The purpose of this Standard Operating Procedure SOP For Preventive Maintenance of Vial Washing Machine is to provide guidelines and instructions for the preventive maintenance of the Vial Washing Machine to ensure its optimal performance, cleanliness, and compliance with quality standards during the vial washing process.
SOP for Preventive Maintenance of Vial Washing Machine
- OBJECTIVE:
- This SOP is describing the preventive maintenance procedure of vial washing machine.
- SCOPE:
- This SOP is applicable for preventive maintenance of vial washing machine installed in the production department .
- RESPONSIBILITY:
- Technician/ Operator shall be responsible for proper execution of operation 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.
- 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 before start of preventive maintenance activity.
- Preventive Maintenance – Mechanical
- Checking of fasteners
- Check that all the fasteners / mounting bolts of Vial Washing machine are properly tightened.
- There should not be any loose bolts, If found loose, tighten the bolts and nuts by using suitable spanners.
- Checking shall be done monthly.
- Checking of pneumatic tubes and fittings
- Physically check the pneumatic tubes and connectors for any damage/leakage. There should not be any damage/ leakage in the tubes and connectors, if any damage/leak is observed, replace the tube/connector.
- Checking shall be done monthly.
- Checking of leakages.
- Check for any leakage of from pipefitting and connectors. If any leakage is observed, check O-rings, gaskets and replace if found damaged or worn out.
- Check all the clamps and tighten them if required.
- Check the leakages from recirculation water pump at its inlet and outlet port, if any leakage is observed arrest the same by providing new gasket and tightening the line connectors.
- Checking shall be done monthly.
- Checking of pumps
- Check the pump for any abnormal noise if found, Disconnect the pump motor wiring.
- Disconnect the pump from the pipeline and open the pump.
- Check the condition of bearings, mechanical seal, shaft, impeller and replace if found damaged.
- Checking of the pumps shall be done quarterly.
- 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 the valves shall be done quarterly.
SOP for Preventive Maintenance of Vial Washing Machine
- Checking of Filter housing
- Physical verify the filter housing for any damage, shape change, dents; surface roughness and end connections. If found, then rectify or replace the same.
- Checking of the filter housing shall be done six monthly
- Checking of printer
- Check the printer for paper alignment and printer cartridge ribbon.
- Checking shall be done after every six month.
- Checking and lubrication of bearings, chains, gears and sprockets.
- Check sprockets, gears, chain and cams for any damage. If found damaged, replace the same.
- Lubricate bearings, cams, gears, chain and sprocket with the help of grease gun.
- Checking shall be done quarterly.
- Preventive Maintenance – Electrical
- Checking of terminals and wiring
- Ensure that the main electrical supply to the machine is switched OFF.
- Visually check all the power & control wiring, terminals in the electrical panel and control elements mounted on the machine for any loose connection and tight them. If required.
- Check and ensure by using the screwdriver that all the wires are properly tightened at the distribution terminals inside the electrical panel and on the terminals of all the control elements.
- Checking shall be done six monthly.
- Checking of contactors
- Switch OFF the Electrical supply to the Machine.
- Remove all the power and control wires from the contactor terminals.
- Remove the dust from control panel with help of vacuum cleaner.
- Remove the contactor from the panel and visually check all the contacts for the signs of pitting and deposit of carbon on the contacts.
- Clean the contacts, terminals and all the moving parts of the contactor by spraying contactor cleaner.
- Replace the contacts if found damaged / welded.
- Put back the contactor in the panel and re-terminate all the power and control wires properly to their 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 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.
- Checking of 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 and ampere ratings of motor with the help of multimeter.
- Check the direction of rotation; it should be as per recommended direction.
- Checking shall be done after every six month.
- Check the availability of spares before doing preventive maintenance.
- Checking of safety Alarms
- The following safety alarms shall be study at an after every six months intervals.
