The Second pass Reverse Osmosis System will generate 2200 liters/hr of water with an overall recovery of 80%. The generated water will have total dissolved solids less than 15-20 ppm.
  • The Reverse Osmosis System consists of thin film composite type Reverse Osmosis membrane of DOW. The material of construction of the RO membrane is Polyamide. The RO membrane is housed in the High Pressure SS 316L Wettable Parts Housing having TC end connection.
  • This soft water is then fed to the Reverse Osmosis First pass System by means of a High Pressure Vertical multistage Pump with SS 304 wettable parts. The First pass Reverse Osmosis System will generate 2700 liters/hr water with an overall recovery of 70 %. The generated water will have total dissolved solids less than 150 ppm. The semi-permeable reverse osmosis membrane has molecular weight cut off less than 150 MWCO. The Reveres Osmosis membrane acts as positive barrier to remove dissolved solids, organic compounds & bacteria.
  • ORP Analyzer is provided so as to check the absence/presence of chlorine in the feed water to the RO System. If free chlorine is sensed in the feed water it will give an indication on the panel & open the dumping valve and dump the high ORP water for 300 secs. & Even if the ORP value is not below the set point it will trip the system.
  • pH Correction Dosing System is provided to adjust the feed pH of  RO feed water as 6.5 – 8.5. The treated water is then passed through 5 micron Cartridge Filter to trap the suspended solids. This will avoid chocking of RO membranes due to suspended solids.
  • Antiscalent Dosing System is then dosed in the soft water to avoid scale formation on the RO Membranes.
  • Sodium Metabisulphite (Na2S2O5) is then dosed in the chlorinated water to neutralize the free chlorine (excess chlorine) present in the filtered water.
  • Soft Water after Softener unit is fed to Purified Water Generation System.
  • .SYSTEM DESCRIPTION:
  • POST TREATMENT:
  • Hot Water Sanitizable Electro – Deionization Unit
  • Conductivity meter with Alarm
  • SYSTEM DESCRIPTION
  • The Fully Automated PLC based Purified Water Generation system generates 2.0 m3/hr. of Purified water as Per USP 34.
  • SCHEME:
  • FIRST PASS REVERSE OSMOSIS (HOT WATER SANITISABLE) SYSTEM:
  • SMBS Dosing System
  • Antiscalent Dosing System
  • pH Correction System
  • 5 – Micron Cartridge Filter
  • ORP Analyzer and pH sensor along with auto Dumping Valve
  • RO High Pressure Pump
  • Reverse Osmosis Membranes along with High Pressure Housing
  • Conductivity Meter with Alarm
  • SECOND PASS REVERSE OSMOSIS (HOT WATER SANITISABLE) SYSTEM:
  • RO High Pressure Pumps
  • Reverse Osmosis Membranes along with High Pressure Housings
  • Conductivity meter with Alarm
  • Circulate the hot water for 1 hr after the temperature reaches 850
  • After 1 hr. of recirculation stop the heater & allow the temp in the system to come down gradually.
  • After the temperature reaches 50-570 C, stop the system & drain the CIP tank water through the tank drain valve.
  • SOP VERIFICATION
SOP No. Revision No. Effective Date Title Operating Personnel Testing Date
 

 

 

Observation Observation – Yes / No

(If no, state why in comments)

Most current revision in use
Operating personnel understands and follows SOP description and requirements.
SOP provides adequate direction
  • Comments:
  • SOP Passes / Fails Verification Criteria:
  • Inspected & Reviewed By    : _________________________
  • Date                                        : _________________________

 

