Department that involve deaeration using vacuum deaerators or equivalent systems.

3. Responsibilities

• Production Operator: Operates the deaeration system and records parameters.
• Production Chemist: Verifies effectiveness of deaeration based on real-time data.
• Quality Assurance: Ensures compliance with SOP and records review.
• Engineering: Responsible for calibration and maintenance of deaeration sensors.

4. Accountability

The Head – Manufacturing shall be accountable for ensuring proper implementation and adherence to this SOP.

5. Procedure

5.1 Pre-Deaeration Checks

1. Ensure the deaeration equipment is clean, operational, and calibrated.
2. Check for availability and functionality of pressure gauges, sensors, and control interfaces.
3. Review the BMR for deaeration specifications such as pressure range, time, and batch-specific instructions.
4. Ensure the mixing process is completed before initiating deaeration.

5.2 Deaeration Process

1. Transfer the gel formulation into the vacuum deaerator vessel.
2. Set the vacuum level as per the BMR (typically -600 to -750 mmHg depending on gel viscosity).
3. Initiate the deaeration cycle using the control panel.
4. Monitor foam formation, vacuum level, and deaeration time on the display console.
5. Record readings at every 5-minute interval or as defined in the BMR.

5.3 Real-Time Monitoring Parameters

Parameter	Set Point	Acceptable Range	Monitoring Tool
Vacuum Pressure	-700 mmHg	-600 to -750 mmHg	Vacuum Gauge
Time Duration	15 minutes	±2 minutes	Timer
Air Bubble Observation	No bubbles	Visual Inspection	Transparent View Panel
Noise Level	Low humming	No rattling	Auditory Observation

5.4 Criteria for Acceptable Deaeration

• No visible air bubbles when gel is dispensed from sampling valve.
• Steady vacuum pressure maintained throughout cycle.
• Recorded parameters within specified range.

5.5 Post-Deaeration Activities

1. End the vacuum cycle and release pressure gradually.
2. Close valves and transfer gel to bulk storage tanks or directly to filling line as per BMR.
3. Document final observations and upload real-time sensor data to batch record database.

6. Abbreviations

• BMR: Batch Manufacturing Record
• SOP: Standard Operating Procedure
• QA: Quality Assurance

7. Documents

1. Deaeration Monitoring Log – Annexure-1
2. Equipment Usage and Calibration Log – Annexure-2

8. References

• WHO GMP Guidelines for Pharmaceuticals
• ICH Q8 – Pharmaceutical Development

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 Monitoring Log

Date	Batch No.	Time	Vacuum Level (mmHg)	Observation (Foam/Bubbles)	Remarks	Operator Initials
		00:00
		05:00
		10:00
		15:00

Annexure-2: Equipment Usage and Calibration Log

Equipment ID	Date	Used For Batch	Calibration Due	Status	Operator Initials
				Calibrated

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
03/06/2022	1.0	Initial SOP Release	New Process	QA Head
02/06/2025	2.0	Real-Time Monitoring Added	Process Optimization	QA Head