Capsule: SOP for Process Optimization of Capsule Sealing – V 2.0

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Capsule: SOP for Process Optimization of Capsule Sealing – V 2.0

Standard Operating Procedure for Process Optimization of Capsule Sealing

Department Capsule Manufacturing
SOP No. SOP/CM/041/2025
Supersedes SOP/CM/041/2022
Page No. Page 1 of 7
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 optimizing the capsule sealing process to ensure uniform, efficient, and secure sealing of capsules. Proper sealing is crucial for preventing content leakage, ensuring product integrity, and enhancing shelf life.

2. Scope

This SOP applies to the process of sealing hard gelatin capsules during the manufacturing process. It covers optimization strategies for sealing methods, equipment adjustments, and quality control measures.

3. Responsibilities

  • Manufacturing Team: Responsible for executing the capsule sealing process according to the optimized settings and maintaining the equipment for continuous operation.
  • Formulation Development Team: Provides input on the capsule fill material properties and ensures that the sealant formulation is compatible with the capsule contents.
  • Quality Control (QC) Team: Responsible for inspecting and testing the capsules to ensure that seals meet the required quality standards for strength, uniformity, and integrity.
  • Quality Assurance (QA) Team: Ensures that the sealing process is optimized as per this SOP and that all records are reviewed for compliance with regulatory standards.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the sealing process is properly optimized, while the QA Manager is responsible for reviewing the optimization records and ensuring regulatory compliance.

5. Procedure

5.1 Pre-Optimization Setup

Before optimizing the sealing process, the following preparatory steps should be completed:

  1. Review of Formulation and Fill Material

    1. Ensure that the formulation is compatible with the capsule material, taking into consideration the moisture content, viscosity, and particle size of the fill material.
  2. Sealing Material Selection

    1. Choose an appropriate sealant material (e.g., gelatin, HPMC) based on the capsule size, formulation, and required release profile.
  3. Machine Setup

    1. Ensure that the capsule sealing machine is calibrated and set up according to the required specifications for capsule size, sealing temperature, and pressure.
    2. Check that the sealing machinery is free of contaminants and that all components (e.g., seals, rollers, and heaters) are functioning properly.
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5.2 Optimization of Capsule Sealing

Optimization of the sealing process involves adjusting the following key parameters:

  1. Sealing Temperature

    1. Adjust the temperature of the sealing machine to ensure that it is high enough to melt the capsule rims but not so high as to cause degradation of the capsule or fill material.
    2. The typical temperature range for sealing hard gelatin capsules is between 45°C to 55°C, but it may vary depending on the capsule and sealant used.
  2. Sealing Pressure

    1. Adjust the sealing pressure to ensure that the capsule halves are securely joined without causing deformation or leakage.
    2. Increase the pressure if the seal is weak or decrease it if the capsules are getting crushed during sealing.
  3. Sealing Time

    1. Ensure that the sealing time is long enough for a uniform seal to form but not so long that it causes excessive capsule deformation or material wastage.
  4. Speed of Sealing

    1. Adjust the speed of the capsule filling and sealing process to balance throughput and the quality of the capsule seals. Slower speeds may improve seal quality but may not be suitable for high-volume production.

5.3 Monitoring During Sealing

During the sealing process, continuously monitor the following parameters:

  1. Seal Integrity

    1. Inspect the capsule seals to ensure that they are secure and free of defects such as cracks, misalignments, or incomplete seals.
  2. Capsule Appearance

    1. Check the appearance of the capsules to ensure that the seal does not cause deformation, bulging, or other aesthetic issues that could affect product quality.
  3. Fill Weight and Uniformity

    1. Monitor the weight of the filled capsules and verify that they are within the required weight range.
    2. Ensure uniformity of the capsule fills, with consistent distribution of the fill material within each capsule.
  4. Sealing Yield

    1. Calculate the sealing yield by measuring the percentage of capsules with properly sealed halves. A high yield indicates effective sealing, while a low yield suggests that process adjustments are needed.
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5.4 Testing Capsule Seals

After the sealing process, perform the following tests to verify the integrity of the capsule seals:

  1. Seal Strength Test

    1. Perform a seal strength test to determine whether the seal can withstand pressure during handling and transportation without breaking or leaking.
  2. Leakage Test

    1. Use a leak detection method (e.g., vacuum or dye test) to ensure that no contents are leaking from the sealed capsules.
  3. Visual Inspection

    1. Perform a visual inspection of the capsules under light to identify any signs of seal defects, such as gaps or incomplete seals.

5.5 Adjustments Based on Testing Results

If testing reveals any issues with the capsule seals, the following adjustments should be made:

  1. Temperature Adjustment

    1. If seals are weak, increase the sealing temperature slightly to improve adhesion. If seals are deformed or excessively sticky, reduce the temperature.
  2. Pressure Adjustment

    1. If capsules are not sealing properly, increase the pressure slightly to ensure the capsules are securely joined. If capsules are crushed, reduce the pressure.
  3. Sealing Time Adjustment

    1. If seals are incomplete, increase the sealing time. If there is excess melting or deformation, reduce the sealing time.
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5.6 Documentation and Record-Keeping

Ensure that all aspects of the process optimization and sealing tests are documented:

  1. Sealing Process Record

    1. Document all adjustments made to the sealing process, including temperature, pressure, time, and speed settings.
  2. Capsule Seal Test Records

    1. Record all test results, including seal strength, leakage, and visual inspection results.
  3. Batch Records

    1. Ensure that all sealing trials are logged in the batch records for traceability and compliance purposes.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • API: Active Pharmaceutical Ingredient
  • GMP: Good Manufacturing Practice
  • USP: United States Pharmacopeia

7. Documents

  1. Sealing Process Record (Annexure-1)
  2. Capsule Seal Test Report (Annexure-2)

8. References

  • USP <711> – Dissolution Testing
  • FDA Guidance for Industry: Stability Testing of Drug Products
  • International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Development

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 Process Record

Batch ID Machine Settings Sealing Temperature Sealing Pressure Sealing Time
Batch 001 Speed: 100 rpm, Force: 15 N 50°C 5 N 1.2 seconds

Annexure-2: Capsule Seal Test Report

Test Type Test Result Specification Remarks
Seal Strength Pass Min 10 N Strong, no leakage

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 process parameters Optimization and standardization QA Head
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