SOP Guide for Pharma

Creams: SOP for Maintenance of High-Shear Mixers – V 2.0

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Creams: SOP for Maintenance of High-Shear Mixers – V 2.0

Standard Operating Procedure for Maintenance of High-Shear Mixers

Department Creams
SOP No. SOP/CRM/091/2025
Supersedes SOP/CRM/091/2022
Page No. Page 1 of 6
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to define the procedure for the maintenance of high-shear mixers used in the production of cream products. The objective is to ensure that the mixers are maintained in optimal working condition to prevent equipment malfunction and ensure product quality.

2. Scope

This SOP applies to all high-shear mixers used in the Creams Department for the preparation of cream formulations. It covers the cleaning, inspection, lubrication, and troubleshooting of the mixers.

3. Responsibilities

4. Accountability

The Head of Production is accountable for ensuring that all high-shear mixers are maintained according to this SOP. The QA Manager is responsible for verifying that the maintenance procedures are followed and that equipment is operating as required during production.

5. Procedure

5.1 Pre-Maintenance Checks

  1. Ensure that the high-shear mixer is turned off and disconnected from the power supply before starting maintenance activities.
  2. Verify that the area around the mixer is clean and free from any unnecessary items that could obstruct maintenance work.
  3. Check that all necessary tools and spare parts are available for the maintenance procedure.
  4. Ensure that personal protective equipment (PPE) is worn as per safety guidelines (e.g., gloves, goggles, and safety shoes).
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5.2 Cleaning the High-Shear Mixer

  1. Clean the exterior of the mixer using a soft cloth to remove dust and any external residue.
  2. Remove any cream residue from the mixing chamber using an approved cleaning solution as per the cleaning SOP for equipment.
  3. Ensure that all removable parts, such as blades, agitators, and seals, are thoroughly cleaned and free of product residue.
  4. Rinse the cleaned parts with warm water to remove any cleaning solution residues.
  5. Dry all cleaned components using a lint-free cloth or allow them to air dry completely before reassembling.

5.3 Inspection and Lubrication

  1. Inspect all moving parts of the high-shear mixer, including the motor, blades, and agitators, for signs of wear and tear.
  2. Check the seals, bearings, and other critical components for any damage, such as cracks or leaks, and replace any faulty parts.
  3. Lubricate moving parts as required with the appropriate lubricant, following manufacturer recommendations for the type of lubricant to be used.
  4. Inspect the electrical components and control system to ensure they are functioning properly. Tighten any loose connections and replace damaged wiring if necessary.

5.4 Calibration

  1. Verify that the high-shear mixer is calibrated according to the manufacturer’s specifications.
  2. Ensure that all settings, such as mixing speed, pressure, and temperature (if applicable), are adjusted to the correct values for the upcoming production run.
  3. Document the calibration results and record any adjustments made to the equipment in the Equipment Calibration Log (Annexure-1).
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5.5 Troubleshooting

  1. If the mixer is not functioning properly during operation, check for common issues such as motor malfunction, imbalance in the blades, or excessive vibrations.
  2. Consult the manufacturer’s troubleshooting guide for specific error codes or problems and follow the recommended solutions.
  3. If the issue persists, contact the maintenance team for further inspection and repair.
  4. Document any troubleshooting actions and corrective measures taken in the Equipment Maintenance Log (Annexure-2).

5.6 Post-Maintenance Checks

  1. Once maintenance is complete, reassemble any parts that were removed during cleaning or inspection.
  2. Check the alignment and operation of all components to ensure they are working correctly before resuming production.
  3. Perform a test run of the mixer with water or a similar non-product substance to verify that it is functioning properly.
  4. Monitor the mixer for any unusual noises, vibrations, or errors during the test run, and make adjustments as needed.
  5. Record the results of the test run and any adjustments made in the Equipment Test Run Log (Annexure-3).

5.7 Documentation

  1. Record all maintenance activities in the Equipment Maintenance Log (Annexure-2), including the date, type of maintenance performed, and any issues identified during the process.
  2. Document any calibration results, including any adjustments made, in the Equipment Calibration Log (Annexure-1).
  3. Record the results of the post-maintenance test run in the Equipment Test Run Log (Annexure-3).

5.8 Final Approval

  1. The QA team must review all maintenance and testing documentation to ensure compliance with SOPs and equipment readiness for production.
  2. Once approved, the equipment can be used for the next production run. If any discrepancies are noted, the batch should be reviewed and corrective actions should be taken before proceeding to production.
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6. Abbreviations

7. Documents

  1. Annexure-1: Equipment Calibration Log
  2. Annexure-2: Equipment Maintenance Log
  3. Annexure-3: Equipment Test Run 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 Calibration Log

Equipment ID Calibration Date Calibration Type Operator Comments
HM-001 21/01/2026 Speed, pressure calibration John Doe Successfully calibrated

Annexure-2: Equipment Maintenance Log

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

Annexure-3: Equipment Test Run Log

Equipment ID Test Date Test Performed Operator Results
HM-001 21/01/2026 Test run with water Jane Smith Successful, no abnormalities detected

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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