  • PURPOSE:
  • KEY FUNCTIONALITY
  • The purpose of this procedure is to demonstrate that the control panel of Purified Water Generation System provides the proper functionality as specified by the manufacturer.
  • TESTING:
  • Check that all the displays on the panel are properly Labeled / Identified.
  • Turn on the power from the electrical panel.
  • Set the control(s) on the panel.
  • Verify functionality of each component on the panel against its Specified functions. Observe and record the responses of the control panel.
  • KEY FUNCTIONALITY
  • Name Equipment : Purified Water Generation system
  • Equipment Make :
  • Location : Purified Water Generation Plant Room
  • PANEL:  FOR PURIFIED WATER GENERATION PLANT OPERATION
Key / Switch Description Specified Function Matches with Specified Function (Yes / No)
ON / OFF for RO High Pressure Pump – I To start and stop the RO High Pressure Pump-I in manual mode
ON / OFF for RO High Pressure Pump – II To start and stop the RO High Pressure Pump-II in manual mode
ON / OFF for EDI. To start and stop the EDI in manual mode.
ON / OFF for CIP Feed Pump To start and stop the CIP Feed Pump in manual mode.
ON / OFF for CIP Heater To start and stop the CIP Heater in manual mode.
Auto – Manual Switch for RO-EDI System Two-way switch is provided for change over from Auto to Manual operation for RO-EDI System.
Accept To accept the alarm and hooter stop.
Emergency Stop To stop the system immediately.
  • Comments:
  • Checked By   : _________________
  • Verified By    : _________________

 

  • DISPLAY FUNCTIONALITY
  • Name Equipment : Purified Water Generation System
  • Equipment Make :
  • Location : Purified Water Generation Plant Room
  • PANEL:  FOR PURIFIED WATER GENERATION PLANT OPERATION
Key Indicator Specified Function Matches with Specified Function (Yes / No)
Indication Lamp provided for three phases (R, Y & B) To indicate the condition / status of the three phases of power.
Indication Lamp provided for ON / OFF/ TRIP of RO High Pressure Pump I To indicate the condition / status of the RO High Pressure pump I in auto as well as manual mode.
Indication Lamp provided for ON / OFF/ TRIP of RO High Pressure Pump II To indicate the condition / status of the RO High Pressure pump II in auto as well as manual mode.
Indication Lamp provided for ON / OFF/ TRIP of EDI. To indicate the condition / status of EDI in auto as well as manual mode.
Indication Lamp provided for ON / OFF / TRIP of CIP Feed Pump To indicate the condition / Status of CIP Feed Pump in auto as well as manual mode.
Indication Lamp provided for ON / OFF of CIP Heater To indicate the condition / Status of CIP Heater in auto as well as manual mode.
Digital DC Voltmeter for EDI. To display the applied DC voltage across the EDI electrodes.
Digital DC Ammeter for EDI. To display the DC current drawn by the EDI unit.
RO Output Conductivity To display the conductivity at the outlet of the RO.
MMI To indicate overview of the plant and display interlocking and fault of the plant.
  • Comments:
  • Checked By   : _________________
  • Verified By    : _________________

 

  • INITIAL SET POINTS:
Sr. No. Instruments Initial Set

Point

Actual Set Point Remark

(Yes / No)

1. Rotameter at inlet of RO System (RM-04)
      2. Rota meter at Reject line Of RO-I System

(RM-05)

      3. Low Pressure Switch at inlet of ROHP-I

( LPS-001)

      4. High Pressure Switch at outlet of ROHP-I (HPS-001)
      5. ORP value at inlet of RO System

( ORP-001)

      6. Conductivity Meter at outlet of

RO-I System (CIC-01)

      7. Rota meter at Reject line Of RO-II System

(RM-06)

      8. Low Pressure Switch at inlet of ROHP-II

( LPS-002)

      9. High Pressure Switch at outlet of ROHP-II (HPS-002)
  10. Conductivity Meter at outlet of

RO-II System (CIC-02)

  11. Rota meter at Feed line Of EDI (RM-07)
  12. Rota meter at Conc.  line Of EDI (RM-08)
  13. Low Pressure Switch at inlet of EDI(LPS-003)
  14. Conductivity at the outlet of EDI (CIC-03)
  • Inspected & Reviewed By    : _________________________
  • Date                                     : _________________________

 

  • CRITICAL VARIABLES TO BE MET:
  • PURIFIED WATER GENERATION SYSTEM (TWO PASS RO-EDI)
Test Function: Sodium Metabisulphite(SMBS-01) Dosing Tank  Low Level Switch

Procedure: Operate the Purified Water Generation system by following the Standard Operating Procedure for operation of Purified Water Generation system. Pull the low level switch from the SMBS dosing tank.

After an operation record the response.

