Capsule: SOP for Validation of Cleaning Procedures for Drying Trays and Racks – V 2.0

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Capsule: SOP for Validation of Cleaning Procedures for Drying Trays and Racks – V 2.0

Standard Operating Procedure for Validation of Cleaning Procedures for Drying Trays and Racks

Department Capsule Manufacturing
SOP No. SOP/CM/165/2025
Supersedes SOP/CM/165/2022
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 cleaning validation procedures for drying trays and racks used in capsule manufacturing. Proper cleaning of drying equipment is essential to avoid contamination and ensure the safety and quality of the capsules. This SOP ensures that the cleaning procedures for drying trays and racks are validated, reproducible, and compliant with GMP and regulatory standards.

2. Scope

This SOP applies to the cleaning validation of drying trays and racks used in the drying process for capsules. It covers the cleaning steps, validation of the cleaning process, and the necessary documentation required for ensuring effective cleaning.

3. Responsibilities

  • Production Operators: Responsible for executing the cleaning procedure for drying trays and racks according to the validated procedure.
  • Quality Control (QC) Team: Responsible for sampling and testing cleaned equipment to ensure compliance with cleanliness standards and to verify the efficacy of the cleaning process.
  • Quality Assurance (QA) Team: Reviews and approves the cleaning validation plan and results, ensuring that the cleaning process complies with GMP and regulatory standards.
  • Engineering Team: Ensures the cleaning equipment is calibrated and properly maintained during the validation process.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the cleaning procedures for drying trays and racks 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 starting the cleaning validation process, ensure the following preparations are completed:

  1. Review Validation Plan

    1. Review the cleaning validation plan, which should include the cleaning agents to be used, 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, brushes, and equipment, are available and meet the required quality specifications for the validation process.
    2. Ensure that drying trays and racks are ready for cleaning and validation.
  3. Calibrate Equipment

    1. Ensure that all equipment used in the cleaning process, such as washing systems and sprayers, are 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 drying trays and racks:

  1. Pre-Cleaning Setup

    1. Set up the cleaning system according to the SOP for cleaning drying trays and racks. Ensure the cleaning agents, temperature, and time are set according to the cleaning validation plan.
    2. Ensure that all parts of the drying trays and racks are accessible for cleaning.
  2. Start the Cleaning Process

    1. Start the cleaning process by applying cleaning agents to the trays and racks. Ensure that the cleaning is done for the required duration and at the specified temperature.
    2. Record all cleaning parameters, such as time, temperature, and cleaning agent concentration, in the Cleaning Validation Log (Annexure 2).
  3. Post-Cleaning Rinse

    1. After cleaning, perform a rinse with an appropriate solution to remove any residual cleaning agents.
    2. Ensure that the rinse is thoroughly documented and no residues remain on the drying trays or racks.
  4. Sampling and Testing

    1. Collect samples from the cleaned trays and racks to test for any residual contaminants, such as cleaning agents, residues, or microbial contamination.
    2. Perform swab tests and rinse water tests. 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. If any deviations occur, investigate the cause and take corrective actions.
    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 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 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 stored 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
Drying Tray 101 01/02/2025 John Doe Calibration of drying time and temperature control 01/02/2026

Annexure 2: Cleaning Validation Log

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Annexure 2: Cleaning Validation Log

Batch ID Cleaning Date
Batch ID Cleaning Date Operator Cleaning Parameters Remarks
Batch 001 02/02/2025 Jane Smith Temperature: 50°C, Time: 45 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 drying trays and racks 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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