Procedure for Monitoring Mixing Speeds
| Department | Production/Quality Control (QC)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/071 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define a standardized approach for monitoring mixing speeds during ointment manufacturing. Proper mixing speed control ensures uniformity, homogeneity, and consistency of the final product.
2. Scope
This SOP applies to all personnel in the Production, Quality Control (QC), and Engineering departments responsible for setting, monitoring, and verifying mixing speeds in ointment manufacturing.
3. Responsibilities
- Production Operator: Monitors and records mixing speeds as per the batch manufacturing record (BMR).
- Production Supervisor: Verifies and ensures that mixing speeds comply with standard operating conditions.
- Quality Control Analyst: Checks product homogeneity and consistency to validate the impact of mixing speed.
- Engineering Team: Maintains and calibrates mixing equipment to ensure proper functioning.
4. Accountability
The Production and Quality Control Managers are accountable for ensuring that mixing speeds are maintained, monitored, and documented as per regulatory and GMP standards.
5. Procedure
5.1 Equipment and Materials
- Mixing tanks with variable speed control
- Digital tachometer (if applicable)
- Mixing speed monitoring logs
- Batch Manufacturing Record (BMR)
- Calibration tools for speed verification
5.2 Pre-Mixing Checks
- Ensure that the mixing vessel and agitator are clean and free from residues.
- Check that the equipment is calibrated and in working condition.
- Verify the speed setting range as per the batch manufacturing record (e.g., 100 – 500 RPM).
- Ensure that raw materials are correctly weighed and ready for mixing.
5.3 Monitoring Mixing Speeds
5.3.1 Setting Mixing Speeds
- Set the initial mixing speed as per batch requirements.
- Gradually increase the speed as needed to achieve uniform mixing.
- Observe any changes in viscosity or foaming and adjust accordingly.
5.3.2 Continuous Speed Monitoring
- Record mixing speed at defined intervals (e.g., every 15 minutes).
- Ensure that speed fluctuations are within acceptable limits.
- If speed deviations occur, document and take corrective actions.
5.4 Speed Adjustment Guidelines
- If the mixture is too thick, increase speed gradually.
- If excessive foaming occurs, reduce speed and use defoaming agents if required.
- Ensure speeds are within optimal shear stress limits to prevent ingredient degradation.
5.5 Post-Mixing Verification
- Check the final homogeneity of the batch.
- Perform a viscosity test to confirm consistency.
- Ensure that no unmixed particles or phase separation are present.
5.6 Documentation
- Record all mixing speed readings in the Mixing Speed Log.
- Document any speed adjustments made during processing.
- QA personnel must review and approve the log before batch release.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- RPM – Revolutions Per Minute
7. Documents
- Mixing Speed Log (Annexure-1)
- Batch Manufacturing Record (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q8 – Pharmaceutical Development
- USP <1151> – Pharmaceutical Dosage Forms
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
| Date | Batch Number | Time | Speed (RPM) | Observed Consistency | Result | Verified By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | 10:00 AM | 250 | Homogeneous | Pass | QA Officer |
| 01/02/2025 | OINT-101 | 10:30 AM | 300 | Foaming observed | Adjusted | QA Officer |
Annexure-2: Batch Manufacturing Record
| Date | Batch Number | Mixing Stage | Target Speed (RPM) | Actual Speed (RPM) | Final Status | Approved By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Primary Mixing | 250 | 250 | Approved | QA Head |
| 01/02/2025 | OINT-101 | Final Homogenization | 300 | 295 | Approved | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |