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.

5. Procedure

5.1 Preparation for Sanitization

Before beginning 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, 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. Prepare the Sanitization Log (Annexure-1) to document all actions taken, including the date, operator, and any observations or deviations from the standard procedure.

5.2 Disassembling the Storage Containers

If applicable, disassemble the storage containers for effective 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 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 previous batches.
   2. Ensure that all internal and external surfaces are rinsed thoroughly.
2. Apply Sanitizing Agent
   1. Apply an approved sanitizing 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 the containers and components thoroughly with warm water to remove all sanitizing agents and residues.
   2. Ensure that no sanitizing agents remain on the surfaces of the containers.
4. Disinfection (If Required)
   1. If required, 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.

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. After the components are dry, carefully reassemble the storage containers, ensuring that 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).

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