The objective of this Standard Operating Procedure for Preventive Maintenance of Purified Water Generation System is to outline the steps and guidelines for conducting preventive maintenance on a Purified Water Generation System to ensure the continuous production of high-quality purified water that meets pharmaceutical and regulatory standards.
SOP for Preventive Maintenance of Purified Water Generation System
- OBJECTIVE:
- This SOP is describing the preventive maintenance of Purified Water Generation System installed in technical area.
- SCOPE:
- This SOP is applicable for preventive maintenance of Purified Water Generation System installed in technical area.
- RESPONSIBILITY:
- Technician/ Operator / Engineer shall be responsible for proper execution of preventive maintenance of Purified Water Generation System as per SOP.
- Engineering – Head shall be responsible for reviewing the SOP and for ensuring proper execution of preventive maintenance of Purified Water Generation System.
- ACCOUNTABILITY:
- Engineering – Head shall be accountable for proper implementation of the SOP.
- DEFINITIONS:
- Nil
- PROCEDURE:
- Preventive maintenance of Purified Water Generation System shall be executed as per the SOP No.: SOP/EN/XXXYYY – Execution of Preventive Maintenance.
- Ensure that spare parts are available before the start of preventive maintenance activity.
- Preventive Maintenance of Purified Water Generation System – Mechanical
- Checking of pipeline and fittings
- Physically check all the pipe line supports and clamps and tighten them if found loose.
- Physically check the tri-clover clamps on pipeline and fittings for leakages. If any leakage is present then physically check the silicon gaskets, if found damaged (cut, deform, leached, shape changed) replace the same and tighten the clamp.
- Check the piping insulation and cladding if required rectify the same.
- Checking shall be done six monthly ± 15 days.
- Checking of Diaphragm Valve
- Check the valve for smoothly movements, if the operating hand wheel of valve is found jammed or stuck, then open the valve and carry out the maintenance as follows.
- Switch off the pump.
- Close the nearby upside and down side valves.
- Open the TC ends, loose the diaphragm valves nut by the Allen key, check the valve for damaged diaphragm, clean the valves, and check for the locking nut of diaphragm.
- If gasket found damaged (cut, leached, deform, shape and size change) change the diaphragm.
- After physically checking of diaphragm valve, refit in to the system and check for leakage and valve operation if found satisfactorily then it is okay otherwise replace the valve.
- For actuated diaphragm valve check for the performance of actuator for valve opening and closing as per interlocks of the system
- Checking of valves hall be done after every six month ± 15 days.
- Checking of pumps
- Physically check the pump for any abnormal noise if found, Disconnect the pump motor wiring.
- Disconnect the pump from the pipeline and open the pump.
- Physically check the condition of bearings, mechanical seal, shaft, impeller and replace if found damaged.
- Clean the motor fan to remove dust and dirt.
- Checking of the pumps shall be done quarterly ± 7 days.
- Checking of instruments performance
- Ensure that the installed instruments are calibrated.
- Physically check the instruments end connection, if required tight the contacts. The following instruments are installed in Purified Water Generation Plant.
- Level sensor installed on multipurpose (RO Feed water tank).
- Compound pressure gauge installed on top nozzle of tank.
- Capacitance type level transmitter installed on top nozzle of tank.
- Temperature transmitter installed in suction of high pressure pump.
- High pressures switch in high pressure pump (109.1 HPP-01) discharge line.
- Pressure gauge in RO (109.1 HSRO-01) inlet line.
- Pressure gauge in RO (109.1 HSRO-01) permeates line.
- Flow indicator in RO (109.1 HSRO-01) permeates line.
- Conductivity Transmitter in RO (109.1 HSRO-01) permeates line.
- Flow indicator in RO (109.1 HSRO-01) recirculation line.
- Flow indicator in RO (109.1 HSRO-01) rejects / drains line.
- LPS in suction of high pressure pump (110.1 HPP-01) suction line.
- High pressures switch in high pressure pump (110.1 HPP-01) discharge line.
