Capsule: SOP for Cleaning Validation of Gelatin Preparation Equipment – V 2.0

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Capsule: SOP for Cleaning Validation of Gelatin Preparation Equipment – V 2.0

Standard Operating Procedure for Cleaning Validation of Gelatin Preparation Equipment

Department Capsule Manufacturing
SOP No. SOP/CM/162/2025
Supersedes SOP/CM/162/2022
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 outline the procedures for cleaning validation of gelatin preparation equipment used in capsule manufacturing. Ensuring the cleanliness of gelatin preparation equipment is critical to prevent cross-contamination and ensure the quality and safety of the finished capsules. This SOP defines the cleaning validation process to ensure compliance with GMP and regulatory standards.

2. Scope

This SOP applies to the cleaning validation of gelatin preparation equipment, including gelatin dissolving tanks, mixing vessels, and other related systems. It covers the steps from pre-cleaning setup to post-cleaning testing and approval, including cleaning agents, procedures, and validation of cleaning effectiveness.

3. Responsibilities

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

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the cleaning procedures for gelatin preparation equipment are validated according to this SOP. The QA Manager is responsible for reviewing and approving the cleaning validation results and ensuring that the cleaning process meets 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, including 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 quality standards required for the validation process.
    2. Ensure that all gelatin preparation equipment, including mixing tanks and dissolution vessels, is available and ready for 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 gelatin preparation equipment:

  1. Pre-Cleaning Setup

    1. Set up the cleaning system according to the SOP for cleaning gelatin preparation equipment. Ensure the cleaning agents, temperature, and time are appropriately set.
    2. Ensure that all parts of the gelatin preparation equipment, including tanks and mixing systems, are accessible for cleaning.
  2. Start the Cleaning Process

    1. Begin the cleaning process by applying cleaning agents to the equipment. Ensure the process is carried out for the specified duration and under the required conditions.
    2. Document all relevant cleaning parameters, such as 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. Document the post-cleaning rinse process to ensure all surfaces are thoroughly cleaned and free from residual agents.
  4. Sampling and Testing

    1. Collect samples from cleaned equipment to test for any residual contaminants, including cleaning agents, gelatin residues, and microbial contamination.
    2. Perform swab tests and rinse water tests to confirm cleanliness and compliance with established criteria. 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 cleaning process does not meet the 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 compliance:

  1. Cleaning Validation Log

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

    1. Document the results of all 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 by the QA Manager and filed for future reference.
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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. 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 Mixer 501 01/02/2025 John Doe Calibration of mixing speed and temperature 01/02/2026

Annexure 2: Cleaning Validation Log

Batch ID Cleaning Date Operator Cleaning Parameters Remarks
Batch 001 02/02/2025 Jane Smith Temperature: 50°C, Time: 30 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 Gelatin Preparation Equipment QA Head
01/02/2025 2.0 Updated cleaning validation parameters and added new testing procedures Optimization of cleaning process and inclusion of updated testing methods QA Head
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