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SOP on assembling of vial filling & bunging machine

  • Objective:
  • To lay down a procedure for assembling of vial filling & bunging machine.
  • Scope:
  • This SOP describes the procedure for assembling of vial filling & bunging machine.
  • Responsibility:
  • Production operator / technician – responsible for assembling of vial filling & bunging machine.
  • Production officer / Executive – to ensure that assembling of vial filling & bunging machine is carried out as per SOP.
  • Accountability:
  • Production Head and Head QA shall be accountable for the compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating ProcedureSS : Stainless Steel
  • Procedure:
  • Pre-checks:
  • Critically inspect the area and all machine parts for cleanliness and dryness.
  • Check the star wheel and other Teflon guide of turn table which should be suitable with respect to vial size.
  • Check the in-feed turn table, out-feed turntable and conveyor belt for cleanliness.
  • Check the non-detachable parts of vial filling and bunging machine for cleanliness.
  • Check the star wheels for cleanliness and ensure none of them is missing.
  • Assembling of star wheel and other Teflon guides in filling room:
  • Transfer the corresponding star wheel SS side plate to filling room through Pass box as per SOP on usage of pass box.
  • Star wheels of channel 2 shall be carefully mounted into its sockets.
  • Ensure that none of them is loose, and fitted properly.
  • Star wheels of channel  shall be carefully mounted into its corresponding sockets.
  • Ensure that none of them is loose, and fitted properly.
  • Mount the Teflon guide of in-feed turn table and in-feed belt.
  • Ensure that bolts are sufficiently tightened and there will be no hurdle in smooth running of vials.
  • Mount the Teflon guide of out-feed turn table and out feed belt.
  • Ensure that bolts are sufficiently tightened and there will be no hurdle in smooth running of vials.
  • Assembly of dosing disk
  • Assembly in Cool Zone
  • Critically inspect the dosing wheel, its pistons and other parts for any residue of moisture.
  • Select the suitable dosing wheel and pistons by visually checking the diameter of piston holes as per product strength.
  • Place and fix the lower plate of dosing wheel and correctly match its marking with marking on dosing disk.
  • Place and fix centre ring into the lower plate of dosing wheel.
  • Correctly place long and short piston into the respective holes by visually checking its marking (L for long & S for short) in internal side of dosing wheel.
  • Lock the pistons by placing locking pin into corresponding groove on lower plate.
  • Rotate centre ring to verify the movement of piston weather all piston moving or not.
  • If any of the pistons is not moving again inspect all pistons and make necessary corrections.
  • Adjustment for all piston shall be carried out together by archimede spiral for proper level of accuracy.
  • Correctly fix the upper t plate (marking on plate) on center ring.
  • Transfer assembled sterilized dosing disk to filling room through Pass box as per SOP on usage of pass box.
  • Assembly in filling room
  • Dosing disk shall be Carefully mount on its corresponding shaft round protrude on back side of dosing disk with its respective pot on non-detachable brown colored plate of dosing disk assembly.
  • To verify the perfection of settings press the dosing disk against the non-detachable brown colored plate of dosing disk assembly.
  • Fix external adjustment locking system nut.
  • Carefully match all the settings on external adjustment locking system cover with the    settings on shaft and dosing disk and fix it.
  • Assembly Of Intermediate Hopper
  •  Assembly in Cool Zone
  • Carefully inspect the intermediate hopper, impeller and its other parts for any residue of moisture.
  • Teflon piece shall be carefully mounted on the lower parts of intermediate hopper and fix its cover into holes by inserting long pin.
  • Insert the 8 springs into corresponding pot on intermediate hopper, 4 for each channel.
  • Place the brown colored moon shaped piece on the springs.
  • Fix the knife and SS cover plate with screw and tighten the assembly.
  • Fix disc scrapping blade, lower plate and other components of intermediate hopper.
  • Transfer assembled sterilized intermediate hopper to filling are through Pass box.
  • Assembly in filling room
  • Mount the intermediate hopper to the main machine.
  • Assembly of main hopper
  • Assembly in cool zone
  • Ensure that there are no remnants of moisture in main hopper and powder mixer plate.
  • Mount the powder mixer plate into the main hopper care fully and tighten it with the help of clamps.
  • Transfer main hopper to filling room through Pass box as per SOP on usage of pass box.
  • Assembly in filling room
  • Fix the gasket on intermediate hopper.
  • Mount the main hopper by carefully matching the groves and protrudes on main hopper and main machine.
  • Fix it tightening the clamps on back side.
  • Fix it by tightening the clamps at joint of intermediate hopper and main hopper.
  • Assembly on the main hopper
  • Cool zone operation
  • Visually inspect all the components for cleanliness and dryness.
  • Transfer all the components like powder charging assembly, vibration generator, and    butterfly clamp to the vial filling room through Pass box as per SOP on usage of pass box.
  • Assembly in filling room
  • Place the gasket on main hopper mouth and fix the powder charging assembly by passing it through hole on main machine.
  • Tighten it with the help of screw.
  • Fix the butter fly clamp on mouth of powder charging pipe.
  • Fix the vibration generator on powder charging pipe and insert compressed air line to corresponding place.
  • Assembly of Rubber Stopper Hopper
  • Cool zone operation
  • Visually check rubber stopper hopper for cleanliness and dryness.
  • Transfer sterilized rubber stopper hopper to filling are through Pass box as per SOP on usage of pass box.
  • Filling area operation
  • Care fully fix the rubber stopper hopper to its respective place provided on back side of vial filling and bunging machine.
  • Tightened it by screwing the nut in the middle of rubber stopper hopper.
  • Dismantling of vial filling and bunging machine
  • Pre checks
  • Check the height of dosing disk and stoppering unit height which must be in sufficiently lifted to facilitate the removal of machine parts.
  • There is no vial, stopper remain stucked in the star wheel, in-feed belt and out – feed belt.
  • Check that machine is in emergency stop mode and corresponding message displayed in PLC.
  • Procedure
  • To dismantle the vial filling and bunging machine follow the reverse order of its assembling.
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –   Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP

 

 

 

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