SOP for Preventive Maintenance of Vial Capping Machine EN-61

The objective of this (Standard Operating Procedure) SOP For Preventive Maintenance of Vial Capping Machine is to describe the steps for performing preventive maintenance on the Vial Capping Machine to ensure its optimal performance, reliability, and longevity.SOP For Preventive Maintenance of Vial Capping Machine

SOP For Preventive Maintenance of Vial Capping Machine

  • OBJECTIVE:
    • This SOP is describing the preventive maintenance procedure of the vial capping machine.
  • SCOPE:
    • This SOP is applicable for preventive maintenance of the vial capping machine installed in the production department
  • RESPONSIBILITY:
    • The technician/ Operator shall be responsible for the proper execution of preventive maintenance as per SOP.
    • Engineering – The 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 at the time of preventive maintenance.

Preventive Maintenance of Vial Capping Machine –Mechanical

  • Checking of fasteners
    • Check that all the fasteners / mounting bolts of the vial capping 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 damaged/leakage. There should not be any damaged/leakage in the tubes and connectors.
    • If any damage/leak is observed, replace the tube/connector.
    • Checking shall be done six monthly.
  • Checking of belts
    • Check the timing belts of the vial capping machine and all the conveyor belts of the vial capping machine.
    • If found damaged/worn out, replace the same.
    • Checking shall be done six monthly.
  • Checking and lubrication of bearings, chains, gears and sprockets.
    • Check sprockets, gears, chain and cams for any damaged. If found damaged, replace the same.
    • Lubricate bearings, cams, gears, chain and sprocket with the help of grease gun.
    • Checking shall be done quarterly.
    • Check the availability of spares before doing preventive maintenance.
GEP

SOP For Preventive Maintenance of Vial Capping Machine check list for Electrical:

  • 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 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 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 the motor with the help of the multimeter.
    • Check the current drawn by thr motor with the help of the 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 contactors
    • Switch OFF the Electrical supply to the Machine.
    • Remove all the power and control wires from the contactor terminals
    • Remove dust from the 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
  • 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.

The SOP For Preventive Maintenance of Vial Capping Machine check list of safety Alarms:

  • Checking for safety alarms
    • Check the system for following alarms; Checking of contactors shall be done six monthly.
Sr. No.Alarms and ConditionsAlarm MessageControl Action
1.INFEED TORQUE OVERLIMIT The infeed turret stops when the sensor is not in correct position.  Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message (INFEED TORQUE OVERLIMIT)The machine stops. Place the sensor in position. Reset the fault by pressing the RESET button.  
2OUTFEED TORQUE OVERLIMIT The outfeed turret stops when the sensor is not in correct position.  Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (OUTFEED TORQUE OVERLIMIT)The machine stops. Place the sensor in position. Reset the fault by pressing the RESET button.  
3LOW VIAL AT INFEED Less number of vials at infeed which stops the machine operation.  Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (LOW VIAL AT INFEED)The machine stops. Ensure sufficient amt of vials at infeed and Reset the fault by pressing the RESET button.  
4MOTOR OVERLOAD The main motor stops so the conveyor as well as the turntable motor stops.  Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (MOTOR OVERLOAD)The machine stops. Place the sensor in position. Reset the fault by pressing the RESET button.  
5LOW CAP ON TRACK The machine stops because of low cap on the feed chute track.  Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. ( LOW CAP ON TRACK )The machine stops. Reset the fault by pressing the RESET button after the motor load is set.  
6EMERGENCY STOP Emergency push button is pressed.  Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message (EMERGENCY STOP)The machine stops. Release the emergency push button. Reset the fault by pressing the RESET button.  
7MAXIMUM ACCUMULATION AT OUTFEED The maximum accumulation of the sealed vials takes place at the outfeed.  Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (MAXIMUM ACCUMULATION OUTFEED)The machine stops. Ensure vials move from the outfeed to downline machines and Reset the fault by pressing the RESET button  
8DOOR OPEN Door is in the open position and the machine stops.  Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message (DOOR OPEN)The machine stops. Keep the door in proper closed position and Reset the fault by pressing the RESET button  
9LAF 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.  
10VIBRATOR CURRENT OVERLOAD The vibrator current overload Occurs due to tripping of overload relay.Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message (VIBRATOR CURRENT OVERLOAD)The machine stops. Reset the fault by pressing the RESET button.  
11VIAL COUNT WITHOUT SEAL EXCEEDED The machine stops when Continuous vials (counter is set) without seals exceeds the set value & enter the rejection tray.Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message (VIAL COUNT WITHOUT SEAL EXCEEDED)  The machine stops. Reset the fault by pressing the RESET button.  