Response:
Acceptance criteria:  Should give an alarm “LOW LEVEL IN SMBS TANK” and after some time if condition remains same Should Trip the Plant with Hooter and indicate on the panel

“LOW LEVEL IN SMBS TANK PLANT TRIP”

( Note :  To be checked in Normal Auto mode / Auto flushing Mode)

Comments (if any)
Pass  Fail
Done By: _________________                                        Verified By_________________              

Date      : __________________

Reviewed By: _________________________                         Date: ________________________

Test Function: Anti Scalant Dosing Tank Low Level Switch

Procedure: Operate the Purified Water Generation system by following the Standard Operating Procedure for operation of Purified Water Generation system. Pull the low level switch from the Anti Scalant dosing tank.

After an operation record the response.

Response:
Acceptance criteria:  Should give an alarm “LOW LEVEL IN ADS TANK” and after some time if condition remains same Should Trip the Plant with Hooter and indicate on the panel

“LOW LEVEL IN ADS TANK PLANT TRIP”

( Note :  To be checked in Normal Auto mode/ Auto flushing Mode )

Comments (if any):
Pass  Fail
Done By : _________________                                      Verified By_________________              

 Date       :__________

Reviewed By: _________________________                         Date: ________________________

 

Test Function: pH Correction Dosing Tank Low Level Switch

Procedure: Operate the Purified Water Generation system by following the Standard Operating Procedure for operation of Purified Water Generation system. Pull the low level switch from the pH Correction dosing tank.

After an operation record the response.

Response:
Acceptance criteria:  Should give an alarm “LOW LVL IN pHC TANK” and after some time if condition remains same Should Trip the Plant with Hooter and indicate on the panel

 “LOW LVL IN pHC TANK PLANT TRIP”

 ( Note :  To be checked in Normal Auto mode/ Auto flushing Mode )

Comments (if any):
 Pass  Fail
 Done By : _________________                                      Verified By_________________              

Date       :__________

Reviewed By: _________________________                         Date: ________________________

Test Function: ORP Sensor, Transmitter & Controller:

Procedure: Operate the Purified Water Generation system by following the SOP for operation of Purified Water Generation system. Stop the SMBS dosing pump allow the high free chlorine water to pass through

Case I:  Restart the SMBS dosing pump after 1 min.

Case II:  Not to start SMBS dosing pump for 5 mins.

Allow to pass chlorinated water (less than 0.5 ppm free chlorine) through ORP analyser and check the response of sensor.

(Note:  To be checked in Normal Auto mode / Autoflushing Mode / PLC Manual Mode.)

Response:
Acceptance criteria: Case I: After getting the response more than set value the control valve AV-02 should open up & the chlorinated water should be dumped. If the ORP value comes within the limit it should close the AV-02 after 30 sec. of consistent low reading.

(“HIGH ORP “)

OR

Case II: If the ORP value is high for more than 5 min. It should trip the plant with an alarm & indication on MMI.

(“VERY HIGH ORP “)

Comments (if any):
 Pass  Fail
 Done By_________________             Verified By_________________               Date__________

Reviewed By: _________________________Date: ________________________

Test Function: Reverse Osmosis System (Pass – I) 

Procedure: Operate the Purified Water Generation system as per the SOP for operation of Purified Water Generation System. Check and record the conductivity of RO Pass – I water on Conductivity indicator provided on the panel and simultaneously take the sample for QC analysis and check the conductivity.

After an operation record the response.

Response:
Acceptance criteria:

Permeate Water should be clear & colourless, conductivity should be less than 150 µs/cm & the reject flow rate should be 1.1 m3/hr and Feed Flow rate at 3.8 m3/hr

 (Note:  To be checked in Normal Auto mode.)

Comments (if any):
Pass  Fail
 Done By :_________________                                        Verified By_________________             

Date        :_________________

 

Reviewed By: _________________________                         Date: ________________________

Test Function: Reverse Osmosis System (Pass – II)

Procedure: Operate the Purified Water Generation system as per the SOP for operation of Purified Water Generation System. Check and record the conductivity of RO Pass – II water on Conductivity indicator provided on the panel and simultaneously take the sample for QC analysis and check the conductivity.

