Procedure for Adding Emulsifiers to the Mixture
| Department | Production/Quality Assurance (QA)/Research and Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/032 |
| 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 establish a standardized method for adding emulsifiers to the ointment mixture. Proper emulsification ensures stability, uniformity, and homogeneity of the final product.
2. Scope
This SOP applies to all personnel involved in the preparation and emulsification of ointments in the manufacturing process.
3. Responsibilities
- Production Supervisor: Ensures emulsifiers are added as per the formulation.
- Machine Operator: Controls mixing speed, temperature, and timing during emulsification.
- Quality Assurance (QA) Personnel: Monitors emulsifier addition for compliance with GMP standards.
- R&D Scientist: Defines emulsification parameters for different formulations.
4. Accountability
The Production and QA Managers are accountable for ensuring that emulsifier addition is performed as per GMP standards and documented correctly.
5. Procedure
5.1 Pre-Addition Preparations
- Ensure that all emulsifiers are weighed and verified against the Batch Manufacturing Record (BMR).
- Check that the heating vessel is clean and pre-heated to the required temperature.
- Confirm that temperature probes and mixing systems are operational.
5.2 Adding Emulsifiers
- Slowly introduce emulsifiers into the heated base material.
- Ensure emulsifiers are dispersed evenly to avoid agglomeration.
- Increase mixing speed to promote
uniform emulsification.
5.3 Mixing Parameters
- Maintain the mixing speed as per the formulation specifications.
- Monitor temperature throughout the emulsification process.
- Continue mixing for the time specified in the batch record.
5.4 Monitoring During Addition
- Check for uniform dispersion of emulsifiers.
- Ensure no foaming or phase separation occurs.
- Record all process parameters in the Emulsification Log.
5.5 Completion of Emulsification
- Confirm that the emulsification process is complete and homogeneous.
- Hold the mixture at the final temperature before cooling.
- Record final temperature, mixing speed, and duration.
5.6 Documentation and Approval
- Record emulsifier addition parameters in the Mixing Log.
- QA must verify and approve emulsified mixture before further processing.
- Label the batch as “Emulsified and Ready for Cooling.”
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Emulsification Log (Annexure-1)
- Temperature Monitoring Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- Equipment Manufacturer Guidelines
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Emulsification Log
| Date | Batch Number | Emulsifier Name | Temperature (°C) | Mixing Speed (RPM) | Time (Min) | Verified By |
|---|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Polysorbate 80 | 65°C | 800 | 30 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | Cetyl Alcohol | 70°C | 1000 | 40 | QA Officer |
Annexure-2: Temperature Monitoring Report
| Date | Batch Number | Material Name | Initial Temp (°C) | Final Temp (°C) | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Polysorbate 80 | 20°C | 65°C | QA Head |
| 02/02/2025 | SOP/Ointment/002 | Cetyl Alcohol | 22°C | 70°C | 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 |