The objective of this Standard Operating Procedure for Preventive Maintenance of WFI Water Distribution Loops is to outline the steps and guidelines for conducting preventive maintenance on Water for Injection (WFI) water distribution loops to ensure the consistent delivery of high-quality water meeting pharmaceutical standards.
SOP for Preventive Maintenance of WFI Water Distribution Loops
- OBJECTIVE:
- To lay down the procedure for Preventive Maintenance of WFI Water Distribution Loops.
- SCOPE:
- This SOP is applicable for Preventive Maintenance of WFI Water Distribution Loops, installed in technical area.
- RESPONSIBILITY:
- Technician/ Officer engineering shall be responsible for proper execution of preventive maintenance as per SOP.
- Engineering – Head shall be responsible for reviewing the SOP and for ensuring proper execution of preventive maintenance.
- ACCOUNTABILITY:
- Engineering – Head shall be accountable for proper implementation of the SOP for Preventive Maintenance of WFI Water Distribution Loops.
- DEFINITIONS:
- Nil
- PROCEDURE:
- Preventive maintenance 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 – 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.
- 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.
- Checking of Back pressure regulating valve
- Check the back pressure regulating valve for the end connections if required tight the same.
- Checking of back pressure regulating valve shall be done after every six month.
- 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 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 distribution loop.
- Temperature transmitter installed on top nozzle of tank
- Compound pressure gauge installed on top nozzle of tank.
- Capacitance type level transmitter installed on top nozzle of tank.
- Conductivity transmitter installed in suction line of pump.
- Temperature transmitter installed on return line of distribution loop.
- Flow transmitter installed on return line of distribution loop.
- Pressure gauge installed on discharge line of pump.
- Siphon type pressure gauge installed on plant steam line.
- Checking of 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.
- After carrying out the preventive maintenance of tank, pump and distribution piping sanitization cycle should conduct and verify the sanitization procedure as per SOP No. SOP/EN/XXXYYY
- Checking shall be done after every six months
- Checking of vent filter
- Physically check the vent filter housing for the roughness, crashes, cleanliness, damage, dent and rusting, if found clean thoroughly and rectify the same.
- The vent filter replacement and integrity testing should be carried out as per SOP/EN/XXXYYY
- Checking of printer
- Check the printer for paper alignment and printer cartridge ribbon.
- Checking of printer shall be done after every six month.
- Checking of Spare Parts
- Check the stock for following spare parts.
- Checking frequency shall be after very six month
| Sr. No. | Spare Part Descriptions | Specification | Quantity (Nos.) |
| WFI LOOP | |||
| Spray Ball | 1 – ¼ ” NB | 1 | |
| Capacitance type level transmitter | Overall length 1540 mm; measuring length 1300 mm | 1 | |
| Temperature Sensor for Top Dish | 0 – 150 deg C length 1665 mm | 1 | |
| Temperature Transmitter | 0 – 150 deg C | 1 | |
| Compound Pressure Gauge | -1 to 9 bar | 1 | |
| Vent filter cartridge | 0.2 micron ; 10 ” Long | 1 | |
| Vent Filter Housing | 10” Long | 1 | |
| Steam safety Valve | ¾” | 1 | |
| Siphon type pressure gauge | 0 to 7 Kg/cm2; ½” NB | 1 | |
| Vent valve | ½” NB | 1 | |
| Steam trap for tank condensate | ¾” NB | 1 | |
| Manual ball valve | ¾” NB | 3 | |
| Actuated piston valve | 1” NB | 1 | |
| VFD for Distribution Pump | 7.5 HP | 1 | |
| Manual Diaphragm Valve | 2.5” OD | 1 | |
| Sampling Valve | 8 mm | 1 | |
| Sr. No. | Spare Part Descriptions | Specification | Quantity (Nos.) |
| Vent valve | ½” NB | 1 | |
| Steam trap for tank condensate | ¾” NB | 1 | |
| Manual ball valve | ¾” NB | 3 | |
| Actuated piston valve | 1” NB | 1 | |
| VFD for Distribution Pump | 7.5 HP | 1 | |
| Pressure Gauge | 0 to 10 Kg/cm2 | 1 | |
| Temperature sensor line mounted | Overall length 50 mm from TC | 1 | |
| Temperature Transmitter | 1 | ||
| Conductivity Sensor and Transmitter | 0 to 10 µs / cm | 1 | |
| Flow transmitter | 4.13 m3/hr maximum flow | 1 | |
| Manual Diaphragm valve | 1.5” NB | 2 | |
| Manual Diaphragm valve | 2.5” NB | 1 | |
| Manual Diaphragm valve | 3.0” NB | 2 | |
| Actuated Diaphragm Valve | 1.5” NB | 3 | |
| Sampling Valve | 8 mm | 2 | |
- Checking of tank (WFI distribution) and pipelines for any rouging
- Check the tank (WFI distribution) and pipelines for any rouging.If found, clean the surface of WFI distribution tank and pipelines with buffing or electro polishing process.
- Checking shall be done after every six month
- Challenge test for dumping valve.
- 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 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 WFI Water Distribution Loops – 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 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
- Check the insulation resistance of motor winding with the help of meagger.
- 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.
- 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 – Check List
- Record the PM details as per the Format No.: SOP/EN/XXXYYY “Preventive Maintenance Checklist & Record for WFI Distribution Loops”.
- 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
- LED : Light Emitting Diode
- PLC : Programmable Logical Controller
- VFD : Variable Frequency Drive
- 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 WFI Distribution Loops:- SOP/EN/XXXYYY
Preventive Maintenance of WFI Water Distribution Loops Checklist and Records
| Equipment Name | Location | ||
| Equipment ID | Frequency |
| Things to be done: | Check List | Remarks | ||||
| Monthly Check List | ||||||
| Checking of diaphragm valve for properly opening and closing of the valves. | ||||||
| Checking of back pressure regulating valve. | ||||||
| Challenge test for dumping valve AF1VT1 3301 | ||||||
| Current conductivity value (µs/cm) | Changed conductivity Value (µs/cm) | Reset conductivity value. (µs/cm) | Function of Dumping valve | |||
| complies | Does not complies | |||||
| Quarterly Check List : Preventive Maintenance of WFI Water Distribution Loops | ||||||
| Checking of pump for abnormal sound; damage of bearings, mechanical seal; shaft; impeller. | ||||||
| Checking of vent filter and integrity testing. | ||||||
| Half Yearly Check List: Preventive Maintenance of WFI Water Distribution Loops | ||||||
| Checking of pipe line and pipe fittings for leakages; pipe support; if required tighten them if found loose. | ||||||
| Checking of instruments for end connection tightness; if required tight the contacts. | ||||||
| Ensure that the installed instruments are calibrated. | ||||||
| Checking of filter housing for any dents; leakages; internal finishes. | ||||||
| Checking of tank and tank accessories. | ||||||
| Checking of printer for paper alignment and printer cartridge ribbon. | ||||||
| Checking of contactors. | ||||||
| Checking of terminals and wiring. | ||||||
| Checking of VFD for contacts. | ||||||
| Checking of electrical motor. | ||||||
| Checking of PLC for display; blinking of LED and wiring contacts. | ||||||
| Check the tank (WFI distribution) and pipelines for any rouging.If found, clean the surface of WFI distribution tank and pipelines with buffing or electro polishing process | ||||||
| Yearly Check List: Preventive Maintenance of WFI Water Distribution Loops | ||||||
| Check the burning hours of the UV lamp; if it is exceeds than the recommending hours; then replace the UV lamp. | ||||||
You may also read about Good Laboratory Practices (GLP)