1.0 Purpose

To lay down the procedure for the operation, cleaning, and maintenance of the paste kettle to ensure uniform binder preparation in compliance with cGMP.

2.0 Scope

This SOP applies to the paste kettle used in the production area for binder solution preparation at [Company Name].

3.0 Responsibility

• Production Operator: To operate and clean the paste kettle as per this SOP.

• Production Supervisor: To verify operations and ensure compliance.

• Engineering: For maintenance, calibration (if applicable), and repair.

• Quality Assurance (QA): To verify cleaning and operational records.

4.0 Definitions

• Paste Kettle: A jacketed vessel with an agitator and heating system (usually steam/electrical), used for binder solution preparation.

5.0 Procedure

5.1 Operation

1. Ensure the equipment is clean and “Cleaned” status label is affixed.

2. Connect the steam line/electrical supply to the kettle jacket.

3. Add purified water or solvent as per batch manufacturing record (BMR).

4. Switch on the agitator/stirrer and gradually add binder powder under continuous stirring.

5. Maintain temperature as per BMR by adjusting steam/electric heating control.

6. Stir the mixture until a uniform binder solution/paste is formed.

7. On completion, transfer the binder solution to the granulation area using appropriate transfer method (pump, discharge valve, or manual).

8. Switch off power supply after use.

5.2 Cleaning

Type A – Batch-to-Batch Cleaning

1. Ensure power supply is disconnected.

2. Drain remaining solution and rinse kettle with purified water.

3. Wash internal surfaces with 1% detergent solution using a soft nylon brush.

4. Rinse thoroughly with purified water until detergent-free.

5. Finally rinse with purified water (or hot purified water if applicable).

6. Dry using a clean lint-free cloth or hot air.

7. Affix “Cleaned” label after QA verification.

Type B – Product Changeover Cleaning

1. Follow steps in Type A cleaning.

2. Additionally wipe external surfaces with 70% IPA.

3. Ensure no cross-contamination risk.

Type C – Weekly / Periodic Cleaning

1. Perform deep cleaning of agitator, valves, and outlet pipe.

2. Inspect for scaling, corrosion, or clogging.

5.3 Maintenance

1. Engineering shall perform preventive maintenance as per schedule.

2. Check agitator motor, heating jacket, and temperature sensors periodically.

3. Ensure pressure gauges and safety valves are functional.

4. Record maintenance activities in equipment logbook.

6.0 Safety Precautions

• Do not operate kettle without purified water or solvent inside.

• Do not open outlet valve under pressure.

• Wear safety gloves, apron, and goggles during operation.

• Ensure steam pressure does not exceed manufacturer’s limits.

• Use lockout/tagout during maintenance.

7.0 Documentation

• Equipment usage logbook

• Cleaning record

• Preventive maintenance record

• Calibration certificate (if temperature probe installed)

8.0 References

• Equipment manufacturer’s manual

• cGMP guidelines

• Batch manufacturing record (BMR)

9.0 Abbreviations

• SOP: Standard Operating Procedure

• cGMP: Current Good Manufacturing Practices

• BMR: Batch Manufacturing Record

• IPA: Isopropyl Alcohol

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