SOP For Preventive Maintenance of combi Ampoule/vial  Filling and Sealing Machine EN-60

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

SOP For Preventive Maintenance of combi Ampoule/vial  Filling and Sealing Machine:

• OBJECTIVE:
  • This SOP is describing the Preventive Maintenance procedure of combi Ampoule/vial Filling and Sealing Machine.
• SCOPE:
  • This SOP is applicable for Preventive Maintenance of combi Ampoule/vial Filling and Sealing Machine.
• RESPONSIBILITY:
  • Technician/ Operator 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.
• DEFINITIONS:
  • Preventive Maintenance: The preventive maintenance describes all scheduled work done on a routine, predefined basis to maintain facilities, equipment, utilities and devices in good status in order to ensure reliable performance.
• 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 fasteners
  • Check that all the fasteners / mounting bolts of filling, and sealing 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 damage/leakage in the tubes and connectors.
  • If any damage/leak is observed, replace the tube/connector.
  • Checking shall be done monthly.
• Checking of waste gas ducting / exhaust gas piping
  • Check the tightness of end connections if required tightens the same.
  • Check and clean the duct for any kind of obstruction or plugging.
  • Checking shall be done yearly.
• Checking of the gas piping
  • Check and clean the gas line filters for compressed air and nitrogen.
  • Check the end connection of oxygen and LPG gas.
  • Check the hose connection of gas piping for any leakages; if required replaces the same.
  • Check the performance of pressure regulator.
  • Check for the gas backflow preventer installed between gas connection point and the burner.
  • Clean the torch flames; dirty mixing nozzles and pressure nozzles leads to irregular torch flames and make it difficult to adjust.
  • Check the torch nozzles orifice for wear.
  • Check the position of pointing tongs ensures that it must not be within the range of torch limits.
  • The checking shall be done monthly.
• Checking of  Valve pumps for filling
  • Check the valve filling pumps for any damaged. If found damaged /worn out, replace the same.
  • Checking shall be done six monthly.
• Checking of belts
  • Check the timing belts of the filling machine and all the conveyor belts of the filling,
  • Physically check the wear and tear of conveyor belts, if required rectify or replace the conveyor belts.
  • Stoppering and capping line. If found damaged / worn out, replace the same.
  • Checking shall be done monthly.
• 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.
• Recommended Oil and grease for the lubrication as follows.

• Checking of Valves
  • Check the valves for smoothly movements, if the operating handle of valve is found jammed or stuck, then open the valve and carry out the maintenance as follows.
  • Switch off the supply system.
  • Close the nearby upside and down side valves.
  • Open the end connections and dismantle the valve.
  • If gasket found damaged (cut, leached, deform, shape and size change) change the same.
  • After physically checking of valve, refit in to the system and check for leakage and valve operation if found satisfactorily then it is okay otherwise replace the valve.
  • Check frequency shall be quarterly.
• Checking of Cutting assembly
  • Check the clippers physically.
  • Check the condition of clipper springs.
  • Checking shall be done monthly.
• Checking of Cams
  • Check the cams for radial play.
  • Check the cam bushes and connecting shafts.
  • Checking shall be done monthly.
• Checking of clutches
  • Check the proper functioning of clutches.
  • Check the electrical wiring and connections of clutches.
  • Checking of clutches shall be done monthly.
• Cleaning of Utility inline Filters cartridge
  • Check the reading of differential pressure gauges; if it filters get choked and not giving uniform flow; then the cleaning of cartridge filter is necessary.
  • To clean the cartridge filter follows the following procedure.
  • Close the inlet and outlet valves of filter.
  • Open the drain plug, and drain out the hold water form filter housing; through close drain piping.
  • Loose the body flange of cartridge filter housing.
  • Remove the cartridge filter; check the condition of filter; if it is found damaged; then replace the same or sterilized the cartridge filter and check for the integrity testing as per “Procedure for Cleaning and Operation of Filter Integrity Test Instrument” SOP No.:  SOP/PR/XXXYYY
  • Frequency of checking and replacement of filter cartridge shall be as needed.
• Checking of Filter housing
  • Physical verify the filter housing for any damaged, shape change, dents; surface roughness and end connections. If found, then rectify or replace the same.
  • Check frequency shall be half yearly.
• Checking of printer
  • Check the printer for paper alignment and printer cartridge ribbon.
  • Check frequency shall be half yearly.
• 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 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 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 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 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.
• Check the stock of recommended spare part list as follows;
  • List of recommended Spare part list; checking frequency shall be after every six month.

SOP For Preventive Maintenance of combi Ampoule/vial spares:

SOP For Preventive Maintenance of combi Ampoule/vial:

• Checking for safety alarms
  • Check the system for following alarms; frequency shall be after every six month

• Record the Preventive Maintenance details as per the Format No.: SOP/EN/XXXYYY “Preventive Maintenance Checklist & Record for Combi Ampoule/vial filling and Sealing 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
  • MMI          :     Man Machine Interface
  • PLC           :     Programmable Logical Controller
  • LED          :     Light Emitting Diode
  • LAF          :     Laminar Air Flow
• REFERENCES:
  • Operational & Maintenance Manual of combi Ampoule/vial filling and sealing machine
• DISTRIBUTION LIST:
  • SOP shall be distributed to following departments Quality Assurance, Engineering as per user request.
• ANNEXURES:
  • Preventive maintenance checklist and record for                           :            SOP/EN/XXXYYY
  • Combi Ampoule/vial filling and Sealing Machine

PREVENTIVE MAINTENANCE CHECKLIST & RECORD FOR COMBI AMPOULE/VIAL FILLING AND SEALING MACHINE

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