The purpose of this (Standard Operating Procedure) SOP for Preventive Maintenance Procedure of Vial Filling and Bunging Machine is to provide guidelines and instructions for the preventive maintenance of the Vial Filling and Bunging Machine to ensure its optimal performance, reliability, and compliance with quality standards during the filling and bunging process.
SOP for Preventive Maintenance Procedure of Vial Filling and Bunging Machine:
- OBJECTIVE:
- This SOP is describing the Preventive Maintenance Procedure of Vial Filling and Bunging Machine.
- SCOPE:
- This SOP is applicable for Preventive Maintenance Procedure of Vial Filling and Bunging Machine installed in the production department.
- RESPONSIBILITY:
- Technician/ Operator shall be responsible for proper execution of Preventive Maintenance Procedure of Vial Filling and Bunging Machine.
- 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 Procedure of Vial Filling and Bunging Machine.
- 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 filling, and bunging 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.
- Checking shall be done monthly.
- Checking of Vacuum pump
- Vacuum pump connection is provided for bunging and rejection of vials.
- Check the end connections of vacuum pump; it should not be loose; if required tight the same.
- Check the utility end connection; if required tight the same.
- Check that there is no excessive leakage of water through the side covers and glands are tightened properly; so as to avoid entry of air from atmosphere inside the working chamber.
- There is no leakage from through the automatic drain valve. This could be done by placing a finger or thumb over the automatic drain valve opening; if there is a leakage, replace the valve balls.
- Checking shall be done six monthly.
- Checking of belts
- Check the timing belts of the filling and bunging machine and all the conveyor belts of the filling and bunging machine.
- If found damaged / worn out, replace the same.
- Checking shall be done quarterly.
- 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 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 diaphragm valves shall be done after every month.
- 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 filter housing shall be done after every month.
- Checking of printer
- Check the printer for paper alignment and printer cartridge ribbon.
- Checking of printer shall be done after every six month.
- Preventive Maintenance Procedure of Vial Filling and Bunging Machine – Electrical
- Checking of terminals and wiring
- Ensure that the main electrical supply to the machine is switched OFF.
- Visually check all the power and control wiring and terminals in the electrical panel and for control elements mounted on the machine for any loose connection and damage.
- 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 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 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.
- 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 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 air blower.
- 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.
- Check the availability of spares before doing preventive maintenance.
- Preventive Maintenance Procedure of Vial Filling and Bunging Machine & spare parts
| Sr. No. | Part No. | Quantity |
| 1 | Ball Bearing | 2 Nos. |
| 2 | Ball Bearing | 16 Nos. |
| 3 | Ball bearing | 8 Nos. |
| 4 | Ball Bearing | 2 Nos. |
| 5 | Ball Bearing | 4 Nos. |
| 6 | Cam follower | 2 Nos. |
| 7 | Ball Bearing | 4 Nos. |
| 8 | Pillow block bearing | 2 Nos. |
| 9 | Pillow block bearing | 2 Nos. |
| 10 | Ball Bearing | 2 Nos. |
| 11 | Sleeve Bearing, Type S | 16 Nos. |
| 12 | Flange Bearing, Type F | 8 Nos. |
| 13 | Sleeve Bearing, Type S | 2 Nos. |
| 14 | Flange Bearing, Type F | 4 Nos. |
| 15 | Cam follower | 1 Nos. |
| 16 | Ball Bearing | 2 Nos. |
| 17 | Flange Bearing, Type F | 4 Nos. |
| 18 | Flange Bearing, Type F | 2 Nos. |
| 19 | Flange Bearing, Type F | 8 Nos. |
| 20 | Ball Bearing | 16 Nos. |
| 21 | Ball Bearing | 48 Nos. |
| 22 | Linear Ball Bearing | 16 Nos. |
| 23 | Tapped roller bearing | 2 Nos. |
| 24 | Ball Bearing | 2 Nos. |
| 25 | Ball Bearing | 4 Nos. |
