Standard Operating Procedure for High-Shear Mixing in Cream Manufacturing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/068/2025 |
| Supersedes | SOP/CRM/068/2022 |
| 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 Standard Operating Procedure (SOP) is to define the process for high-shear mixing in the manufacturing of creams. High-shear mixing is essential for achieving uniform dispersion of ingredients, enhancing texture, and improving the stability of cream formulations. This SOP ensures that high-shear mixing is conducted in a controlled, efficient, and compliant manner.
2. Scope
This SOP applies to all cream formulations that require high-shear mixing during the manufacturing process in the Creams Department. It covers the setup, operation, and monitoring of high-shear mixers, ensuring that the process is performed accurately and within the defined product specifications.
3. Responsibilities
- Production Team: Responsible for setting up, operating, and monitoring the high-shear mixing process according to this SOP. They must ensure that the correct procedure is followed to achieve the desired product consistency.
- Quality Control (QC): Responsible for monitoring the high-shear mixing process, verifying that the mixing parameters are within specifications, and conducting tests to ensure product uniformity and stability.
- Quality Assurance (QA): Ensures that the high-shear mixing process adheres to GMP standards and reviews the process records to approve the batch for the next stage of production.
- Maintenance Team: Responsible for ensuring that the high-shear mixer is in good working condition, properly calibrated, and maintained regularly to prevent malfunctions during operation.
4. Accountability
The Head of Creams Manufacturing is responsible for overseeing the high-shear mixing process, ensuring it is performed according to this SOP. The QA Manager is accountable for reviewing the process logs and ensuring that the batch meets the required specifications for quality before moving to the next stage.
5. Procedure
5.1 Pre-Mixing Preparation
- Verify that all ingredients required for the cream formulation are available, pre-weighed, and ready for mixing.
- Inspect the high-shear mixing equipment for cleanliness, functionality, and proper calibration. Ensure that the mixer’s blades or other parts are free from contaminants and properly positioned.
- Ensure that the mixing area is clean, organized, and free from any foreign materials that could contaminate the batch.
- Ensure that the required protective equipment (PPE) is worn by the operators, including gloves, goggles, and lab coats, to ensure safety and prevent contamination.
5.2 High-Shear Mixing Setup
- Set up the high-shear mixer according to the manufacturer’s instructions, ensuring that it is configured for the required mixing speed and duration.
- Set the mixer to the correct speed for the cream formulation. For creams, high shear typically ranges between 1500 and 3000 RPM, depending on the product specifications.
- Check that the mixing vessel is properly positioned under the mixer, and ensure that the product will be evenly mixed without any air pockets or unmixed ingredients.
- Ensure that the mixer’s temperature control system is set to the required temperature range, if applicable, for the specific cream formulation.
5.3 High-Shear Mixing Process
- Begin the mixing process, gradually adding ingredients to the mixer as per the formulation. Ensure that all ingredients are added in the correct order to prevent separation or clumping.
- Monitor the consistency of the cream throughout the mixing process. Check for uniformity, smoothness, and the absence of lumps or agglomerates.
- Maintain the specified mixing speed and duration to ensure proper emulsification and blending of ingredients.
- Periodically stop the mixer to check the product for consistency. Record any observations in the Mixing Log (Annexure-1).
- If necessary, adjust the speed or mixing duration based on the product’s response during mixing. Ensure that the final product exhibits the desired texture and consistency.
5.4 Post-Mixing Checks
- Once the mixing process is complete, inspect the cream’s texture, smoothness, and consistency. Perform a spreadability test to ensure that the product meets the required specifications.
- Check the product for any visible air pockets or separation of phases. If these issues are observed, repeat the mixing process to achieve uniformity.
- Record the mixing parameters (e.g., time, speed, temperature) and observations in the High-Shear Mixing Log (Annexure-2).
- If any deviations or issues are observed, document them in the Deviation Report Form (Annexure-3) and investigate corrective actions.
5.5 Quality Control Testing
- After high-shear mixing, perform quality control tests on the cream batch to verify the product’s consistency, viscosity, and stability.
- Use a viscometer to measure the viscosity of the cream, ensuring it falls within the specified range. Record the results in the Viscosity Testing Log (Annexure-4).
- Perform a sensory evaluation of the cream, checking for odor, texture, and spreadability. Record the results in the Sensory Evaluation Log (Annexure-5).
- If the product passes all quality control tests, proceed to the next step in production. If it fails, review the mixing process and take corrective actions as needed.
5.6 Documentation
- Complete all necessary documentation, including the High-Shear Mixing Log (Annexure-2), Viscosity Testing Log (Annexure-4), and Sensory Evaluation Log (Annexure-5).
- Ensure that all records are signed by the operator and reviewed by the QA team for compliance with the required standards.
5.7 Final Approval
- The QA team must review all mixing and testing records before approving the batch for the next stage of production or release.
- If any deviations or issues occurred during the mixing process, the QA team must approve the corrective actions taken before final approval.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
- PPE: Personal Protective Equipment
7. Documents
- High-Shear Mixing Log (Annexure-2)
- Viscosity Testing Log (Annexure-4)
- Sensory Evaluation Log (Annexure-5)
- Deviation Report Form (Annexure-3)
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: High-Shear Mixing Log
| Batch Number | Start Time | End Time | Mixing Speed (RPM) | Operator | Comments |
|---|---|---|---|---|---|
| 12345 | 08:00 AM | 09:00 AM | 2500 | Jane Smith | No issues |
Annexure-2: Viscosity Testing Log
| Batch Number | Viscosity (cP) | Test Type | Operator | Comments |
|---|---|---|---|---|
| 12345 | 1500 | Brookfield | John Doe | No issues |
Annexure-3: Deviation Report Form
| Deviation Description | Time | Batch Number | Operator | Immediate Action |
|---|---|---|---|---|
| High shear speed variation | 08:30 AM | 12345 | Jane Smith | Adjusted speed to 2500 RPM |
Annexure-4: Sensory Evaluation Log
| Batch Number | Odor | Texture | Spreadability | Operator | Comments |
|---|---|---|---|---|---|
| 12345 | Pleasant | Smooth | Good | John Doe | No issues |
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 |