SOP for Preventive Maintenance of Ampoule Washing Machine EN-46

The objective of this (Standard Operating Procedure) SOP for Preventive Maintenance of Ampoule Washing Machine is to outline the steps and guidelines for conducting preventive maintenance on the Ampoule Washing Machine to ensure its optimal performance, extend its lifespan, and minimize downtime.

SOP for Preventive Maintenance of Ampoule Washing Machine

• OBJECTIVE:
  • This SOP describes the Preventive Maintenance of Ampoule Washing Machine.
• SCOPE:
  • This SOP is applicable for Preventive Maintenance of Ampoule Washing installed in the Production department.
• RESPONSIBILITY:
  • Technician/ Operator shall be responsible for the proper execution of Preventive Maintenance of Ampoule Washing Machine as per SOP.
  • Engineering – Head shall be responsible for reviewing the SOP and for ensuring the 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 – Mechanical
• Checking of fasteners
  • Check that all the fasteners / mounting bolts of Ampoule 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 damaged/leakage, if any damage/leak is observed, replace the tube/connector.
  • Checking shall be done monthly.
• Checking of leakages.
  • Check for any leakage of WFI 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 WFI recirculation pumps 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 six 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 six 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 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 of 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 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 thoroughly and check for the integrity testing as per SOP “ 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 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.
• Checking of sprockets with chain alignment
  • Check the loose or damaged chain or sprocket unbalanced, misalignment visually .if found damaged replace the same
  •  Checking of sprocket and chain alignment shall be done after every month.
• 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 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.
• Checking of motor
  • Physically 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.
• Check the stock of recommended spare part list as follows;
  • Check the stock of recommended spare parts after every six month.

• Checking of safety Alarms
  • The following safety alarms shall be study at an after every six months intervals.

• Post Preventive Maintenance – Check List
  • Record the Preventive Maintenance details as per the Format No.: SOP/EN/XXXYYY “Preventive Maintenance Checklist & Record for Ampoule Washing 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
  • WFI           :     Water for Injection
• REFERENCES:
  • Operational & Maintenance Manual of Ampoule 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 :SOP/EN/XXXYYY Ampoule Washing Machine

PREVENTIVE MAINTENANCE CHECKLIST & RECORD FOR AMPOULE WASHING MACHINE

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