- Pressure gauge in RO (110.1 HSRO-01) inlet.
- Pressure gauge in RO (110.1 HSRO-01) permeates line.
- Conductivity transmitter in RO (110.1 HSRO-01) permeates line.
- Flow indicator in RO (110.1 HSRO-01) permeates line.
- Flow indicator in RO(110.1 HSRO-01) recirculation line.
- Flow indicator in RO (110.1 HSRO-01) rejects / drains line.
- Flow switch in EDI inlet line.
- Pressure gauge in EDI outlet.
- Flow indicator in EDI outlet.
- Checking of the instruments shall be done after every six month ± 15 days.
- Checking of multipurpose tank (RO-1 Feed Water Tank) and accessories
- Visually inspect the tank internally for surface roughness, crashes, and cleanliness, damaged, and dent and rusting; if found clean thoroughly and rectify the same.
- Physically check and inspect the tank insulation and cladding, if required repair.
- Physically check the end connection to tank for leakages, if required rectifies the same.
- Physically check the tank installed instruments such as level transmitter, compound pressure gauge for proper functioning, if required remove, clean and refit the same or if necessary replace the same.
- Checking frequency shall be after every six month ± 15 days.
- Checking of heaters in preventive maintenance of Purified Water Generation System
- Check the proper functioning of band heaters.
- Check the electrical terminals of band heaters
- Check the current by clamping of heaters.
- Check for the insulation over the heaters; if required rectifiy the same.
- Checking frequency shall be after every six month ± 15 days.
- Checking of RO Membrane Housing in preventive maintenance of Purified Water Generation System.
- Visually inspect the RO Membrane housing externally for surface cleanliness if required clean the surface thoroughly.
- Visually inspect the surface for dents, damages; surface roughness and dent and rusting; if found clean thoroughly remove the rusting and rectify the same.
- Check the end connections for any leakages; if found rectify the same.
- Check the TC end gaskets for any damaged; shape changed; leached; cut; and for deformation of shape; if found replace the TC gaskets.
- Check the tightness of TC clamp; if required replaces the same.
- Checking shall be done after every six month ± 15 days.
- Checking the performance of RO membrane annually based on flow .If permeate flow gets low then go for chemical cleaning as per vendor recommendation. If we get the desired flow then no need of RO membrane replacement. If not get the desired flow then replaces RO membrane with new one.
- Check the conductivity of first pass and second pass RO membrane for its pre defined limits, if it is not within limit then check the RO membrane O-ring, gaskets if found damage replace with new one.
- Checking of EDI in preventive maintenance of Purified Water Generation System
- Check the foundation bolts of EDI unit; if required tight the same.
- Check the end nuts for tightness.
- Conduct the sanitization procedure as per the manufacturer’s recommendations.
- Checking of feed water, product water and waste water fittings gasket after every year, if found damaged then replaced with new one.
- Checking of diaphragm in feed and product water valves after every year, if found damaged replaced with new one.
- Check the conditions of EDI stacks after every 5 years if found final conductivity abnormality then replace or as per manufacturer’s recommendations.
- Checking frequency shall be after every six month ± 15 days.
- Checking of Spare Parts in preventive maintenance of Purified Water Generation System
- Check the stock for following spare parts.
- Checking frequency shall be after very six month.
