SOP for Preventive Maintenance of Blister Pack Machine EN-45

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

SOP for Preventive Maintenance of Blister Pack Machine

  • OBJECTIVE:
    • To lay down the Procedure for the Preventive Maintenance of Blister Pack Machine installed in packing area .
  • SCOPE:
    • This SOP is applicable for the Preventive Maintenance of Blister Pack Machine installed in packing area.
  • RESPONSIBILITY:
    • Technician/ Operator shall be responsible for proper execution of Preventive Maintenance of Blister Pack Machine 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 of Preventive Maintenance of Blister Pack Machine.
  • DEFINITIONS:
    • Nil
  • PROCEDURE:
    • Preventive maintenance shall be executed as per the SOP No.: SOP/EN/XXXYYY– Execution of Preventive Maintenance of Blister Pack Machine.
    • Ensure that the spare parts are available at the time of preventive maintenance.
  • Preventive Maintenance –  Mechanical
  • Checking of belts
    • Check the timing belts of Blister pack machine. If found damaged / worn out, replace the same.
    • Checking shall be done quarterly.
  • Checking of pneumatic tubes and fittings
    • Physically check the pneumatic tubes and connectors for any damaged/leakage, if any damaged/leak is observed, replace the tube/connector.
    • The air filters bowls are to be drained and cleaned from time to time using water and a soft detergent and not with any solvent.
    • Checking shall be done monthly.
  • Checking of cooling unit connection
    • Check the cooling unit inlet and outlet connections to blister machine for any leakages; if required tightened the same.
    • Ensure the cooling unit flow of 250 Liters/hr at minimum of 12 deg C.
    • Check the connections of thermostat, if required tightened the same.
    • Checking shall be done monthly.
  • Checking of lid foil holder
    • Check the position of lid foil holder; it should be properly align with platen heaters, rollers; if required align the same.
    • The entire pre-heater assembly must be positioned closest possible (1 to 2 mm) to the left hand edge of the forming die and clamped so as to minimize the unheated portion of film.
    • Check the rotation of mandrel on which lid foil roll is mounted.
    • Check for the stretching and shrinkage due to overheating of the PVC film; if required check the connections of platen heater; if required tighten the same and clean the contactors.
    •  Checking shall be done monthly.
blister mac
  • Checking of Blister forming station in preventive maintenance of Blister Pack Machine.
    • Check the utility connections for air and water lines for any leakages at respective inlet and outlet ports of the blow-head and blister forming platen; if required rectify the same.
    • Check the position of pusher rod and check nut; if required tighten the same.
    • Check the position of blister forming die is centralized with the upper blow head platen.
    • Check the gap in between of blister forming station die platen and heater plates; the gap shall be 2 to 3 mm.
    • The distance between the blister forming die and blow head can be adjusted by screwing in or out the pneumatic cylinder rod into the station plug holder plate. The distance should be adjusted as clearance of 2 to 3 mm between top of blister and the bottom of plug.
    • Checking shall be done monthly.
  • Checking of sealing station
    • Check the pneumatic connection of the sealing station.
    • Check the sealing pressure by adjusting the air pressure regulator. The over pressure may cause for mechanical overloads or bolt breakages due to fouling up of product between sealing platens, by compliance of the upper platen.
    • Checking shall be done monthly.
  • Checking of embossing and perforation station
    • Check the movement of die plates.
    • Lubricate the guide pillars and bushes with the recommended oil.
    • Check the guards cover of the station.
    • 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.
    • Recommended/identical lubricants and frequency of lubrication are as follows
Sr. No. Part Of The Machine Lubricants to be used Frequency of Lubrication
1 Gears, Cambox Mobil Plex 47 120 Hr.
2 Bearings Shell Vitra 100 100 Hr
3 Ball Cages and sleeves Shell Vitra 100 40 Hr.
4 Chain Mobil Plex 47 120 Hr.
5 Gear box Mobil Glygoyle 12000 Hr.
6 Parts operating at high temperatures Kluber Amblygon TA 15/2 200 Hr.
  • In preventive maintenance of Blister Pack Machine: –Checking of sensors and machines for proper performance as follows
    • Clean all the switches and electrical connections, sensors for the dust and dirt and check for the proper functioning.
    • Check the performance of Blister magazine and sensor. The blister magazine has a high level and low level sensor. The magazine will dispense blister into the Blisterer product conveyor only when the stack is within this two limit.
    • Check the blister dispensing, is by a pair of counting wheels on which the stack is rests. Each rotation of the wheels dispenses exactly one blister. Wheels are given required number of rotation by a servo motor.
    • Check the working of Blister magazine. Blister magazine is designed to hold a stack of flat Blisters.
    • Check the performance of Blister delivery and placement sensors.
    • Check the performance of Blister transport mechanism.
    • Check the embossing machine performance.
    • Check the overload product pushing sensor, overload during the product pushing is detected by the sensor and stops the machine.
    • Check the performance of flap closing arrangement.
    • Check tuck in mechanism; front and rear flaps are closed by corresponding tuck in mechanisms which are mechanically driven and synchronized with other movements.
    • Check the Blister outfeed; a pair of timing belts, whose separation is adjusted for Blister length, carries closed Blister out of the Blister chain. If the Blister is earlier sensed as incomplete, then the Blister is rejected.
    • Checking shall be done quarterly

