Standard Operating Procedure for Preparation of Emulsion Bases for Creams
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/042/2025 |
| Supersedes | SOP/CRM/042/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 23/09/2025 |
| Effective Date | 28/09/2025 |
| Review Date | 23/09/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the process for preparing emulsion bases for cream formulations. The emulsion base serves as the foundation of cream products, enabling the uniform dispersion of active ingredients and ensuring the stability of the final product. This SOP ensures that emulsion bases are prepared consistently and meet the required quality specifications.
2. Scope
This SOP applies to the preparation of all emulsion bases within the Creams Department. It covers the procedures for selecting ingredients, preparing the emulsion, monitoring critical parameters (such as temperature and mixing time), and ensuring the emulsion base meets the necessary quality control standards before further processing.
3. Responsibilities
- Formulation Development Team: Responsible for defining the formulation of the emulsion base, selecting suitable emulsifiers, and ensuring the emulsion base provides the desired texture, stability, and performance.
- Quality Control (QC): Responsible for conducting quality checks on the emulsion base, including verifying ingredient specifications, checking consistency, and testing for microbial contamination.
- Quality Assurance (QA): Ensures that the preparation of the emulsion base is performed according to this SOP and meets the necessary regulatory and quality standards. QA is also responsible for approving the final emulsion base for further processing.
- Production Team: Responsible for carrying out the preparation of the emulsion base according to the formulation and process guidelines, ensuring compliance with all specified parameters.
4. Accountability
The Head of Creams Manufacturing is responsible for overseeing the preparation of emulsion bases. The QA Manager is accountable for ensuring compliance with this SOP and approving the emulsion base for use in subsequent cream manufacturing processes.
5. Procedure
5.1 Selection of Ingredients for Emulsion Base
-
Select the ingredients required for the emulsion base based on the formulation requirements. Common ingredients in emulsion bases for creams include:
- Water phase: Water, glycerin, aloe vera extract, etc.
- Oil phase: Plant oils (e.g., coconut oil, jojoba oil), synthetic oils (e.g., mineral oil), emulsifiers (e.g., cetyl alcohol, stearic acid).
- Emulsifiers: Agents like polysorbates or lecithin that allow the water and oil phases to blend together effectively.
- Ensure that all ingredients are of the correct grade and meet the specifications outlined in the Master Formula Record (MFR).
- Confirm that all raw materials have been stored appropriately and are within their shelf life.
5.2 Preparation of Water Phase
- Weigh the required amount of water phase ingredients as specified in the MFR.
- Heat the water phase ingredients to the specified temperature (usually between 70°C and 80°C) to ensure proper dissolution and mixing of the components.
- Mix the water phase ingredients thoroughly to ensure uniformity and homogeneity.
5.3 Preparation of Oil Phase
- Weigh the required amount of oil phase ingredients as specified in the MFR.
- Heat the oil phase ingredients to the specified temperature (usually between 70°C and 80°C), ensuring that all solid ingredients (such as emulsifiers) are fully melted and dissolved.
- Mix the oil phase ingredients thoroughly to ensure uniformity and complete dissolution.
5.4 Emulsification Process
- Once both the water and oil phases have reached the required temperatures, combine the oil phase into the water phase slowly while stirring continuously.
- Use a homogenizer or high-shear mixer to blend the two phases together. Ensure that the mixing time is sufficient to achieve a uniform emulsion.
- Monitor the temperature during the emulsification process to ensure that it does not exceed the specified range, as overheating can lead to instability in the emulsion.
- Continue mixing until the emulsion base reaches the desired consistency and appears stable. The emulsified product should show a smooth, homogeneous texture with no separation of phases.
5.5 Cooling the Emulsion Base
- After the emulsification process is complete, gradually cool the emulsion base to room temperature while continuing to mix gently. The cooling process should be slow to avoid disrupting the emulsion structure.
- Monitor the viscosity and pH of the emulsion base as it cools to ensure that it falls within the acceptable ranges specified in the MFR.
5.6 Quality Control Testing of Emulsion Base
-
Once the emulsion base has cooled to room temperature, conduct the following quality control tests:
- Viscosity: Measure the viscosity using a viscometer to ensure that it matches the desired consistency.
- pH: Test the pH to ensure that it falls within the specified range for the cream formulation (typically between 4.5 and 6.5).
- Microbial Testing: Conduct microbial testing to ensure that the emulsion base is free from contaminants.
- If the emulsion base does not meet the required specifications, investigate the issue, make necessary adjustments (e.g., adding stabilizers or emulsifiers), and repeat the quality control testing until the desired results are achieved.
5.7 Documentation and Approval
-
Document all preparation steps, quality control results, and any adjustments made during the process. The documentation should include:
- Batch number and formulation details
- Weighing and temperature records
- Quality control test results (e.g., viscosity, pH, microbial testing)
- Any deviations from the standard process and corrective actions taken
- Submit the batch record and quality control results for review and approval by the QA team before proceeding to the next phase of production (e.g., adding active ingredients).
5.8 Final Approval and Use of Emulsion Base
- Once the emulsion base is approved by the QA team, it is ready for use in the next step of cream manufacturing (e.g., incorporating active ingredients or packaging).
- Ensure that all records related to the emulsion base preparation are properly filed and retained for future reference and compliance.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
- MFR: Master Formula Record
- API: Active Pharmaceutical Ingredient
7. Documents
- Emulsion Base Preparation 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 Cosmetic 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: Emulsion Base Preparation Log
| Batch Number | Ingredient | Quantity Used | Temperature | Remarks |
|---|---|---|---|---|
| 12345 | Water | 500 mL | 75°C | Used as per formula |
Annexure-2: Batch Record
| Batch Number | Process Step | Time | Operator |
|---|---|---|---|
| 12345 | Emulsification | 08:30 AM | John Doe |
Annexure-3: Quality Control Test Report
| Test Parameter | Result | Specification | Remarks |
|---|---|---|---|
| Viscosity | 3200 cP | 3000-3500 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 |