Standard Operating Procedure for Operation of Vacuum Deaerators in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/043/2025 |
| Supersedes | SOP/GM/043/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2026 |
1. Purpose
This SOP outlines the procedure for the correct and safe use of vacuum deaerators during gel manufacturing, ensuring the removal of entrapped air to improve product homogeneity, stability, and aesthetic appearance.
2. Scope
This procedure applies to all vacuum deaerators used
in the Gel Manufacturing area of the pharmaceutical manufacturing facility.
3. Responsibilities
- Production Operator: Operates the vacuum deaerator following instructions.
- Production Supervisor: Reviews operation and ensures compliance with BMR.
- QA Executive: Performs line clearance and periodic observation.
- Engineering Personnel: Maintains and calibrates the equipment.
4. Accountability
The Head – Manufacturing shall ensure overall implementation and compliance of this SOP.
5. Procedure
5.1 Pre-Operational Checks
- Verify that the vacuum deaerator is clean, status labeled, and released by QA.
- Check for the integrity of vacuum seals, valves, pressure gauge, and glass viewports.
- Ensure that the vacuum pump oil level is adequate.
- Verify all electrical and pneumatic connections are intact.
5.2 Equipment Setup
- Connect the product inlet and outlet hoses as per batch-specific piping diagram.
- Secure all clamps and seals before starting the process.
- Switch on the vacuum pump and allow the chamber to reach the desired vacuum (typically -600 to -750 mmHg).
5.3 Deaeration Process
- Start recirculation of the gel batch through the deaerator vessel using a suitable transfer pump.
- Maintain the vacuum level and monitor the visibility of air bubble release via the glass viewport.
- Continue deaeration for the specified time (e.g., 15–30 minutes) or until no further air bubbles are observed.
- Monitor and record pressure, product temperature, and batch number in Annexure-1.
5.4 Post-Use Procedure
- Stop recirculation and release vacuum slowly to avoid turbulence.
- Disassemble and clean the chamber, pipelines, and filters as per SOP/GM/058/2025.
- Affix “To be Cleaned” status label and report completion in BMR and logbook.
5.5 Safety Measures
- Do not open the chamber under vacuum.
- Use PPE, especially gloves and goggles while operating the vacuum system.
- Ensure emergency stop button is accessible at all times.
- Do not exceed validated temperature and pressure ranges.
6. Abbreviations
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Vacuum Deaeration Log – Annexure-1
- Equipment Pre-Use Checklist – Annexure-2
- BMR – Batch Manufacturing Record
8. References
- WHO TRS 986 – Annex 2 GMP for Pharmaceutical Products
- Equipment User Manual
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: Vacuum Deaeration Log
| Date | Batch No. | Product Name | Start Time | End Time | Vacuum Level (mmHg) | Product Temp (°C) | Operator Signature |
|---|---|---|---|---|---|---|---|
Annexure-2: Equipment Pre-Use Checklist
| Checklist Item | Status (OK/Not OK) | Remarks | Checked By | Date |
|---|---|---|---|---|
| Equipment Clean and Status Label Affixed | ||||
| Vacuum Gauge Functioning | ||||
| Vacuum Seal and Pipeline Intact | ||||
| Oil Level Adequate in Pump | ||||
| Electrical Connections Secure | ||||
| Emergency Stop Button Functional |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/05/2022 | 1.0 | Initial version | New SOP | QA Head |
| 02/06/2025 | 2.0 | Added safety precautions and annexure formats | Scheduled Review | QA Head |