Capsule: SOP for Validation of Cleaning Procedures for Capsule Polishing Machines – V 2.0

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Capsule: SOP for Validation of Cleaning Procedures for Capsule Polishing Machines – V 2.0

Standard Operating Procedure for Validation of Cleaning Procedures for Capsule Polishing Machines

Department Capsule Manufacturing
SOP No. SOP/CM/163/2025
Supersedes SOP/CM/163/2022
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 capsule polishing machines in capsule manufacturing. Cleaning validation is essential to prevent cross-contamination between batches and ensure that no residues from previous batches remain on the machines. This SOP ensures that cleaning procedures are consistent, reproducible, and comply with GMP and regulatory standards.

2. Scope

This SOP applies to the cleaning validation of capsule polishing machines used in the capsule production process. It covers all aspects of the cleaning process, from pre-cleaning setup to post-cleaning testing, including the cleaning agents, procedures, and validation of cleaning efficacy.

3. Responsibilities

  • Production Operators: Responsible for executing the cleaning procedure and ensuring 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.
  • Quality Assurance (QA) Team: Reviews and approves the cleaning validation plan and results, ensuring compliance with GMP and regulatory standards.
  • Engineering Team: Responsible for ensuring that the polishing machines are properly maintained and calibrated during the validation process.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that cleaning procedures for capsule polishing machines 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 complies with GMP and regulatory standards.

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5. Procedure

5.1 Preparation for Cleaning Validation

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

  1. Review Validation Plan

    1. Review the cleaning validation plan, including the equipment to be cleaned, the cleaning agents, the cleaning parameters, and the acceptance criteria. Ensure that the plan is approved by the QA department before beginning the validation process.
  2. Gather Materials and Equipment

    1. Ensure that all cleaning materials, including cleaning agents, tools, and equipment, are available and meet the required quality specifications for the validation process.
    2. Ensure that capsule polishing machines are ready for cleaning and validation.
  3. Calibrate Equipment

    1. Ensure that all equipment, including cleaning systems, are properly calibrated and functioning as per specifications. Record calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Cleaning Procedure Validation

Follow these steps to validate the cleaning process for capsule polishing machines:

  1. Pre-Cleaning Setup

    1. Set up the cleaning system in accordance with the SOP for cleaning capsule polishing machines. Ensure that cleaning agents, temperature, and time are set according to the cleaning validation plan.
    2. Ensure that all parts of the capsule polishing machine are accessible for cleaning, including polishing brushes, drums, and feed mechanisms.
  2. Start the Cleaning Process

    1. Begin the cleaning process by applying the cleaning agents to the polishing machine surfaces. Ensure that the cleaning process is carried out for the required duration and at the correct temperature and pressure.
    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 machine.
    2. Ensure that the rinsing process is thoroughly documented in the Cleaning Validation Log (Annexure 2) to confirm that no cleaning residues remain.
  4. Sampling and Testing

    1. Take samples from the 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 cleaning validation tests to ensure that the 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 not, 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, 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 stored 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

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
Polishing Machine 120 01/02/2025 John Doe Calibration of polishing speed and brush rotation 01/02/2026

Annexure 2: Cleaning Validation Log

Batch ID Cleaning Date Operator Cleaning Parameters Remarks
Batch 001 02/02/2025 Jane Smith Temperature: 60°C, Time: 40 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 capsule polishing machines 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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