Capsule: SOP for Cleaning Stainless Steel Surfaces in Capsule Areas – V 2.0

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Capsule: SOP for Cleaning Stainless Steel Surfaces in Capsule Areas – V 2.0

Standard Operating Procedure for Cleaning Stainless Steel Surfaces in Capsule Areas

Department Production
SOP No. SOP/PROD/250/2025
Supersedes SOP/PROD/250/2022
Page No. Page 1 of 5
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedure for cleaning stainless steel surfaces in capsule manufacturing areas. Regular cleaning of stainless steel surfaces ensures that they remain free of contaminants and residues, which is essential for maintaining product quality and compliance with GMP (Good Manufacturing Practices).

2. Scope

This SOP applies to all stainless steel surfaces in the capsule manufacturing area, including surfaces of machinery, tools, equipment, and other stainless steel components used in the production of capsules.

3. Responsibilities

  • Production Operators: Responsible for cleaning the stainless steel surfaces as per the SOP and ensuring that all tools and equipment are properly cleaned and documented.
  • Production Supervisor: Ensures that the cleaning procedures are followed correctly, verifies the effectiveness of the cleaning, and ensures that cleaning logs are accurately completed.
  • Quality Assurance (QA) Team: Verifies that the cleaning procedure meets GMP standards, ensures that the surfaces are clean and ready for use, and reviews the cleaning logs for completeness and accuracy.
  • Maintenance Team: Assists with any necessary maintenance or repairs to stainless steel surfaces during or after the cleaning process, ensuring they are in proper working condition.
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4. Accountability

The Production Supervisor is accountable for ensuring the cleaning of stainless steel surfaces as per this SOP. The QA team is responsible for ensuring that the cleaning methods are validated and compliant with GMP standards.

5. Procedure

5.1 Preparing for Cleaning

Before cleaning stainless steel surfaces, the following steps must be completed:

  1. Ensure the Equipment is Not in Use

    1. Confirm that the equipment and tools are not in use during the cleaning process. If necessary, disconnect equipment from the power source to ensure safety.
    2. Make sure the area is isolated from the rest of the production line to prevent contamination.
  2. Gather Cleaning Supplies

    1. Ensure that all cleaning materials are ready, including approved cleaning agents, brushes, lint-free cloths, deionized water, and sanitizing agents.
    2. Check that all cleaning agents are GMP-approved and safe for use on stainless steel surfaces.

5.2 Cleaning Procedure

Follow these steps to clean stainless steel surfaces:

  1. Initial Rinse

    1. Rinse the stainless steel surfaces with warm water to remove any loose particles or residue.
    2. Ensure that the rinse water is discarded properly and that no contaminants remain on the surface.
  2. Apply Cleaning Solution

    1. Apply an appropriate cleaning solution to the stainless steel surfaces. Ensure that the solution is safe for use on stainless steel and does not cause corrosion.
    2. Use a brush or soft cloth to scrub the surface and remove any accumulated residue or product materials.
  3. Rinse Thoroughly

    1. Rinse the surface thoroughly with deionized water to remove all cleaning agents and residues.
    2. Ensure that no cleaning agents are left on the surface as they may affect the quality of the next production batch.
  4. Sanitize the Surface

    1. If necessary, apply a GMP-approved sanitizing solution to disinfect the stainless steel surfaces.
    2. Allow the sanitizing agent to remain for the recommended contact time before rinsing it off with deionized water.
  5. Dry the Surface

    1. Dry the stainless steel surfaces with a lint-free cloth or allow them to air dry completely before reassembly.
    2. Ensure that no moisture remains on the surface, as this could cause rusting or microbial growth.
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5.3 Reassembly and Final Inspection

After cleaning, the following steps must be taken:

  1. Inspect the Surface

    1. Inspect the cleaned stainless steel surfaces to ensure that no residue or cleaning agents remain.
    2. Check for any visible damage or signs of corrosion. If any defects are found, report them to the Maintenance Team for further action.
  2. Reassemble Equipment

    1. If any parts were disassembled for cleaning, reassemble them and ensure that all components are securely fastened.
    2. Verify that the equipment is properly aligned and functioning as intended before restarting production.
  3. QA Inspection

    1. The QA team must inspect the cleaned stainless steel surfaces to verify that the cleaning has been carried out according to the SOP.
    2. Once the inspection is completed and the surfaces are approved, the equipment is ready for use in the next production cycle.

5.4 Documentation and Recordkeeping

Ensure that all cleaning activities are properly documented as follows:

  1. Complete Cleaning Logs

    1. Document all cleaning activities, including the date, time, operator, equipment ID, cleaning methods, and inspection results (refer to Annexure 1).
  2. Maintain Records for Audits

    1. Store cleaning records for the required retention period (typically 5 years or as required by local regulations) and ensure that they are available for internal or regulatory audits.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control

7. Documents

  1. Annexure 1: Stainless Steel Surface Cleaning Log

8. References

  • Good Manufacturing Practice (GMP) Guidelines
  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Stainless Steel Surface Cleaning Log

Equipment ID Cleaning Date Operator Name Cleaning Method Inspection Results Approval
Filling Machine 01 01/03/2025 Jane Smith Standard cleaning with detergent and sanitizing solution Cleaned, no residue Approved

12. Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version of SOP Creation of SOP for cleaning stainless steel surfaces QA Head
01/02/2025 2.0 Added detailed inspection steps and cleaning documentation Revised cleaning and validation procedures QA Head
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