SOP for Preventive Maintenance of Vial Washing Machine
| Sr. No. | Alarms and Conditions | Alarm message | Control Action |
| 1 | Emergency stop (Emergency stop push button is pressed) | Audio Alarm is activated, HMI screen displays the alarm message EMERGENCY STOP | The machine stops, release the emergency push button. Reset the fault by pressing reset button. |
| 2 | PROTECTION GUARD OPEN Protection guard is open in AUTO mode | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (POLYCARBONATE PROTECTION GUARD OPEN | The machine stops. Keep the guard in position. Reset the fault by pressing the RESET button. |
| 3 | MOTOR OVERLOAD The main motor stops so the turntable motor stops. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (MOTOR OVERLOAD) | The machine stops. Reset the fault by pressing the RESET button after the motor load is set |
| 4 | RECYCLE WATER PRESSURE LOW Recycled water pressure is low in the recycled water line. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message (RECYCLE WATER PRESSURE LOW) | The machine stops. Reset the fault by pressing the RESET button after the required pressure is set. |
| 5 | RECYCLE WATER PRESSURE VERY HIGH Recycled water pressure is high in the recycled water line. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (RECYCLE WATER PRESSURE VERY HIGH) | The machine stops. Reset the fault by pressing the RESET button after the required pressure is set. |
| 6 | COMPRESSED AIR PRESSURE LOW Compressed air pressure is low in the compressed air line. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message (COMPRESSED AIR PRESSURE LOW) | The machine stops. Reset the fault by pressing the RESET button after the required pressure is set. |
| 7 | COMPRESSED AIR PRESSURE VERY HIGH Compressed air pressure is very high in the compressed air line. | Interface Terminal) displays the following alarm message (COMPRESSED AIR PRESSURE VERY HIGH) | The machine stops. Reset the fault by pressing the RESET button after the required pressure is set. |
| 8 | WFI WATER PRESSURE LOW WFI pressure is low in the WFI line. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (WFI PRESSURE LOW) | The machine stops. Reset the fault by pressing the RESET button after the required pressure is set. |
| 9 | WFI WATER PRESSURE VERY HIGH WFI pressure is very high in the WFI line pressure gauge. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (WFI PRESSURE VERY HIGH ) | The machine stops. Reset the fault by pressing the RESET button after the required pressure is set |
| 10 | PURIFIED WATER PRESSURE LOW Purified water pressure is low in the Purified line pressure gauge. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (PURIFIED WATER PRESSURE LOW) | The machine stops. Reset the fault by pressing the RESET button after the required pressure is set. |
| 11 | PURIFIED WATER PRESSURE VERY HIGH Purified water pressure is high in the Purified line pressure gauge. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (PURIFIED WATER PRESSURE VERY HIGH) | The machine stops. Reset the fault by pressing the RESET button after the required pressure is set. |
| 12 | RECYCLE WATER TANK LEVEL LOW The level in the recycle water tank is low. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (RECYCLE WATER TANK LEVEL LOW ) | The machine stops. Put the required amount of water in the tank. Reset the fault by pressing the RESET button. |
| 13 | INFEED TORQUE OVERLIMIT The machine stops when the infeed turret gets jammed while in operation. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (INFEED TORQUE OVERLIMIT) | The machine stops. Rotate the turret so that the clutch sensor is high again. Reset the fault by pressing the RESET button. |
| 14 | OUTFEED TORQUE OVERLIMIT The machine stops when the outfeed turret gets jammed while in operation. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (OUTFEED TORQUE OVERLIMIT) | The machine stops. Rotate the turret so that the clutch sensor is high again. Reset the fault by pressing the RESET button. |
| 15 | MINIMUM ACCUMULATION AT INFEED The machine stops due to less no. of vials at infeed. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (MINIMUM ACCUMULATION AT INFEED) | The machine stops. Keep maximum vials in position. Reset the fault by pressing the RESET button. |
| 16 | OUTFEED MAXIMUM ACCUMULATION The machine stops due to max accumulation of vials at outfeed. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (MAXIMUM ACCUMULATION AT OUTFEED) | The machine stops. Check at the outfeed for max accumulation Reset the fault by pressing the RESET button. |
| 17 | RECYCLE WATER TRANSDUCER FAULT The sensor for pressure transducer in recycle water line fault occurs. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (RECY WATER TRANSDUCER FAULT) | The machine stops. Reset the fault by pressing the RESET button after the sensor position is set. |
| 18 | VAPOUR EXHAUST MALFUNCTIONING The overload relay for vapour exhaust trips while in auto mode operation. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (VAPOUR EXHAUST MALFUNCTIONING) | The machine stops. Reset the fault by pressing the RESET button after the overload fault is set. |