| 26 | Oil seal | 1 Nos. |
| 27 | Oil seal | 1 Nos. |
| 28 | Ball Bearing | 8 NOS |
| 29 | Ball Bearing | 4 Nos. |
| 30 | Ball Bearing | 2 Nos. |
| 31 | Ball Bearing | 4 Nos. |
| 32 | Ball Bearing | 4 NOS |
| 33 | Ball Bearing | 4 NOS |
- Checking for safety alarms
- Check the system for following alarms
- Checking of alarms shall be done after every six month
Preventive Maintenance Procedure of Vial Filling and Bunging 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 | 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 |
| 3 | LOW BUNG ON TRACK Less number of bungs on the feed chute track. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (LOW BUNG ON TRACK) | The machine stops. Ensure sufficient amt of bungs on track. Reset the fault by pressing the RESET button. |
| 4 | MACHINE JAM The star wheels stops when the sensor is not in correct position. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (MACHINE JAM) | The machine stops. Place the sensor in position. Reset the fault by pressing the RESET button. |
| 5 | PUMP OVERLOAD The pump stops working as the sensor is not position. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (PUMP OVERLOAD) | The machine stops. Place the sensor in position. Reset the fault by pressing the RESET button. |
| 6 | DOOR OPEN The door is the open position i.e. the sensor is in improper position. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message (DOOR OPEN) | The machine stops. Set the sensor in correct position. Reset the fault by pressing the RESET button. |
| 7 | LAF FAULT LAF system stops working. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message (LAF FAULT) | The machine stops. Reset the fault by pressing the RESET button. After LAF is made functional as per SOP No. SOP/EN/010 |
| 8 | LOW PRESSURE NITROGEN Nitrogen pressure is low. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (LOW PRESSURE NITROGEN) | The machine stops. Reset the fault by pressing the RESET button after the required pressure is set or Achieved. |
| 9 | MAXIMUM ACCMULATION AT OUTFEED No of Vials at out feed is more than that required. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (MAX. ACCUMULATION AT OUTFEED) | The machine stops. Reset the fault by pressing the RESET button. |
| 10 | LOW PRESSURE VACUUM Vacuum pressure is low. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (LOW PRESSURE VACUUM) | The machine stops. Reset the fault by pressing the RESET button after the required pressure is set. |
| 11 | MINIMUM ACCUMULATION AT INFEED Less no of VIALS at infeed conveyor in Auto Mode Operation. | Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message (MINIMUM ACCUMULATION AT INFEED) | The machine stops. Reset the fault by pressing the Reset Button after ensuring enough VIALS at infeed. |
- Post Preventive Maintenance Procedure of Vial Filling and Bunging Machine – Check List
- Record the PM details as per the Format No.: SOP/EN/XXXYYY “Preventive Maintenance Checklist & Record for Vial Filling and Bunging Machine”.
- 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
- PM : Preventive Maintenance
- SOP : Standard Operating procedure
- LED : Light emitted diode
- PLC : Programmable logical controller
- REFERENCES:
- Operational & Maintenance Manual of Vial filling and Bunging 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 Filling : SOP/EN/XXXYYY And Bunging Machine.
Preventive Maintenance Procedure of Vial Filling and Bunging Machine and its check lists:
PREVENTIVE MAINTENANCE CHECKLIST & RECORD FOR VIAL FILLING AND BUNGING MACHINE
| Equipment Name | Location | ||
| Equipment ID | Frequency |
| Things to be done: | Check List | Remarks |
| Monthly Check List | ||
| Checking of fasteners; mounting bolts. | ||
| Checking of pneumatic tubes and fittings. | ||
| Checking of lubrication of bearings; chains; gears and sprockets. | ||
| Checking of diaphragm valves. | ||
| Checking of filter housing. | ||
| Quarterly Check List | ||
| Checking of conveyor belts. | ||
| Half Yearly Check List | ||
| Checking of vacuum pumps. | ||
| Checking of the printer | ||
| Checking of terminal and wiring | ||
| Checking of motor. | ||
| Checking of PLC. | ||
| Checking of contactors. | ||
| Check the safety alarms. |