| Sr. No. | Spare Part Descriptions | Specification | Quantity (Nos.) |
| Dosing Tank | 50 liter | 2 | |
| Dosing Pump | 2.88 LPH @8Bar | 1 | |
| Isolation valve for pH sensor | 1/4″ OD | 2 | |
| PH Sensor and Transmitter | 2-14 ph | 2 | |
| ORP Sensor + Transmitter | 0-350 mV | 1 | |
| Isolation valve for ORP Sensor Flow through chamber | 1/4″ OD | 1 | |
| Actuated Valves | 1.5″OD | 1 | |
| Micron Filter Assembly | 5 Micron | 1 | |
| PP cartridge | 5 Micron | 1 | |
| High Pressure RO Feed Pump | 9.44 m3/hr @ 12.4Bar | 1 | |
| RO membrane with O ring & interconnector | 8″ | ||
| Ball Valve | ¾” | 2 | |
| Ball Valve | 2” | 2 | |
| spring loaded reject valve | 1.5” | 2 | |
| Ball Valve | 8 mm | 1 | |
| Sr. No. | Spare Part Descriptions | Specification | Quantity (Nos.) |
| Level switch | |||
| Temperature Transmitter | 0 TO 1500C | ||
| Conductivity transmitter | 0 – 100 μS /CM | ||
| Pressure gauge | 0 – 16 Kg /sq.cm | 4 | |
| Pressure gauge | 0 – 6 Kg /sq.cm | 3 | |
| Flow indicator | 630-6300LPH | 4 | |
| Flow indicator | 250 – 2500LPH | 1 | |
| Flow indicator | 1000-10000LPH | 1 | |
| Flow indicator | 63 – 630LPH | 1 | |
| Second pass RO system feed pump | 10 m3/hr @ 25 Bar | 1 | |
| Second pass RO membrane | 8” | 1 | |
| RO pressure tube | 8” x 3 element long | 1 | |
| EDI Unit | 3M3/HR | 1 | |
| Rectifier (EDI) | 1 | ||
| Ball Valve | 2” OD | 3 | |
| Pneumatically Actuated Flow Diverter Valve | 1”OD | 1 | |
| Diaphragm valve EDI concentrated inlet | ½” OD | 1 | |
| EDI outlet to PW tank and recirculation line | 1” OD | 1 | |
| Conductivity transmitter | 0 – 100 μS /CM | 1 | |
| Conductivity transmitter | 0 – 10 μS/cm | 1 | |
| Flow switch | 30 – 300 lph | 1 |
- Checking of tank (Multipurpose) and pipelines for any rouging
- Check the tank (Multipurpose) and pipelines for any rouging.If found, clean the surface of Multipurpose tank and pipelines with buffing or electro polishing process.
- Checking shall be done after every six month.
- Challenge test for dumping valve in preventive maintenance of Purified Water Generation System
- Change the set value of conductivity parameter in HMI system and put the set value less than the Current value.
- Once the process value becomes higher than the set value, dump valve shall open automatically and dumping of PW shall start. Record the changed value and functioning of dumping valve in preventive maintenance record Format Number.: SOP/EN/XXXYYY
- Sanitization shall be carried out after testing of valve.
- Change the conductivity value in HMI as per original value.
- Checking shall be done monthly.
- Preventive maintenance of Purified Water Generation System – Electrical
- Checking of terminals and wiring
- Ensure that the power supply to the panel is switched off.
- Visually check all the power and control wiring and terminals in the electric control panel and at field instruments.
- Check and ensure by using screwdriver that all the wires are properly tightened.
- Checking shall be done six monthly ± 15 days.
- Checking of contactors
- Switch off the main switch on the electrical panel.
- Disconnect all the control and power wires from the contactor terminals.
- Remove dust from control panel with help of air blower.
- Remove the contactor from the panel and visually check all the contacts for pitting and carbon deposits on the contacts.
- Clean all the contacts with carbon tetra chloride or with contactor cleaner. Replace the contacts if found damaged or welded.
- Put back the contactor in the panel and connect all the wires to the original locations.
- Check the earthing of the panel body.
- A good earthing shall show less than 2 Volts between the Neutral Wire of the Incoming Power supply and Panel Body.
- Checking of contactors shall be done six monthly ± 15 days.
- Checking of pump motor
- Check the insulation resistance of motor winding with the help of megger.
- Check the phase continuity and winding continuity of motor with the help of tong tester.
- Physically check the motor terminal box and terminal connections.
- Check the voltage drawn by motor with the help of multimeter.
- Check the current drawn by motor with the help of tong tester.
- Physically check the direction of rotation; it should be as per recommended direction.
- Checking shall be done after every six month ± 15 days.
- Checking of PLC
- Check the PLC for blinking of LED.
