Operational qualification purified water generation system

October 22, 2016June 21, 2024 Pharma Editor

Water generation system Operational qualification

The purpose of Operational Qualification is to establish confidence that the Purified Water Generation System is capable of operating within these established limits and tolerances with the following features but not limited to:

The functional design specification addresses 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 are 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 the Purified Water Generation System and its components operate as specified and within the anticipated range.

Why:

This document is to verify that all aspects of the 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 the 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 a change in the location of the Purified Water Generation System.

Responsibility:

The team for the Operational Qualification shall be comprised of the 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 minute.)

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.

SANITIZATION PROCEDURE:

The water generated from the outlet of EDI will be as per USP 34 Standards for Purified Water.

The Permeate water from the 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.

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 current USP.

SCHEME:

FIRST PASS REVERSE OSMOSIS (HOT WATER SANITISABLE) SYSTEM:

SMBS Dosing System
Antiscalant 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:-

Observation	Observation – Yes / No
Most current revisions in use
Operating personnel understand and follow SOP descriptions and requirements.
SOP provides adequate direction

PURPOSE:

KEY FUNCTIONALITY

The purpose of this procedure is to demonstrate that the control panel of the 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	The two-way switch is provided for change over from Auto to Manual operation for the RO-EDI System.
Accept	To accept the alarm and hooter stop.
Emergency Stop	To stop the system immediately.

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 drawn by the EDI unit.
RO Output Conductivity	To display the conductivity at the outlet of the RO.
MMI	To indicate an overview of the plant and display interlocking and faults of the plant.

INITIAL SET POINTS:

Instruments	Initial SetPoint	Actual Set Point
Rotameter at the inlet of RO System
Rota meter at Reject line Of RO-I System
Low-pressure switch at the inlet of ROHP-I
High Pressure Switch at outlet of ROHP-I (HPS-001)
ORP value at the inlet of RO System
Conductivity Meter at the outlet of RO-I System
Rota meter at Reject line Of RO-II System
Low-pressure switch at the inlet of ROHP-II
High Pressure Switch at outlet of ROHP-II (HPS-002)
Conductivity Meter at the outlet of RO-II System
Rota meter at Feed line Of EDI (RM-07)
Rota meter at Conc. line Of EDI (RM-08)
Low-Pressure Switch at the inlet of EDI(LPS-003)
Conductivity at the outlet of EDI (CIC-03)

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 the 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 the condition remains the 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)

Test Function: Anti-Scaling Dosing Tank Low-Level Switch

Procedure: Operate the Purified Water Generation system by following the Standard Operating Procedure for the operation of the Purified Water Generation system. Pull the low-level switch from the 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 the condition remains the 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 )

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 the 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 the condition remains the 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 )

Test Function: ORP Sensor, Transmitter & Controller:

Procedure: Operate the Purified Water Generation system by following the SOP for the operation of the Purified Water Generation system. Stop the SMBS dosing pump and 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 the ORP analyzer and check the response of the sensor. (Note: To be checked in Normal Auto mode / Autoflushing Mode / PLC Manual Mode.)

Response:

Acceptance criteria: Case I: After getting a 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 “)

Test Function: Reverse Osmosis System (Pass – I)

Procedure: Operate the Purified Water Generation system as per the SOP for the operation of the Purified Water Generation System. Check and record the conductivity of RO Pass – I water on the 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 & colorless, conductivity should be less than 150 µs/cm & the reject flow rate should be 1.1 m³/hr, and the Feed Flow rate at 3.8 m³/hr , (Note: To be checked in Normal Auto mode.)

Test Function: Reverse Osmosis System (Pass – II)

Procedure: Operate the Purified Water Generation system as per the SOP for the operation of the Purified Water Generation System. Check and record the conductivity of RO Pass – II water on the 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 & colorless, conductivity should be less than 20µs/cm & the reject flow rate should be 0.5 m³/hr, and the Feed Flow rate at 2.7 m³/hr,(Note: To be checked in Normal Auto mode.)

