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
- Formulation Development Team: Responsible for defining the target viscosity for each cream formulation and specifying the method and ingredients for adjusting viscosity, as outlined in the MFR.
- Quality Control (QC): Responsible for measuring the viscosity of the cream at the specified stages and verifying that it falls within the required specifications. QC also monitors the adjustments made during production.
- Quality Assurance (QA): Ensures that the viscosity adjustment process is performed according to this SOP and that all adjustments are properly documented.
- Production Team: Responsible for performing the viscosity adjustment and ensuring that all equipment and materials are used according to the SOP and the MFR.
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
- Ensure that all ingredients for viscosity adjustment, such as thickeners, stabilizers, or rheology modifiers, are available and within specification.
- Prepare all mixing and measuring equipment, such as viscometers, mixers, and homogenizers. Ensure they are clean and calibrated according to the equipment maintenance SOP.
- Verify that the raw material and cream formulations meet the quality standards before proceeding with viscosity adjustment.
5.2 Viscosity Measurement
- 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.
- Record the viscosity reading in the batch record, noting the time, temperature, and any specific observations during the measurement.
- 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
- 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.
- 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.
- 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.
- Monitor the viscosity throughout the adjustment process to ensure that it is brought within the desired range.
5.4 Post-Adjustment Viscosity Check
- 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.
- 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.
- 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
- 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.
- If the cream passes all required tests, it is approved for the next stage of production, such as packaging or further processing.
- Document all quality control test results and corrective actions taken during viscosity adjustments in the batch record.
5.6 Documentation and Reporting
- 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.
- Submit the batch record for review and approval by the QA team before proceeding with the final steps of production.
5.7 Final Approval and Use of Cream
- 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.
- Ensure that all records related to viscosity adjustments are properly filed and retained for future reference and regulatory compliance.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
- API: Active Pharmaceutical Ingredient
- MFR: Master Formula Record
7. Documents
- Viscosity Adjustment Log (Annexure-1)
- Batch Record (Annexure-2)
- Quality Control Test Report (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: 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 |