Capsule: SOP for Validation of Encapsulation Processes for Liquid Fill Materials – V 2.0

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Capsule: SOP for Validation of Encapsulation Processes for Liquid Fill Materials – V 2.0

Standard Operating Procedure for Validation of Encapsulation Processes for Liquid Fill Materials

Department Capsule Manufacturing
SOP No. SOP/CM/159/2025
Supersedes SOP/CM/159/2022
Page No. Page 1 of 8
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 process for validating the encapsulation of liquid fill materials in capsules. Liquid-filled capsules require careful formulation, encapsulation, and sealing to ensure that the fill material is contained securely and meets the required quality standards for pharmaceutical use. This SOP ensures the encapsulation process is consistent, reproducible, and compliant with GMP and regulatory standards.

2. Scope

This SOP applies to the validation of the encapsulation process for liquid fill materials in capsule manufacturing. It includes the preparation of the liquid fill material, the encapsulation process, and the associated quality control testing. The SOP covers all aspects of the process, from the selection of materials to the final product testing.

3. Responsibilities

  • Production Operators: Responsible for operating the encapsulation equipment and ensuring that process parameters are maintained during the validation process.
  • Quality Control (QC) Team: Performs testing on the filled capsules to ensure that they meet quality specifications for fill weight, encapsulation integrity, and dissolution characteristics.
  • Quality Assurance (QA) Team: Reviews and approves the validation plan, process parameters, and results, ensuring that the process complies with GMP and regulatory standards.
  • Engineering Team: Ensures that the encapsulation equipment is properly calibrated, maintained, and functioning during the validation process.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the encapsulation process for liquid fill materials is validated according to this SOP. The QA Manager is responsible for reviewing and approving the validation results and ensuring compliance with GMP and regulatory standards.

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5. Procedure

5.1 Preparation for Encapsulation Validation

Before initiating the validation process, ensure the following preparations are made:

  1. Review Validation Plan

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

    1. Ensure that all materials, including the liquid fill formulation, excipients, and capsule shells, are available and meet the quality specifications for the validation process.
    2. Ensure that all encapsulation equipment, such as filling machines and sealing systems, are available and ready for use.
  3. Calibrate Equipment

    1. Ensure that all encapsulation equipment is calibrated, including filling machines, sealing equipment, and weight monitoring systems. Record calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Encapsulation Process Validation

Follow these steps to validate the encapsulation process:

  1. Pre-Validation Setup

    1. Set up the encapsulation system according to the SOP for operating capsule filling machines. Ensure that the liquid fill formulation, temperature, viscosity, and other relevant process parameters are set to the validated levels.
    2. Ensure that environmental conditions, such as temperature and humidity, are controlled and documented in the Environmental Monitoring Log (Annexure 2).
  2. Start the Encapsulation Process

    1. Start the encapsulation process by filling the capsules with the liquid formulation. Monitor the fill volume, capsule integrity, and sealing process to ensure uniformity and consistency.
    2. Record all relevant process parameters such as fill volume, temperature, and viscosity in the Encapsulation Process Log (Annexure 3).
  3. Monitor Key Process Parameters

    1. Monitor parameters such as fill volume, capsule weight, liquid fill viscosity, and sealing integrity throughout the validation run.
    2. Ensure that all parameters remain within defined limits, and that the capsules meet the required quality specifications. Document these observations in the Encapsulation Validation Log (Annexure 4).
  4. Quality Control Testing

    1. Test the filled capsules for weight uniformity, fill volume, and dissolution performance. Perform other tests such as leakage, capsule hardness, and dissolution as required.
    2. Document the test results in the Encapsulation QC Report (Annexure 5) and ensure that they meet the established acceptance criteria.
  5. Assess Results and Approve Validation

    1. Review the results from the validation run and assess whether all process parameters and product attributes meet the established criteria. If successful, approve the process for routine production.
    2. If any deviations or non-conformances are identified, investigate the cause and take corrective actions. Revalidate the process if necessary.
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5.3 Post-Validation Documentation

Ensure proper documentation of the validation process:

  1. Encapsulation Validation Report

    1. Prepare the Encapsulation Validation Report (Annexure 6) summarizing the validation activities, results, and any corrective actions taken during the process.
  2. Approval of Validation Results

    1. Review and approve the validation report to ensure that all data meets the validation criteria. The report should be signed and approved by the QA Manager.

5.4 Documentation

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

  1. Encapsulation Process Log

    1. Document all parameters related to the encapsulation process, including fill volume, temperature, viscosity, and sealing parameters in the Encapsulation Process Log (Annexure 3).
  2. Encapsulation QC Report

    1. Document all quality control test results in the Encapsulation QC Report (Annexure 5).
  3. Encapsulation Validation Report

    1. Complete the Encapsulation Validation Report (Annexure 6) and ensure it is signed and approved by the QA Manager.

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
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7. Documents

  1. Annexure 1: Equipment Calibration Log
  2. Annexure 2: Environmental Monitoring Log
  3. Annexure 3: Encapsulation Process Log
  4. Annexure 4: Encapsulation Validation Log
  5. Annexure 5: Encapsulation QC Report
  6. Annexure 6: Encapsulation Validation Report

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 1: Equipment Calibration Log

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Filling Machine 304 01/02/2025 John Doe Filling volume calibration 01/02/2026

Annexure 2: Environmental Monitoring Log

Date Temperature (°C) Humidity (%) Operator Remarks
02/02/2025 22°C 50% Jane Smith No issues

Annexure 3: Encapsulation Process Log

Batch ID Process Date Operator Fill Volume (mL) Sealing Temp (°C) Coating Thickness (mm) Remarks
Batch 001 02/02/2025 John Doe 1.2 mL 50°C 0.5 mm Uniform fill and sealing

Annexure 4: Encapsulation Validation Log

Batch ID Validation Date Operator Test Parameters Results
Batch 001 02/02/2025 Jane Smith Fill volume, sealing integrity Pass

Annexure 5: Encapsulation QC Report

Batch ID Test Date Test Type Results Remarks
Batch 001 02/02/2025 Fill Weight Uniformity Pass No issues

Annexure 6: Encapsulation Validation Report

Batch ID Validation Date Operator Test Parameters Results Action Taken
Batch 001 02/02/2025 John Doe Fill volume, sealing integrity Pass Approved for production

12. Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version of SOP Creation of SOP for liquid fill encapsulation process validation QA Head
01/02/2025 2.0 Updated validation steps, added equipment calibration details Process improvement and inclusion of new equipment calibration procedures QA Head
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