Creams: SOP for Setting Parameters for Planetary Mixers – V 2.0

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Creams: SOP for Setting Parameters for Planetary Mixers – V 2.0

Standard Operating Procedure for Setting Parameters for Planetary Mixers

Department Creams
SOP No. SOP/CRM/082/2025
Supersedes SOP/CRM/082/2022
Page No. Page 1 of 5
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

This SOP defines the procedure for setting the parameters for planetary mixers used in cream production. The objective is to ensure consistent product quality and uniform mixing by properly setting up and operating the planetary mixer.

2. Scope

This SOP applies to all planetary mixers used in the Creams Department for the production of cream products. It includes the process of setting and adjusting the mixing speed, time, and other parameters to achieve optimal mixing results.

3. Responsibilities

  • Production Team: Responsible for setting up and operating the planetary mixers according to the SOP, ensuring that all parameters are set correctly for each batch.
  • Quality Control (QC): Ensures that the final product meets the desired texture, consistency, and uniformity by monitoring the mixing process and verifying the parameters.
  • Maintenance Team: Ensures that the planetary mixer is in good working condition, performs regular checks, and maintains the equipment to prevent malfunctions during production.

4. Accountability

The Head of Production is 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.
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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.
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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.
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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: 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
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