Standard Operating Procedure for Operating Batch Mixers in Cream Manufacturing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/100/2025 |
| Supersedes | SOP/CRM/100/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 21/01/2026 |
| Effective Date | 26/01/2026 |
| Review Date | 21/01/2027 |
1. Purpose
The purpose of this SOP is to define the procedure for operating batch mixers used in cream manufacturing. This ensures that batch mixers are operated efficiently, maintaining proper mixing, consistency, and quality of the cream products.
2. Scope
This SOP applies to all batch mixers used in the Creams Department for mixing cream ingredients. It includes procedures for setup, operation, monitoring, and post-operation cleaning of batch mixers.
3. Responsibilities
- Production Team: Responsible for correctly setting up the batch mixer, operating it during production, and ensuring that the mixture is uniform and meets the required specifications.
- Maintenance Team: Responsible for maintaining and calibrating the batch mixers, ensuring that they are functioning correctly and performing preventive maintenance as needed.
- Quality Control (QC): Ensures that the batch mixers are set to the correct parameters and that the final product meets the required quality standards.
4. Accountability
The Head of Production is accountable for ensuring that the batch mixers are set up and operated according to this SOP. The QA Manager is responsible for verifying the uniformity and quality of the cream produced during the mixing process.
5. Procedure
5.1 Pre-Operation Setup
- Ensure that the batch mixer is clean and free from any previous product residues. Follow the cleaning SOP for batch mixers before starting a new production run.
- Check that the mixer is properly calibrated and all components (e.g., paddles, agitators) are in good condition and functioning properly.
- Verify that all necessary ingredients (e.g., cream base, active ingredients, stabilizers) are available, measured, and ready for use. Ensure that the ingredients meet quality standards.
- Check the mixer’s settings, including mixing speed, temperature, and time. Set them according to the production specifications for the batch to be produced.
- Ensure that the correct recipe and process parameters are entered into the system, if applicable, and that the mixing vessel is properly sealed and secured.
5.2 Operating the Batch Mixer
- Start the batch mixer following the manufacturer’s start-up procedure. Monitor the mixer to ensure it starts smoothly without any unusual vibrations or sounds.
- Gradually add the ingredients to the mixer as per the recipe, ensuring that the correct order of addition is followed to achieve uniform blending.
- Monitor the mixer during operation to ensure that all ingredients are being mixed thoroughly and uniformly. If the mixer is equipped with a control system, verify that it is operating within the specified parameters (e.g., speed, temperature, time).
- Ensure that the mixing speed is adjusted as required to prevent over-shearing or under-shearing, which could affect the texture of the cream.
- Take periodic samples from the mixer to ensure that the product is homogeneous and meets the quality standards. Document any deviations in the Production Log (Annexure-1).
5.3 Monitoring During Operation
- Ensure that the temperature of the cream mixture is maintained within the specified range. Use a thermometer or temperature control system to monitor and adjust the temperature as needed.
- Periodically check the consistency and texture of the mixture to ensure it meets the required specifications for cream quality.
- If any issues are detected, such as incorrect viscosity, clumping, or inconsistent mixing, stop the mixer and troubleshoot the issue following the manufacturer’s guidelines.
- Ensure that the mixer is running at the correct speed and that all ingredients are being evenly incorporated.
5.4 Post-Operation Shutdown
- Once the mixing process is complete, turn off the batch mixer following the manufacturer’s shutdown procedure. Ensure that the mixer is safely powered down and that any residual product is removed from the mixer.
- Clean the batch mixer thoroughly to prevent contamination from the previous batch. Follow the cleaning SOP for the batch mixers to ensure all surfaces are sanitized before the next use.
- Document the completion of the mixing process, including the time, batch number, and any deviations encountered, in the Production Log (Annexure-1).
5.5 Troubleshooting
- If any issues arise during the operation of the batch mixer, such as inconsistent mixing, temperature control issues, or unusual noise, stop the machine immediately and troubleshoot the issue.
- Common issues include equipment malfunction (e.g., motor failure, belt slippage), improper speed settings, or incomplete mixing. Resolve these issues by adjusting settings, performing maintenance, or replacing faulty components as necessary.
- Document any corrective actions taken during the troubleshooting process in the Equipment Maintenance Log (Annexure-2).
5.6 Documentation
- Record all production details, including the recipe used, batch number, start and end times, and any issues encountered during the mixing process, in the Production Log (Annexure-1).
- Document any maintenance or troubleshooting activities in the Equipment Maintenance Log (Annexure-2) to ensure traceability and future reference.
5.7 Final Approval
- The QA team must verify that the final batch is consistent and meets the required quality standards for texture, consistency, and flavor.
- Upon successful verification, the batch is approved for the next stages of production, such as packaging or further processing.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Production Log
- Annexure-2: Equipment Maintenance 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
- Manufacturer’s Manual for Batch Mixers
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Production Log
| Batch Number | Start Time | End Time | Operator | Comments |
|---|---|---|---|---|
| 12345 | 08:00 AM | 04:00 PM | Jane Smith | Successfully completed, no issues |
Annexure-2: Equipment Maintenance Log
| Equipment ID | Maintenance Date | Maintenance Type | Operator | Comments |
|---|---|---|---|---|
| BM-001 | 21/01/2026 | Inspection, lubrication | John Doe | Successfully completed maintenance |
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 |