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 the 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 challenging test of the 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)

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

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)

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

Procedure: Operate the Purified Water Generation System as per the operating procedure for the Operation of the 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 minutes.

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 consistently low value above the set point the control value AV-04 automatically closes & system starts automatically.

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

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

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

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 minutes.

After an operation record the response.

Response:

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

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 minutes.

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)

Test Function: Emergency Stop

Procedure: Press Emergency Stop on the main control panel during normal operation. Note the alarm is generated and the 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 the reset button on the MMI

Response:

Acceptance criteria:

The e-stop button shall be locked upon pressing. The Purified Water Generation System should stop operation immediately. An audio-visual Alarm shall be generated.

“EMERGENCY PRESSED”

FEED LIMITING FACTOR FOR RAW WATER:

Raw water will be analyzed for a minimum of three consecutive days for chemical and microbiological and based on the results feed limiting factor for raw water will be established. The final feed limiting factor for raw water will be established only after three days of validation.

LIMIT FOR RAW WATER CHEMICAL ANALYSIS

Test	Limit
Colour	< 5 CTU
Ph	7.5
SDI	900
Total Dissolved Solids	1.8
Total Alkalinity	Not check
Total Suspended Solids	750 ppm
Total Hardness	120 ppm
Calcium as CaCO₃	300 ppm
Magnesium as CaCO₃	100 ppm
Sulphate as SO₄	200 ppm
Nitrates as NO₃	36.11 ppm
Chlorides as Cl	0.975ppm
Silica as SiO2	43.68 ppm
Colloidal Silica	2.3 ppm
Reactive Silica	92.3 ppm
Total Chloride as CaCO₃	0.7 ppm
Sulphate as CaCO₃	5.6 ppm
TOC	5.6 ppm
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, Staphylococcus aureus for a minimum of 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

The trend of Three Day chemical and microbiological analyses of raw water is as follows:

Description	Limit	Day 01	Day 02	Day 03	Result (Pass/Fail)
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

CALIBRATION REVIEW

Pressure Gauges:

Test Instrument Number	Location of Test Instrument	Calibration Certificate
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:

Rotameter:

Test Instrument Number	Location of Test Instrument	Calibration Certificate
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:

ORP Sensor, Transmitter & Controller:

Test instrument Number	Location of Test Instrument	Calibration Certificate
ORP-01	The inlet of the RO System
Verified By:

Conductivity Sensor, Transmitter & Controller:

Test instrument Number	Location of Test Instrument	Calibration Certificate
CIC-01	Outlet of RO pass – I
CIC-02	Outlet of RO pass – II
CIC-03	Outlet of EDI System
Verified By:

High Pressure Switch:

Test instrument Number	Location of Test Instrument	Calibration Certificate
HPS-01	Outlet of RO High-Pressure Pump I
HPS-02	Outlet of RO High-Pressure Pump II
Verified By:

Low Pressure Switch:

Test instrument Number	Location of Test Instrument	Calibration Certificate
LPS-01	The inlet of RO High-Pressure Pump-01
LPS-02	The inlet of RO High-Pressure Pump-02
LPS-03	Inlet of EDI
Verified By:

Level Sensor for CIP Tank:

Test instrument Number	Location of Test Instrument	Calibration Certificate
CIP-LLS-01	CIP Tank
Verified By:

Temperature Indicator & Transmitter:

Test instrument Number	Location of Test Instrument	Calibration Certificate
CIP – TT-01	CIP Feed Pump Discharge
Verified By:

Control Valves:

Test instrument Number	Location of Test Instrument	Calibration Certificate
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:

SAFETY INTERLOCK FEATURES TEST

Interlock Description	Action Taken	Working (Y/N)
Low level in SMBS dosing tank	RO-EDI system will trip
Low level in ADS dosing tank	RO-EDI system will trip
Low level of pH dosing tank	RO-EDI system will trip
A higher ORP value than the pre-set value	1.) Free chlorine will pass through and the 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.
Low Pressure at ROHP-I suction	This will trip the ROHP-01

High Pressure at ROHP-1	RO-EDI System will trip
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 system. The entire system will start automatically. 3)If the RO outlet conductivity is high for more than 300 secs. it will trip the Plant
Low Pressure at ROHP II suction.	This will trip the ROHP II
High Pressure at ROHP II	System will trip
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

Interlock Description	Action Taken	Working (Y/N)
Low pressure at EDI inlet	Will trip the EDI unit
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.
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)
Emergency Stop	Should Trip the System
Air Pressure Low	Will trip the system
Auto Manual Switch Over	Will trip the System

TRAINING

PERSONNEL TRAINING RECORD

Training Details	Name	Trained By	Training Documented (Yes / No)

FINAL REPORT

SUMMARY:

ANALYSIS / EVALUATION OF DATA:

Report approval.

The Operational qualification report for the Purified Water Generation System is reviewed and complies/does not comply with requirements.

Comments:

We certify that the Operational qualification report for the Purified Water Generation System is Accepted / Rejected.

