SOP for Operation of Capsule Polishing Machine

OBJECTIVE

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

SCOPE

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

RESPONSIBILITY

The operator is responsible for the 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 the chute to the lower half of the polishing chamber.

• Upper and lower half polishing chamber.
• Hopper assembly and slitter guards.
• Conveyer belt side guards and capsule guides.

ALSO READ: SOP for Reprocessing of Capsules

Operation:

• Ensure that all parts of the machine are cleaned as per standard cleaning procedure.
• Load-filled capsules in a hopper.
• Switch on the mains of the machine, put on the tube light, and start the vacuum, brush drive, and belt.
• Adjust the flow of capsules on the conveyor belt by increasing/decreasing the gap between the acrylic plate and the conveyor belt.
• Adjust the speed of the polishing brush by moving the variable pulley clockwise/anticlockwise to get the required polishing quality.
• After completion of the operation, stop the conveyor belt then brush drive and vacuum, and lastly the tube light and mains of the machine.
• Inspect and remove capsules that are defective due to:

1. Knocked ends & cracked/squashed shells.
2. Spots, Empty shells, and Improper printing.

Dismantling:

• Remove the powder collection trays and sieves of the hopper.
• Remove the slitter guards and hopper assembly from the hopper mounting shaft by losing the side knobs.

• Remove the capsule transfer chute (lower and upper).
• Remove the upper and lower half of the polishing chamber.
• Remove the vacuum chute from the lower polishing chamber.
• Remove the guards of the conveyor belt and capsule guides.
• Remove the vacuum filter bag from the vacuum can.
• Clean the machine and dismantle parts as per standard cleaning procedure.
• All the operation details shall be entered in the equipment usage log.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No. : Number

P.D: Production

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: SOP for Storage Procedure of In-Process Capsules