SOP Guide for Pharma

Capsule: SOP for Sealing Soft Gelatin Capsules – V 2.0

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Capsule: SOP for Sealing Soft Gelatin Capsules – V 2.0

Standard Operating Procedure for Sealing Soft Gelatin Capsules

Department Capsule Manufacturing
SOP No. SOP/CM/059/2025
Supersedes SOP/CM/059/2022
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 define the procedure for sealing soft gelatin capsules to ensure that they are properly sealed to prevent leakage of fill material, contamination, or degradation. Proper sealing is critical for maintaining the integrity and stability of the capsule.

2. Scope

This SOP applies to the sealing process for all soft gelatin capsules manufactured at the facility. It includes the preparation, sealing, and inspection steps necessary to achieve properly sealed capsules.

3. Responsibilities

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring the proper sealing of soft gelatin capsules. The QA Manager is responsible for reviewing records and ensuring that the sealing process complies with GMP and regulatory requirements.

5. Procedure

5.1 Pre-Sealing Setup

Before starting the sealing process, ensure the following steps are completed:

  1. Equipment Inspection
    1. Inspect the sealing machine to ensure it is clean, calibrated, and in good working condition. Verify that there is no debris or residual material from previous batches that could affect the sealing process.
    2. Ensure that all parts of the machine, such as the die and heating plates, are aligned properly.
  2. Material Preparation
    1. Ensure that the soft gelatin capsules are properly filled and that the fill material is in the correct state (e.g., viscosity, temperature) for sealing.
    2. Ensure that any excipients used for sealing (e.g., glycerin, sorbitol) are prepared and available in the required quantities.
  3. Documentation
    1. Document the batch details, including capsule size, fill material, and sealing equipment settings.
    2. Ensure that all necessary quality checks are scheduled for the sealing process.
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5.2 Sealing Process

Once the pre-sealing setup is complete, follow these steps to seal the soft gelatin capsules:

  1. Load Capsules into the Sealing Machine
    1. Load the filled soft gelatin capsules into the sealing machine hopper, ensuring that they are positioned correctly to avoid any misalignment during sealing.
    2. Ensure that the capsules are inserted into the sealing dies or pockets in the machine in an orderly manner.
  2. Sealing Parameters
    1. Set the machine’s sealing temperature and pressure according to the specifications for the type of gelatin and fill material used. The standard temperature range is typically 60°C to 80°C for soft gelatin capsules.
    2. Ensure the sealing pressure is set to an appropriate level to achieve a uniform seal while preventing deformation of the capsule.
  3. Start Sealing
    1. Activate the sealing machine and begin the sealing process. Monitor the machine’s operation to ensure that the capsules are sealed properly and that there are no issues such as poor adhesion or leakage of fill material.
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5.3 Post-Sealing Inspection

After the sealing process, perform the following checks:

  1. Visual Inspection
    1. Visually inspect the sealed capsules to ensure that they are sealed properly. Check for any signs of broken seals, incomplete seals, or deformities.
    2. Reject any capsules that show visible signs of defects, such as cracks, improperly sealed edges, or leakage of fill material.
  2. Integrity Test
    1. Perform a capsule integrity test by gently pressing the sealed capsules. Capsules that break or leak during this test should be rejected.
  3. Moisture Content Check
    1. Check the moisture content of the sealed capsules to ensure it is within the required range. Excess moisture can weaken the seal, while insufficient moisture can cause the capsule to crack.

5.4 Quality Control Checks

In addition to the post-sealing inspections, perform the following quality control checks:

  1. Capsule Weight and Size
    1. Check the weight and size uniformity of the sealed capsules to ensure consistency. Reject capsules that do not meet the weight or size specifications.
  2. Leakage Test
    1. Perform a leakage test using water or another appropriate solvent to ensure that the capsules are properly sealed and will not leak under typical storage and handling conditions.

5.5 Post-Sealing Cleaning and Maintenance

After completing the sealing process, follow these cleaning and maintenance steps:

  1. Cleaning the Sealing Equipment
    1. Turn off the machine and clean all parts that came into contact with the capsules or the sealing material. Use appropriate cleaning agents to ensure that no residues remain.
    2. Ensure that all cleaning steps are documented and that the equipment is inspected for any wear and tear.
  2. Routine Maintenance
    1. Perform routine maintenance on the sealing machine, including lubrication of moving parts, inspection of heating plates, and replacement of worn-out components.
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5.6 Documentation and Record-Keeping

Ensure proper documentation of the sealing process:

  1. Sealing Batch Records
    1. Document the details of the sealing process, including capsule type, sealing temperature, sealing pressure, and operator information. Record any issues or deviations encountered during the process.
  2. Quality Control Records
    1. Maintain records of all quality control checks, including the visual inspection results, integrity tests, leakage tests, and moisture content checks.
  3. Deviation Reports
    1. Document any deviations from the specified sealing parameters and outline the corrective actions taken to resolve the issues.

6. Abbreviations

7. Documents

  1. Sealing Batch Record (Annexure-1)
  2. Quality Control Test Report (Annexure-2)
  3. Deviation Report (Annexure-3)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sealing Batch Record

Batch ID Sealing Temperature Sealing Pressure Moisture Content Operator Name Production Date
Batch 001 75°C 3 bar 12% John Doe 01/02/2025

Annexure-2: Quality Control Test Report

Test Type Result Specification Remarks
Leakage Test Pass No leakage Meets standards

Annexure-3: Deviation Report

Deviation ID Description Corrective Action Action Taken By
DR-001 Poor sealing Adjusted sealing temperature and pressure Manufacturing Supervisor

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 sealing parameters Standardization QA Head
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