Capsule: SOP for Cleaning Filter Elements in Capsule Production Lines – V 2.0

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Capsule: SOP for Cleaning Filter Elements in Capsule Production Lines – V 2.0

Standard Operating Procedure for Cleaning Filter Elements in Capsule Production Lines

Department Capsule Manufacturing
SOP No. SOP/CM/128/2025
Supersedes SOP/CM/128/2022
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 procedures for cleaning filter elements used in capsule production lines. Filters are critical to maintain the quality of the raw materials and prevent contamination in the production process. Regular cleaning of these filter elements ensures optimal performance and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all filter elements used in capsule production lines, including filters used in powder transfer systems, air filtration, and liquid filtration systems. It describes the process for cleaning and maintaining these filters after each production batch to ensure they remain free from contaminants and function efficiently.

3. Responsibilities

  • Production Operators: Responsible for cleaning the filter elements after each production run and ensuring that all components are properly reassembled.
  • Quality Control (QC) Team: Verifies that the filter elements are cleaned thoroughly and free from contamination before the next production cycle.
  • Quality Assurance (QA) Team: Ensures compliance with GMP standards and reviews the cleaning process documentation.
  • Maintenance Team: Ensures that the filter elements are in good working condition and ready for cleaning when necessary.
  • Production Supervisor: Oversees the cleaning process, ensuring adherence to the SOP and confirming that the filter elements are ready for use in the next production cycle.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the filter cleaning process is carried out according to this SOP. The QA Manager ensures that the process complies with GMP and that cleaning records are complete and accurate.

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5. Procedure

5.1 Preparation for Cleaning

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

  1. Turn Off the Equipment

    1. Ensure that the equipment connected to the filters is turned off and disconnected from the power supply to avoid electrical hazards.
    2. Ensure that no materials are left in the filters that could contaminate the cleaning solution.
  2. Gather Cleaning Materials

    1. Collect all necessary cleaning materials, including approved cleaning agents, warm water, soft brushes, lint-free cloths, and Personal Protective Equipment (PPE).
    2. Ensure that the cleaning agents are compatible with the filter materials and effective in removing contaminants.
  3. Inspect the Filters

    1. Inspect the filters for any visible damage or wear. Ensure that no components are cracked or deteriorated, which could affect the cleaning process or filter performance.
  4. Prepare Cleaning Log

    1. Prepare the Cleaning Log (Annexure-1) to record all cleaning activities, including operator details, cleaning times, and any issues encountered during the process.

5.2 Cleaning Process

Follow these steps to clean the filter elements:

  1. Initial Rinse

    1. Rinse the filters with warm water to remove any loose material or debris. Ensure that all filter surfaces are thoroughly rinsed to remove visible contaminants.
  2. Apply Cleaning Solution

    1. Apply the cleaning solution (detergent) to the filter elements and let it soak for a specified amount of time to break down any accumulated material or oil residue.
    2. Use soft brushes or sponges to scrub all parts of the filter, including the internal components, ensuring all residues are removed.
  3. Rinse with Clean Water

    1. After the cleaning solution has been applied and scrubbed, rinse the filters thoroughly with clean water to remove any remaining detergent or debris.
    2. Ensure that all parts of the filter are properly rinsed to avoid contamination in the next production cycle.
  4. Disinfection (If Required)

    1. If required, apply an appropriate disinfectant to the filter elements and circulate it through the system for the specified time to eliminate any microbial contamination.
    2. Follow the manufacturer’s instructions for the disinfectant, including correct dilution and application time.
  5. Final Rinse

    1. Perform a final rinse with clean water to remove any residual disinfectant or cleaning solution.
    2. Ensure that all cleaning agents are thoroughly removed from the filter elements.
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5.3 Drying the Filter Elements

Once cleaning is complete, the filter elements must be dried:

  1. Dry the Filters

    1. Use clean, dry, lint-free cloths to wipe down accessible parts of the filter elements.
    2. If necessary, allow the filters to air dry in a clean and controlled environment to ensure all moisture is removed.
    3. If applicable, use compressed air or drying fans to assist in drying the filters and remove any trapped moisture.

5.4 Reassembling the Filters

After drying, the filters should be reassembled:

  1. Reassemble the Filters

    1. Carefully reassemble the filter elements, ensuring that all parts are securely fastened and correctly installed.

5.5 Post-Cleaning Inspection

After the cleaning and reassembly process, perform the following checks:

  1. Inspect for Residual Contamination

    1. Inspect the filter elements for any visible cleaning agents, dust, or material residue. If contamination is found, repeat the cleaning process.
  2. Check for Proper Reassembly

    1. Ensure that all parts of the filter system are correctly reassembled and securely fastened.
  3. Test Run

    1. Perform a test run of the filter system to ensure it is functioning properly and free of contamination before the next production cycle.
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5.6 Documentation

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

  1. Complete Cleaning Log

    1. Record all cleaning actions, including operator details, cleaning times, and equipment ID in the Cleaning Log (Annexure-1).
  2. Post-Cleaning Inspection

    1. Document the results of the post-cleaning inspection in the Equipment Inspection Log (Annexure-2).

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-1)
  2. Equipment Inspection Log (Annexure-2)
  3. Maintenance Log (Annexure-3)

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-1: Cleaning Log

Batch ID Cleaning Date Operator Cleaning Action Comments
Batch 001 02/02/2025 John Doe Completed cleaning of filter elements No residue found

Annexure-2: Equipment Inspection Log

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Filter 001 02/02/2025 No defects found, equipment fully sanitized Jane Smith 02/02/2026

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Filter 001 02/02/2025 Checked and calibrated filter system John Doe 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 steps and added inspection checks Improved cleaning accuracy QA Head
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