After an operation record the response.

Response:
Acceptance criteria:

Permeate Water should be clear & colourless, conductivity should be less than 20µs/cm & the reject flow rate should be 0.5 m3/hr and Feed Flow rate at 2.7 m3/hr

(Note:  To be checked in Normal Auto mode.)

Comments (if any):
 Pass  Fail
Done By :_________________                                        Verified By_________________               

Date        :________________

Reviewed By: _________________________                         Date: ________________________

Test Function: Reverse Osmosis System: High pressure Switch (HPS-001)

 Procedure: Operate the Purified Water Generation System as per the operating procedure for Operation of Purified Water Generation System. Reset the High Pressure Switch value in the operating condition below the operating feed pressure of the RO system. Perform this challenged test of High Pressure switch.

After an operation record the response.

Response:

 

Acceptance criteria:  The plant should trip with an alarm & indication on the panel.

“HPS AT ROHP-I”

(Note :  To be checked in Normal Auto mode/ Auto flushing Mode)

Comments (if any):
 Pass  Fail
Done By :_________________                                        Verified By_________________              

Date        :_________________

 

Reviewed By: _________________________                         Date: ________________________

Test Function: Reverse Osmosis System: High pressure Switch (HPS-002)

 Procedure: Operate the Purified Water Generation System as per the operating procedure for Operation of Purified Water Generation System. Reset the High Pressure Switch value in the operating condition below the operating feed pressure of the RO system. Perform this challenged test of High Pressure switch.After an operation record the response

Response:
Acceptance criteria:  The plant should trip with an alarm & indication on the panel.

“HPS AT ROHP-II”

(Note :  To be checked in Normal Auto mode/ Auto flushing Mode)

Comments (if any):
 Pass  Fail
Done By :_________________                                        Verified By_________________             

Date        :_________________

 

Reviewed By: _________________________                         Date: ________________________

Test Function: RO: Conductivity sensor (CIC-01) & Control Valve (AV-04)

Procedure: Operate the Purified Water Generation System as per the operating procedure for Operation of Purified Water Generation System. Reset the conductivity set point below the actual operating value.

Case I   : Bring it to the normal set point after 1 min. up to 4 mins.

Case II   : Allow the set point below the actual reading for more than 5 mins.

After an operation record the response

Response:
Acceptance criteria:

Case I:  The Dumping Valve AV-04 should open immediately & dump the permeate water.

The CIC-01 High should be indicated on the panel. (“HIGH COND AT RO 01”)

After the conductivity value is changed to the original pre-set value After 30 secs. of consistent low value above the set point the control value AV-04 automatically close & system starts automatically.

Case II:  After 5 mins of consistent dumping it will trip the system with alarm and indication on the panel.                                   (“VERY HIGH COND AT RO 01”)

(Note:  To be checked in Normal Auto mode/ Auto flushing Mode)

Comments (if any):

 

 Pass  Fail
 

Done By :_________________                                        Verified By_________________              

Date        :_________________

 

Reviewed By: _________________________                         Date: ________________________

Test Function: RO: Conductivity sensor (CIC-02) & Control Valve (AV-06)

Procedure: Operate the Purified Water Generation System as per the operating procedure for Operation of Purified Water Generation System. Reset the conductivity set point below the actual operating value.

Case I   : Bring it to the normal set point after 1 min. up to 4 mins.

Case II   : Allow the set point below the actual reading for more than 5 mins.

After an operation record the response.

Response:
Acceptance criteria:

Case I:  The Dumping Valve AV-06 should open immediately & dump the permeate water.

The CIC1 High should be indicated on the panel. (“HIGH COND AT RO 02”)

After the conductivity value is changed to the original preset value After 30 secs. of consistent high value above the set point the control value AV-06 automatically close & system starts automatically.

Case II:  After 5 mins of consistent dumping it will trip the system with alarm and indication on the panel. (“VERY HIGH COND AT RO 02”)

(Note:  To be checked in Normal Auto mode/ Auto flushing Mode)

Comments (if any):
 Pass  Fail
Done By :_________________                                        Verified By_________________              

Date  :_________________

 

Reviewed By: _________________________                         Date: ________________________

 

Test Function: Electro-Deionization Unit: Conductivity Sensor (CIC-03) & Flow Diverter Valve  (FDV 01)  

Procedure: Operate the Purified Water Generation System as per the operating procedure for Operation of Purified Water Generation System. Reset the conductivity set point below the actual operating value.

