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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