SOP for Preventive Maintenance of Water for Injection Generation system EN-20

The objective of this Standard Operating Procedure for Preventive Maintenance of Water for Injection Generation system is to outline the steps and guidelines for conducting preventive maintenance on a Water for Injection (WFI) generation system to ensure its consistent production of high-quality water meeting pharmaceutical standards.

SOP for Preventive Maintenance of Water for Injection Generation System

• OBJECTIVE:
  • This SOP is describing the Preventive Maintenance of Water for Injection Generation System
• SCOPE:
  • This SOP is applicable for Preventive Maintenance of Water for Injection Generation System installed at the technical area.
• RESPONSIBILITY:
  • Technician/ Operator shall be responsible for proper execution of Preventive Maintenance of Water for Injection Generation System as per SOP.
  • Engineering – Head shall be responsible for reviewing the SOP and for ensuring proper execution of Preventive Maintenance of Water for Injection Generation System
• ACCOUNTABILITY:
  • Engineering – Head shall be accountable for proper implementation of the SOP.
• DEFINITIONS:
  • Nil
• PROCEDURE:
  • Preventive Maintenance of Water for Injection Generation System shall be executed as per the SOP No.: SOP/EN/XXXYYY – Execution of Preventive Maintenance.
  • Ensure that the spare parts are available at the time of preventive maintenance.
• Preventive Maintenance of Water for Injection 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.
  • Checking shall be done monthly.
• 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 valve shall be done monthly.
• Checking of evaporator and condenser column
  • Visually inspect the evaporator and condenser internally for surface roughness, crashes, cleanliness, damage, and dent and rusting; if found clean thoroughly and rectify the same.
  • Physically check and inspect the evaporator and condenser insulation and cladding, if required repair.
  • Physically check the end connection to evaporator and condenser for leakages, if required rectifies the same.
  • Physically check the evaporator and condenser 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 done after every six month
• De-rusting and De-scaling Procedure for Evaporator and Condenser
  • The de-rusting and de-scaling frequency shall be yearly.
  • Details of the chemical / reagents use
  • ACID / CHEMICAL                                 : – Caustic soda, Sulphonic Acid & Nitric Acid.
  • CONCENTRATION                                 : – 5% of total volume of water. (In Liters.)
  • CIRCULATION TIME                             : – Two hours for each acid & Alkaline.
  • SOAKING OF PART                               : – N. A.
  • EQUIPMENT FOR CIRCULATION         : – S. S. Circulation Pump 1 Phase capacity:-400-500 Liters / hr., Hose Pipe with TC Connection Suitable for Acids, Tank for preparation of solution.
  • Safety Precautions for Cleaning
  • Isolate all sensors from pipe and Put the blind plugs, Isolate the pure steam outlet line, remove the orifice from the pure  steam condensate line
  • Isolate first column and last column purging valve.
  • Isolate WFI outlet line and dumping line and close the sampling point valve of WFI.
  • Rubber or PVC gloves ,eye goggles & aprons should be provided to the workers during preparing  the solution 
• Procedure for the Preventive Maintenance of Water for Injection Generation System:
  • Take one 300 Liters surge tank & fill up with Purified Water with connecting circulation pump
  • Disconnect the pipe from Rota-meter outlet & connect the circulation pump outlet pipe to this line.
  • Connect the return line to the cooler vent line & put in the surge tank.
  • Fill up 250 liter Purified Water in the surge tank. Start the circulation pump of surge tank & keep filling surge tank once again with Purified Water & maintain it 250 liter in the surge tank till the purified water return from the cooler vent pipe & it will drop inside the surge tank. Check for any leakages if found rectify it.
  • Stop the circulation pump of surge tank.
  • Dilute 5% of caustic soda of total Purified Water volume; & Circulate for 2 Hrs.
  • Check the availability of steam; it should be available throughout complete process.
  •  Maintain the 250 liter Purified Water temperature at 60°C -70°C in the surge tank, by switching  ON/OFF steam in valve through the manual operation box for 2 Hrs.
  • After completion of two hours drain out all the solution from the surge tank;  as well as from the column
  • Rinse the entire column with fresh water after each chemical process.
  • As per this procedure de-scale all the balance columns & after that drain out all the solution from columns & surge tank. Flush out the same with hot purified  water
  •  Follow the same procedure for below acids
  • Sulphonic Acid                       : 1 hour
  • Nitric Acid                              : 1 hour
  • Drain out all the chemicals from the surge tank. As well as column & disconnect the pipe line & reconnect Rota- meter pipe line. 
  • Remove the blind plug on first column overflow line; Remove the blind plug in last column overflow .WFI outlet line & also in dumping line & close the sampling point valve of WFI.
  • Start the MEDS & put it on for 30min for stabilization. & Flush it out.
  • Again restart the MEDS and flush it out till the WFI gets pass.
• 1’st Column H/E   
  • Disconnect Plant steam inlet & condensate line.
  • Connect Pump outlet to columns condensate outlet line.
  • Connect return line from plant steam inlet point (hose Pipe) back to surge tank.
  • Fill up 250 liter Purified Water in the surge tank. & dilute 5% of caustic soda of total purified water volume. & Circulate for 2 Hrs.
  • After that drain out all the solution from H/E & surge tank. Flush out the same with hot purified water
  • Follow the same procedure for below acids
  • Sulphonic Acid                       : 1 hour
  • Nitric Acid                              : 1 hour
  • Rinse entire system with fresh purified water for 30 minutes.
• COOLER (COOLING WATER COIL):
  • Disconnect cooling water inlet line & connect Pump outlet line
  • Disconnect cooling water outlet line & connect it to surge tank.
  • Repeat the same procedure as mentioned in 1’st Column H/E.

