Capsule: SOP for Sanitizing Capsule Storage Containers – V 2.0

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Capsule: SOP for Sanitizing Capsule Storage Containers – V 2.0

Standard Operating Procedure for Sanitizing Capsule Storage Containers

Department Capsule Manufacturing
SOP No. SOP/CM/121/2025
Supersedes SOP/CM/121/2022
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 procedure for sanitizing capsule storage containers used during the capsule manufacturing process. Proper sanitization ensures that containers are free from contaminants and prevents cross-contamination between batches, ensuring the integrity and quality of the final product.

2. Scope

This SOP applies to all capsule storage containers used to store capsules during and after the production process. The procedure described ensures that the containers are sanitized before being used for storage in subsequent batches.

3. Responsibilities

  • Production Operators: Responsible for disassembling, cleaning, and sanitizing the storage containers according to this SOP.
  • Quality Control (QC) Team: Verifies the sanitization process, ensuring that the containers are free of any contaminants or residues.
  • Quality Assurance (QA) Team: Ensures compliance with GMP standards and reviews the sanitization logs for completeness and accuracy.
  • Production Supervisor: Oversees the sanitization process, ensuring adherence to this SOP, and confirms that the sanitized containers are ready for use.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the storage containers are sanitized in accordance with this SOP. The QA Manager ensures compliance with GMP and confirms that the sanitization process is appropriately documented.

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5. Procedure

5.1 Preparation for Sanitization

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

  1. Turn Off the Equipment

    1. Ensure that the storage containers are empty and removed from the production line. Power down any automated systems connected to the containers, if applicable.
  2. Gather Sanitization Materials

    1. Collect all necessary sanitization materials, including approved sanitizing agents, clean water, soft brushes, lint-free cloths, sponges, and appropriate Personal Protective Equipment (PPE).
    2. Ensure that the sanitizing agents are compatible with the material of the containers and effective for microbial control.
  3. Prepare Sanitization Log

    1. Ensure that the Sanitization Log (Annexure-1) is ready to record all actions taken, including the date, operator, and any observations or deviations during the process.

5.2 Disassembling the Storage Containers

If applicable, disassemble the storage containers for proper sanitization:

  1. Remove Components for Cleaning

    1. Carefully disassemble any removable parts of the storage containers, such as lids, seals, or trays, to ensure complete cleaning and sanitization.
  2. Label Parts for Reassembly

    1. Label each disassembled component to ensure correct reassembly after sanitization.
  3. Place Parts in Sanitization Area

    1. Place the disassembled parts in the designated sanitization areas or stations for cleaning.

5.3 Sanitization Process

Follow these steps for the sanitization of capsule storage containers:

  1. Initial Rinse

    1. Rinse the containers and their components with warm water to remove any visible dust, debris, or residues from the previous batch.
    2. Ensure that all internal and external surfaces are rinsed thoroughly.
  2. Apply Sanitizing Agent

    1. Apply an approved, mild, non-abrasive cleaning agent to all parts of the storage containers. Use soft brushes to scrub the surfaces, ensuring that the entire container and components are cleaned properly.
  3. Rinse with Water

    1. Rinse all parts thoroughly with warm water to remove any cleaning agents and contaminants.
    2. Ensure that no cleaning agents remain on the surfaces of the containers.
  4. Disinfection (If Required)

    1. If necessary, apply an appropriate disinfectant to the storage containers to eliminate any microbial contaminants.
    2. Follow the manufacturer’s instructions for the correct dilution and application of the disinfectant.
  5. Final Rinse

    1. Perform a final rinse with clean water to remove any disinfectant or cleaning agents remaining on the containers.
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5.4 Drying and Reassembly

After sanitization, proceed with drying and reassembly:

  1. Dry the Components

    1. Use a clean, dry, lint-free cloth to dry the storage containers and their components. If necessary, allow parts to air dry completely in a clean environment.
  2. Reassemble the Storage Containers

    1. Once dry, carefully reassemble the storage containers, ensuring all parts are correctly reinstalled and securely fastened.

5.5 Post-Sanitization Inspection

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

  1. Inspect for Residual Contamination

    1. Visually inspect the storage containers for any residues from cleaning agents, dust, or contaminants. If contamination is found, repeat the sanitization process.
  2. Verify Proper Reassembly

    1. Ensure that all components are properly reassembled and securely fastened.
  3. Run Test Check

    1. Conduct a test to ensure that the containers function as expected and that there is no residual contamination from the previous batch.

5.6 Documentation

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

  1. Complete Cleaning and Sanitization Log

    1. Record all cleaning and sanitization actions, including dates, times, actions performed, and operator information in the Cleaning Log (Annexure-1).
  2. Post-Sanitization Inspection

    1. Document the results of the post-sanitization 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 Sanitized storage containers No residue found

Annexure-2: Equipment Inspection Log

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

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Storage Container 001 02/02/2025 Replaced seals and cleaned the interior 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 sanitization steps and added post-sanitization inspection Improved sanitization accuracy QA Head
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