Standard Operating Procedure for High-Shear Mixer Operation in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/177/2025 |
| Supersedes | SOP/GM/177/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To establish a standardized procedure for the safe and efficient operation of high-shear mixers in gel manufacturing, ensuring uniform dispersion and product consistency.
2. Scope
This SOP applies to all operators and production staff involved in the setup, operation, and monitoring of high-shear mixers used in the manufacturing of pharmaceutical gels.
3. Responsibilities
- Machine Operator: Responsible for setup, operation, and initial checks.
- Production Supervisor: Oversee adherence to procedure and authorize start-up and shut-down.
- Engineering/Maintenance: Responsible for maintenance and calibration.
- Quality Assurance: Verify compliance with operational parameters and approve production batches.
4. Accountability
The Head of Manufacturing is
accountable for ensuring proper training, implementation, and adherence to this SOP.
5. Procedure
5.1 Pre-Operation Checklist
- Verify the cleanliness and readiness of the mixer using the Equipment Readiness Checklist (Annexure-1).
- Check that all electrical and safety interlocks are functional.
- Ensure that all required raw materials are approved and available as per the BMR (Batch Manufacturing Record).
- Calibrate mixer RPM and temperature control settings.
5.2 Equipment Setup
- Secure the mixing vessel on the platform and ensure proper alignment with the high-shear head.
- Connect inlet and outlet pipelines if recirculation is required.
- Set the initial speed (RPM) and time duration as per formulation specifications.
5.3 Operation
- Start the mixer at low RPM and gradually increase to the desired speed.
- Monitor temperature, torque, and RPM throughout the mixing process.
- Ensure homogeneous mixing by visual inspection or sampling if applicable.
- Document process parameters in the Mixing Log Sheet (Annexure-2).
5.4 Post-Operation Activities
- Stop the machine as per shutdown procedure.
- Clean the mixer and surrounding area according to SOP/GM/106/2025.
- Inspect equipment for wear and report any maintenance needs.
5.5 Safety Precautions
- Always wear PPE during operation.
- Do not open the vessel lid while the mixer is running.
- Follow lockout/tagout procedures before maintenance.
6. Abbreviations
- PPE: Personal Protective Equipment
- BMR: Batch Manufacturing Record
- RPM: Revolutions Per Minute
7. Documents
- Equipment Readiness Checklist – Annexure-1
- Mixing Log Sheet – Annexure-2
8. References
- SOP/GM/106/2025 – Cleaning of Mixing Equipment
- Manufacturer’s Equipment Manual
- GMP Guidelines on Mixing Uniformity
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Equipment Readiness Checklist
| Checklist Item | Status (Yes/No) | Remarks |
|---|---|---|
| Cleaning Verified | ||
| Power Supply Checked | ||
| Safety Interlocks Functional | ||
| Calibration Done |
Annexure-2: Mixing Log Sheet
| Batch No. | Start Time | End Time | RPM | Temperature (°C) | Operator Signature |
|---|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 10/04/2022 | 1.0 | Initial issue | New SOP | QA Head |
| 09/06/2025 | 2.0 | Updated procedure and new annexures | Annual Review | QA Head |