SOP Guide for Pharma

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

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

Standard Operating Procedure for Cleaning Stainless Steel Surfaces in Capsule Manufacturing Areas

Department Capsule Manufacturing
SOP No. SOP/CM/135/2025
Supersedes SOP/CM/135/2022
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 process for cleaning stainless steel surfaces in capsule manufacturing areas. Proper cleaning is necessary to prevent contamination and maintain compliance with Good Manufacturing Practices (GMP). The cleaning procedures are designed to ensure that stainless steel surfaces are free from residues, product build-up, or microbial contamination.

2. Scope

This SOP applies to all stainless steel surfaces used in capsule manufacturing, including equipment, tools, and work surfaces. It covers daily and periodic cleaning procedures to maintain the cleanliness and integrity of the manufacturing environment.

3. Responsibilities

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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the cleaning of stainless steel surfaces is done according to this SOP. The QA Manager is accountable for ensuring that the cleaning process complies with GMP standards and that all relevant documentation is properly reviewed and approved.

5. Procedure

5.1 Preparation for Cleaning Stainless Steel Surfaces

Before starting the cleaning process, complete the following steps:

  1. Turn Off Equipment
    1. Ensure that all equipment connected to stainless steel surfaces is turned off and disconnected from the power supply to prevent any hazards during cleaning.
    2. Remove any product or materials from the surfaces that require cleaning.
  2. Gather Cleaning Materials
    1. Collect the necessary cleaning agents, such as detergents, non-abrasive cleaners, and disinfectants.
    2. Gather PPE (Personal Protective Equipment), including gloves, masks, and goggles, to ensure safety during cleaning.
  3. Inspect Surfaces for Visible Contamination
    1. Inspect stainless steel surfaces for visible contamination, product residues, or build-up.
    2. Record any areas of concern that may require additional attention during the cleaning process.

5.2 Cleaning Process for Stainless Steel Surfaces

Follow these steps to clean stainless steel surfaces effectively:

  1. Initial Rinse
    1. Rinse the stainless steel surfaces with warm water to remove any loose residues or dust.
    2. Ensure that all exposed surfaces are adequately rinsed.
  2. Apply Cleaning Solution
    1. Apply a non-abrasive detergent or cleaning solution that is suitable for use on stainless steel surfaces.
    2. Use soft brushes, sponges, or cloths to scrub the surfaces gently, focusing on areas with visible contamination or build-up.
  3. Scrub the Surfaces
    1. Scrub all areas thoroughly, including any joints, crevices, or difficult-to-reach surfaces.
    2. Ensure that no abrasives are used that could scratch or damage the stainless steel surface.
  4. Rinse with Clean Water
    1. Rinse all surfaces thoroughly with clean water to remove any detergent or cleaning solution residues.
    2. Ensure that no cleaning agents remain on the stainless steel surfaces, as they could cause contamination in future production runs.
  5. Disinfect the Surfaces (if necessary)
    1. If required, apply a disinfectant to the cleaned stainless steel surfaces to eliminate any microbial contamination.
    2. Ensure that the disinfectant is safe for use on stainless steel and is effective in eliminating microorganisms.
    3. Allow the disinfectant to remain on the surface for the recommended time before rinsing with clean water.
  6. Dry the Surfaces
    1. Wipe down the surfaces with a clean, lint-free cloth to remove excess moisture.
    2. If necessary, use compressed air or a drying fan to speed up the drying process and ensure that the surfaces are completely dry.
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5.3 Post-Cleaning Inspection

After cleaning, perform the following steps to ensure the cleanliness of the stainless steel surfaces:

  1. Inspect for Residues
    1. Visually inspect the stainless steel surfaces to ensure that there are no visible residues or cleaning agents remaining on the surface.
    2. Use a wipe test or swab sample if needed to ensure that there are no traces of contamination left.
  2. Verify Surface Condition
    1. Inspect the stainless steel surface for any signs of damage, such as scratches or dents that could affect cleanliness or future cleaning efforts.
  3. Document Results
    1. Document the cleaning actions, results of inspections, and any deviations in the Cleaning Log (Annexure-1).
    2. Record any corrective actions taken in the event of failed inspections or discrepancies during the cleaning process.
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5.4 Documentation

Ensure that all cleaning actions are documented for traceability and compliance:

  1. Complete Cleaning Log
    1. Document all cleaning actions in the Cleaning Log (Annexure-1), including the date, surfaces cleaned, operator details, and any discrepancies found.
  2. Inspection Report
    1. Document the results of the post-cleaning inspection in the Equipment Inspection Log (Annexure-2), including any issues discovered during the inspection.

6. Abbreviations

7. Documents

  1. Cleaning Log (Annexure-1)
  2. Post-Cleaning Inspection Report (Annexure-2)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Log

Batch ID Cleaning Date Operator Cleaning Action Comments
Batch 001 02/02/2025 John Doe Completed cleaning of stainless steel surfaces No residue found

Annexure-2: Post-Cleaning Inspection Report

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Stainless Steel Surface 001 02/02/2025 Clean and ready for use Jane Smith 02/02/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version New SOP Creation QA Head
01/02/2025 2.0 Updated cleaning and inspection procedures Improved process clarity QA Head
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