Gel Manufacturing Department.

3. Responsibilities

• Production Operator: Responsible for operating the mixing vessel as per instructions.
• Production Supervisor: To monitor compliance and verify records.
• Engineering Team: Responsible for maintenance and troubleshooting of mixing vessels.
• Quality Assurance: To oversee compliance and authorize cleaning and start-up.

4. Accountability

The Head – Manufacturing is accountable for ensuring the correct and safe operation of gel mixing vessels.

5. Procedure

5.1 Pre-Operation Checks

1. Ensure the mixing vessel is cleaned and released by QA. Verify the Equipment Status Label.
2. Check calibration of control panel indicators (temperature, speed, pressure).
3. Inspect vessel parts: impeller, shaft, lid, gasket, and valves for any physical damage or foreign particles.
4. Ensure that all valves are in the closed position before starting.
5. Review the Batch Manufacturing Record (BMR) for specific instructions or process parameters.

5.2 Startup Procedure

1. Switch on the main power supply and control panel.
2. Start the water circulation system (if applicable) for jacketed vessels.
3. Open the air vent and vacuum valve slowly to avoid pressure shock.
4. Set RPM (rotations per minute) as per formulation requirements using the control panel.

5.3 Mixing Operation

1. Gradually add the gel base or pre-dispersed polymers into the vessel.
2. Start impeller movement at low speed; increase gradually to required RPM.
3. Maintain temperature within validated range using heating/cooling jacket.
4. Monitor homogenization visually and via in-process checks for viscosity and clarity.
5. Document all critical parameters such as speed, temperature, and time in the Equipment Logbook – Annexure-1.

5.4 Completion and Transfer

1. Once mixing is complete, stop the impeller and turn off the heating system.
2. Ensure complete discharge of the gel using the discharge valve to the next stage (deaeration or filling).
3. Perform line clearance after complete transfer and document as per SOP.

5.5 Safety Precautions

• Always wear PPE: gloves, goggles, and gown during vessel operation.
• Never operate vessel with open lid when mixer is on.
• Do not exceed vessel capacity or rated RPM to avoid mechanical stress.
• Follow lock-out/tag-out (LOTO) procedure during maintenance.

6. Abbreviations

• RPM: Rotations Per Minute
• BMR: Batch Manufacturing Record
• SOP: Standard Operating Procedure
• QA: Quality Assurance

7. Documents

1. Equipment Logbook – Annexure-1
2. Pre-Start Checklist – Annexure-2
3. Batch Manufacturing Record (BMR)

8. References

• Schedule M Guidelines for Equipment Operation
• WHO GMP – Equipment Qualification and Use

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: Equipment Logbook

Logbook for recording start-up parameters, RPM, temperature, mixing time, and cleaning status of the vessel.

Annexure-2: Pre-Start Checklist

Checklist for vessel integrity, power check, status label verification, and line clearance confirmation.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial SOP for gel mixing vessels	New system installation	QA Head
02/06/2025	2.0	Expanded procedure to include safety and annexures	Periodic Review	QA Head