Capsule: SOP for Cleaning Capsule Fill Tanks Between Batches – V 2.0

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Capsule: SOP for Cleaning Capsule Fill Tanks Between Batches – V 2.0

Standard Operating Procedure for Cleaning Capsule Fill Tanks Between Batches

Department Capsule Manufacturing
SOP No. SOP/CM/088/2025
Supersedes SOP/CM/088/2022
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 procedures for cleaning capsule fill tanks between batches. Proper cleaning of the fill tanks is crucial to prevent cross-contamination and ensure the quality of the capsules produced, in compliance with GMP guidelines.

2. Scope

This SOP applies to all capsule manufacturing batches where fill tanks are used. It covers the cleaning procedures to be followed between batches to ensure that the tanks are free from any residual product and contaminants.

3. Responsibilities

  • Production Operators: Responsible for performing the cleaning of the fill tanks according to the SOP and ensuring that all residual materials are removed.
  • Quality Control (QC) Team: Responsible for verifying that the fill tanks have been cleaned properly and that there is no residue or contamination before the next batch is processed.
  • Quality Assurance (QA) Team: Ensures that the cleaning procedures comply with GMP standards and approves the final cleaning after verification.
  • Production Supervisor: Oversees the cleaning process and ensures that the SOP is followed properly. Signs off on the cleaning completion.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the cleaning procedure is followed and documented correctly. The QA Manager is responsible for reviewing and approving the cleaning procedure before production can resume.

5. Procedure

5.1 Preparing for Cleaning

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

  1. Notify Relevant Departments

    1. Inform all relevant personnel (Production, QC, and Maintenance) that cleaning is about to begin and that the fill tanks must be cleaned thoroughly between batches.
  2. Shut Down the Equipment

    1. Power off all equipment associated with the capsule fill tank, ensuring it is safe to clean.
    2. Ensure that the fill tank is empty and there is no remaining product or material inside the tank.
  3. Gather Cleaning Materials

    1. Ensure that all necessary cleaning materials are available, including appropriate detergents, solvents, cleaning cloths, and brushes.
    2. Confirm that the cleaning materials are compatible with the equipment and the previous batch materials.
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5.2 Cleaning the Capsule Fill Tanks

Follow these steps to clean the capsule fill tanks:

  1. Clean with Water

    1. Rinse the fill tank with water to remove any loose residual product. Ensure that all surfaces of the tank, including the inside and outside, are thoroughly rinsed.
    2. Ensure the water temperature is appropriate for cleaning and safe for the materials of the tank.
  2. Apply Cleaning Detergents or Solvents

    1. Apply the appropriate cleaning detergent or solvent to the tank, ensuring that it is suitable for removing any remaining product or contamination.
    2. Use brushes or cleaning pads to scrub the internal and external surfaces of the fill tank, paying particular attention to any hard-to-reach areas.
    3. Ensure that all product residues are removed during this stage. Allow the detergent to sit for the recommended time before scrubbing.
  3. Rinse Thoroughly

    1. Rinse the fill tank thoroughly with clean water to remove all detergent or solvent residues. It is important that no cleaning agents remain in the tank.
  4. Dry the Tank

    1. Allow the fill tank to air dry or use a clean, dry cloth to wipe down the tank to remove excess moisture.
    2. Ensure that no water or cleaning solution remains inside the tank before it is used again.

5.3 Verifying Cleanliness

Once the cleaning is completed, the following verification steps must be conducted:

  1. Visual Inspection

    1. QC personnel should perform a visual inspection of the fill tank to confirm that no product residues, contaminants, or cleaning solution remains inside or on the tank.
    2. Ensure that the tank is dry and free of any foreign materials, including dust or debris.
  2. Verify Residual Material Removal

    1. Use swabbing techniques or residue tests to verify that no residual material from the previous batch remains in the tank.
    2. If residual product is detected, repeat the cleaning procedure until the tank passes the verification tests.
  3. Document Cleaning Completion

    1. Once cleaning and verification are complete, document the procedure in the Cleaning Log. Include details such as the time, cleaning agents used, and any deviations or corrective actions taken.
    2. Ensure the Cleaning Log is signed off by the operator and the QC personnel who verified the cleanliness.
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5.4 Approving the Cleaning Process

Once the cleaning process has been completed and verified, the following approval process must be followed:

  1. Final QA Review

    1. The QA team should review the cleaning documentation and verify that the cleaning process was completed according to the SOP.
    2. The QA team will also verify the inspection results to ensure that no contamination risks are present before production begins.
  2. Approval for Production

    1. Once the cleaning and verification are approved by the QA team, the fill tank is cleared for use in the next production batch.
    2. The QA team will sign off on the cleaning approval, and production can proceed once the tank is deemed ready.

5.5 Handling Deviations During Cleaning

If deviations from the cleaning procedure occur, take the following steps:

  1. Document the Deviation

    1. Document the deviation in the deviation log, including the cause, impact, and corrective actions taken.
  2. Implement Corrective Actions

    1. Take corrective actions to address the cause of the deviation, such as re-cleaning the tank or modifying the cleaning process.
  3. Review and Approve Corrective Actions

    1. The corrective actions should be reviewed and approved by the QA team before the production process can begin.
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5.6 Post-Cleaning Actions

After cleaning has been verified and approved, the following steps should be taken:

  1. Prepare for Production

    1. Ensure that all necessary materials, tools, and equipment are in place and ready for the next production batch.
  2. Documentation

    1. Ensure that the cleaning log, deviation log, and corrective action reports (if applicable) are properly filed for future reference and audits.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • BPR: Batch Production Record

7. Documents

  1. Cleaning Log (Annexure-1)
  2. Deviation Log (Annexure-2)
  3. Corrective Action Report (CAPA) (Annexure-3)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • International Conference on Harmonization (ICH) Guidelines for Pharmaceutical 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 Name Cleaning Status Approval Status
Batch 001 01/02/2025 John Doe Completed Approved

Annexure-2: Deviation Log

Deviation ID Description Corrective Action Taken Operator Name Approval Status
DEV-001 Cleaning tools unavailable Procured new tools Jane Smith Approved

Annexure-3: Corrective Action Report (CAPA)

CAPA ID Root Cause Corrective Action Preventive Action Completion Date Approval Status
CAPA-001 Inadequate cleaning of tanks Updated cleaning procedure Routine training for operators 03/02/2025 Approved

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 Revised cleaning procedure and updated log format Standardization QA Head
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