Case I   : Bring it to the normal set point after 1 min. up to 4 min.

Case II   : Allow the set point below the actual reading for more than 5 mins.

After an operation record the response

Response:
Acceptance criteria:

Case I:  The dumping valve – FDV should open immediately & dump the EDI outlet water. The CIC-03 High should be indicated on the panel. After the conductivity value is changed to the original preset value After 30 secs of consistent low value below the set point the flow diverter valve – FDV 01 will automatically close & EDI starts automatically.

(“HIGH COND AT EDI OUTLET”)

Case II:  After 5 mins of consistent dumping it will trip the system with alarm and indication on the panel.

(“VERY HIGH COND AT EDI OUTLET”)

(Note:  To be checked in Normal Auto mode)

Comments (if any):
 Pass  Fail
 Done By :_________________                                        Verified By_________________              

Date        :_________________

Reviewed By: _________________________                         Date: ________________________

Test Function: Emergency Stop

Procedure: Press Emergency Stop on main control panel during normal operation. Note the alarm is generated and message is displayed on MMI when Emergency Stop is pressed. Release the Emergency stop button. Switch ON the control power and reset the system by pressing reset button on MMI

Response:
Acceptance criteria:

E-stop button shall be locked upon pressed. Purified Water Generation System should stop operation immediately. Audio-visual Alarm shall generate.

“EMERGENCY PRESSED”

Comments (if any):
 Pass  Fail
Done By :_________________                                        Verified By_________________              

Date        :_________________

Reviewed By: _________________________                         Date: ________________________

 

FEED LIMITING FACTOR FOR RAW WATER:

  • Raw water will be analyzed for minimum three consecutive days for chemical and microbiological and based on the results feed limiting factor for raw water will be established. Final feed limiting factor for raw water will be established only after three day validation.
  • LIMIT FOR RAW WATER CHEMICAL ANALYSIS
Sr.  No. Test Limit
1. Colour < 5 CTU
2. Ph 7.5
3. SDI 900
4. Total Dissolved Solids 1.8
5. Total Alkalinity Not check
6. Total Suspended Solids 750 ppm
7. Total Hardness 120 ppm
8. Calcium as CaCO3 300 ppm
9. Magnesium as CaCO3 100 ppm
10. Sulphate as SO4 200 ppm
11. Nitrates as NO3 36.11 ppm
12. Chlorides as Cl 0.975ppm
13. Silica as SiO2 43.68 ppm
14. Colloidal Silica 2.3 ppm
15. Reactive Silica 92.3 ppm
16. Total Chloride as CaCO­3 0.7 ppm
17. Sulphate as CaCO3 5.6 ppm
18. TOC 5.6 ppm
19. TVC 1000 ppb

 

  • MICROBIOLOGICAL MONITORING OF RO-EDI PLANT:
  • Samples from the different sampling points of RO-EDI Plant shall be tested for Total Aerobic Microbial Count and Absence of Pathogens namely coliforms including E. coli and Pseudomonas aeruginosa, Salmonella, Staphylococcusaurues for minimum seven days consecutive days and only after getting results within limit Purified water generation system can be taken into operation.
  • The microbiological tests will be carried out as per the standard operating procedures
  • Acceptance Criteria for Pre Treatment Plant:
 Test Limits for System+
Total Plate Count 79 CFU/ml
TOC 1000 ppb
Coliforms including E. Coli/100 ml Should be absent
Pseudomonas aeruginosa/100 ml Should be absent
Staphylococcus aureus/100 ml Should be absent
Salmonella species/100 ml Should be absent

 

