Capsule: SOP for Handling and Cleaning Vacuum Loaders in Capsule Filling Machines – V 2.0

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Capsule: SOP for Handling and Cleaning Vacuum Loaders in Capsule Filling Machines – V 2.0

Standard Operating Procedure for Handling and Cleaning Vacuum Loaders in Capsule Filling Machines

Department Capsule Manufacturing
SOP No. SOP/CM/127/2025
Supersedes SOP/CM/127/2022
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 outline the standardized procedure for handling and cleaning vacuum loaders used in capsule filling machines. Vacuum loaders are critical for transferring powder and granular materials to the filling machines. Proper handling and cleaning of these components ensure the prevention of cross-contamination, maintain equipment performance, and comply with GMP standards.

2. Scope

This SOP applies to all vacuum loaders used in capsule filling machines in the capsule manufacturing department. It provides instructions for handling, cleaning, and maintaining the vacuum loaders after each batch to ensure proper functioning and prevent contamination between batches.

3. Responsibilities

  • Production Operators: Responsible for handling the vacuum loaders during material loading and unloading and for cleaning them thoroughly after each batch.
  • Quality Control (QC) Team: Verifies the cleanliness of the vacuum loaders after each cleaning process and ensures no contamination remains before the next use.
  • Quality Assurance (QA) Team: Ensures compliance with GMP during the handling and cleaning process and reviews cleaning logs for completeness and accuracy.
  • Maintenance Team: Ensures that the vacuum loaders are in good working condition, free of obstructions, and ready for cleaning when necessary.
  • Production Supervisor: Oversees the vacuum loader cleaning process, ensuring adherence to this SOP and confirming that the equipment is clean and ready for the next production run.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the vacuum loaders are handled and cleaned according to this SOP. The QA Manager ensures compliance with GMP and verifies that the cleaning process is properly documented.

5. Procedure

5.1 Preparation for Cleaning

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

  1. Turn Off the Equipment

    1. Ensure the vacuum loader is turned off and disconnected from the power supply to prevent any electrical hazards during cleaning.
    2. Ensure that no material is left in the vacuum loader after the completion of the filling process.
  2. Gather Cleaning Materials

    1. Collect the necessary cleaning materials, including cleaning agents, warm water, soft brushes, lint-free cloths, and appropriate PPE (Personal Protective Equipment).
    2. Ensure that the cleaning agents are suitable for the materials being loaded and will not cause any damage to the vacuum loader components.
  3. Inspect the Vacuum Loader

    1. Inspect the vacuum loader for any visible damage or wear that may affect the cleaning process or machine functionality.
  4. Prepare Cleaning Log

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

5.2 Cleaning Process

Follow these steps for cleaning the vacuum loader:

  1. Initial Rinse

    1. Rinse the vacuum loader and connected pipes with warm water to remove any loose powder or residual materials.
    2. Ensure that all internal surfaces are thoroughly rinsed.
  2. Apply Cleaning Solution

    1. Apply the appropriate cleaning solution (detergent) to all parts of the vacuum loader, including the hopper, hoses, and any other areas that come into contact with the material.
    2. Use soft brushes or sponges to scrub any areas that may have built-up material residue.
  3. Rinse with Water

    1. After the cleaning solution has been applied and scrubbed, rinse the system thoroughly with warm water to remove all cleaning agents and any remaining residues.
    2. Ensure that no cleaning agents are left inside the loader.
  4. Disinfect (If Required)

    1. If necessary, apply an appropriate disinfectant to the loader and circulate it through the system to eliminate any microbial contamination.
    2. Follow the manufacturer’s instructions for disinfectant use, including proper dilution and application time.
  5. Final Rinse

    1. Perform a final rinse with clean water to remove any traces of disinfectant or cleaning solution.
    2. Ensure that all parts are thoroughly rinsed and free of cleaning agents.
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5.3 Drying the Equipment

Once the cleaning process is complete, follow these steps to dry the vacuum loader:

  1. Dry the Equipment

    1. Use clean, dry, lint-free cloths to wipe down all accessible surfaces of the vacuum loader.
    2. If necessary, allow the equipment to air dry in a clean and controlled environment to ensure complete dryness.
    3. If the vacuum loader is designed for it, use compressed air or drying fans to speed up the drying process.

5.4 Post-Cleaning Inspection

After cleaning and drying, perform the following checks:

  1. Inspect for Residual Contamination

    1. Inspect the vacuum loader for any remaining 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 vacuum loader are correctly reassembled and securely fastened.
  3. Test Run

    1. Perform a test run of the vacuum loader to ensure that it is functioning properly and is free from any contaminants before the next production run.
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5.5 Documentation

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

  1. Complete Cleaning Log

    1. Record all cleaning actions, including operator details, dates, and cleaning times 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 vacuum loader No residue found

Annexure-2: Equipment Inspection Log

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Vacuum Loader 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
Vacuum Loader 001 02/02/2025 Checked WIP system, replaced filters 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 process and added post-cleaning inspection Improved cleaning efficiency QA Head
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