Pharma More Jobs and post Please click here

Validation & Qualification Aberdeen, Aberdeenshire, Abu Dhabi, Abu Dhalouf, Abu Hamour, Abu Samra, ABUJA, ACCRA, Acre, Ad Dawhah al Jadidah, ADDIS ABABA, Adelaide, AFGHANISTAN, Agra, Agrigento, Ahmedabad, Aïn Beïda, Ain Khaled, Ain Sinan, Ajman, Ajman and Ra’s al-Khaimah, Ajmer, Al Ain, Al Aziziya, Al Bidda, Al Daayen, Al Dafna, Al Ebb, Al Egla, Al Gharrafa, Al Ghuwariyah, Al Hilal, Al Jasrah, Al Jeryan, Al Karaana, Al Kharaitiyat, Al Kharayej, Al Kharrara, Al Kheesa, Al Khor, Al Khulaifat, Al Luqta, Al Mamoura, Al Mansoura, Al Markhiyah, Al Mashaf, Al Masrouhiya, Al Mearad, Al Messila, Al Mirqab, Al Najada, Al Nasraniya, Al Qassar, Al Rufaa, Al Sadd, Al Sailiya, Al Sakhama, Al Seej, Al Shagub, Al Souq, Al Tarfa, Al Thakhira, Al Themaid, Al Thumama (Al Wakrah), Al Thumama (Doha), Al Utouriya, Al Waab, Al Wajba, Al Wakrah, Al Wukair, Al Zubarah, Al-Shahaniya, Alagoas, ALBANIA, Alberta, Alessandria, ALGERIA, Algiers, Aligarh, Allahabad, Allerdale, Amapa, Amazonas, Amber Valley, Amersham, AMMAN, Ampthill, Amravati, Amritsar, Amsterdam, Amur, Ancona, and Craigavon, and Down, ANDORRA, ANDORRA LA VELLA, ANGOLA, Angus, ANKARA, Annaba, ANTANANARIVO, ANTIGUA & BARBUDA, Antrim and Newtownabbey, Antwerp, Aosta, APIA, Ar Ru'ays, Ards and North Down, ARGENTINA, Argyll and Bute, Arkhangelsk, Arlington, Armagh, ARMENIA, As Salatah, Ascoli Piceno, Ashbourne, ASHGABAT, ashington, Ashland, Ashmore and Cartier Islands, ASMARA, Asti, Astrakhan, ASUNCIÓN, Athens, Auckland, Aurangabad, australia, Australian Antarctic Territory, Australian Capital Territory, Austria, Avellino, Aylesbury, Aylesbury Vale, AZERBAIJAN, Baaya, BAGHDAD, BAHAMAS, Bahia, BAHRAIN, BAKU, BAMAKO, Banbridge, BANDAR SERI BEGAWAN, Bangalore, BANGKOK, Bangladesh, Bangor, BANGUI, Bani Hajer, BANJUL, Barahat Al Jufairi, BARBADOS, Barcelona, Bareilly, Bari, Barletta-Andria-Trani, Barrow-in-Furness, BASSETERRE, Bath, Batna, Bavaria, Beaconsfield, Béchar, Bedford, BEIJING, BEIRUT, Béjaïa, Belarus, Belfast, Belgium, Belgorod, Belgrade, BELIZE, Belluno, BELMOPAN, Belper, Benevento, BENIN, Bergamo, Berlin, BERN, Bhavnagar, Bhilai Nagar, Bhiwandi, Bhopal, Bhubaneswar Salem, BHUTAN, Biella, Bikaner, Birmingham, Birmingham (West Midlands), BISHKEK, Biskra, BISSAU, Blackburn with Darwen, Blackpool, Blaenau Gwent, Blida, BLOEMFONTEIN, Bloomsbury, Bodmin, BOGOTÁ, BOLIVIA, Bologna, Bolsover, Bordj Bou Arreridj, BOSNIA & HERZEGOVINA, BOTSWANA, Bou Saâda, Bournemouth, Bracknell Forest, Bradford, BRASILIA, BRATISLAVA, brazil, BRAZZAVILLE, Bremen, Brescia, Bridgend, BRIDGETOWN, Brighton, Brighton and Hove, Brindisi, Brisbane, Bristol, British Columbia, BRUNEI, BRUSSELS, Brussels-Capital Region, Bryansk, Bu Fasseela, Bu Samra, Bu Sidra, Bucharest, Buckinghamshire, Budapest, BUENOS AIRES, BUJUMBURA, Bulgaria, BURKINA FASO, Burlington, BURUNDI, Buxton, CABO