SOP Guide for Pharma

Creams: SOP for Operating Homogenizers in Cream Production – V 2.0

Auditor

Creams: SOP for Operating Homogenizers in Cream Production – V 2.0

Standard Operating Procedure for Operating Homogenizers in Cream Production

Department Creams
SOP No. SOP/CRM/081/2025
Supersedes SOP/CRM/081/2022
Page No. Page 1 of 6
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

This SOP defines the procedure for the proper operation of homogenizers used in cream production. The objective is to ensure that the homogenization process is performed efficiently to achieve uniformity in texture, consistency, and product quality.

2. Scope

This SOP applies to all homogenizer operations in the Creams Department. It covers the setup, operation, and maintenance of homogenizers during the cream production process.

3. Responsibilities

4. Accountability

The Head of Production is accountable for ensuring that homogenization is performed according to this SOP. The QA Manager is responsible for ensuring compliance with regulatory standards and reviewing batch records for quality assurance.

5. Procedure

5.1 Homogenizer Setup

  1. Ensure that the homogenizer is clean and free of any contaminants before use. Perform a thorough cleaning and sanitization as required.
  2. Check the homogenizer for proper calibration and functionality. Ensure that all gauges, controls, and pumps are working correctly.
  3. Verify that the required homogenization parameters (e.g., pressure, temperature, and flow rate) are set according to the batch record and formulation requirements.
  4. Ensure that the raw materials to be homogenized are properly prepared, and their quantities have been confirmed before initiating the process.
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5.2 Starting the Homogenization Process

  1. Start the homogenizer slowly to allow for proper material loading and to ensure that no air is introduced into the system.
  2. Gradually increase the pressure to the desired level according to the batch record specifications.
  3. Monitor the flow rate and ensure that it stays within the specified range throughout the homogenization process.
  4. Ensure that the material passes through the homogenizer multiple times to achieve the desired uniformity. The number of passes should be determined based on the product specification (usually 2-3 passes).
  5. Monitor the temperature during the homogenization process to ensure that it remains within the acceptable range. Excessive heat may affect the product quality.

5.3 Monitoring the Homogenization Process

  1. Continuously monitor the homogenizer during operation for any irregularities, such as abnormal pressure readings, unusual noise, or leakage.
  2. Check the consistency and texture of the mixture during the process to ensure it is within the expected range.
  3. Use sampling and viscosity testing to confirm that the mixture is homogenized properly and meets the required specifications.
  4. If any deviations are observed, stop the process immediately and investigate the cause. Document any issues and the corrective actions taken in the Homogenization Log (Annexure-1).
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5.4 Completing the Homogenization Process

  1. Once the desired product characteristics (e.g., texture, viscosity) are achieved, stop the homogenizer.
  2. Ensure that the final mixture meets all quality standards and specifications for the cream formulation.
  3. Record the final homogenization pressure, flow rate, temperature, and number of passes in the Batch Production Record (Annexure-2).
  4. Perform a sensory check to ensure that the product is smooth, without any lumps or visible air pockets.

5.5 Post-Process Cleaning

  1. Immediately after the homogenization process, clean the homogenizer thoroughly to prevent cross-contamination between batches.
  2. Follow the standard cleaning and sanitization procedure, which may include rinsing with water, followed by a suitable cleaning agent.
  3. Ensure that the homogenizer is properly dried before the next use.
  4. Document the cleaning process in the Equipment Cleaning Log (Annexure-3).

5.6 Documentation

  1. Complete all relevant documentation, including the Homogenization Log (Annexure-1) and the Batch Production Record (Annexure-2).
  2. Ensure that the operator and QA team sign off on the records to confirm compliance with the SOP and product specifications.

5.7 Final Approval

  1. The QA team must review the homogenization process records, including any deviations and corrective actions, before approving the batch for the next production phase.
  2. Ensure that the final product meets all specifications for texture, consistency, and viscosity before it moves to the filling or packaging stages.
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6. Abbreviations

7. Documents

  1. Annexure-1: Homogenization Log
  2. Annexure-2: Batch Production Record
  3. Annexure-3: 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: Homogenization Log

Batch Number Mixing Time Pressure Flow Rate Temperature Operator Comments
12345 20 minutes 1500 psi 200 L/min 25°C John Doe No issues

Annexure-2: Batch Production Record

Batch Number Production Date Homogenization Parameters Operator Comments
98765 21/01/2026 Pressure: 1500 psi, Flow Rate: 200 L/min Jane Smith Homogenization completed successfully

Annexure-3: Equipment Cleaning Log

Equipment Cleaning Date Cleaning Method Operator Comments
Homogenizer 21/01/2026 Rinsed with water and sanitized Jane Smith Cleaned after each 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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