Capsule: SOP for Cleaning Dust Collection Systems in Capsule Production – V 2.0

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Capsule: SOP for Cleaning Dust Collection Systems in Capsule Production – V 2.0

Standard Operating Procedure for Cleaning Dust Collection Systems in Capsule Production

Department Capsule Manufacturing
SOP No. SOP/CM/142/2025
Supersedes SOP/CM/142/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to define the procedure for cleaning dust collection systems used in capsule production. These systems are essential for maintaining air quality by capturing dust and particles generated during capsule manufacturing. Regular cleaning ensures the system functions efficiently, prevents cross-contamination, and maintains a safe and clean manufacturing environment.

2. Scope

This SOP applies to the cleaning of all dust collection systems in capsule manufacturing areas, including systems used in granulation, capsule filling, and other processing steps. It includes the removal of dust, debris, and other residues from the filters, ducts, and collection bins to ensure proper air filtration and system operation.

3. Responsibilities

  • Production Operators: Responsible for performing the cleaning of dust collection systems, ensuring all components are free from dust and debris as per this SOP.
  • Cleaning Staff: Assist with the cleaning of dust collection components and ensure that all areas are properly cleaned to prevent contamination.
  • Maintenance Team: Responsible for inspecting dust collection systems and ensuring that all equipment is functioning properly after cleaning.
  • Quality Control (QC) Team: Ensures that the cleaning process meets GMP standards and verifies that no residues are left in the dust collection system after cleaning.
  • Quality Assurance (QA) Team: Reviews cleaning documentation and ensures that cleaning activities are performed in compliance with regulatory requirements.
  • Production Supervisor: Oversees the cleaning of the dust collection systems and ensures that the process is carried out in a timely manner and according to the SOP.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that dust collection systems are cleaned in accordance with this SOP. The QA Manager ensures that cleaning activities are compliant with GMP standards and reviews all cleaning records.

5. Procedure

5.1 Preparation for Cleaning Dust Collection Systems

Before starting the cleaning process, the following steps must be completed:

  1. Turn Off Equipment and Isolate the System

    1. Ensure that the dust collection system is turned off and isolated from any active processes to prevent contamination during cleaning.
    2. Shut down any equipment connected to the system to avoid accidental operation during cleaning.
  2. Gather Cleaning Materials

    1. Collect necessary cleaning agents, such as non-abrasive cleaners, disinfectants, and brushes.
    2. Ensure that cleaning materials are safe for use on the dust collection system components and will not cause damage or degradation.
  3. Inspect the Dust Collection System

    1. Inspect the dust collection system for any visible debris, dust build-up, or damage that needs special attention during the cleaning process.
    2. Note any areas that require additional maintenance or repairs and document them in the Equipment Maintenance Log (Annexure-1).

5.2 Cleaning Process for Dust Collection Systems

Follow these steps to clean the dust collection system effectively:

  1. Remove Dust and Debris

    1. Using a soft brush or vacuum cleaner, carefully remove any dust and debris from the internal and external surfaces of the dust collection system, including ducts and filters.
    2. Be cautious not to damage delicate components while cleaning the filters and ducts.
  2. Apply Cleaning Solution

    1. Apply an appropriate cleaning solution to the dust collection components that require cleaning. This may include wiping down the filters, ducts, and collection bins.
    2. Use non-abrasive cleaning materials to avoid damaging the system’s components.
  3. Rinse and Clean Filters

    1. If the filters are removable, rinse them with clean water to remove any remaining dust or cleaning agents. Ensure that all residues are removed from the filters.
    2. If the filters cannot be removed, clean them in place by using a vacuum or air compressor to remove any dust or debris.
  4. Clean and Disinfect Collection Bins

    1. Clean the collection bins by removing any accumulated dust and wiping them down with a clean cloth and suitable disinfectant.
    2. Ensure that no cleaning solution residue is left in the bins, as this could contaminate future products.
  5. Dry the System

    1. Use clean, lint-free cloths to wipe down all parts of the dust collection system and remove any excess moisture.
    2. If required, use compressed air or drying equipment to ensure all parts are completely dry before reassembly.
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5.3 Post-Cleaning Inspection

After cleaning, inspect the dust collection system to ensure it is free from residues and ready for use:

  1. Visual Inspection

    1. Visually inspect all components of the dust collection system, including filters, ducts, and collection bins, to ensure they are clean and free from any residues or cleaning agents.
    2. Check that the system is properly reassembled and that no components are missing or damaged.
  2. Functionality Check

    1. Test the dust collection system to ensure it is functioning properly. This includes checking airflow and ensuring that all components are operating as expected.
  3. Document Cleaning Results

    1. Record the cleaning process in the Cleaning Log (Annexure-2), including the date, operator details, and any issues encountered during cleaning.
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5.4 Documentation

Ensure that all cleaning activities are properly documented for traceability and compliance:

  1. Complete Cleaning Log

    1. Document all cleaning actions, including the date, operator name, and any issues found during cleaning, in the Cleaning Log (Annexure-2).
  2. Post-Cleaning Inspection Report

    1. Document the results of the post-cleaning inspection in the Equipment Inspection Log (Annexure-3), including the functional test results and any corrective actions taken.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Cleaning Log (Annexure-2)
  2. Post-Cleaning Inspection Report (Annexure-3)

8. References

  • USP <1163 You said: Continue ChatGPT said: Here is the continuation of SOP 142: SOP for Cleaning Dust Collection Systems in Capsule Production: html Copy

    8. References

    • USP <1163> – Pharmaceutical Dosage Forms: Capsules
    • FDA Guidelines for Capsule Manufacturing
    • Good Manufacturing Practice (GMP) Guidelines

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-2: Cleaning Log

    Batch ID Cleaning Date Operator Cleaning Action Comments
    Batch 001 02/02/2025 John Doe Completed cleaning of dust collection system No issues found

    Annexure-3: Post-Cleaning Inspection Report

    System ID Inspection Date Inspection Results Operator Next Maintenance Due
    Dust Collection System 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 process steps Improved cleaning methodology QA Head
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