Capsule: SOP for Cleaning Dispensing Equipment – V 2.0

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Capsule: SOP for Cleaning Dispensing Equipment – V 2.0

Standard Operating Procedure for Cleaning Dispensing Equipment

Department Capsule Manufacturing
SOP No. SOP/CM/009/2025
Supersedes SOP/CM/009/2022
Page No. Page 1 of 7
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

To establish the procedure for cleaning dispensing equipment in capsule manufacturing to ensure that equipment is free from any contamination or residues and to maintain product integrity and quality.

2. Scope

This SOP applies to all dispensing equipment, including balances, scoops, containers, and automated dispensing systems, used in capsule manufacturing to dispense APIs and excipients.

3. Responsibilities

  • Manufacturing Personnel: Responsible for cleaning the dispensing equipment according to the SOP and ensuring it is free of residues before and after use.
  • Quality Control (QC) Team: Responsible for verifying the cleanliness of equipment and ensuring that cleaning procedures are followed correctly.
  • Maintenance Personnel: Responsible for inspecting equipment for any damage and for ensuring that cleaning is performed without affecting the equipment’s functionality.
  • Quality Assurance (QA) Team: Oversees compliance with GMP standards and verifies that cleaning activities are documented and meet regulatory requirements.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring that dispensing equipment is cleaned properly. The QA Manager is responsible for overseeing the cleaning procedures and ensuring compliance with GMP and regulatory requirements.

5. Procedure

5.1 Preparation for Cleaning

Before cleaning the dispensing equipment, ensure the following steps are completed:

  1. Shut Down Equipment

    1. Turn off all dispensing equipment to prevent any accidents during cleaning. Disconnect power supply if required (for automated systems).
  2. Disassemble Equipment

    1. If applicable, disassemble the equipment to ensure all parts that come into contact with materials are cleaned properly (e.g., trays, scoops, containers).
    2. Ensure that any removable parts (e.g., weighing platforms, trays) are placed in a clean area and are ready for cleaning.
  3. Gather Cleaning Materials

    1. Ensure the correct cleaning agents (approved for use with the dispensing equipment) are available, such as detergents, disinfectants, or alcohol-based cleaners.
    2. Ensure that cleaning tools such as brushes, cloths, and wipes are clean and suitable for the cleaning process.
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5.2 Cleaning Process

Follow these instructions for cleaning dispensing equipment:

  1. Clean External Surfaces

    1. Wipe down all external surfaces of the dispensing equipment with a clean cloth or wipe soaked in an appropriate cleaning solution.
    2. Pay special attention to high-touch areas (e.g., control panels, knobs) to ensure they are free from residues.
  2. Clean Internal Components

    1. For equipment with removable parts (e.g., weighing platforms, containers), clean the internal components using soft brushes and appropriate cleaning agents to remove any material residues.
    2. For automated dispensing systems, ensure that any parts in contact with materials, such as dispensers or feeders, are cleaned thoroughly to avoid contamination.
  3. Rinse Thoroughly

    1. After cleaning, rinse all parts with clean water to remove any cleaning solution residue.
    2. Ensure that no cleaning agents remain on any part of the equipment that will come into contact with materials.
  4. Drying Equipment

    1. Allow all parts of the dispensing equipment to air dry or use lint-free cloths to dry the equipment to avoid water stains or contamination.
    2. Ensure that no moisture is left on the equipment to prevent mold or residue formation.
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5.3 Cleaning of Automated Dispensing Systems

Automated dispensing systems require additional attention to ensure no contamination:

  1. Disassemble Parts

    1. Disassemble any parts of the automated dispensing system that come into direct contact with materials (e.g., dispensers, hoppers, containers).
  2. Use Specific Cleaning Programs

    1. For automated systems with a built-in cleaning program, activate the program to clean the system according to the manufacturer’s instructions.
    2. Ensure that the cleaning cycle uses appropriate cleaning agents and removes all residues.
  3. Manually Clean Hard-to-Reach Areas

    1. Manually clean any areas that the automated system cannot reach, such as corners or crevices, to ensure thorough cleaning.

5.4 Post-Cleaning Inspection

After cleaning, perform the following checks to ensure the equipment is ready for use:

  1. Visual Inspection

    1. Perform a visual inspection of all cleaned equipment to ensure that no material residues are present.
    2. Check for any signs of wear, damage, or contamination, such as scratches or stains.
  2. Functional Check

    1. Check that all equipment parts are functioning correctly after cleaning. This includes ensuring that dispensers, balances, and scales are working as intended.

5.5 Documentation and Record-Keeping

Ensure proper documentation for all cleaning activities:

  1. Cleaning Log

    1. Document the details of each cleaning session, including the date, the equipment cleaned, the cleaning materials used, and the personnel involved in the process in the Cleaning Log (Annexure-1).
  2. Inspection and Verification

    1. Ensure that the post-cleaning inspection and functional checks are recorded in the Inspection Log (Annexure-2), including any discrepancies found and corrective actions taken.

5.6 Handling Non-Conforming Equipment

If any equipment is found to be non-conforming after cleaning, follow these steps:

  1. Quarantine the Equipment

    1. Quarantine the non-conforming equipment and label it as “Rejected” or “Under Investigation” to prevent it from being used in the dispensing process.
    2. Notify the Maintenance team for further inspection and corrective actions.
  2. Record the Issue

    1. Document the non-conformance in the Discrepancy Report (Annexure-3), specifying the issue, cause, and corrective actions taken.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • CAPA: Corrective and Preventive Action
  • PO: Purchase Order
  • API: Active Pharmaceutical Ingredient

7. Documents

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

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
  • WHO Guidelines for Good Manufacturing Practices

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

Date Equipment Name Cleaning Materials Used Personnel Involved
03/02/2025 Weighing Balance Alcohol-based Cleaner Jane Smith

Annexure-2: Inspection Log

Date Equipment Name Inspection Status Action Taken
03/02/2025 Weighing Balance Passed Ready for Use

Annexure-3: Discrepancy Report

Date Equipment Name Issue Description Corrective Action
04/02/2025 Dispensing Scale Residue Found Re-cleaned equipment

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 Added preventive measures and standardized cleaning process Updated guidelines QA Head
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