SOP Guide for Pharma

Creams: SOP for End-Point Detection during Cream Mixing – V 2.0

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Creams: SOP for End-Point Detection during Cream Mixing – V 2.0

Standard Operating Procedure for End-Point Detection during Cream Mixing

Department Creams
SOP No. SOP/CRM/075/2025
Supersedes SOP/CRM/075/2022
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 defines the procedure for end-point detection during the mixing process of cream formulations. The goal is to identify when the cream mixture has reached the desired consistency, texture, and homogeneity, ensuring that it meets quality standards before moving to the next production phase.

2. Scope

This SOP applies to the cream mixing process in the Creams Department, covering all stages of mixing and the detection of the end-point for different types of cream formulations.

3. Responsibilities

4. Accountability

The Head of Production is accountable for ensuring that the mixing process is conducted according to this SOP and that the end-point is correctly detected. The QA Manager is responsible for reviewing and ensuring the process complies with regulatory and quality standards.

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5. Procedure

5.1 Pre-Mixing Preparation

  1. Ensure that all ingredients for the cream formulation are pre-weighed, prepared, and ready for mixing.
  2. Verify that the mixing vessel is clean and properly prepared for use.
  3. Check that all mixing equipment (e.g., mixers, paddles, and sensors) are calibrated and functioning correctly.

5.2 Mixing Process

  1. Transfer the ingredients into the mixing vessel in the correct order, following the formulation’s requirements.
  2. Start the mixing process at a low speed to combine the ingredients and gradually increase the speed as the mixture becomes more uniform.
  3. Ensure that the mixing process is controlled to prevent the incorporation of air and achieve the desired consistency.

5.3 End-Point Detection

  1. During the mixing process, monitor key indicators for the end-point, including viscosity, consistency, and texture.
  2. Use a rheometer or viscometer to measure the cream’s viscosity. The end-point is reached when the viscosity readings stabilize within the required range.
  3. Alternatively, perform sensory checks by testing the texture and spreadability of the cream. The end-point is confirmed when the cream is smooth, with no lumps, and exhibits the correct consistency.
  4. Perform a sample test by taking a small quantity of the mixture and allowing it to cool to check for uniformity in texture.
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5.4 Post Mixing Checks

  1. Once the end-point is detected, stop the mixing process to prevent over-processing or degradation of the product.
  2. Conduct a visual and tactile inspection of the cream to ensure it meets the required consistency and texture standards.
  3. Document the end-point detection results in the Mixing Log (Annexure-1), noting the time, temperature, and readings taken during the process.

5.5 Documentation

  1. Complete all relevant documentation, including batch numbers, mixing parameters (time, speed, temperature), and end-point test results in the Mixing Log (Annexure-1).
  2. Ensure that all records are reviewed and signed by the operator and the QA team to confirm compliance with the SOP.

5.6 Final Approval

  1. The QA team must review the mixing and end-point detection records and confirm that the cream batch has met the quality specifications before it moves to the next phase (e.g., transfer to storage or packaging).
  2. If the cream batch does not meet the required end-point characteristics, the process should be flagged for corrective action.

6. Abbreviations

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7. Documents

  1. Annexure-1: Mixing Log
  2. Annexure-2: Sensory Testing Log
  3. Annexure-3: End-Point Detection Report

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: Mixing Log

Batch Number Mixing Time Mixing Speed End-Point Detected (Yes/No) Operator Comments
12345 30 minutes 200 RPM Yes John Doe No issues

Annexure-2: Sensory Testing Log

Batch Number Texture Spreadability Color Fragrance Test Result
12345 Smooth Good White Lavender Pass

Annexure-3: End-Point Detection Report

Batch Number End-Point Detected (Yes/No) Final Viscosity Final Texture Operator Comments
12345 Yes 1000 cP Smooth Jane Smith End-point achieved successfully

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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