Standard Operating Procedure for Avoiding Air Entrainment in Cream Manufacturing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/076/2025 |
| Supersedes | SOP/CRM/076/2022 |
| 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 measures to avoid air entrainment during cream manufacturing. The goal is to ensure the product’s smooth texture and consistency by preventing the incorporation of unwanted air into the cream mixture.
2. Scope
This SOP applies to all cream manufacturing processes in the Creams Department where mixing or blending operations occur. It covers methods for minimizing air entrainment during product preparation.
3. Responsibilities
- Production Team: Responsible for following the procedures to avoid air entrainment during mixing and blending.
- Quality Control (QC): Ensures that the final cream product meets the required texture, consistency, and air content specifications.
- Quality Assurance (QA): Ensures that the SOP is adhered to during production and reviews batch records for compliance.
- Maintenance Team: Ensures that all equipment used in the mixing process is functioning properly and does not contribute to air entrainment.
4. Accountability
The Head of Production is accountable for ensuring that air entrainment is minimized during the manufacturing process. The QA Manager is responsible for verifying compliance with this SOP and ensuring product quality.
5. Procedure
5.1 Pre-Mixing and Blending Preparation
- Ensure that the mixing vessel is clean and free of contaminants.
- Verify that the ingredients are weighed and ready for mixing, ensuring that all solid and liquid components are at the correct temperatures for mixing.
- Ensure that the mixing equipment, such as mixers and paddles, is in good condition and calibrated to avoid excessive air incorporation.
5.2 Mixing Process
- Begin the mixing process at low speed to gently combine ingredients without causing air entrapment.
- Gradually increase the speed only as necessary to ensure even distribution of the ingredients while maintaining control over air incorporation.
- Use equipment such as high-shear mixers or mixers with controlled speed settings to limit the introduction of air into the mixture.
- Ensure that mixing is done in a sealed environment or with minimal exposure to open air to prevent air from being trapped in the cream.
5.3 Monitoring and Control
- Monitor the mixture regularly for signs of air entrainment, such as foaming or bubbling. If these signs appear, reduce the speed or stop mixing to allow the air to escape.
- Use a vacuum or deaeration process if necessary to remove any air that has been incorporated into the product.
- Ensure that the final product has the desired smoothness and uniformity with no visible air pockets or bubbles.
5.4 Post-Mixing Checks
- Once the mixing is complete, perform a sensory test to check for smoothness and texture consistency. The cream should be free from lumps and air pockets.
- If air is detected in the final product, adjust the mixing technique, reduce the mixing speed, or use a vacuum process to remove the excess air.
- Document all batch details, including the mixing time, speed, temperature, and any deviations in the Mixing Log (Annexure-1).
5.5 Documentation and Record Keeping
- Complete all necessary documentation, including the batch number, mixing parameters, and air entrapment control measures used during the mixing process.
- Ensure that all records are signed by the operator and reviewed by the QA team to confirm compliance with the SOP and GMP standards.
5.6 Final Approval
- The QA team must review all records, including batch number, mixing parameters, and air entrapment checks, to verify that the product is compliant with quality standards before it moves to the next stage of manufacturing.
- If any issues with air entrainment are detected, corrective actions must be taken, and the batch should be reprocessed if necessary.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Mixing Log
- Annexure-2: Air Entrapment Control 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: Mixing Log
| Batch Number | Mixing Time | Mixing Speed | Air Entrainment Check | Operator | Comments |
|---|---|---|---|---|---|
| 12345 | 30 minutes | 200 RPM | None | John Doe | No issues |
Annexure-2: Air Entrapment Control Log
| Batch Number | Air Detection (Yes/No) | Method Used for Air Removal | Time | Operator | Comments |
|---|---|---|---|---|---|
| 12345 | No | Standard Mixing | 10:00 AM | Jane Smith | No issues |
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 |