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SOP for Operation of Capsule Polishing Machine

OBJECTIVE
To lay down a procedure for operation of capsule polishing machine.

SCOPE

This procedure applies for production department in Pharmaceutical Manufacturing Facilities of XYZ Limited, Formulation division.

RESPONSIBILITY
The operator is responsible for implementation of the process.
The In-Charge is responsible for the execution of the procedure.

PROCEDURE
Assembling: 
Assemble the clean and dry accessories in the following manner:
  • Polishing brush to the shaft with clamps provided at both ends.
  • Polishing cloth to the two halves of the polishing chamber.
  • Vacuum chute to lower half of polishing chamber.
  • Upper and lower half polishing chamber.
  • Hopper assembly and slitter guards.
  • Conveyer belt side guards and capsules guides.
Operation:
  • Ensure that all parts of the machine are cleaned as per standard cleaning procedure.
  • Load filled capsules in hopper.
  • Switch on mains of the machine, put on tube light, start vacuum, brush drive and belt.
  • Adjust flow of capsules on conveyer belt by increasing/decreasing gap between acrylic plate and Conveyer belt.
  • Adjust speed of polishing brush by moving variable pulley clockwise/anticlockwise to get required polishing quality.
  • After completion of operation, stop the conveyer belt then brush drive and vacuum and lastly the tube light and mains of machine.
  • Inspect and remove capsules that are defective due to:
  1. Knocked ends & Crack/squashed shells.
  2. Spots, Empty shells and Improper printing.
Dismantling:
  • Remove the powder collection trays and sieves of hopper.
  • Remove the slitter guards and hopper assembly from hopper mounting shaft by loosing the side knobs.
  • Remove capsule transfer chute (lower and upper).
  • Remove the upper and lower half of polishing chamber.
  • Remove the vacuum chute from the lower polishing chamber.
  • Remove the guards of conveyer belt and capsule guides.
  • Remove the vacuum filter bag from the vacuum can.
  • Clean the machine and dismantled parts as per standard cleaning procedure.
  • All the operation details shall be entered in the equipment usage log.

ABBREVIATION(s)
Q.A : Quality Assurance
SOP : Standard Operating Procedure
No. : Number
P.D : Production

ANNEXURE(s)
Nil.

REVISION CARD
Nil.

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