SOP For Preventive Maintenance of Vial Capping Machine

GMP Audit Checklist
  • Post Preventive Maintenance – Check List
    • Record the Preventive Maintenance details as per the Format No.: SOP/EN/XXXYYY “Preventive Maintenance Checklist & Record for Vial Capping 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
    • LED          :     Light emitting diode
    • SOP          :      Standard operating procedure
    • EN            :      Engineering
  • REFERENCES:
    • Operational & Maintenance Manual of Vial Capping Machine. 
  • DISTRIBUTION LIST:
    • SOP shall be distributed to following departments Quality Assurance, Engineering as per user request
  • ANNEXURES:
    • Preventive Maintenance Checklist &                 :                       SOP-EN-XXXYYY Record for Vial Capping Machine

PREVENTIVE MAINTENANCE CHECKLIST & RECORD FOR ROTARY VIAL CAPPING MACHINE

Equipment Name  Location 
Equipment ID Frequency 
Things to be done:Check ListRemarks
Monthly Check List  
Checking of fastener for tightness; if required tighten the same.  
Quarterly Check List  
Checking and lubrication of bearings; chains; gears and sprockets.  
Half Yearly Check List  
Checking of pneumatic tubes and fittings.  
Checking of conveyor belts.  
Check the stock of recommended spare parts.  
Checking of terminals and wiring.  
Checking of the motor and terminal boxes and terminal connections.  
Checking of contactors.  
Checking of safety alarms.  
 Checking of PLC.  

Frequently Asked Questions:

What is the purpose of the SOP for Preventive Maintenance of Vial Capping Machine?

Answer: The purpose of this SOP is to outline the steps and procedures for conducting preventive maintenance on the Vial Capping Machine to ensure its optimal performance, reliability, and longevity.

Who is responsible for performing the preventive maintenance on the Vial Capping Machine?

Answer: The responsibility for performing preventive maintenance on the Vial Capping Machine lies with the operators and maintenance personnel.

How often should preventive maintenance be conducted on the Vial Capping Machine?

Answer: Preventive maintenance should be conducted at regular intervals as specified in the machine manufacturer’s guidelines or as determined by the maintenance team based on the machine usage and condition.

What personal protective equipment (PPE) should be worn during the maintenance process?

Answer: Safety goggles, gloves, and appropriate work attire are required as personal protective equipment (PPE) during the maintenance process.

What are the key steps involved in the preventive maintenance procedure?

Answer: The key steps involved in the preventive maintenance procedure include exterior cleaning, interior cleaning, inspection of parts, lubrication, alignment and calibration, functional testing, and verification of capping quality.

Why is lubrication important during preventive maintenance?

Answer: Lubrication is crucial during preventive maintenance as it ensures smooth operation of moving parts, reduces friction, and prevents premature wear and tear of components.

What should be checked during the functional testing of the Vial Capping Machine?

Answer: During functional testing, the Vial Capping Machine should be observed for any unusual noises, vibrations, and abnormalities. Additionally, test vials are used to verify proper capping and sorting performance in preventive maintenance of Vial Capping Machine

How should the capping quality be verified during maintenance?

Answer: The capping quality should be verified by inspecting the capped vials for proper tightness and sealing. If adjustments are needed to achieve the desired capping quality, the capping heads can be adjusted accordingly in preventive maintenance of Vial Capping Machine.

What safety precautions should be followed during preventive maintenance?

Answer: The following safety precautions should be followed during Preventive Maintenance of Vial Capping Machine:

  • Wear appropriate personal protective equipment (PPE) such as safety goggles and gloves.
  • Ensure the machine is turned off and disconnected from the power supply before starting maintenance.
  • Implement lock-out and tag-out procedures to prevent accidental machine startup.
  • Handle electrical components with care and avoid working on the machine when it is wet.
  • Maintain a clean and organized work area to prevent accidents and tripping hazards.

Why is documentation important during preventive maintenance?

Answer: Documentation is essential to keep a record of the maintenance activities performed, the date of maintenance, any observations made, and any corrective actions taken. It helps in tracking the maintenance history of the machine and facilitates better planning for future maintenance tasks in the Preventive Maintenance of Vial Capping Machine

Aseptic Area 001

(Good Laboratory Practices)GLP in Microbiology Laboratory

Leave a Comment

error: Content is protected !! please mail your query on flairpharma28@gmail.com we provide you the printed copy.