Capsule: SOP for Capsule Polishing Procedures – V 2.0

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Capsule: SOP for Capsule Polishing Procedures – V 2.0

Standard Operating Procedure for Capsule Polishing Procedures

Department Capsule Manufacturing
SOP No. SOP/CM/070/2025
Supersedes SOP/CM/070/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to describe the procedure for polishing capsules during the manufacturing process. Capsule polishing enhances the appearance of capsules, removes any dust or residues, and ensures smooth, shiny, and uniform capsules for final packaging.

2. Scope

This SOP applies to all capsules that require polishing as part of the post-manufacturing process. It covers the equipment, materials, procedures, and documentation related to capsule polishing.

3. Responsibilities

  • Manufacturing Team: Responsible for executing the capsule polishing procedures according to this SOP. Ensure that the polishing process is carried out safely and efficiently.
  • Quality Control (QC) Team: Responsible for verifying the appearance and quality of capsules after polishing and ensuring that polishing parameters are within specifications.
  • Quality Assurance (QA) Team: Ensures compliance with the SOP and reviews records related to the polishing process. Ensures that the process meets GMP and regulatory requirements.
  • Maintenance Team: Responsible for ensuring that polishing equipment is regularly maintained and calibrated for optimal performance.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring the proper execution of the polishing procedure. The QA Manager is responsible for overseeing the entire process and ensuring that quality and compliance standards are maintained.

5. Procedure

5.1 Pre-Polishing Preparation

Before beginning the capsule polishing process, ensure the following preparations are made:

  1. Equipment Setup

    1. Ensure that the polishing machine is clean and free from any residues from previous batches. Perform a thorough inspection of the polishing equipment, including rollers, brushes, and other components.
    2. Set up the polishing machine according to the manufacturer’s instructions. Verify that all settings, such as speed and temperature, are in compliance with the specifications for the current batch of capsules.
  2. Polishing Materials

    1. Ensure that all materials used in the polishing process, such as polishing powder, wax, or vegetable-based lubricants, are approved for use and stored appropriately. Use only the recommended materials for the specific capsule type.
  3. Documentation

    1. Document all preparation activities, including the setup of equipment and materials, in the batch production record (BPR). Note any deviations from the standard procedure.
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5.2 Capsule Polishing Process

Follow these steps to polish the capsules:

  1. Loading Capsules

    1. Carefully load the capsules into the polishing machine hopper, ensuring that the capsules are properly aligned to prevent damage during polishing.
    2. Do not overfill the hopper to avoid blockages or uneven polishing.
  2. Polishing Action

    1. Start the polishing machine and allow it to operate according to the specified settings. During the polishing process, capsules will pass through rotating rollers or brushes coated with polishing materials.
    2. Monitor the capsules during the process to ensure uniform polishing. The machine speed should be adjusted as necessary to achieve the desired finish without causing damage to the capsules.
  3. Polishing Material Application

    1. Ensure that the polishing material is applied evenly and that excess powder or wax is removed after polishing. Adjust the amount of polishing material if necessary to avoid over-coating the capsules.
  4. Inspection

    1. After polishing, visually inspect the capsules for uniformity in appearance, shine, and smoothness. Capsules should be free from dust or residual polishing materials. Any defects should be recorded, and defective capsules should be segregated for rework or disposal.
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5.3 Post-Polishing Actions

After the polishing process is complete, perform the following actions:

  1. Final Inspection

    1. Inspect the polished capsules for the desired appearance, including a smooth, shiny surface free from blemishes, scratches, or foreign particles. Ensure that the capsules meet all visual standards.
    2. Check for any remaining polishing material on the surface of the capsules and remove any excess residue using an air blower or brush.
  2. Segregation of Defective Capsules

    1. Immediately segregate any defective capsules identified during the final inspection. Place them in a “Rejected” container and document the defects for further action.
  3. Documentation

    1. Document the polishing process in the batch production record (BPR), including the number of capsules polished, any defects found, and any corrective actions taken. Record the batch number and date of the polishing operation.
  4. Packaging

    1. Once capsules have passed the final inspection, transfer them to the packaging area for further processing. Ensure that the polished capsules are carefully handled and properly stored until they are ready for packing.

5.4 Cleaning and Maintenance of Polishing Equipment

After completing the polishing process, ensure the polishing equipment is cleaned and maintained to prevent contamination in future batches:

  1. Cleaning

    1. Clean all parts of the polishing machine, including rollers, brushes, and hoppers, to remove any remaining polishing powder or wax. Use approved cleaning agents and follow the manufacturer’s cleaning instructions.
  2. Inspection

    1. Inspect the polishing equipment for wear and tear, and ensure that all moving parts are functioning smoothly. Replace any worn-out components as needed.
  3. Documentation

    1. Document the cleaning and maintenance activities in the maintenance log. Record the date of cleaning, maintenance tasks performed, and any parts replaced or repaired.

5.5 Documentation and Record-Keeping

Ensure proper documentation of all polishing activities:

  1. Batch Production Record (BPR)

    1. Document the polishing procedure in the BPR, including the batch number, quantity of capsules polished, any defects observed, and any corrective actions taken.
  2. Inspection Log

    1. Maintain a log of all inspections performed during the polishing process, including the date, operator, and results of the inspection. Note any capsules that were rejected or reworked.
  3. Maintenance Log

    1. Document any maintenance or cleaning activities performed on the polishing equipment, including the tasks completed, parts replaced, and the date of completion.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • BPR: Batch Production Record

7. Documents

  1. Capsule Polishing Log (Annexure-1)
  2. Polishing Defect Report (Annexure-2)
  3. Equipment Maintenance Log (Annexure-3)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Capsule Polishing Log

Batch ID Capsule Size Polishing Date Quantity Polished Operator Name
Batch 001 Hard Gelatin 01/02/2025 10,000 John Doe

Annexure-2: Polishing Defect Report

Defect ID Description Quantity Defective Action Taken Operator Name
DEF-001 Discolored Capsules 200 Rejected John Doe

Annexure-3: Equipment Maintenance Log

Equipment ID Maintenance Date Tasks Performed Technician Name
Polishing Machine 1 01/02/2025 Cleaned and calibrated machine Jane Smith

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated polishing procedure Standardization QA Head
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