- Check the display
- Check the wiring contacts, if required tight the same.
- Checking of PLC shall be done after every six month ± 15 days
- Post Preventive maintenance of Purified Water Generation System – Check List
- Record the Preventive Maintenance details as per the Format No.: SOP/EN/XXXYYY Preventive Maintenance Checklist & Record for Purified Water Generation System.
- Whenever any modifications and major works are carried out to the equipment, the same shall be mentioned in the equipment history card as per the respective SOP.
- Connect the equipment main power supply and start the equipment.
- Ensure that the equipment is running smoothly, without any abnormality.
- If any abnormality is observed in the above, same will be attended in co-ordination with User department Head.
- ABBREVIATIONS:
- CRF No. : Change Request Form number
- QA : Quality Assurance
- MMI : Man Machine Interface
- RO : Reverse Osmosis
- TC : Tri Clover Clamp
- EDI : Electro De-Ionization
- PLC : Programmable Logical Controller
- LED : Light Emitting Diode
- SOP : Standard operating procedure
- TC : Tri Clover
- REFERENCES:
- Nil
- DISTRIBUTION LIST:
- SOP shall be distributed to following departments Quality Assurance, Engineering as per user request.
- ANNEXURES:
- Preventive maintenance checklist and record for Purified Water Generation System:-SOP/EN/XXXYYY
PREVENTIVE MAINTENANCE CHECKLIST & RECORD FOR PURIFIED WATER GENERATION SYSTEM
Preventive Maintenance of Purified Water Generation System Checklist & Records
| Equipment Name | Location | ||
| Equipment ID | Frequency |
| Things to be done: | Check List | Remarks | ||||||
| Monthly Check List | ||||||||
| 1. Challenge test for dumping valve AF1VT1 110.1-01 | ||||||||
| Current conductivity value (µs/cm) | Changed conductivity Value (µs/cm) | Reset conductivity value. (µs/cm) | Function of Dumping valve | |||||
| complies | Does not comply | |||||||
| 2 Challenge test for dumping valve AF1VT1 110.1-02 | ||||||||
| Current conductivity value (µs/cm) | Changed conductivity Value (µs/cm) | Reset conductivity value. (µs/cm) | Function of Dumping valve | |||||
| complies | Does not comply | |||||||
| Quarterly Check List Preventive maintenance of Purified Water Generation System | ||||||||
| 1 Checking of pumps. | ||||||||
| Half Yearly Check List Preventive maintenance of Purified Water Generation System | ||||||||
| 1 Checking of pipe line and pipe fittings. | ||||||||
| 2 Checking of diaphragm valves. | ||||||||
| 3 Checking of installed instruments. | ||||||||
| 4 Checking of multipurpose tank (RO-1 Feed Water Tank) | ||||||||
| 5 Replace the U Bend mesh installed on the vent of multipurpose tank. | ||||||||
| 6 Checking of heaters. | ||||||||
| 7 Checking of RO membrane housing. | ||||||||
| 8 Checking of stock for spare parts. | ||||||||
| 9 Checking of EDI system | ||||||||
| 10 Checking of terminals and wiring. | ||||||||
| 11 Checking of contactors. | ||||||||
| 12 Checking of pump motor. | ||||||||
| 13 Checking of PLC | ||||||||
| 14 Check the tank (Multipurpose) and pipelines for any rouging.If found, clean the surface of tank and pipelines with buffing or electro polishing process. | ||||||||
| Yearly Check List Preventive maintenance of Purified Water Generation System | ||||||||
| Checking the performance of RO membrane annually based on flow | ||||||||
| Check the conductivity of first pass and second pass RO membrane for its pre defined limits, if it is not within limit then check the RO membrane O-ring, gaskets if found damage replace with new one. | ||||||||
| Checking of feed water, product water and waste water fittings gasket after every year, if found damaged then replaced with new one. | ||||||||
| Checking of diaphragm in feed and product water valves after every year, if found damaged replaced with new one. | ||||||||
You may also read about Good Laboratory Practices (GLP)
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