Creams: SOP for Operating Ointment Mills in Cream Manufacturing – V 2.0

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Creams: SOP for Operating Ointment Mills in Cream Manufacturing – V 2.0

Standard Operating Procedure for Operating Ointment Mills in Cream Manufacturing

Department Creams
SOP No. SOP/CRM/085/2025
Supersedes SOP/CRM/085/2022
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 outlines the procedure for operating ointment mills in the cream manufacturing process. The objective is to ensure that the ointment mills are used effectively to achieve the desired consistency, smoothness, and uniformity of the cream product.

2. Scope

This SOP applies to the operation of ointment mills used in the Creams Department for processing and refining the texture of cream products. It covers setup, operation, monitoring, and maintenance of the ointment mills.

3. Responsibilities

  • Production Team: Responsible for setting up, operating, and monitoring the ointment mills to ensure proper cream processing and consistency.
  • Quality Control (QC): Ensures that the final cream product meets the required specifications for texture, viscosity, and uniformity after milling.
  • Maintenance Team: Ensures that the ointment mills are in good working condition, properly cleaned, and maintained regularly to prevent malfunction.

4. Accountability

The Head of Production is accountable for ensuring that ointment mills are operated in compliance with this SOP. The QA Manager is responsible for verifying that the final cream product meets quality standards after milling.

5. Procedure

5.1 Pre-Operation Checks

  1. Ensure the ointment mill is clean and free from any contaminants. Follow the cleaning SOP for proper sanitization of the equipment.
  2. Check all components of the ointment mill, including rollers, gauges, and motors, to ensure they are properly fitted and in good condition.
  3. Verify that the correct type of cream product is being processed and that all required raw materials are ready for milling.
  4. Set the appropriate mill speed, pressure, and gap settings based on the formulation requirements and batch specifications.
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5.2 Operating the Ointment Mill

  1. Start the ointment mill and gradually increase the speed to the desired level. Ensure that the product is flowing smoothly through the rollers.
  2. Monitor the flow of cream through the ointment mill to ensure that it is evenly processed and does not exhibit any signs of clogging or blockage.
  3. Adjust the pressure settings if necessary to achieve the desired particle size and smoothness of the cream product.
  4. Allow the product to pass through the mill for the required number of passes, typically 2-3, or as specified in the batch record.
  5. Ensure that the consistency and texture of the cream are consistently checked throughout the milling process. Take samples for testing at regular intervals to verify product quality.

5.3 Monitoring During Operation

  1. Continuously monitor the ointment mill for any irregularities such as unusual noise, vibrations, or changes in product consistency.
  2. Check the temperature of the cream during milling, ensuring it remains within the required range to prevent degradation of sensitive ingredients.
  3. Ensure that the product passes through the mill without any issues, and maintain a uniform consistency by adjusting the gap between rollers if needed.
  4. In case of any malfunction, stop the operation immediately, identify the issue, and document it in the Equipment Maintenance Log (Annexure-1).
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5.4 Post-Milling Checks

  1. Once the milling process is complete, inspect the cream for uniformity and smoothness. Check for any lumps or inconsistencies that may have resulted from improper milling.
  2. Verify the texture and viscosity of the cream using the required testing methods (e.g., viscosity tests, sensory checks). Ensure that the product meets the quality specifications.
  3. Record the milling parameters (e.g., speed, pressure, temperature) and the results of quality checks in the Batch Production Record (Annexure-2).
  4. If any discrepancies are observed in the final product, document the issue and corrective actions taken in the Yield Deviation Log (Annexure-3).

5.5 Maintenance and Cleaning

  1. After completing the milling process, clean the ointment mill thoroughly to remove any cream residue and prevent cross-contamination between batches.
  2. Perform routine maintenance checks, including lubrication and inspection of rollers, motors, and control systems. Ensure that all components are in good working condition.
  3. Document all maintenance activities in the Equipment Maintenance Log (Annexure-1).

5.6 Documentation

  1. Ensure that all relevant details of the milling process, including mill settings, number of passes, and test results, are recorded in the Batch Production Record (Annexure-2).
  2. Document any maintenance or issues encountered during the milling process in the Equipment Maintenance Log (Annexure-1) and Yield Deviation Log (Annexure-3).

5.7 Final Approval

  1. The QA team must review the final cream product, including all records from the milling process, to verify that it meets the required product specifications before approval for the next production phase.
  2. If any deviations from the set parameters or product quality are identified, the batch should be reviewed, and corrective actions should be taken.
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6. Abbreviations

  • GMP: Good Manufacturing Practices
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Annexure-1: Equipment Maintenance Log
  2. Annexure-2: Batch Production Record
  3. Annexure-3: Yield Deviation Log

8. References

  • Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
  • International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • FDA Guidelines for Cosmetics Manufacturing

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
OM-001 21/01/2026 Lubrication, inspection Jane Smith Successfully completed

Annexure-2: Batch Production Record

John Doe
Batch Number Production Date Mixing Parameters Operator Comments
12345 21/01/2026 Speed: 150 RPM, Pressure: 2 bar Successfully completed milling

Annexure-3: Yield Deviation Log

Batch Number Deviation Percentage Cause of Deviation Corrective Action Operator
12345 5% Over-mixing Reduced mixing time Jane Smith

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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