accountable for ensuring that the planetary mixer parameters are set correctly and that the mixer is operating within defined specifications. The QA Manager is responsible for ensuring that product quality is maintained throughout the process.

5. Procedure

5.1 Pre-Operation Checks

1. Ensure that the planetary mixer is clean and free of contaminants before use. Perform a cleaning procedure according to the equipment cleaning SOP.
2. Check the mixer for proper assembly and ensure that all components are securely in place. Verify that there are no leaks or defects in the mixer.
3. Verify that the mixer is calibrated and ready for use by inspecting the control panel, gears, and other operational components.

5.2 Setting the Mixing Speed

1. Set the initial speed based on the type of cream being produced. Typically, the speed should be low for initial mixing and gradually increased as needed for uniform blending.
2. The recommended mixing speed for creams typically ranges between 50 to 200 RPM, depending on the viscosity and formulation of the cream.
3. Adjust the mixing speed using the control panel to achieve the desired consistency and texture. Verify the set speed by cross-checking the RPM on the mixer’s display.

5.3 Setting the Mixing Time

1. Determine the required mixing time based on the batch size and formulation specifications. Mixing times typically range from 20 minutes to 1 hour.
2. Set the mixing time on the control panel according to the recipe requirements. Monitor the mixing time to ensure that it aligns with the batch production record.
3. Ensure that the mixer is running for the full specified time and that the mixture is properly blended at the end of the cycle. Do not exceed the set time unless specified by the formulation.

5.4 Temperature Control

1. Monitor the temperature of the cream during mixing, especially when sensitive ingredients such as emulsifiers or stabilizers are being used.
2. Ensure that the temperature remains within the required range as per the batch record, typically between 20°C and 40°C for most cream formulations.
3. If necessary, adjust the mixer’s heating or cooling settings to maintain the desired temperature during the mixing process.

5.5 Monitoring Mixing Consistency

1. Regularly check the consistency of the cream during mixing to ensure that it is becoming smooth and uniform.
2. Perform viscosity testing as needed to ensure the cream has reached the required consistency. Adjust the mixing time or speed if the consistency is not satisfactory.
3. Ensure that the cream is free from lumps or inconsistencies. If any issues are detected, adjust the mixing parameters or restart the process as necessary.

5.6 Post-Mixing Checks

1. After the mixing is complete, perform a sensory check to ensure the product is smooth and uniform.
2. Check the final product for proper texture, viscosity, and consistency. If any issues are observed, investigate the cause and take corrective action.
3. Document the mixing parameters, including speed, time, temperature, and any deviations, in the Batch Production Record (Annexure-1).

5.7 Maintenance and Cleaning

1. After completing the mixing process, perform routine maintenance on the planetary mixer, including cleaning and sanitizing it for the next batch.
2. Ensure that all components are cleaned thoroughly and that the mixer is checked for wear and tear, ensuring its continued functionality.
3. Document the cleaning process in the Equipment Cleaning Log (Annexure-2).

5.8 Documentation

1. Record all relevant mixing parameters, including speed, time, and temperature, in the Batch Production Record (Annexure-1).
2. Complete the Homogenization Log (Annexure-2) to document any maintenance or adjustments made during the mixing process.

5.9 Final Approval

1. The QA team must review the mixing parameters and verify that the cream has been produced to the required specifications before approving the batch for further processing.
2. Any deviations in the mixing process must be investigated and documented in the Yield Deviation Log (Annexure-3), with corrective actions taken as necessary.

6. Abbreviations

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

7. Documents

1. Annexure-1: Batch Production Record
2. Annexure-2: Equipment Cleaning Log
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: Batch Production Record

Batch Number	Production Date	Mixing Speed	Mixing Time	Temperature	Operator	Comments
12345	21/01/2026	150 RPM	30 minutes	25°C	Jane Smith	Homogenization completed successfully

Annexure-2: Equipment Cleaning Log

Equipment	Cleaning Date	Cleaning Method	Operator	Comments
Planetary Mixer	21/01/2026	Rinsed with water, cleaned with detergent	John Doe	No residue or contamination

Annexure-3: Yield Deviation Log

Batch Number	Deviation Percentage	Cause of Deviation	Corrective Action	Operator
12345	3%	Insufficient mixing time	Extended 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