| 19 | WFI LINE RTD FAULT The RTD sensor for WFI line fault occurs. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message (WFI LINE RTD FAULT) | The machine stops. Reset the fault by pressing the RESET button after the sensor position is set. |
| 20 | WFI LINE TEMPERATURE LOW The temperature in the WFI line is low. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (WFI LINE TEMPERATURE LOW) | The machine stops. Reset the fault by pressing the RESET button after the temperature is set |
| 21 | WFI LINE TEMPERATURE HIGH The temperature in the WFI line is high. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (WFI LINE TEMPERATURE HIGH) | The machine stops. Reset the fault by pressing the RESET button after the temperature is set |
| 22 | COMPRESSED AIR TRANSDUCER FAULT The sensor for pressure transducer in CA line fault occurs. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (COMPRESSED AIR TRANSDUCER FAULT) | The machine stops. Reset the fault by pressing the RESET button after the sensor position is set. |
| 23 | PURIFIED WATER TRANSDUCER FAULT The sensor for pressure transducer in purified water line fault occurs. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (PUR WATER TRANSDUCER FAULT) | The machine stops. Reset the fault by pressing the RESET button after the sensor position is set. |
| 24 | WFI TRANSDUCER FAULT The sensor for pressure transducer in WFI line fault occurs. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (WFI LINE TRANSDUCER FAULT) | The machine stops. Reset the fault by pressing the RESET button after the sensor position is set. |
| 25 | RECYCLE WATER TANK TEMPERATURE LOW The recycle tank water temperature is low | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (RECYCLE WATER TANK TEMPERATURE LOW ) | The machine stops. Reset the fault by pressing the RESET button after required temperature is set. |
| 26 | RECYCLE WATER TANK TEMPERATURE VERY HIGH The recycle tank water temperature is high. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (RECYCLE WATER TANK TEMPERATURE VERY HIGH ) | The machine stops. Reset the fault by pressing the RESET button after required temperature is set. |
| 27 | RECYCLE WATER TANK RTD FAULT The RTD sensor for recycle water tank fault occurs. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (RECYCLE WATER TANK RTD FAULT) | The machine stops. Reset the fault by pressing the RESET button after the sensor connection is set properly. |
| 28 | PURIFIED WATER LINE RTD FAULT The RTD sensor for purified water line fault occurs. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (PURIFIED WATER LINE RTD FAULT)\ | The machine stops. Reset the fault by pressing the RESET button after the sensor position is set. |
| 29 | PURIFIED WATER LINE TEMPERATURE LOW The temperature in the purified water line is low. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (PURIFIED WATER TEMP LOW) | The machine stops. Reset the fault by pressing the RESET button after the temperature is set |
| 30 | PURIFIED WATER LINE TEMPERATURE VERY HIGH The temperature in the purified water line is high | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm Message (PURIFIED WATER TEMP VERY HIGH) | The machine stops. Reset the fault by pressing the RESET button after the temperature is set |
- Post Preventive Maintenance Check List
- 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.
- Record the Preventive maintenance details for Vial Washing Machine as per Format No. SOP/EN/XXXYYY.
- ABBREVIATIONS:
- CRF No. : Change Request Form number
- QA : Quality Assurance
- WFI : Water For Injection
- PS : Pure Steam
- REFERENCES:
- Operational & Maintenance Manual of Vial Washing Machine.
- DISTRIBUTION LIST:
- SOP shall be distributed to following departments Quality Assurance, Engineering as per user request.
- ANNEXURES:
- Preventive maintenance checklist and record for Vial Washing Machine. SOP/EN/XXXYYY
PREVENTIVE MAINTENANCE CHECKLIST & RECORD FOR VIAL WASHING MACHINE
Preventive Maintenance Checklist & Record in SOP for Preventive Maintenance of Vial Washing Machine
| Equipment Name | Location | ||
| Equipment ID | Frequency |
| Things to be done: | Check List | Remarks |
| Monthly Check List | ||
| Check the fasteners; if required tighten the bolts and nuts by using suitable spanner. | ||
| Checking of pneumatic tubes and fittings. | ||
| Checking of leakages from pipe and pipe fittings. | ||
| Checking of shaft couplers | ||
| Checking of radial play of CAMs to the shafts. | ||
| Quarterly Check List | ||
| Checking of pumps for bearings; mechanical seal lubrications; shaft and impellers. | ||
| Checking of valves for freely opening and closing. | ||
| Checking and lubrication of bearings; chains; gears and sprockets | ||
| Checking of grippers, gripper blocks, spring and gripper bush. | ||
| Checking of oscillating ring rollers | ||
| Checking of Exhaust system. | ||
| Half Yearly Check List | ||
| Checking of filter housings. | ||
| Checking of printer | ||
| Checking of terminals and wiring. | ||
| Checking of contactors. | ||
| Checking of PLC | ||
| Checking of electrical motor. | ||
| Checking of safety alarms and interlocks. |