SOP Guide for Pharma

Creams: SOP for Cleaning Homogenizers Post-Production – V 2.0

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Creams: SOP for Cleaning Homogenizers Post-Production – V 2.0

Standard Operating Procedure for Cleaning Homogenizers Post-Production

Department Creams
SOP No. SOP/CRM/086/2025
Supersedes SOP/CRM/086/2022
Page No. Page 1 of 5
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

This SOP outlines the procedure for cleaning homogenizers post-production to ensure that they are free from residues and contaminants. The objective is to maintain hygienic conditions and prevent cross-contamination between batches.

2. Scope

This SOP applies to all homogenizers used in the Creams Department. It covers the cleaning process for homogenizers after each production run to ensure they are adequately sanitized before the next batch.

3. Responsibilities

4. Accountability

The Head of Production is accountable for ensuring that homogenizers are cleaned properly after each use. The QA Manager is responsible for verifying that the cleaning process complies with GMP standards and that the homogenizer is ready for use in the next production batch.

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5. Procedure

5.1 Pre-Cleaning Checks

  1. Ensure that the homogenizer has been turned off and disconnected from the power source before cleaning.
  2. Verify that all materials from the previous batch have been removed from the homogenizer, including any cream or emulsions.
  3. Ensure that all components to be cleaned (e.g., valves, nozzles, and hoses) are accessible and ready for cleaning.

5.2 Cleaning Process

  1. Rinse the homogenizer with warm water to remove any leftover product. Use a low-pressure flow to avoid splashing.
  2. Prepare a cleaning solution, usually a detergent solution compatible with food-grade or cosmetic production equipment. Follow the manufacturer’s recommendations for detergent concentration.
  3. Apply the cleaning solution to all parts of the homogenizer, including internal and external surfaces, seals, and nozzles. Use a clean, soft brush to scrub areas that may have accumulated product residue.
  4. Rinse the homogenizer thoroughly with warm water to remove all detergent residues.
  5. Sanitize the homogenizer with an appropriate sanitizing agent (e.g., alcohol-based sanitizer or other approved sanitizers). Follow the recommended contact time for the sanitizer to ensure effective disinfection.
  6. Rinse the homogenizer again with water to remove any residual sanitizer. Ensure that no cleaning or sanitizing agents remain in the system.

5.3 Post-Cleaning Inspection

  1. Inspect all components of the homogenizer, including the nozzles, hoses, and seals, to ensure they are thoroughly cleaned and free of residue.
  2. Ensure that there is no visible dirt or product residue on any part of the homogenizer.
  3. Check for any damage to the equipment that may have occurred during cleaning (e.g., broken seals or worn-out components). Document any repairs or replacements required in the Equipment Maintenance Log (Annexure-1).
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5.4 Drying the Homogenizer

  1. After cleaning and sanitizing, allow the homogenizer to air dry completely or use clean, dry compressed air to remove any remaining water from the internal components.
  2. Ensure that all components are completely dry before reassembling the homogenizer to prevent microbial growth or rusting.

5.5 Post-Cleaning Documentation

  1. Document the cleaning procedure in the Equipment Cleaning Log (Annexure-2), including the date, time, and operator details.
  2. Record any deviations from the standard cleaning procedure, including the reason for the deviation and any corrective actions taken.
  3. Document any maintenance performed during the cleaning process in the Equipment Maintenance Log (Annexure-1).

5.6 Reassembly and Readiness Check

  1. Reassemble the homogenizer and perform a readiness check to ensure that all components are securely attached and the machine is functioning correctly.
  2. Test the homogenizer with water or a non-product material to ensure it is operating properly before starting production with a new batch.

5.7 Final Approval

  1. The QA team must review the cleaning records to ensure that the homogenizer was cleaned in compliance with the SOP.
  2. Once approved, the homogenizer can be used for the next production run. If there are any issues or concerns, the batch production may be delayed until corrective actions are taken.
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6. Abbreviations

7. Documents

  1. Annexure-1: Equipment Maintenance Log
  2. Annexure-2: Equipment Cleaning Log

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: Equipment Maintenance Log

Equipment ID Maintenance Date Maintenance Type Operator Comments
HM-001 21/01/2026 Inspection, lubrication Jane Smith Successfully completed

Annexure-2: Equipment Cleaning Log

Equipment Cleaning Date Cleaning Method Operator Comments
Homogenizer 21/01/2026 Rinsed with warm water, detergent solution John Doe Cleaned after every batch

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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