Procedure for Agitation and Stirring in Ointment Production
| Department | Production/Quality Assurance (QA)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/038 |
| 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 systematic process for agitation and stirring during ointment production. Proper agitation ensures homogeneity, prevents ingredient separation, and maintains product consistency.
2. Scope
This SOP applies to all personnel involved in the stirring and agitation of ointments at various stages of manufacturing, including pre-mixing, emulsification, cooling, and final mixing.
3. Responsibilities
- Production Supervisor: Ensures agitation is conducted as per specified parameters.
- Machine Operator: Monitors stirring speed, direction, and duration.
- Quality Assurance (QA) Personnel: Verifies compliance with GMP and product consistency.
- Engineering Technician: Maintains and calibrates stirring and agitation equipment.
4. Accountability
The Production and QA Managers are accountable for ensuring that agitation and stirring processes comply with GMP guidelines and are properly documented.
5. Procedure
5.1 Pre-Stirring Preparations
- Ensure all mixing tanks and agitators are clean and sanitized.
- Verify that the stirring equipment is calibrated and functional.
- Confirm that all raw materials have been added to the vessel as per the Batch Manufacturing Record (BMR).
5.2 Agitation Parameters
- Set the initial stirring speed according to the formulation requirements.
- Use low-speed stirring
for pre-mixing and high-speed agitation for emulsification.
Maintain agitation at a controlled temperature to prevent ingredient degradation.
5.3 Agitation and Stirring at Different Stages
5.3.1 Pre-Mixing Stage
- Use slow-speed stirring (e.g., 50-100 RPM) to blend initial ingredients.
- Ensure uniform dispersion of waxes, oils, and emulsifiers.
- Monitor for clumps or undissolved particles.
5.3.2 Emulsification Stage
- Increase stirring speed (e.g., 500-1000 RPM) to achieve uniform emulsification.
- Monitor temperature closely to prevent phase separation.
- Ensure stable emulsion formation by maintaining the mixing speed for a minimum of 30 minutes.
5.3.3 Cooling and Final Mixing Stage
- Reduce stirring speed gradually to avoid air entrapment.
- Ensure continuous stirring (e.g., 100-300 RPM) until the mixture reaches the final temperature.
- Check homogeneity through viscosity and particle size analysis.
5.4 Monitoring During Agitation
- Monitor stirring speed at defined time intervals.
- Check for uniformity by visually inspecting the batch.
- Ensure there is no excessive foaming or aeration.
5.5 Completion of Agitation
- Reduce mixing speed to a complete stop.
- Inspect the final product for uniform consistency.
- Record all agitation parameters before batch transfer.
5.6 Documentation and Approval
- Record all agitation parameters in the Agitation Log.
- QA must review and approve the batch before further processing.
- Label the batch as “Agitated and Ready for Next Stage.”
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- RPM – Revolutions Per Minute
- BMR – Batch Manufacturing Record
7. Documents
- Agitation Log (Annexure-1)
- In-Process Quality Control Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Agitation Log
| Date | Batch Number | Stage | Stirring Speed (RPM) | Time (Min) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Pre-Mixing | 100 | 20 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | Final Mixing | 500 | 30 | QA Officer |
Annexure-2: In-Process Quality Control Report
| Date | Batch Number | Test Parameter | Specification | Result | Final Status |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Viscosity | 1000-2000 cP | 1500 cP | Pass |
| 02/02/2025 | SOP/Ointment/002 | Phase Separation | None | None | Pass |
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 |