Capsule: SOP for Cleaning Validation for Soft Gelatin Capsule Lines – V 2.0

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Capsule: SOP for Cleaning Validation for Soft Gelatin Capsule Lines – V 2.0

Standard Operating Procedure for Cleaning Validation for Soft Gelatin Capsule Lines

Department Capsule Manufacturing
SOP No. SOP/CM/164/2025
Supersedes SOP/CM/164/2022
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 cleaning validation procedures for soft gelatin capsule production lines. Cleaning validation ensures that all equipment used in the production of soft gelatin capsules is cleaned thoroughly between manufacturing batches to prevent cross-contamination and ensure product quality. This SOP ensures that cleaning procedures are effective, reproducible, and compliant with GMP and regulatory requirements.

2. Scope

This SOP applies to the cleaning validation procedures for soft gelatin capsule production lines, including soft gelatin capsule filling machines, encapsulation units, and related equipment. The SOP covers the process from pre-cleaning setup to post-cleaning testing, including cleaning agents, procedures, and validation of cleaning effectiveness.

3. Responsibilities

  • Production Operators: Responsible for executing the cleaning procedure and ensuring that all equipment is cleaned according to the validated procedure.
  • Quality Control (QC) Team: Responsible for sampling and testing cleaned equipment to ensure compliance with cleanliness standards and validation criteria.
  • Quality Assurance (QA) Team: Reviews and approves the cleaning validation plan and results, ensuring compliance with GMP and regulatory standards.
  • Engineering Team: Ensures that cleaning equipment, including washing systems, is calibrated and functioning correctly during the validation process.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that cleaning procedures for soft gelatin capsule production lines are validated according to this SOP. The QA Manager is responsible for reviewing and approving the cleaning validation results, ensuring that the cleaning process complies with GMP and regulatory standards.

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5. Procedure

5.1 Preparation for Cleaning Validation

Before starting the cleaning validation process, ensure the following preparations are completed:

  1. Review Validation Plan

    1. Review the cleaning validation plan, which should include equipment to be cleaned, cleaning agents, cleaning 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 cleaning materials, such as cleaning agents, tools, and equipment, are available and meet the required quality specifications for the validation process.
    2. Ensure that soft gelatin capsule production equipment, such as encapsulation units and related machines, are available and ready for cleaning validation.
  3. Calibrate Equipment

    1. Ensure that all cleaning equipment, such as washing systems and pumps, is calibrated and functioning correctly. Record calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Cleaning Procedure Validation

Follow these steps to validate the cleaning process for soft gelatin capsule production lines:

  1. Pre-Cleaning Setup

    1. Set up the cleaning system according to the SOP for cleaning soft gelatin capsule lines. Ensure that cleaning agents, temperature, and time are set according to the cleaning validation plan.
    2. Ensure that all parts of the soft gelatin capsule production equipment, including the encapsulation unit and mixing tanks, are accessible for cleaning.
  2. Start the Cleaning Process

    1. Start the cleaning process by applying cleaning agents to the equipment. Ensure the cleaning process is carried out for the specified duration and at the correct temperature.
    2. Record all relevant cleaning parameters, including time, temperature, and concentration of cleaning agents, in the Cleaning Validation Log (Annexure 2).
  3. Post-Cleaning Rinse

    1. After cleaning, perform a rinse with appropriate solutions to remove any residual cleaning agents from the equipment.
    2. Ensure that the rinse is thorough to remove all cleaning residues and that the process is documented in the Cleaning Validation Log (Annexure 2).
  4. Sampling and Testing

    1. Take samples from cleaned equipment to test for any residual contaminants, including cleaning agents, product residues, and microbial contamination.
    2. Perform swab tests and rinse water tests to check for cleanliness. Document the results in the Cleaning Validation Report (Annexure 3).
  5. Review Results

    1. Review the results of the testing to ensure that all equipment meets the established cleanliness standards. Investigate any deviations and take corrective actions if necessary.
    2. If the equipment passes the validation criteria, approve the cleaning process for routine use. If the process does not meet the acceptance criteria, revalidate the process and perform corrective actions.
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5.3 Post-Validation Documentation

Ensure proper documentation of the cleaning validation process:

  1. Cleaning Validation Report

    1. Prepare the Cleaning Validation Report (Annexure 4) summarizing the cleaning activities, results, and any corrective actions taken during the validation process.
  2. Approval of Validation Results

    1. Review and approve the cleaning 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 for traceability and regulatory compliance:

  1. Cleaning Validation Log

    1. Document all cleaning parameters, including cleaning time, temperature, concentration of cleaning agents, and post-cleaning rinse details in the Cleaning Validation Log (Annexure 2).
  2. Cleaning Validation Report

    1. Document the results of cleaning validation tests, including swab tests and rinse water tests, in the Cleaning Validation Report (Annexure 3).
  3. Final Cleaning Validation Report

    1. Ensure that the final Cleaning Validation Report (Annexure 4) is signed and approved by the QA Manager and filed for future reference.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment
  • API: Active Pharmaceutical Ingredient
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7. Documents

  1. Annexure 1: Equipment Calibration Log
  2. Annexure 2: Cleaning Validation Log
  3. Annexure 3: Cleaning Validation Report
  4. Annexure 4: Final Cleaning Validation Report

8. References

  • FDA Guidelines on Cleaning and Sanitization
  • Good Manufacturing Practice (GMP) Guidelines
  • USP <1072> – Cleaning Procedures

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
Gelatin Machine 302 01/02/2025 John Doe Calibration of mixing and filling mechanism 01/02/2026

Annexure 2: Cleaning Validation Log

Batch ID Cleaning Date Operator Cleaning Parameters You said:
Continue till Revision History
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Annexure 2: Cleaning Validation Log

Batch ID Cleaning Date Operator Cleaning Parameters Remarks
Batch 001 02/02/2025 Jane Smith Temperature: 55°C, Time: 35 minutes No issues

Annexure 3: Cleaning Validation Report

Batch ID Test Date Test Type Results Remarks
Batch 001 02/02/2025 Swab Test Pass No contamination detected

Annexure 4: Final Cleaning Validation Report

Batch ID Validation Date Operator Validation Results Action Taken
Batch 001 02/02/2025 John Doe 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 cleaning validation of soft gelatin capsule lines QA Head
01/02/2025 2.0 Updated cleaning validation parameters and included new testing procedures Optimization of cleaning process and addition of updated testing methods QA Head
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