Capsule: SOP for Validation of Soft Gelatin Capsule Sealing Processes – V 2.0

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Capsule: SOP for Validation of Soft Gelatin Capsule Sealing Processes – V 2.0

Standard Operating Procedure for Validation of Soft Gelatin Capsule Sealing Processes

Department Capsule Manufacturing
SOP No. SOP/CM/155/2025
Supersedes SOP/CM/155/2022
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 establish a standardized process for validating the sealing process for soft gelatin capsules. Proper sealing is essential to ensure that the capsules remain intact during storage, transport, and use, preventing leakage or contamination. This SOP ensures that the sealing process is consistent, reproducible, and compliant with regulatory and quality standards.

2. Scope

This SOP applies to the validation of the soft gelatin capsule sealing process in the manufacturing environment. It includes the validation of equipment, process parameters, and personnel involved in sealing the capsules to ensure the process meets the necessary quality attributes and regulatory requirements.

3. Responsibilities

  • Production Operators: Responsible for operating the sealing machines according to this SOP and ensuring that the sealing process is carried out according to specifications during the validation run.
  • Quality Control (QC) Team: Performs testing on sealed capsules to ensure they meet the required specifications, including leak resistance, integrity, and appearance.
  • Quality Assurance (QA) Team: Reviews and approves the sealing process validation plan and results, ensuring that the process is compliant with GMP and regulatory standards.
  • Engineering Team: Ensures that the sealing equipment is maintained, calibrated, and operational for the validation study.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring the validation of the sealing process is performed according to this SOP. The QA Manager is responsible for reviewing and approving the validation report and ensuring compliance with GMP and regulatory requirements.

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5. Procedure

5.1 Preparation for Sealing Process Validation

Before starting the validation, ensure the following preparations are made:

  1. Review Validation Plan

    1. Review the sealing process validation plan, which should include the validation objectives, materials, equipment, process parameters, and acceptance criteria. Ensure the plan is approved by the QA department before starting the validation activities.
  2. Gather Materials and Equipment

    1. Ensure that the soft gelatin capsules are prepared, and all necessary materials, such as gelatin solution and filling materials, are available for the validation runs.
    2. Ensure that sealing equipment, including the sealing machines and temperature control systems, are set up and ready for use in the validation study.
  3. Calibrate Equipment

    1. Ensure that all sealing equipment is calibrated to the required parameters, such as temperature, pressure, and sealing time. Record calibration details in the Equipment Calibration Log (Annexure-1).

5.2 Sealing Process Validation

Follow these steps to validate the soft gelatin capsule sealing process:

  1. Pre-Validation Setup

    1. Set up the sealing equipment according to the SOP for capsule sealing. Ensure that all seals are intact and that there is no damage to the equipment.
    2. Ensure that the sealing area is controlled for temperature, humidity, and air quality, as these factors may affect the sealing quality.
  2. Initiate Sealing Process

    1. Start the sealing process, ensuring that the gelatin capsule halves are sealed using the correct parameters, including temperature, pressure, and time.
    2. Monitor the sealing process continuously to ensure that the capsules are sealed without any issues such as misalignment or improper sealing.
  3. Monitor Process Parameters

    1. During the validation run, monitor key parameters such as sealing time, pressure, temperature, and seal integrity. Ensure that these parameters are within the acceptable range as specified in the validation plan.
    2. Record all data in the Sealing Process Log (Annexure-2) for traceability and further review.
  4. Quality Control Testing

    1. After sealing, perform tests on the capsules to assess the seal integrity, including leak resistance, uniformity, and visual appearance. Conduct any additional tests as required by the validation plan.
    2. Record the results of the QC tests in the Soft Gelatin Capsule Sealing QC Report (Annexure-3) and compare the results to the acceptance criteria.
  5. Assess Results and Approve Validation

    1. Review the results of the sealing validation and determine if the process meets the defined specifications. If the results are satisfactory, approve the process for routine production.
    2. If any deviations or issues arise, investigate the cause, take corrective actions, and revalidate the process as necessary.
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5.3 Post-Validation Documentation

Ensure proper documentation of the validation process:

  1. Sealing Process Validation Report

    1. Prepare the Sealing Process Validation Report (Annexure-4) summarizing the validation procedure, equipment used, test results, and any corrective actions taken.
  2. Approval of Validation Results

    1. Review the validation report and ensure that all data meets the validation criteria. The report should be approved by the QA Manager before the sealing process is used for routine production.

5.4 Documentation

Ensure proper documentation of the sealing process for traceability and regulatory compliance:

  1. Sealing Process Log

    1. Document the sealing conditions for each batch, including sealing time, pressure, temperature, and other relevant parameters in the Sealing Process Log (Annexure-2).
  2. Sealing QC Report

    1. Document the quality control test results in the Soft Gelatin Capsule Sealing QC Report (Annexure-3).
  3. Sealing Process Validation Report

    1. Complete the Sealing Process Validation Report (Annexure-4) and ensure that it is signed and approved by the QA Manager.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment
  • API: Active Pharmaceutical Ingredient
  • RPM: Revolutions Per Minute

7. Documents

  1. Sealing Process Log (Annexure-2)
  2. Soft Gelatin Capsule Sealing QC Report (Annexure-3)
  3. Sealing Process Validation Report (Annexure-4)
  4. Equipment Calibration Log (Annexure-1)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-2: Sealing Process Log

Batch ID Sealing Date Operator Sealing Time Pressure Temperature Remarks
Batch 001 02/02/2025 John Doe 30 sec 3 bar 85°C No issues

Annexure-3: Soft Gelatin Capsule Sealing QC Report

Batch ID QC Test Date Seal Integrity Leak Test Visual Inspection Remarks
Batch 001 02/02/2025 Pass No leakage Uniform Pass

Annexure-4: Sealing Process Validation Report

Batch ID Validation Date Operator Test Parameters Results
Batch 001 02/02/2025 Jane Smith Seal integrity, leak test Pass

Annexure-1: Equipment Calibration Log

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Sealing Machine 001 02/02/2025 John Doe Pressure and temperature calibration 02/02/2026

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 validation procedure Improved validation steps and added new tests QA Head
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