VERDE, Caerphilly, Cagliari, CAIRO, Caltanissetta, CAMBODIA, Cambridge, Cambridgeshire, Camden, CAMEROON, Campobasso, canada, Canberra, Canterbury, CAPE TOWN, Cardiff, Carlisle, Carmarthenshire, Caserta, CASTRIES, Catania, Catanzaro, Causeway Coast and Glens, Ceara, Centerville, CENTRAL AFRICAN REPUBLIC, Central Bedfordshire, Ceredigion, CHAD, Chalfont St. Giles, Chandigarh, Charlottetown, Chelmsford, Chelyabinsk, Chennai, Cheshire East, Cheshire West and Chester, Chester, Chesterfield, Chichester, Chieti, CHILE, Chiltern, China, Chlef, Christmas Island, City of London, Clackmannanshire, Clayton, Cleveland, Clinton, Clydebank, Coatbridge, Cockermouth, Cocos (Keeling) Islands, Coimbatore, Coldstream, colombia, COLOMBO, Como, COMOROS, CONAKRY, Congleton, CONGO, Constantine, Conwy, Copeland, Copenhagen, Coral Sea Islands, Cornwall, Cosenza, COSTA RICA, CÔTE D'IVOIRE(Ivory Coast), Coventry, Cremona, Crewe, CROATIA, Cromarty, Crotone, CUBA, Cumbernauld, Cumbria, Cuneo, Cuttack, CYPRUS, Czech Republic, CZECH REPUBLIC (Czechia), Dahl Al Hamam, DAKAR, Dalkeith, DAMASCUS, Darlington, Darwin, Dayton, Dehradun Garhwali, Delhi, Denbighshire, denmark, Derby, Derbyshire, Derbyshire Dales, Derry, Derry and Strabane, Devon, DHAKA, Djelfa, DJIBOUTI, DJIBOUTI (CITY), DODOMA, Doha, Dombivali, DOMINICA, DOMINICAN REPUBLIC, Donetsk, Dorset, Dover, dubai, Dublin, Duhail, Dukhan, Dumfries and Galloway, Dunbar, Dundee, Dunkeld, Duns, Dunstable, Durgapur Asansol, Durham, DUSHANBE, East Ayrshire, East Devon, East Dunbartonshire, EAST JERUSALEM, East Lothian, East Midlands, East of England, East Renfrewshire, East Riding of Yorkshire, East Sussex, ECUADOR, Eden, Edinburgh, Edmonton, Egypt, El Eulma, El Oued, EL SALVADOR, Elgin, Ely, England, Enna, EQUATORIAL GUINEA, Erewash, ERITREA, Espirito Santo, Essex, estado, estados, ESTONIA, ESWATINI (formerly Swaziland), ETHIOPIA, european countries, Exeter, Fairview, Falkirk, Falmouth, Faridabad, Fenland, Fereej Abdel Aziz, Fereej Al Amir, Fereej Al Asiri, Fereej Al Asmakh, Fereej Al Manaseer, Fereej Al Murra, Fereej Al Nasr, Fereej Al Soudan, Fereej Al Zaeem, Fereej Bin Durham, Fereej Bin Mahmoud, Fereej Bin Omran, Fereej Kulaib, Fereej Mohammed Bin Jassim, Fermanagh and Omagh, Fermo, Ferrara, Fife, FIJI, Finland, Firozabad, Flintshire, Florence, Foggia, Forlì-Cesena, Forres, Fort William, Fowey, france, Frankfurt Rhine-Main Region, Franklin, Fredericton, FREETOWN SINGAPORE, Frosinone, Fujairah, FUNAFUTI, Fuwayrit, GABON, GABORONE, Galashiels, GAMBIA, Genoa, Georgetown, Georgia, Germany, GHANA, Gharrafat Al Rayyan, Ghaziabad, Glasgow, Gloucester, Gloucestershire, Goias, Gorakhpur, Gorizia, Grasmere, Greater Glasgow, Greater London, Greater Manchester, greece, Greenock, Greenville, GRENADA, Grosseto, GUATEMALA, GUATEMALA CITY, Guelma, GUINEA, GUINEA-BISSAU, Gujarati, Gulbarga, Guntur, Gurgaon, Guwahati, GUYANA, Gwalior, Gwynedd, Haddington, HAITI, Halifax, Halton, Hamad