Standard Operating Procedure (SOP)

Here is a Standard Operating Procedure (SOP) for the Cleaning of Blister Packing Machine, typically used in pharmaceutical manufacturing to ensure hygiene, prevent cross-contamination, and comply with GMP.

1. Objective

To establish a procedure for cleaning the Blister Packing Machine to ensure the removal of residues, prevent cross-contamination, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to the cleaning of all blister packing machines used in the production of pharmaceutical products.

3. Responsibility

• Operator: Perform cleaning as per this SOP.

• Production Supervisor: Supervise and verify that cleaning is done in compliance with this procedure.

• QA/QC Personnel: Inspect and approve the cleanliness of the machine after cleaning.

4. Materials and Equipment Required

• Purified Water

• Cleaning Agent (approved detergent)

• Lint-free cloths

• Soft brushes (e.g., nylon brushes)

• Vacuum cleaner (optional)

• Compressed air (optional)

• PPE (gloves, mask, goggles, gown)

• Cleaning Logbook

5. Procedure

5.1 Pre-Cleaning Steps

1. Power Off the Machine:

   • Ensure the machine is turned off and disconnected from the power supply.

   • Display a “Under Cleaning” sign on the machine.

2. Wear Appropriate PPE:

   • Ensure that personal protective equipment (PPE) is worn, including gloves, gown, mask, and goggles.

3. Remove Product Residues:

   • Remove any leftover product, packaging materials, and debris from the machine.

   • Remove any trays, foils, or films from the machine.

5.2 Cleaning Procedure

1. Dry Cleaning:

   • Use a vacuum cleaner or a soft brush to remove loose particles and powder from accessible areas such as the feed area, forming plates, and film feeders.

   • Clean any visible product residues from the blister pockets or feeding paths.

2. Cleaning of Internal Parts:

   • Remove the forming plates, sealing tools, and any removable parts as per the equipment manual.

   • Clean all parts using a soft brush and a damp lint-free cloth soaked in an approved cleaning solution.

3. Clean the Machine Body and External Parts:

   • Wipe down the machine body, film rollers, and any other external parts using a cloth dampened with the approved cleaning solution.

   • Ensure all corners, crevices, and mechanical areas are cleaned thoroughly.

4. Cleaning of the Feeding and Sealing Areas:

   • Pay special attention to the areas where film is fed and sealed, as residues can accumulate in these areas.

   • Clean these sections using appropriate tools, like soft brushes and lint-free cloths, soaked in the cleaning solution.

5. Final Rinse:

   • Use purified water to rinse off all detergent residues from cleaned areas.

   • Ensure that no cleaning agent or water remains on any part of the machine.

5.3 Drying and Reassembly

1. Drying:

   • Use a clean, dry, lint-free cloth and/or compressed air to dry all surfaces and components.

   • Ensure there is no moisture left on the machine before reassembly.

2. Reassemble the Machine:

   • Reinstall all parts (such as forming plates, sealing tools, and other components) after ensuring they are completely dry.

3. Visual Inspection:

   • Inspect the entire machine to ensure that all cleaning steps have been completed, and there is no visible residue or contamination.

   • Log any observations in the cleaning log.

6. Post-Cleaning Activities

1. Label the Equipment:

   • Affix a “CLEANED” label to the machine with date, time, and the initials of the operator.

2. Cleaning Documentation:

   • Complete the cleaning log with details including the time, date, equipment ID, and cleaning procedure performed.

3. Line Clearance:

   • Notify QA for inspection and approval before using the machine for the next production batch.

7. Precautions

• Do not use abrasive materials or harsh cleaning agents that could damage the machine parts.

• Ensure that electrical components are not exposed to moisture.

• Do not skip any cleaning steps, especially in areas where product residues may remain.

• Handle sensitive parts, such as forming plates, with care to prevent damage.

8. References

• Equipment Operating Manual

• GMP Guidelines

• Cleaning Validation Protocol

• Cleaning Agent Approval Documents

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