Capsule: SOP for Cleaning Conveyors in Capsule Manufacturing Lines – V 2.0

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Capsule: SOP for Cleaning Conveyors in Capsule Manufacturing Lines – V 2.0

Standard Operating Procedure for Cleaning Conveyors in Capsule Manufacturing Lines

Department Capsule Manufacturing
SOP No. SOP/CM/123/2025
Supersedes SOP/CM/123/2022
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 establish a standard procedure for cleaning conveyors used in capsule manufacturing lines. Proper cleaning of the conveyors is essential to prevent cross-contamination, maintain hygiene standards, and ensure the production of high-quality capsules in compliance with GMP guidelines.

2. Scope

This SOP applies to all conveyors used in the capsule manufacturing process, including those used for material transport, capsules movement, and packaging. The procedure outlined ensures the removal of contaminants and residues from previous batches.

3. Responsibilities

  • Production Operators: Responsible for disassembling, cleaning, and reassembling the conveyors according to the procedure described in this SOP.
  • Quality Control (QC) Team: Verifies that the conveyors are cleaned properly and ensures no contaminants remain on the conveyor surfaces.
  • Quality Assurance (QA) Team: Ensures compliance with GMP standards and reviews the cleaning records for completeness and accuracy.
  • Production Supervisor: Oversees the cleaning process, ensuring all cleaning steps are followed, and confirms that the conveyors are ready for use in the next production cycle.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the conveyor cleaning process is completed according to this SOP. The QA Manager ensures compliance with GMP standards and reviews the cleaning documentation.

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5. Procedure

5.1 Preparation for Cleaning

Before beginning the cleaning process, ensure the following steps are completed:

  1. Turn Off the Equipment

    1. Ensure that the conveyor systems are powered off and disconnected from the power supply to avoid any safety hazards during cleaning.
    2. Ensure that no materials are left on the conveyor belts.
  2. Gather Cleaning Materials

    1. Collect the required cleaning materials such as approved cleaning agents, warm water, soft brushes, sponges, lint-free cloths, and PPE (Personal Protective Equipment).
    2. Ensure that the cleaning agents used are non-corrosive and compatible with the conveyor materials.
  3. Prepare Cleaning Log

    1. Prepare the Cleaning Log (Annexure-1) to document the cleaning actions, operator details, date, and any observations or deviations.

5.2 Disassembling the Conveyor (If Required)

If applicable, disassemble the conveyor for cleaning:

  1. Remove Parts for Cleaning

    1. Carefully remove any detachable parts of the conveyor, such as belts, rollers, or any other components that require cleaning.
  2. Label Components for Reassembly

    1. Label each part to ensure correct reassembly after cleaning.
  3. Place Parts in Cleaning Area

    1. Place all removable components in the designated cleaning area to ensure thorough cleaning and sanitization.

5.3 Cleaning Process

Follow these steps for cleaning the conveyors:

  1. Initial Rinse

    1. Rinse the conveyor parts with warm water to remove any dust, debris, or residues left from the previous batch.
    2. Ensure all internal surfaces and parts of the conveyor are thoroughly rinsed.
  2. Apply Cleaning Agents

    1. Apply an approved, mild, non-abrasive cleaning agent to all conveyor surfaces, ensuring complete coverage of all parts.
    2. Use soft brushes to scrub areas that are hard to reach, including rollers and corners.
  3. Rinse with Water

    1. Rinse the conveyor thoroughly with warm water to remove any cleaning agents and contaminants from the surfaces.
    2. Ensure that no cleaning agents are left on the conveyor surfaces.
  4. Disinfect (If Required)

    1. If necessary, apply an appropriate disinfectant to the conveyor surfaces to kill any microbial contaminants.
    2. Follow the manufacturer’s instructions for the proper dilution and application of the disinfectant.
  5. Final Rinse

    1. Perform a final rinse with clean water to ensure that no disinfectant or cleaning agents remain on the conveyor.
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5.4 Drying and Reassembly

After cleaning, follow these steps:

  1. Dry the Components

    1. Dry the conveyor components using a clean, dry, lint-free cloth. Allow components to air dry completely if needed.
  2. Reassemble the Conveyor

    1. Once the components are dry, carefully reassemble the conveyor, ensuring that all parts are correctly installed and securely fastened.

5.5 Post-Cleaning Inspection

Once the cleaning and reassembly are complete, perform the following checks:

  1. Inspect for Residual Contamination

    1. Visually inspect the conveyor for any remaining cleaning agents, dust, or contaminants. If contamination is found, repeat the cleaning process.
  2. Check for Proper Reassembly

    1. Ensure that all conveyor components are correctly reassembled and securely fastened.
  3. Test Run

    1. Conduct a test run of the conveyor system to ensure it is functioning properly before it is used for the next production cycle.

5.6 Documentation

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

  1. Complete Cleaning and Sanitization Log

    1. Record all cleaning actions, including dates, times, operator details, and actions taken 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).
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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 Cleaned conveyor systems No residue found

Annexure-2: Equipment Inspection Log

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

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Conveyor 001 02/02/2025 Replaced rollers and cleaned the belt 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 sanitization accuracy QA Head
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