Capsule: SOP for Cleaning Gelatin Solution Preparation Tanks – V 2.0

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Capsule: SOP for Cleaning Gelatin Solution Preparation Tanks – V 2.0

Standard Operating Procedure for Cleaning Gelatin Solution Preparation Tanks

Department Capsule Manufacturing
SOP No. SOP/CM/112/2025
Supersedes SOP/CM/112/2022
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 define the procedures for cleaning gelatin solution preparation tanks used in the capsule manufacturing process. Effective cleaning ensures the removal of residual gelatin, prevents cross-contamination, and ensures compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all gelatin solution preparation tanks in capsule manufacturing. It covers cleaning procedures after each batch to ensure that the tanks are free from residue and prepared for the next batch.

3. Responsibilities

  • Production Operators: Responsible for carrying out the cleaning procedure as outlined in this SOP and documenting the process.
  • Maintenance Team: Responsible for ensuring that the tank components are in good working condition, performing any necessary repairs, and reassembling the equipment post-cleaning.
  • Quality Control (QC) Team: Responsible for verifying that the cleaning process meets the required standards and performing any required testing to ensure no residual gelatin is present.
  • Quality Assurance (QA) Team: Ensures that the cleaning procedure is documented, and compliance with GMP standards is maintained.
  • Production Supervisor: Oversees the cleaning process and ensures that all steps are followed properly, ensuring that the tank is ready for the next batch of gelatin solution.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the gelatin solution preparation tanks are cleaned according to this SOP. The QA Manager is responsible for confirming the cleaning process meets GMP standards and verifying the proper documentation is maintained.

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5. Procedure

5.1 Preparation for Cleaning

Before beginning the cleaning process, the following preparations should be made:

  1. Ensure the Tank is Empty

    1. Ensure that the gelatin solution tank is completely emptied of all solution. Dispose of any leftover material in accordance with waste disposal protocols.
  2. Disconnect Power and Equipment

    1. Turn off the power to the tank and disconnect any electrical or mechanical connections to ensure safety during cleaning.
  3. Gather Cleaning Materials

    1. Collect all necessary cleaning materials, including warm water, approved cleaning agents, brushes, sponges, lint-free cloths, and any required PPE (Personal Protective Equipment).
    2. Ensure that the cleaning agents are non-corrosive and safe for use on the tank components.
  4. Prepare Cleaning Log

    1. Ensure the Cleaning Log (Annexure-1) is ready to record all cleaning actions and any deviations observed during the cleaning process.

5.2 Disassembly of Tank Components (If Necessary)

If necessary, the following steps should be followed to disassemble the components of the gelatin solution preparation tank that require cleaning:

  1. Remove Components That Require Cleaning

    1. Remove parts such as agitators, nozzles, temperature sensors, or filters that come into direct contact with the gelatin solution. These parts should be disassembled carefully to avoid damage.
  2. Label the Components

    1. Label each disassembled part to ensure proper reassembly after cleaning.
  3. Place Parts in Cleaning Stations

    1. Place all disassembled parts into designated cleaning stations to ensure they are cleaned thoroughly.

5.3 Cleaning Process

Follow these steps to clean the gelatin solution preparation tank:

  1. Initial Rinse

    1. Rinse the tank and all components with warm water to remove any gelatin residue. Make sure all surfaces, including corners and joints, are thoroughly rinsed.
  2. Apply Cleaning Agents

    1. Apply an approved cleaning agent to all surfaces of the tank and components. Use non-abrasive brushes or sponges to scrub surfaces and remove any remaining residue.
  3. Rinse Again

    1. Rinse all surfaces thoroughly with warm water to ensure that all cleaning agents are removed, leaving no residues behind.
  4. Disinfect (If Required)

    1. If required, apply a disinfectant to all cleaned surfaces to prevent microbial contamination. Follow the manufacturer’s instructions for appropriate usage.
  5. Final Rinse

    1. Perform a final rinse with warm water to ensure no traces of disinfectant remain.
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5.4 Drying and Reassembly

Once the cleaning is complete, proceed with drying and reassembly:

  1. Dry Components

    1. Dry all cleaned components with a clean, dry, lint-free cloth. Allow components to air dry if necessary.
  2. Reassemble the Tank

    1. Once the components are dry, carefully reassemble the gelatin solution preparation tank and all related parts according to the labeling provided during disassembly.

5.5 Post-Cleaning Inspection

After cleaning and reassembly, perform an inspection to ensure that the tank is properly cleaned:

  1. Inspect for Residual Gelatin

    1. Visually inspect the tank and components for any remaining gelatin residues. If any residues are found, repeat the cleaning process.
  2. Check for Proper Reassembly

    1. Ensure that all components are correctly reassembled and secured before starting the machine.
  3. Run Test Batch

    1. Run a small test batch to verify that the tank is functioning properly and that no contamination remains from the previous batch.
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5.6 Documentation

Document the cleaning process for traceability and compliance purposes:

  1. Complete Cleaning Log

    1. Record all details of the cleaning process, including the cleaning date, operator, components cleaned, and any issues or observations, in the Cleaning Log (Annexure-1).
  2. Record 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 Disassembled and cleaned gelatin solution preparation tank No residue found

Annexure-2: Equipment Inspection Log

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Gelatin Tank 001 02/02/2025 No defects found, tank fully operational Jane Smith 02/02/2026

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Gelatin Tank 001 02/02/2025 Checked and cleaned the heating system 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 procedure and added inspection details Improved documentation and accuracy QA Head
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