the process for merging the aqueous and oil phases prepared during gel formulation development and production.

3. Responsibilities

• Production Chemist: To execute the phase combination process as per BMR.
• QA Executive: To verify, observe, and document critical processing steps.
• Engineering: To ensure that temperature control systems, mixers, and transfer lines are operational.

4. Accountability

The Head – Manufacturing is responsible for ensuring procedural compliance, equipment availability, and workforce training for combining phases during gel production.

5. Procedure

5.1 Prerequisites

1. Ensure both the water phase and oil phase are prepared as per respective SOPs and meet specified parameters.
2. Confirm that both phases are within the required temperature range (e.g., 40–45°C) for optimal blending.
3. Verify the cleanliness and readiness of the main gel manufacturing vessel.

5.2 Equipment Setup

1. Ensure the main mixing vessel is equipped with a variable speed stirrer and a high-shear homogenizer (if required).
2. Check the availability of a heating/cooling jacket system to maintain required process temperatures.

5.3 Phase Addition Process

1. Start stirring the aqueous phase at a low RPM (30–50).
2. Slowly transfer the oil phase into the aqueous phase under continuous stirring over a period of 15–30 minutes to avoid phase inversion.
3. Increase agitation speed gradually (up to 100 RPM) once the addition is complete.
4. If required, initiate homogenization for 10–15 minutes to ensure uniform phase dispersion and gel matrix formation.

5.4 Temperature Control

1. Maintain the combined mixture at 40°C ± 2°C throughout the blending process to enhance emulsification and uniformity.
2. Monitor and record temperatures every 5 minutes – see Annexure-1.

5.5 In-Process Checks

1. Collect intermediate samples post-mixing for pH, viscosity, and visual inspection – see Annexure-2.
2. Verify absence of phase separation, grittiness, or clumping.

5.6 Documentation and Transfer

1. Record the start and end time of phase combination, RPM, temperature, and operator name in Annexure-3.
2. Once the final product meets predefined specifications, initiate transfer to the filling area or storage tank as per production schedule.

6. Abbreviations

• BMR: Batch Manufacturing Record
• RPM: Revolutions Per Minute
• QA: Quality Assurance

7. Documents

1. Phase Combination Temperature Log – Annexure-1
2. In-Process Testing Report – Annexure-2
3. Phase Mixing Log Sheet – Annexure-3

8. References

• Schedule M – Good Manufacturing Practices
• Internal SOPs for Equipment Calibration and Cleaning
• WHO Technical Report Series – Pharmaceutical Production

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: Phase Combination Temperature Log

Temperature readings at 5-minute intervals with time, date, and operator initials.

Annexure-2: In-Process Testing Report

Includes test parameters like pH, viscosity, and observations with specification limits.

Annexure-3: Phase Mixing Log Sheet

Document phase addition sequence, RPM, start/end time, and equipment used.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial SOP release	Standardization of phase combination	QA Head
02/06/2025	2.0	Enhanced procedural clarity for high-shear mixing	Audit findings and process optimization	QA Head