Standard Operating Procedure (SOP)

Here is a comprehensive SOP that covers the cleaning of Pressure Vessel, Peristaltic Pump, and Spraying Gun, typically used in pharmaceutical, biotech, or sterile manufacturing environments.

1. Objective

To establish a standardized procedure for cleaning the Pressure Vessel, Peristaltic Pump, and Spraying Gun to ensure removal of residues, maintain hygiene, and prevent cross-contamination.

2. Scope

This procedure applies to all units of Pressure Vessels, Peristaltic Pumps, and Spraying Guns used in manufacturing or sterile operations.

3. Responsibility

• Operators / Technicians: Execute the cleaning as per this SOP.

• Production/Engineering Supervisor: Supervise and verify cleaning activities.

• QA Personnel: Inspect and approve the cleanliness as per GMP requirements.

4. Materials and Equipment Required

• Purified Water / WFI (as applicable)

• 

  Approved non-toxic cleaning detergent

• Nylon brushes / pipe brushes

• Lint-free cloths

• Compressed air (filtered, oil-free)

• PPE (gloves, gown, mask, goggles)

• Cleaning Logbook

5. Procedure

5.1 Cleaning of Pressure Vessel

1. Ensure the vessel is disconnected and depressurized before starting.

2. Wear proper PPE.

3. Drain any residual product and rinse the vessel with purified water.

4. Wash the inner surface using a cleaning solution and a brush or CIP system.

5. Pay attention to weld joints, valves, and manhole seals.

6. Rinse thoroughly with purified water or WFI until no detergent residue remains.

7. Wipe external surfaces with a damp cloth.

8. Dry using lint-free cloth and/or compressed air.

9. Visually inspect and log the cleaning activity.

5.2 Cleaning of Peristaltic Pump

1. Switch off and unplug the pump.

2. Remove and dispose of used tubing per waste procedures.

3. Clean the pump rollers, head, and housing with a damp cloth soaked in detergent solution.

4. Use a soft brush if required to remove residues from crevices.

5. Rinse using purified water (damp cloth or controlled stream).

6. Wipe dry and inspect for cleanliness.

7. Reinstall new or sterilized tubing if ready for next use.

8. Record the cleaning.

5.3 Cleaning of Spraying Gun

1. Disconnect the spraying gun from pressure line or liquid source.

2. Dismantle the spray gun nozzle, pipe, and attachments as per SOP.

3. Rinse with purified water to remove product traces.

4. Soak removable parts in approved cleaning solution.

5. Use brushes to scrub nozzle, trigger mechanism, and spray head.

6. Rinse thoroughly with purified water or WFI.

7. Dry using filtered compressed air.

8. Reassemble and check for proper function.

9. Record cleaning details in the logbook.

6. Post-Cleaning Activities

1. Affix “Cleaned” status labels with date, time, and initials.

2. Document all cleaning activities in the Equipment Cleaning Log.

3. Submit for QA inspection and clearance as required.

7. Precautions

• Avoid excessive moisture near electrical components.

• Use appropriate tools to dismantle equipment.

• Do not use harsh or abrasive cleaning agents.

• Ensure full removal of cleaning agents to prevent contamination.

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