SOP Guide for Pharma

Creams: SOP for Cleaning Manufacturing Tanks for Creams – V 2.0

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Creams: SOP for Cleaning Manufacturing Tanks for Creams – V 2.0

Standard Operating Procedure for Cleaning Manufacturing Tanks for Creams

Department Creams
SOP No. SOP/CRM/060/2025
Supersedes SOP/CRM/060/2022
Page No. Page 1 of 6
Issue Date 17/12/2025
Effective Date 22/12/2025
Review Date 17/12/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for cleaning manufacturing tanks used in the production of creams. Cleaning of manufacturing tanks is critical to prevent cross-contamination, ensure product quality, and comply with Good Manufacturing Practices (GMP). This SOP outlines the cleaning procedures to ensure that tanks are sanitized and ready for the next production run.

2. Scope

This SOP applies to all manufacturing tanks used in the production of creams within the Creams Department. It includes procedures for pre-cleaning, cleaning, and post-cleaning verification. It covers all types of tanks, including mixing vessels, homogenization tanks, and storage tanks.

3. Responsibilities

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that this SOP is followed correctly. The QA Manager is accountable for reviewing the cleaning process, verifying documentation, and approving the cleaned tanks for the next production cycle.

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5. Procedure

5.1 Pre-Cleaning Preparation

  1. Before cleaning, ensure that the manufacturing tank is empty, and all materials have been removed. Verify that no residual cream or ingredients remain in the tank.
  2. Prepare all necessary cleaning agents (detergents, disinfectants, solvents) based on the material requirements of the tank and the type of cream produced.
  3. Inspect all cleaning equipment (e.g., hoses, pumps, CIP systems) to ensure it is in good working condition. Make sure the cleaning equipment has been properly sanitized before use.
  4. Review the cleaning logs from previous cycles to ensure no issues were reported, and ensure that the tank is free from any visible contamination.

5.2 Cleaning Process

  1. For tanks equipped with Cleaning In Place (CIP) systems:
    • Start the CIP system according to the manufacturer’s instructions, ensuring that all parts of the tank, including the interior surfaces, nozzles, and hoses, are thoroughly cleaned.
    • Ensure the cleaning cycle includes proper flushing with water to remove all residues and followed by a detergent wash. Perform a final rinse with water to remove any detergent.
    • Verify that the CIP system is calibrated for the correct temperature, pressure, and flow rate to ensure effective cleaning.
  2. For tanks that do not have CIP systems, manually clean the tank by first rinsing with water to remove visible residues, then applying an appropriate detergent and scrubbing the interior surfaces with clean brushes.
  3. After the initial wash, rinse the tank thoroughly with clean water until no detergent residues remain.
  4. Use disinfectant to sanitize the interior surfaces of the tank. Ensure that the disinfectant is compatible with the tank material and the cream formulation.
  5. After the disinfection cycle, perform a final rinse to remove any traces of disinfectant.
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5.3 Post-Cleaning Verification

  1. Once the cleaning process is complete, perform a visual inspection of the tank to ensure that it is free from any residues, stains, or contaminants.
  2. Conduct a swab test or use a cleaning verification kit to ensure that the tank is free from microbial contamination or cleaning agent residues. The swab test results must meet the specified acceptable limits for cleanliness.
  3. Document the results of the cleaning verification, including the swab test results, in the Cleaning Log (Annexure-1).
  4. If the tank fails any part of the verification process (e.g., if swab test results are unsatisfactory), repeat the cleaning process, addressing the identified issues (e.g., inadequate detergent concentration, insufficient cleaning time).

5.4 Documentation

  1. Record all cleaning activities in the Cleaning Log, including:
    • Batch number
    • Cleaning agents used
    • Cleaning start and end times
    • Inspection and test results
    • Any deviations or issues encountered
  2. All cleaning records must be signed by the responsible operator and reviewed by the QA team.
  3. Store cleaning records in the designated database or filing system for easy retrieval during audits and inspections.

5.5 Handling Deviations

  1. If a deviation occurs during the cleaning process (e.g., improper cleaning due to equipment malfunction or human error), document the deviation in the Deviation Report Form (Annexure-2).
  2. Investigate the cause of the deviation, implement corrective actions, and ensure that the tank is re-cleaned and re-verified before it is used for the next batch of cream.
  3. Maintain a record of the deviation, corrective actions taken, and preventive measures to prevent recurrence in the future.
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5.6 Final Approval and Use

  1. Once the cleaning is completed and all verification steps have passed, the QA team must approve the tank for use in the next batch of cream manufacturing.
  2. Ensure that the tank is properly labeled with the date and time of cleaning, and any other relevant information (e.g., batch number, cleaning status) to ensure traceability.

6. Abbreviations

7. Documents

  1. Cleaning Log (Annexure-1)
  2. Deviation Report Form (Annexure-2)
  3. Cleaning Verification Report (Annexure-3)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Log

Batch Number Cleaning Start Time Cleaning End Time Operator Cleaning Verification
12345 08:00 AM 09:00 AM Jane Smith Pass

Annexure-2: Deviation Report Form

Deviation Description Time Batch Number Operator Immediate Action
Cleaning error 08:45 AM 12345 John Doe Re-clean tank

Annexure-3: Cleaning Verification Report

Batch Number Verification Method Result Corrective Action
12345 Swab Test Pass None

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
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