Standard Operating Procedure (SOP)

Here is a complete Standard Operating Procedure (SOP) for the Operation and Cleaning of the Paste Preparation Vessel, which is commonly used in oral liquid/suspension manufacturing or granulation processes in pharmaceutical production.

1.0 Objective

To lay down the procedure for operation and cleaning of the Paste Preparation Vessel, ensuring consistent and GMP-compliant handling of materials used in the preparation of binding paste or other formulations.

2.0 Scope

This SOP is applicable to all Paste Preparation Vessels used for manufacturing paste (e.g., for granulation or suspension preparation) in the production area of [Company Name].

3.0 Responsibility

4.0 Definitions

• Paste Preparation Vessel: A stainless-steel vessel (jacketed or non-jacketed) used to prepare and mix paste using heating, stirring, or homogenizing mechanisms.

• Agitator: A mixing blade inside the vessel to homogenize the paste.

• Jacketed Vessel: A vessel with outer layer for circulating steam or hot water to heat the contents.

5.0 Materials and Tools Required

• Approved cleaning agent (e.g., 2% non-ionic detergent)

• Purified water

• Lint-free cloths

• Brushes (non-shedding, non-metallic)

• PPE: gloves, mask, apron, goggles

• Equipment logbook

6.0 Operation Procedure

6.1 Pre-Operation Checks

1. Ensure the vessel is clean and labeled as “Cleaned”.

2. Check that the drain valve is closed and there are no leaks.

3. Verify agitator/blade movement and controls.

4. If vessel is jacketed, ensure temperature controller and steam connections are functioning.

5. Check the integrity of gaskets, clamps, and lid closures.

6. Record pre-operation check in the equipment usage log.

6.2 Operation Steps

1. Load the required quantity of purified water and raw materials as per BMR/BPR.

2. Switch on the agitator and allow uniform mixing.

3. If heating is required:

   • Open the steam inlet or activate the temperature control system.

   • Maintain the required temperature as per process.

4. Continue mixing for the specified time or until uniform paste is achieved.

5. Once ready, transfer the paste to the next process using discharge valve or transfer pump.

6. Switch off all utilities and disconnect steam supply (if used).

7.0 Cleaning Procedure

7.1 Cleaning Types

• Batch-to-Batch (same product)

• Product Changeover

• Periodic or Maintenance Cleaning

7.2 Cleaning Steps

1. Ensure vessel is switched off and disconnected from power/steam.

2. Drain any remaining contents and rinse with potable or purified water.

3. Wash internal surfaces, agitator, and discharge valve with 2% detergent solution using brushes.

4. Rinse thoroughly with purified water until all detergent is removed.

5. Wipe external surfaces with damp cloth.

6. Dry all parts using lint-free cloth or air drying method.

7. Inspect visually for cleanliness.

8. Affix “Cleaned” label with date and initials.

9. Record the cleaning in the equipment cleaning logbook.

8.0 Safety and Precautions

• Wear appropriate PPE during operation and cleaning.

• Do not open the vessel lid while agitator is running.

• Ensure the vessel is cooled down before cleaning.

• Handle hot surfaces with caution.

• Never bypass safety interlocks or grounding connections.

9.0 Documentation

• Equipment Operation Log

• Equipment Cleaning Log

• Paste Preparation Log (as part of BMR)

• Maintenance/Breakdown Record

10.0 Abbreviations

• SOP: Standard Operating Procedure

• BMR: Batch Manufacturing Record

• PPE: Personal Protective Equipment

• QA: Quality Assurance

11.0 Annexures

• Annexure 1: Cleaning Checklist

• Annexure 2: Equipment Usage Log

• Annexure 3: Calibration and Maintenance Record

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