Procedure for Deaeration of Ointment Mixture
| Department | Production/Quality Assurance (QA)/Research and Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/025 |
| 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 the deaeration of ointment mixtures. Proper deaeration ensures that air bubbles are removed, preventing stability issues, oxidation, and product inconsistencies.
2. Scope
This SOP applies to all personnel responsible for the deaeration process in ointment manufacturing.
3. Responsibilities
- Production Supervisor: Ensures proper execution of the deaeration process.
- Machine Operator: Operates and monitors the deaeration equipment.
- Quality Assurance (QA) Personnel: Verifies process compliance and ensures batch quality.
- R&D Scientist: Defines deaeration parameters for different formulations.
4. Accountability
The Production and QA Managers are accountable for ensuring that the deaeration process is conducted as per GMP guidelines and documented correctly.
5. Procedure
5.1 Pre-Deaeration Preparations
- Ensure the deaeration equipment is clean and calibrated.
- Verify that the ointment mixture is at the specified temperature and viscosity for effective deaeration.
- Check that vacuum pumps and filters are operational.
5.2 Transfer of Ointment to Deaeration System
- Transfer the bulk ointment mixture to the deaeration vessel.
- Ensure that all connections are secure to prevent contamination.
5.3 Deaeration Process
- Set the vacuum pressure as per the formulation guidelines (e.g., -0.8 to -0.9 bar).
- Start slow agitation to facilitate air bubble removal.
- Gradually increase vacuum pressure while monitoring the process.
- Maintain deaeration for the required time (e.g., 15-30 minutes).
5.4 Monitoring During Deaeration
- Observe the ointment mixture for bubble formation.
- Ensure no foaming or overheating occurs.
- Check vacuum levels at regular intervals.
5.5 Completion of Deaeration
- Gradually release vacuum pressure to prevent sudden expansion.
- Inspect the ointment for uniformity and absence of air bubbles.
- Record final temperature, viscosity, and deaeration time.
5.6 Documentation and Approval
- Record all process parameters in the Deaeration Log.
- QA must verify and approve the deaerated batch before further processing.
- Label the bulk material as “Deaerated and Ready for Filling.”
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- R&D – Research and Development
- BMR – Batch Manufacturing Record
7. Documents
- Deaeration 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
- 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: Deaeration Log
| Date | Batch Number | Vacuum Pressure (bar) | Temperature (°C) | Time (Min) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | -0.85 | 65°C | 20 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | -0.88 | 70°C | 25 | QA Officer |
Annexure-2: In-Process Quality Control Report
| Date | Batch Number | Test Parameter | Specification | Result | Final Status |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Bubble Formation | None | None | Pass |
| 02/02/2025 | SOP/Ointment/002 | Foaming | 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 |