  • TREND OF FEED (CHEMICAL & microbiological ANALYSIS) WATER analysis
  • Trend of Three Day chemical and microbiological analysis of raw water is as follows:
Description Limit Day 01 Day 02 Day 03 Result (Pass/Fail) Verified by/ Date
Colour < 5 CTU
pH 7.5
Conductivity (us/cm) 900
Turbidity 1.8
SDI Not check
Total Dissolved Solids 750 ppm
Total Alkalinity 120 ppm
Total Hardness 300 ppm
Calcium as CaCO3 100 ppm
Magnesium as CaCO3 200 ppm
Sodium as Na 36.11 ppm
Potassium as K 0.975ppm
Sulphate as SO4 43.68 ppm
Nitrates as NO3 2.3 ppm
Chlorides as Cl 92.3 ppm
Flouride 0.7 ppm
Colloidal Silica 5.6 ppm
Reactive Silica 5.6 ppm
TOC 1000 ppb
Total Plate Count 79 CFU/ml

 

  • Comments:
  • Reviewed By: ______________                                          Approved By: ______________

 

  • CALIBRATION REVIEW
  • Pressure Gauges:
Test Instrument Number Location of Test Instrument Calibration Certificate Remark Checked

By

PG-05 Top of Cartridge Filter
PG-06 Outlet of 5 micron Cartridge Filter
PG-07 Feed line of RO pass – I
PG-08 Reject line of RO pass – I
PG-09 Feed line of RO pass – II
PG-10 Reject line of RO pass – II
PG-11 Inlet Of EDI
CIP-PG-01 Discharge of CIPFP
Verified By:
  • Comments:
  • Inspected & Reviewed By   : ____________________________
  • Date : ____________________________

 

  • Rotameter:
Test Instrument Number Location of Test Instrument Calibration Certificate Remark Checked

By

RM-04 inlet of RO System (RM-04)
RM-05 Reject line Of RO-I System(RM-05)
RM-06 Reject line Of RO-II System(RM-06)
RM-07 Feed line Of EDI (RM-07)
RM-08 Conc.  line Of EDI (RM-08)
Verified By:
  • Comments:
  • Inspected & Reviewed By   : ____________________________      
  • Date : __________________________

 

  • ORP Sensor, Transmitter & Controller:
Test instrument Number Location of Test Instrument Calibration Certificate Remark Checked

By

ORP-01 Inlet of RO System
Verified By:
  • Comments:
  • Inspected & Reviewed By   : ____________________________   
  • Date : ____________________________

 

  •  Conductivity Sensor, Transmitter & Controller:
Test instrument Number Location of Test Instrument Calibration Certificate Remark Checked

By

CIC-01 Outlet of RO pass – I
CIC-02 Outlet of RO pass – II
CIC-03 Outlet of EDI System
Verified By:
  • Comments:
  • Inspected & Reviewed By : ____________________________  
  • Date: ____________________________

 

  •  High Pressure Switch:
Test instrument Number Location of Test Instrument Calibration Certificate Remark Checked

By

HPS-01 Outlet of RO High Pressure Pump I
HPS-02 Outlet of RO High Pressure Pump II
Verified By:
  • Comments:
  • Inspected & Reviewed By : ____________________________
  • Date : ____________________________

 

  • Low Pressure Switch:
Test instrument Number Location of Test Instrument Calibration Certificate Remark Checked

By

LPS-01 Inlet of RO High Pressure Pump-01
LPS-02 Inlet of RO High Pressure Pump-02
LPS-03 Inlet of EDI
Verified By:
  • Comments:
  • Inspected & Reviewed By : ____________________________
  • Date : ____________________________

 

  •  Level Sensor for CIP Tank:
Test instrument Number Location of Test Instrument Calibration Certificate Remark Checked

By

CIP-LLS-01 CIP Tank
Verified By: 
  • Comments:
  • Inspected & Reviewed By : ____________________________
  • Date : ____________________________

 

  • Temperature Indicator & Transmitter:
Test instrument Number Location of Test Instrument Calibration Certificate Remark Checked

By

CIP – TT-01 CIP Feed Pump Discharge
Verified By:
  • Comments:
  • Inspected & Reviewed By  : ____________________________
  • Date : ____________________________

 

  • Control Valves:
Test instrument Number Location of Test Instrument Calibration Certificate Remark Checked

