Standard Operating Procedure for Deaeration of Gel Formulations
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/025/2025 |
| Supersedes | SOP/GM/025/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2026 |
1. Purpose
The purpose of this SOP is to describe the standard procedure for deaerating gel formulations to remove entrapped air, ensuring homogeneity and preventing air-related defects such as bubbles and foam during filling and storage.
2. Scope
This procedure applies to all gel formulations manufactured in the Gel Manufacturing Department where deaeration is required before packaging
or further processing.
3. Responsibilities
- Production Chemist: To carry out the deaeration process as per BMR.
- Engineering Department: Ensure proper functioning and maintenance of vacuum deaeration equipment.
- Quality Assurance (QA): Monitor and verify the process and maintain records.
4. Accountability
Head – Manufacturing is accountable for the implementation and compliance of this SOP.
5. Procedure
5.1 Equipment and Materials
- Vacuum deaerator or vacuum-capable mixing vessel
- Pressure and temperature gauges
- Vacuum pump system
- Batch Manufacturing Record (BMR)
5.2 Pre-Deaeration Checks
- Ensure the gel batch is prepared and homogenized prior to deaeration.
- Confirm line clearance for the area and equipment from QA.
- Check the vacuum system for operational readiness and calibration status.
- Ensure the gel vessel is properly sealed to prevent vacuum loss.
5.3 Deaeration Process
- Set up the gel vessel or transfer the gel formulation into the vacuum deaerator.
- Start slow agitation (~20–40 RPM) to maintain movement during deaeration.
- Activate the vacuum pump to initiate deaeration. Target vacuum level: -700 to -750 mmHg.
- Maintain vacuum for 20–45 minutes, depending on batch size and viscosity.
- Monitor the gel surface visually; continue until no bubbles are observed.
5.4 Post-Deaeration Activities
- Release the vacuum slowly to avoid sudden aeration of the gel.
- Stop the agitator and collect samples for pH, viscosity, and visual inspection.
- Record deaeration time, vacuum pressure, and observations in BMR.
- Transfer the deaerated gel to the designated filling area or hold for final processing.
5.5 Precautions
- Ensure seals and gaskets of vacuum vessel are intact before starting.
- Do not open the lid or break the vacuum abruptly during operation.
- Avoid over-deaeration that may impact gel consistency.
6. Abbreviations
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- RPM: Revolutions Per Minute
7. Documents
- Batch Manufacturing Record – Annexure-1
- Vacuum Deaeration Log Sheet – Annexure-2
- In-Process Testing Report – Annexure-3
8. References
- ICH Q8 – Pharmaceutical Development
- WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
- Internal SOPs for Homogenization and Mixing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Batch Manufacturing Record
Details of process parameters including vacuum level, time, RPM, and observations.
Annexure-2: Vacuum Deaeration Log Sheet
Log for recording vacuum readings, pump status, and equipment ID.
Annexure-3: In-Process Testing Report
Results of visual inspection, pH, and viscosity testing post deaeration.
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/05/2022 | 1.0 | Initial Issue | New SOP Release | QA Head |
| 02/06/2025 | 2.0 | Updated vacuum levels and monitoring frequency | Process optimization | QA Head |