• Checking for the steam trap
  • Check the steam trap for condensate flow; remove the sediment or dust arrested in the strainer.
  • Checking of the steam traps shall be done quarterly.
• Checking for the steam inlet valve
  • Check the steam inlet valve for the smoothly closing and opening of valves; if it jammed; then carry out the maintenance as follows
  • Close the isolation valve of steam line.
  • Open the valve by loosening the flange nut bolts.
  • Check for the gasket; valve seat stem locking nut; clean and refit the same; if required replace the gasket if it get damaged.
  • Refit the valve and check for any leakage and proper working; if required replace the valve with new one.                                                                                           
  • Checking of the steam valve shall be done after six month.
• Checking of the steam safety valve
  • Increase the steam safety valve above the set point, the safely valve should pop up and steam will come out.
  • If steam is not come out then check the set point. Recheck the operation of safety valve if found okay, then put it in the system or otherwise replace the same.
  • The checking of steam safety valve should be checking once in after six month
• Checking of blow down of system
  • Check the blow down timing it should be as per recommendation of manufacturer.
  • Checking of blow down shall be done monthly.
• 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.
  • Checking of the pumps shall be done quarterly.
• Checking of instruments
  • Ensure that the installed instruments are calibrated.
  • Checking of instruments shall be done monthly.
• Checking of printer
  • Check the printer for paper alignment and printer cartridge ribbon.
  • Checking of printer shall be done quarterly.
• Common faults and remedial action

• Checking the stock of recommended spare part list printer
  • The recommended spare part list as follows; checking shall be done quarterly

• Checking of Multi Columns and pipelines for any rouging
  • Check the Multi columns and pipelines for any rouging.If found, clean the  surface of Multi columns and pipeline with buffing or electro polishing process.
  • Checking shall be done after every six month.

• Checking of Multi Columns and pipelines for any rouging
  • Check the Multi columns and pipelines for any rouging.If found, clean the  surface of Multi columns and pipeline with buffing or electro polishing process.
  • Checking shall be done after every six month.
  • Once the process value becomes higher than the set value, dump valve shall open automatically and dumping of WFI 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 Water for Injection 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.
• Checking of contactors
  • Switch off the main switch on the electrical panel.
  • Disconnect all the control and power wires from the contactor terminals.
  • Remove the 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
• Checking of motor of centrifugal type distribution pump
  • Check the insulation resistance of motor winding with the help of megar.
  • 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.
  • 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 shall be done after every six month.
• Checking of VFD terminals
  • Switch off the main switch on the electrical panel.
  • Check all the contacts and clean with carbon tetra chloride or with contactor cleaner.
  • Checking of VFD contacts shall be done six monthly
• 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.
• Post Preventive Maintenance of Water for Injection Generation System – Check List
  • Record the Preventive Maintenance details as per the Format No.: SOP/EN/XXXYYY “Preventive Maintenance Checklist & Record for Water for Injection Generation”.
  • 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
  • PLC           :     Programmable Logical Controller
  • LED          :     Light Emitting Diode
  • MMI          :     Man Machine Interface
  • MEDS       :     Multi Effect Distillation Still
  • WFI           :     Water For Injection
  • PRV          :     Pressure Reducing Valve
  • SOP         :     Standard Operating procedure
  • TC           :     Tri clover
• REFERENCES:
  • Operational & Maintenance Manual of Multi-Effect Distillation Still
• DISTRIBUTION LIST:
  • SOP for Preventive Maintenance of Water for Injection Generation System shall be distributed to following departments Quality Assurance, Engineering as per user request.
• ANNEXURES:
  • Preventive maintenance checklist and record for:      SOP/EN/XXXYYY Water for Injection Generation System

Preventive Maintenance of Water for Injection Generation System Checklist and the Record:

You may also read about Good Laboratory Practices (GLP)