Medical City, Hamburg, Hampshire, Haora, HARARE, Hartlepool, HAVANA, Hawick, Hawke's Bay, Hazm Al Markhiya, Heard Island and McDonald Islands, Helsinki, Helston, Hereford, Herefordshire, Hertfordshire, Hesse, High Peak, High Wycombe, Highland, Hobart, HONDURAS, HONIARA, Hove, Hubli and Dharwad, Hudson, Hungary, Huntingdon, Huntingdonshire, hyderabad, ICELAND, Imperia, Indonesia, Indore, Inverclyde, Invergordon, Inverness, Iqaluit, Iran, Iraq, ireland, Irkutsk, Irvine, Isernia, ISLAMABAD, Isle of Anglesey, Isle of Wight, Isles of Scilly, ISRAEL, Istanbul, Italy, Ivanovo, Izghawa (Al Rayyan), Izghawa (Umm Salal), Jabal Thuaileb, Jabalpur, Jackson, Jaipur, JAKARTA, Jalandhar, jamaica, Jammu, Jamnagar, Jamshedpur, japan, Jelaiah, JERUSALEM, Jervis Bay Territory, Jeryan Jenaihat, Jeryan Nejaima, Jhansi, Jijel, Jodhpur, jordan, JUBA, KABUL, Kaliningrad, Kaluga, Kalyan, KAMPALA, Kanpur, KATHMANDU, Katowice urban area, KAZAKHSTAN, Kazan, Kemerovo, Kendal, Kent, KENYA, Keswick, Kharkiv, KHARTOUM, Khawr al Udayd, Kiev, KIGALI, Kingston, Kingston upon Hull, KINGSTOWN, Kinross, KINSHASA, KIRIBATI, Kirkintilloch, Kirkwall, Kirov, Knutsford, Kochi, Kolkata, KOSOVO, Kostroma, Kota, Kraków, KUALA LUMPUR, Kurgan, Kursk, kuwait, KUWAIT CITY, KYRGYZSTAN, L'Aquila, La Spezia, Laghouat, Lancashire, Lancaster, LAOS, Latina, LATVIA, Launceston, Leabaib, Lebanon, Lebday, Lecce, Lecco, Leeds, Leicester, Leicestershire, Lejbailat, Lekhwair, Leningrad, Leqtaifiya (West Bay Lagoon), LESOTHO, Lexington, LIBERIA, LIBREVILLE, LIBYA, Lichfield, LIECHTENSTEIN, Lijmiliya, Lille–Kortrijk–Tournai France/ Belgium, LILONGWE, LIMA, Lincoln, Lincolnshire, Lipetsk, Lisbon, Lisburn, Lisburn and Castlereagh, LITHUANIA, Liverpool, Livorno, LJUBLJANA, LOMÉ, london, Loni, Looe, Lossiemouth, Lostwithiel, Luaib, LUANDA, Lucca, Lucknow, Ludhian, Lusail, LUSAKA, Luton, LUXEMBOURG, M'Sila, Macclesfield, Macerata, MADAGASCAR, Madinat Al Kaaban, Madinat ash Shamal, Madinat Khalifa North, Madinat Khalifa South, Madison, Madrid, Madurai, Magadan Moscow, Maghnia, MAJURO, MALABO, malawi, Malaysia, MALDIVES MALE, MALI, MALTA, MANAGUA, MANAMA, Manchester, MANILA, Manitoba, Mantua, Maranhao, Marlborough, Marlow, Marseille, Mascara, MASERU, Massa and Carrara, Matera, Matlock, Mato Grosso, Mato Grosso do Sul, MAURITANIA, mauritius, MBABANE, Mebaireek, Médéa, Medway, Meerut, Mehairja, Melbourne, Merseyside, Merthyr Tydfil, Mesaieed, Mesaimeer, Messina, Mexico, MEXICO CITY, Mid and East Antrim, Mid Ulster, Middlesbrough, Midlothian, Milan, Milford, Milngavie, Milton, Milton Keynes, Minas Gerais, Minsk, Modena, MOGADISHU, Monmouthshire, MONROVIA, MONTEVIDEO, Monza and Brianza, Moradabad, Moray, MORONI, Moscow, Mostaganem, Motherwell and Wishaw, Mount Vernon, Mourne, Muaither, Mumbai, Muraikh, Murmansk, MUSCAT, Mushayrib, Myaanmar (Burma), Mysore, N'DJAMENA, Nagpur, NAIROBI, Najma, NAMIBIA