The purpose of this Standard Operating Procedure i.e. SOP for Preventive Maintenance of Automatic Loading and Unloading System for Lyophilizer is to establish a systematic and consistent approach for performing preventive maintenance on the Automatic Loading and Unloading System of the Lyophilizer. This procedure aims to ensure the reliable and efficient operation of the system, minimize downtime, and extend the equipment’s lifespan.
SOP for Preventive Maintenance of Automatic Loading and Unloading System for Lyophilizer:
OBJECTIVE:
To lay down the procedure for preventive maintenance of the automatic loading and unloading system for Lyophilizer.
SCOPE:
This SOP is applicable to the procedure for preventive maintenance of automatic loading and unloading system for the Lyophilizer, installed in the production area.
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 the proper execution of preventive maintenance
ACCOUNTABILITY:
Engineering – The head shall be accountable for the proper implementation of the SOP.
DEFINITIONS:
Nil
PROCEDURE:
Preventive maintenance shall be executed as per 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 Automatic Loading and Unloading System for Lyophilizer – Mechanical
Check the physical condition of LAF pre-filters, if found dirty then cleaning will be performed as per SOP/PR/XXXYYY.
Replacement Procedure for LAF HEPA filter as follows
Loosen the clamps with the help of the spanner.
With utmost care remove the HEPA Filter and check the condition of the HEPA filter.
Replace the old HEPA filter with the new HEPA filter with the utmost care, and hold the HEPA filters in such a position so that no damage is done to the filters while mounting the HEPA filters.
Carefully hold and position the filter at the desired place and make sure that the mounting is done in a proper way.
After mounting hold the clamp in the proper position so that it holds the filter.
Tighten the bolts back to the clamp.
The replacement frequency of the HEPA filter shall be 7 years or if the integrity fails during revalidation.
Checking of PVC Curtainsin Preventive Maintenance of Automatic Loading and Unloading System for Lyophilizer
Check the condition of PVC curtains for the cutting,
Wear and tear, any damage, if found replace the same.
Regularly check the PVC curtains for cleanliness and clean the curtains daily.
Lubrication of motor bearings
Check the lubrication of blower motor bearings, if required do the lubrication with recommended lubricant.
The frequency of checking of lubrication shall be after every three months.
Checking of fasteners
Check that all the fasteners / mounting bolts of loading and unloading of conveyor belts for lyophilizer feed station are should be 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 conveyor belts
Check the timing belts of the Lyophilizer loading and unloading conveyor belts.
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, chains, and cams for any damage. If found damaged, replace the same.
Lubricate bearings, cams, gears, chains, and sprockets with the help of a grease gun.
Checking shall be done monthly.
Check the installed instruments
Ensure the installed instruments are calibrated.
Check the end connections of instruments; if required tighten the same.
The checking of frequency shall be after every three months.
Preventive Maintenance of Automatic Loading and Unloading System for Lyophilizer – 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 the motor with the help of a tong tester.
Physically check the motor terminal box and terminal connections.
Check the voltage drawn by the motor with the help of a multimeter
Check the current drawn by the motor with the help of a tong tester.
Physically check the direction of rotation; it should be as per recommended direction.
Checking shall be done after every six months.
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 dust from the control panel with the help of an air blower.
Remove the contactor from the panel and visually check all the contacts for signs of pitting and deposit of carbon on the contacts.
Clean the contacts, terminals, and all the moving parts of the contactor by spraying the contactor cleaner, and 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 the Panel Body.
Checking of contactors shall be done six monthly
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’s 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 checklist as per “Preventive Maintenance Checklist & Record for Loading and Unloading System for Lyophilizer” Format No. SOP/EN/XXXYYY.