By

AV-02 Before RO High Pressure – I
AV-03 Reject line of RO pass – I
Av-04 Permeate line of RO pass – I
AV-05 Reject line of RO pass – II
AV-06 Permeate line of RO pass – II
Verified By:
  • Comments:
  • Inspected & Reviewed By   : ____________________________
  • Date : __________________________

 

 

  • SAFETY INTERLOCK FEATURES TEST
Sr. No. Interlock Description Action Taken Working (Y/N) Checked By Date
1 Low level in SMBS dosing tank RO-EDI system will trip
2 Low level in ADS dosing tank RO-EDI system will trip
3 Low level in pH

dosing tank

RO-EDI system will trip
4 High ORP value than the pre-set value 1.)       Free chlorine will pass through and ORP sensor will sense free chlorine. In turn the ORP value will increase above the set point. This will open the ORP dumping valve AV -02

2.)       ORP comes down within the desired limit. After 30 secs. of consistent reading, below the set value , it will close the AV-02. Allow the water to feed to the RO system. The entire system will start automatically.

3.)      If the ORP value is high for more than 300 secs. it will trip the plant.

5 Low Pressure at ROHP-I

suction

This will trip the ROHP-01
Sr. No. Interlock Description Action Taken Working (Y/N) Checked By Date
6 High Pressure at ROHP-1 RO-EDI System will trip
7  

High Conductivity at RO I outlet.

1)      If the Conductivity is above the set point , it will open the dumping valve AV-04

2)      After 30 secs. of consistent reading, below the set value , it will close the AV-04Allow the water to feed to the RO II sytem. The entire system will start automatically.

3)      If the RO outlet conductivity is high for  more than 300 secs. it will trip the  Plant

8 Low Pressure at ROHP II suction. This will trip the ROHP II
9 High Pressure at ROHP II System will trip
10  

High Conductivity at RO II  outlet

1)      If the Conductivity is above the set point , it will open the dumping valve AV-06

2)      After 30 secs. of consistent reading, below the set value , it will close the AV-06 Allow the water to feed to the EDI system. The entire system will start automatically.

3)      If the RO outlet conductivity is high for  more than 300 secs. it will trip the   Plan

Sr. No. Interlock Description Action Taken Working (Y/N) Checked By Date
11 Low pressure at EDI inlet Will trip the EDI unit
12 High conductivity at EDI outlet 1)      If the Conductivity is above the set point, it will open the dumping valve FDV 01.

2)      After 30 secs. of consistent reading, below the set value , it will close the FDV 01. Allow the water to feed to the purified water tank. The entire system will start automatically.

3)      If the EDI outlet conductivity is high for  more than 300 secs. it will trip the  plant.

13  

 

 

Auto Flushing

During High Level in the Purified  Water Tank & If the plant is not operational for more than 60 mins. It will auto flush the entire RO – EDI unit.

( For Settable Time)

14 Emergency Stop Should Trip the System
15 Air Pressure Low Will trip the system
16 Auto Manual Switch

Over

Will trip the System

 

  • TRAINING
  • PERSONNEL TRAINING RECORD

 

Training Details Name Trained By Training Documented (Yes / No)
  • Comments:
  • Inspected & Reviewed By/Date      : _________________________________    

 

  • FINAL REPORT
  • SUMMARY:

 

  • ANALYSIS / EVALUATION OF DATA:

 

  • Report approval.
  • The Operational qualification report for Purified Water Generation System is  reviewed and complies / does not comply with requirements.
Executed & Reviewed by
 Sign / Date :—————

 Name :——————–

        Validation -QA

 Sign / Date :—————

 Name :——————–

            Engineering

  • Comments:
  • We certify that the Operational qualification report for Purified Water Generation System is Accepted / Rejected.
Qualification Approval
 Sign / Date : ___________________

Name :          ___________________

Quality Assurance

Sign / Date :  ___________________

Name :           ___________________

Quality control 

 Sign / Date : ___________________

 Name :          ___________________

Engineering

 Sign / Date :  ___________________

 Name :           ___________________

Manufacturing 

 Sign / Date : ___________________

 Name :          ___________________

Q A Head

 

 Sign / Date :  ___________________

 Name :           ___________________

Unit Head

 

 

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