WINDHOEK, Nanded Kolapur, Nantwich, Naples, Nashik, NASSAU, NAURU, Navi Mumbai, Neath Port Talbot, Nellore, Nelson, Nepal, Netherlands, New Al Hitmi, New Al Mirqab, New Al Rayyan, New Brunswick, New Fereej Al Ghanim, New Fereej Al Khulaifat, New Plymouth, New Salata, New South Wales, new Zealand, Newfoundland and Labrador, Newport, NewportAuburn, Newquay, Newry, NGERULMUD, NIAMEY, NICARAGUA, NICOSIA, NIGER, Nigeria, Nizhniy Novgorod, Nizhny, Noida, Norfolk, Norfolk Island, North, North Ayrshire, North East Derbyshire, North East Lincolnshire, NORTH KOREA, North Lanarkshire, North Lincolnshire, NORTH MACEDONIA, North Somerset, North West, North Yorkshire, Northamptonshire, Northern, Northern Ireland, Northern Territory, Northumberland, Northwest Territories, Northwich, Norway, Norwich, Nottingham, Nottinghamshire, NOUAKCHOTT, Nova Scotia, Novara, Novgorod, Novosibirsk, Nu`ayjah, Nunavut, Nuoro, NUR-SULTAN, Nuremberg, Oakland, Old Al Ghanim, Old Al Hitmi, Old Al Rayyan, oman, Omsk, Onaiza, ontario canada, OntarioToronto, Oran, Orenburg, Oristano, Orkney Islands, Oryol, OSLO, Otago, Ottawa, OUAGADOUGOU, Ouargla, Oxford, Oxfordshire, Padua, Paisley, Pakistan, PALAU, Palermo, PALESTINE, PANAMA, PANAMA CITY, PAPUA NEW GUINEA, Para, PARAGUAY, Paraiba, PARAMARIBO, Parana, Paris, Parma, Patna, Pavia, Pembrokeshire, Penrith, Penryn, Penza, Penzance, Pernambuco, Perth, Perth and Kinross, peru, Perugia, Pesaro and Urbino, Pescara, Peterborough, Philippines, PHNOM PENH, Piacenza, Piaui, Pimpri, Pisa, Pistoia, Plymouth, Poland, Poole, Pordenone, PORT LOUIS, PORT MORESBY, PORT OF SPAIN, PORT VILA, PORT-AU-PRINCE, Porto Portugal, PORTO-NOVO, Portsmouth, portugal, Potenza, Powys, Prague, PRAIA, Prato, Preston, PRETORIA, Prince Edward Island, PRISTINA, Pskov, Pune, PYONGYANG, Qatar, Quebec City, Queensland, QUITO, Ragusa, Raipur, Rajkot, Ramsey, Ranchi, Ras Abu Aboud, Ras Al Khaimah, Ras Lafan, Ravenna, Rawdat Al Hamama, Rawdat Al Khail, Rawdat Egdaim, Rawdat Rashed, Reading, Redcar and Cleveland, Reggio Calabria, Reggio Emilia, Regina, Relizane, Renfrew, Renfrewshire, Repton, REYKJAVIK, Rhondda Cynon Taf, Rieti, RIGA, Rimini, Rio de Janeiro, Rio Grande, Ripon, Riverside, RIYADH, Romania, Rome, ROSEAU, Rostov, Rotterdam, Rovigo, Rumeilah, Russia, Rutland, RWANDA, Ryazan, Saharanpur, Saïda, SAINT GEORGE'S, SAINT JOHN'S, SAINT KITTS & NEVIS, SAINT LUCIA, Saint Petersburg, SAINT VINCENT & THE GRENADINES, Sakhalin, Salem, Salerno, Salford, Salisbury, Saltash, Samara, SAMOA, SAN JOSE, SAN MARINO, SAN SALVADOR, Sandhurst, SANTIAGO, SANTO DOMINGO, SÃO TOMÉ & PRÍNCIPE, SÃO TOMÉ SAUDI ARABIA, SARAJEVO, Saratov, Saskatchewan, Sassari, Savona, Sawda Natheel, Saxony, Scotland, Scottish Borders, SENEGAL, SEOUL, Serbia, Sétif, Seville, SEYCHELLES, Shagra, Sharjah, Sheffield, Shetland Islands, Shropshire, Sidi bel Abbès, Siena, SIERRA