prior to filling in the manufacturing unit.

3. Responsibilities

• Validation Executive: Prepares and executes the deaeration validation protocol.
• Production Officer: Operates the deaeration equipment and assists in sampling.
• QC Analyst: Conducts physical tests on deaerated samples to assess air removal efficiency.
• QA Executive: Reviews and approves validation outcomes.

4. Accountability

Head – Manufacturing

5. Procedure

5.1 Preparation of Validation Protocol

1. Develop a validation protocol that includes:
   • Objective and rationale for deaeration
   • Equipment used and operating parameters
   • Sampling strategy and test methods
   • Acceptance criteria and number of batches
2. Get protocol approved by QA and Head – Manufacturing.

5.2 Execution of Validation

1. Run three consecutive production-scale batches of selected gel formulations through the deaeration equipment.
2. Operate deaerator at standard validated settings:
   • Vacuum pressure (e.g., -0.8 bar)
   • Temperature (as per product requirement)
   • Time duration (e.g., 10–20 minutes)

5.3 Sampling and Testing

1. Collect samples before and after deaeration from three levels (top, middle, bottom) of the batch vessel.
2. Test for:
   • Visual air bubble presence
   • Product density (to detect entrapped air)
   • Microscopic examination for micro-bubbles
   • Viscosity and pH

5.4 Acceptance Criteria

1. Post-deaeration samples must exhibit:
   • No visible air bubbles
   • Consistent density with reference standard
   • Microscopic count within acceptable range (<5 bubbles/field)
   • Viscosity variation <5% from pre-deaeration value

5.5 Documentation and Reporting

1. Compile all data, observations, and test results into a validation report.
2. Include vacuum logs, temperature data, and run durations.
3. Submit the report to QA for review and Head – Manufacturing for approval.
4. Archive validated process parameters for future batch records.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• RPM: Revolutions Per Minute

7. Documents

1. Deaeration Validation Protocol – Annexure-1
2. Deaeration Log Sheet – Annexure-2
3. Validation Report – Annexure-3

8. References

• FDA Process Validation Guidance (2011)
• ICH Q8(R2): Pharmaceutical Development
• WHO Guidelines on Process Validation

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: Deaeration Validation Protocol

Batch No.
Product Name
Vacuum Pressure
Duration
Temperature
Acceptance Criteria

Annexure-2: Deaeration Log Sheet

Date	Batch No.	Operator	Vacuum Level	Time	Observations

Annexure-3: Validation Summary Report

Parameter	Pre-Deaeration	Post-Deaeration	Result
Bubble Count
Density
Viscosity
Conclusion

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
20/07/2022	1.0	Initial SOP	New SOP	QA Head
02/06/2025	2.0	Expanded test parameters and revised log sheets	Annual Review	QA Head