Capsule: SOP for Cleaning Capsule Shell Manufacturing Machines – V 2.0

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Capsule: SOP for Cleaning Capsule Shell Manufacturing Machines – V 2.0

Standard Operating Procedure for Cleaning Capsule Shell Manufacturing Machines

Department Capsule Manufacturing
SOP No. SOP/CM/146/2025
Supersedes SOP/CM/146/2022
Page No. Page 1 of 7
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to establish the procedure for cleaning capsule shell manufacturing machines. These machines are responsible for producing the capsule shells used in capsule production. Proper cleaning of these machines is essential to prevent contamination, ensure the quality of the shells, and maintain GMP standards.

2. Scope

This SOP applies to the cleaning of capsule shell manufacturing machines, including machines used for gelatin preparation, capsule molding, and drying. The procedure ensures that these machines are thoroughly cleaned between production runs to remove any product residues and prevent cross-contamination.

3. Responsibilities

  • Production Operators: Responsible for cleaning the capsule shell manufacturing machines according to this SOP, ensuring all components are free from residues, and documenting the cleaning process.
  • Cleaning Staff: Assist in cleaning activities, ensuring that all parts of the machine are cleaned effectively and in accordance with the SOP.
  • Quality Control (QC) Team: Verifies that cleaning procedures were followed correctly, ensuring no residues are left on the equipment and that the equipment is safe for the next production run.
  • Quality Assurance (QA) Team: Ensures compliance with GMP regulations and reviews all cleaning documentation for completeness and accuracy.
  • Maintenance Team: Inspects the machines after cleaning to ensure that all components are functioning correctly and that no damage occurred during the cleaning process.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that all capsule shell manufacturing machines are cleaned according to this SOP. The QA Manager is responsible for ensuring compliance with GMP and reviewing the cleaning documentation.

5. Procedure

5.1 Preparation for Cleaning Capsule Shell Manufacturing Machines

Before starting the cleaning process, ensure that the following preparations are made:

  1. Turn Off and Isolate Equipment

    1. Ensure that the capsule shell manufacturing machine is turned off and safely isolated from any power, air, or liquid supplies.
    2. Disconnect any hoses or attachments to prevent contamination during cleaning.
  2. Gather Cleaning Materials

    1. Collect the necessary cleaning materials, including detergents, cleaning brushes, microfiber cloths, non-abrasive sponges, and disinfectants.
    2. Ensure that all cleaning agents are compatible with the machine components and will not damage them.
  3. Inspect the Machine

    1. Inspect the capsule shell manufacturing machine for any visible contamination, product residues, or damage that needs special attention during cleaning.
    2. Document any issues that may require maintenance or additional cleaning in the Equipment Maintenance Log (Annexure-1).

5.2 Cleaning Process for Capsule Shell Manufacturing Machines

Follow these steps to clean the capsule shell manufacturing machine:

  1. Remove Dust and Debris

    1. Using a vacuum cleaner or soft brush, remove any dust, particles, or debris from all external and internal parts of the machine, including molds, trays, and mixing chambers.
    2. Ensure that no debris is left in areas that could obstruct airflow or contaminate future production batches.
  2. Apply Cleaning Solution

    1. Apply an appropriate cleaning solution to all machine surfaces that require cleaning, such as the gelatin preparation area, molds, and conveyor systems.
    2. Use a non-abrasive cloth or sponge to scrub surfaces and remove product residues, paying special attention to hard-to-reach areas.
  3. Rinse and Remove Residues

    1. Rinse all cleaned areas thoroughly with clean water to remove any remaining cleaning agents or residues.
    2. Ensure that no cleaning solution remains on the machine components to avoid contamination during the next production cycle.
  4. Disinfect Machine Parts

    1. If required, disinfect the machine parts using an approved disinfectant. Allow the disinfectant to sit for the recommended duration.
    2. After disinfecting, rinse all components again with clean water to remove any disinfectant residues.
  5. Dry Machine Components

    1. Use a clean, lint-free cloth to wipe down all parts of the machine, ensuring that no moisture remains on any component.
    2. Alternatively, use compressed air or a drying unit to dry all parts of the machine.
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5.3 Post-Cleaning Inspection

After the cleaning process, inspect the machine to ensure it is properly cleaned and ready for use:

  1. Visual Inspection

    1. Perform a visual inspection of the capsule shell manufacturing machine, ensuring that all surfaces are clean and free of residues, cleaning agents, or moisture.
    2. Check that all parts, including molds, trays, and conveyors, are properly cleaned and free from contamination.
  2. Functional Check

    1. Test the machine’s functionality to ensure that all components are working as expected, and that there is no clogging, leakage, or malfunctioning parts.
  3. Document Cleaning Results

    1. Record the cleaning process in the Cleaning Log (Annexure-2), documenting the date, operator name, cleaning actions performed, and any observations or issues encountered during the cleaning process.
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5.4 Documentation

All cleaning activities should be documented thoroughly for compliance and traceability:

  1. Complete Cleaning Log

    1. Document the cleaning actions in the Cleaning Log (Annexure-2), ensuring that all fields are completed and signed by the operator.
  2. Post-Cleaning Inspection Report

    1. Complete the Post-Cleaning Inspection Report (Annexure-3), documenting the results of the inspection, any issues found, and 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)
  3. Equipment Maintenance Log (Annexure-1)

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 capsule shell manufacturing machine No issues found

Annexure-3: Post-Cleaning Inspection Report

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

Annexure-1: Equipment Maintenance Log

Machine ID Maintenance Date Maintenance Details Operator Next Inspection Date
Machine 001 02/02/2025 Routine maintenance and cleaning 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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