SOP Guide for Pharma

Creams: SOP for Adjusting Viscosity during Cream Manufacturing – V 2.0

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Creams: SOP for Adjusting Viscosity during Cream Manufacturing – V 2.0

Standard Operating Procedure for Adjusting Viscosity during Cream Manufacturing

Department Creams
SOP No. SOP/CRM/049/2025
Supersedes SOP/CRM/049/2022
Page No. Page 1 of 6
Issue Date 28/10/2025
Effective Date 02/11/2025
Review Date 28/10/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for adjusting the viscosity during cream manufacturing. Viscosity is a critical parameter that influences the texture, stability, and application of the final cream product. This SOP ensures that the viscosity is within the specified range throughout the manufacturing process to achieve a consistent and desirable product.

2. Scope

This SOP applies to the viscosity adjustment process during the manufacturing of cream formulations in the Creams Department. It includes the procedures for measuring and adjusting viscosity at various stages of production to ensure the cream achieves the required consistency as defined in the Master Formula Record (MFR).

3. Responsibilities

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4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that viscosity adjustments are performed correctly and that the final product meets the required specifications. The QA Manager is accountable for ensuring compliance with this SOP and verifying the final viscosity of the cream.

5. Procedure

5.1 Preparation of Ingredients and Equipment

  1. Ensure that all ingredients for viscosity adjustment, such as thickeners, stabilizers, or rheology modifiers, are available and within specification.
  2. Prepare all mixing and measuring equipment, such as viscometers, mixers, and homogenizers. Ensure they are clean and calibrated according to the equipment maintenance SOP.
  3. Verify that the raw material and cream formulations meet the quality standards before proceeding with viscosity adjustment.

5.2 Viscosity Measurement

  1. Measure the viscosity of the cream using an appropriate viscometer (e.g., Brookfield viscometer or rheometer). Take a representative sample of the cream formulation from the mixing vessel or after the homogenization step.
  2. Record the viscosity reading in the batch record, noting the time, temperature, and any specific observations during the measurement.
  3. Compare the measured viscosity with the target viscosity specified in the MFR. If the viscosity is within the acceptable range, proceed to the next stage of manufacturing. If the viscosity is too high or too low, proceed with the adjustment process.

5.3 Viscosity Adjustment

  1. If the viscosity is too low (i.e., the cream is too thin), gradually add viscosity-enhancing agents, such as gums (e.g., xanthan gum, guar gum), synthetic thickeners, or hydrocolloids, depending on the formulation requirements.
  2. If the viscosity is too high (i.e., the cream is too thick), reduce the viscosity by adding diluents or adjusting the mixing speed and time to reduce the shear force.
  3. Add the viscosity-adjusting agents gradually and mix thoroughly to ensure uniform distribution. Allow the cream to mix for an adequate amount of time to ensure the agents are fully hydrated and incorporated.
  4. Monitor the viscosity throughout the adjustment process to ensure that it is brought within the desired range.
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5.4 Post-Adjustment Viscosity Check

  1. After adjusting the viscosity, measure the viscosity again using the same method and equipment as before to verify that the cream now falls within the specified viscosity range.
  2. Record the final viscosity reading in the batch record, along with the details of any adjustments made, such as the amount and type of thickening agents added.
  3. If the viscosity is still outside the specified range after adjustment, repeat the adjustment process until the desired viscosity is achieved.

5.5 Final Quality Control Testing

  1. Once the desired viscosity is achieved, perform additional quality control tests to ensure the cream meets all other required specifications, including pH, texture, and stability.
  2. If the cream passes all required tests, it is approved for the next stage of production, such as packaging or further processing.
  3. Document all quality control test results and corrective actions taken during viscosity adjustments in the batch record.

5.6 Documentation and Reporting

  1. Document all viscosity measurements, adjustments, and test results in the batch record. This includes the initial and final viscosity readings, the amount of viscosity-adjusting agents used, and any corrective actions taken.
  2. Submit the batch record for review and approval by the QA team before proceeding with the final steps of production.
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5.7 Final Approval and Use of Cream

  1. Once the cream meets all the required viscosity specifications and has passed all quality control tests, it is ready for the next stage of manufacturing, such as filling and packaging.
  2. Ensure that all records related to viscosity adjustments are properly filed and retained for future reference and regulatory compliance.

6. Abbreviations

7. Documents

  1. Viscosity Adjustment Log (Annexure-1)
  2. Batch Record (Annexure-2)
  3. Quality Control Test Report (Annexure-3)

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: Viscosity Adjustment Log

Batch Number Initial Viscosity Adjustment Method Final Viscosity Remarks
12345 1500 cP Added 0.5% xanthan gum 2000 cP Viscosity within specification

Annexure-2: Batch Record

Batch Number Process Step Time Operator
12345 Viscosity Adjustment 09:00 AM Jane Smith

Annexure-3: Quality Control Test Report

Test Parameter Result Specification Remarks
Viscosity 2000 cP 1500-2500 cP Pass

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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