 

Blister 1

In preventive maintenance of Blister Pack 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 the motor in preventive maintenance of Blister Pack Machine:
    • Check the VFD operation for machine speed.
    • 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 and ampere ratings of motor with the help of tong tester.
    • Check the direction of rotation; it should be as per recommended direction.
    • Checking shall be done after every six month.
  • Checking of contactors in Preventive Maintenance of Blister Pack Machine:
    • Switch OFF the Electrical supply to the Machine.
    • Remove dust from control panel with help of air blower.
    • Remove all the power and control wires from the contactor terminals
    • 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 safety Alarms and Interlocks
    • The following safety alarms shall be study at an after every six months intervals.
Sr. No. Alarms and Conditions Alarm message Control Action
1 Emergency Stops Press “E – Stop” on the main panel.   Machine stops immediately; heaters go off, preheating platen retracts, sealing platen retracts. Machine remains in the state as it was before “E – Stop” was pressed. Press Start Button. Verify that the machine does not restart. Unlock the E – Stop. Verify that machine can now be started.    
  • Check the pick and place assembly on quarterly basis.
  • Checking of the camera and its connections shall be done after every three month intervals.
  • Checking of printer and its assembly shall be done on quarterly basis.
  • 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 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 all maintenance activity of Blister Pack Machine as per Format No.: SOP/EN/XXXYYY.
  • ABBREVIATIONS
    • CRF No.   :     Change Request Form number
    • QA            :     Quality Assurance
    • VFD          :     Variable Frequency Drive
  • REFERENCES
    • Nil.  
  • DISTRIBUTION LIST
    • SOP of Preventive Maintenance of Blister Pack Machine shall be distributed to following departments Quality Assurance, Engineering as per user request.
  • ANNEXURES
    • Preventive Maintenance Checklist And Record For Blister Pack Machine: SOP/EN/XXXYYY

PREVENTIVE MAINTENANCE CHECKLIST & RECORD FOR BLISTER PACK MACHINE

Equipment Name   Location  
Equipment ID   Frequency  
Things to be done: Check List Remarks
Monthly Check List    
Checking of cooling unit connections.    
Checking of lid foil holder.    
Checking of blister forming station.    
Checking of sealing station.    
Checking of embossing and perforation station.    
Quarterly Check List    
Checking of timing of belts; damaged; wear and tear of belts.    
Checking and lubrication of bearings; chains; gears and sprockets.    
Checking of pick and place assembly.    
Checking of camera.    
Checking of printer.    
Half Yearly Check List    
Checking of sensors for end connection and contacts; if required tight the same.    
Checking of terminals and wiring.    
Checking of VFD and motor.    
Checking of contactors.    
cGMP

(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.