LEONE, Siliguri, Simaisma, singular, Skikda, SKOPJE, Slough, SLOVAKIA, SLOVENIA, Smolensk, Sofia, Solapur, SOLOMON ISLANDS, SOMALIA, Somerset, Sondrio, Souk Ahras, SOUTH AFRICA, South Australia, South Ayrshire, South Bucks, South Cambridgeshire, South Derbyshire, South East, South Gloucestershire, SOUTH KOREA, South Lakeland, South Lanarkshire, South Sardinia, SOUTH SUDAN, SOUTH TARAWA, South Tyrol, South West, South Yorkshire, Southampton, Southend-on-Sea, Southland, spain, Springfield, SRI JAYAWARDENEPURA KOTTE, Sri Lanka, Srinagar, St Albans, St Asaph, St Davids, St. Austell, St. Ives, St. John's, Staffordshire, Stirling, STOCKHOLM, Stockton-on-Tees, Stoke Poges, Stoke-on-Trent, Stuttgart, SUCRE, sudan, Suffolk, Sunderland, Surat, SURINAME, Surrey, SUVA, Sverdlovsk, Swansea, Sweden, Swindon, switzerland, Sydney, Syracuse, SYRIA, TAJIKISTAN, TALLINN, Tambov, TANZANIA, Taranto, TASHKENT, Tasmania, TBILISI, Tébessa, TEGUCIGALPA, TEHRAN, Telford, Telford and Wrekin, Teramo, Terni, Thailand, Thane, The Hague, The Pearl, THIMPHU, Thiruvananthapuram, Thuringia, Thurrock, Thurso, Tiaret, TIMOR-LESTE DILI, Tintagel, TIRANA, Tiruchirappalli, Tizi Ouzou, Tlemcen, TOGO, TOKYO, Tomsk, TONGA NUKUʻALOFA, Torbay, Trapani, Trento, Treviso, Trieste, TRINIDAD & TOBAGO, TRIPOLI, Truro, Tula, TUNIS, TUNISIA, Turin, turkey, TURKMENISTAN, TUVALU, Tver, Tyne and Wear, Tyumen, Udine, UGANDA, Ujjain, Ukraine, Ukraine. Dnipropetrovsk, Ulhasnagar, Ulyanovsk, Umm al-Qaiwain, Umm al-Quwain, Umm Bab, Umm Birka, Umm Ghuwailina, Umm Lekhba, Umm Qarn, Umm Salal Ali, Umm Salal Mohammed, United arab emirates, UNITED ARAB EMIRATES (UAE), united Kingdom, UNITED KINGDOM* (UK), united state, United States, UNITED STATES OF AMERICA (USA), URUGUAY, UZBEKISTAN, Vadodara, VADUZ, Vale of Glamorgan, Valencia, VALLETTA MARSHALL ISLANDS, VANUATU, Varanasi, Varese, Vasai Virar, VATICAN CITY, VATICAN CITY (Holy See), VENEZUELA CARACAS, Venice, Verbano-Cusio-Ossola, Vercelli, Verona, Vibo Valentia, Vicenza, Victoria, Vienna, VIENTIANE, VIETNAM HANOI, Vijayawada, VILNIUS, Visakhapatnam, Viterbo, Vladimir, Volgograd, Vologda, Voronezh, Wadi Al Banat, Wadi Al Sail, Wadi Al Wasaah, Wadi Lusail, Wakefield, Wales, Warrington, Warsaw, Warwickshire, Washington, Wellington, Wells, West Berkshire, West Dunbartonshire, West Lothian, West Midlands, West Sussex, West Yorkshire, West Yorkshire (Bradford–Leeds), Western Australia, Western Isles, Westland, Whitehaven, Whitehorse, Wick, Wiltshire, Winchester, Windsor and Maidenhead, Winnipeg, Wisbech, Wokingham, Wolverhampton, Worcester, Worcestershire, Workington, Wrexham, Wrexham Qatar, Wycombe, YAMOUSSOUKRO, YAOUNDE, YAREN DISTRICT, Yaroslavl, Yellowknife, YEMEN SANA'A ZAMBIA, YEREVAN, York, Yorkshire and the Humber, Yukon, ZAGREB, ZIMBABWE, Zürich

Water generation system Operational qualification

Pharma More Jobs and post Please click here

More Related Articles

Do Not Sell My Personal Information