Standard Operating Procedure for Validating Mixing Speeds in Cream Manufacturing Equipment
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/103/2025 |
| Supersedes | SOP/CRM/103/2022 |
| Page No. | Page 1 of 5 |
| 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 validating the mixing speeds in cream manufacturing equipment. This ensures that the mixing speeds are consistent with product specifications and that the product is uniformly mixed to meet quality standards.
2. Scope
This SOP applies to all cream manufacturing equipment that includes mixing functions. It covers the procedures for setting, monitoring, and validating mixing speeds to ensure product consistency and quality.
3. Responsibilities
- Production Team: Responsible for operating the cream mixing equipment and ensuring that the mixing speeds are validated according to this SOP.
- Maintenance Team: Responsible for maintaining the mixing equipment and ensuring that the equipment is calibrated correctly to achieve the required mixing speeds.
- Quality Control (QC): Ensures that the mixing speeds are validated and that the cream product meets the required consistency and texture specifications.
4. Accountability
The Production Supervisor is accountable for ensuring that the correct mixing speeds are set and validated according to this SOP. The Maintenance Manager is responsible for ensuring that the equipment is properly calibrated and maintained to achieve the desired mixing speeds.
5. Procedure
5.1 Pre-Operation Checks
- Before starting the mixing process, verify that the mixing equipment is clean and free from contaminants. Ensure that all previous residues are removed from the mixing vessel and components.
- Check the equipment’s control panel to verify that the mixing speed settings are configured correctly according to the batch recipe.
- Ensure that the mixing equipment is properly calibrated. Check the speed calibration using a tachometer or other suitable device to measure the actual rotational speed of the mixer.
- Verify that all components of the mixing equipment, including the motor, drive system, and speed controller, are in good working condition.
5.2 Setting the Mixing Speed
- Set the mixing speed according to the product’s formulation specifications. Refer to the Master Formula Record (MFR) to confirm the required mixing speed for the batch being produced.
- If the mixing equipment has multiple settings (e.g., slow, medium, high), set the speed according to the stage of the mixing process (e.g., initial mixing, blending, or homogenization).
- Ensure that the mixing speed is within the specified range provided by the equipment manufacturer to prevent over-shearing or under-mixing, which could affect product quality.
5.3 Monitoring and Validating Mixing Speed
- During the mixing process, monitor the actual mixing speed using a tachometer or speed sensor. Cross-check the measured speed with the set speed displayed on the equipment’s control panel.
- Regularly monitor the equipment during operation to ensure that the set mixing speed is maintained. If any discrepancies are noted, pause the process and troubleshoot the equipment.
- If the mixing speed is outside the acceptable range, adjust the settings on the control panel and re-verify the speed. Record any deviations in the Mixing Speed Log (Annexure-1).
- Document the time and speed at regular intervals during the mixing process to track consistency and ensure that the speed is maintained throughout the operation.
5.4 Post-Operation Verification
- After the mixing process is complete, perform a final verification of the mixing speed to ensure that the equipment operated within the required parameters during the entire batch production.
- Record the final mixing speed and any observations regarding equipment performance or deviations in the Mixing Speed Log (Annexure-1).
- If the final mixing speed is outside the specified limits, investigate the cause (e.g., equipment malfunction, incorrect settings) and document any corrective actions taken.
5.5 Calibration of Mixing Speed
- If the equipment’s actual mixing speed is consistently outside the desired range, recalibrate the equipment. This may involve adjusting the speed controller or replacing faulty components.
- Refer to the equipment manufacturer’s manual for calibration procedures and follow them closely. Record all calibration details in the Equipment Calibration Log (Annexure-2).
- Ensure that calibration is performed regularly and that the equipment is checked for accuracy at scheduled intervals to maintain consistent mixing speeds.
5.6 Documentation
- Record all validation activities, including pre-operation checks, monitoring, and calibration, in the Mixing Speed Log (Annexure-1).
- Document any discrepancies, corrective actions, or maintenance performed on the equipment in the Equipment Maintenance Log (Annexure-2).
- Ensure that all records are reviewed and approved by the Quality Assurance (QA) team to confirm compliance with the required mixing speed specifications.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Mixing Speed Log
- Annexure-2: Equipment Calibration 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 Mixing Equipment
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 Speed Log
| Batch Number | Start Time | End Time | Set Speed (RPM) | Measured Speed (RPM) | Operator | Comments |
|---|---|---|---|---|---|---|
| 12345 | 08:00 AM | 04:00 PM | 100 RPM | 100 RPM | John Doe | No issues, consistent mixing speed |
Annexure-2: Equipment Calibration Log
| Equipment ID | Calibration Date | Calibration Type | Operator | Comments |
|---|---|---|---|---|
| MX-001 | 21/01/2026 | Speed calibration | Jane Smith | Calibration successful, within acceptable range |
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 |