that there are no residues or contaminants left in the equipment.

Quality Assurance (QA) Team: Ensures that the cleaning process complies with GMP standards and that documentation is complete and accurate.

Production Supervisor: Oversees the cleaning process, ensures that the machine is reassembled properly, and verifies that the machine is ready for the next batch of capsules.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule sealing machines are cleaned in accordance with this SOP. The Maintenance Team is responsible for any necessary repairs or maintenance during cleaning. The QA Manager ensures that the cleaning process is in compliance with GMP standards and verifies that all necessary documentation is maintained.

5. Procedure

5.1 Preparation for Cleaning

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

1. Turn Off the Machine
   1. Ensure that the capsule sealing machine is turned off and that the power supply is disconnected to avoid accidents during cleaning.
2. Gather Cleaning Materials
   1. Collect the required cleaning materials, including warm water, approved cleaning agents, brushes, lint-free cloths, sponges, and any required Personal Protective Equipment (PPE).
   2. Ensure that all cleaning agents used are safe for the sealing machine’s components and are non-corrosive.
3. Prepare Cleaning Log
   1. Prepare the Cleaning Log (Annexure-1) to record the cleaning actions, time, operator, and any observations or deviations encountered during the process.

5.2 Disassembling the Capsule Sealing Machine

If necessary, disassemble parts of the sealing machine to ensure thorough cleaning:

1. Remove Sealing Components
   1. Carefully remove the sealing components, such as the sealing wheels, plates, and any other parts that come into direct contact with the capsules during the sealing process.
2. Label Disassembled Parts
   1. Label each disassembled part to ensure that they are reassembled correctly after cleaning.
3. Place Parts in Cleaning Stations
   1. Place all disassembled components in designated cleaning stations where they will be cleaned effectively.

5.3 Cleaning Process

Follow the steps below to clean the capsule sealing machine:

1. Initial Rinse
   1. Rinse the capsule sealing machine and all its components with warm water to remove any gelatin residue or sealing material.
   2. Ensure that all areas, including those hard to reach, are properly rinsed.
2. Apply Cleaning Agents
   1. Apply a non-abrasive, approved cleaning agent to all surfaces of the machine and components.
   2. Use brushes or sponges to scrub surfaces, ensuring that no residue remains on any part of the machine.
3. Rinse with Warm Water
   1. Rinse all components thoroughly with warm water to remove all cleaning agents and residues.
   2. Ensure that no cleaning chemicals are left behind.
4. Disinfect (If Required)
   1. If required, apply an appropriate disinfectant to all machine surfaces to prevent microbial contamination.
   2. Ensure that the disinfectant is suitable for use on capsule sealing machines and is used in accordance with the manufacturer’s guidelines.
5. Final Rinse
   1. Perform a final rinse with warm water to ensure no disinfectant or cleaning agents remain on the equipment.

5.4 Drying and Reassembly

After the cleaning process, proceed with drying and reassembly:

1. Dry the Components
   1. Dry all cleaned components with a clean, dry, lint-free cloth. Allow components to air dry if necessary.
2. Reassemble the Equipment
   1. Once the components are dry, carefully reassemble the capsule sealing machine, ensuring that all parts are properly secured and aligned.

5.5 Post-Cleaning Inspection

After cleaning and reassembly, perform the following checks:

1. Inspect for Residual Contamination
   1. Visually inspect all parts of the sealing machine for any remaining residues of sealing material, gelatin, or cleaning agents. If any residue is found, repeat the cleaning process.
2. Check for Proper Reassembly
   1. Ensure that all components are correctly reassembled and secure before starting the machine.
3. Run a Test Batch
   1. Run a small test batch of capsules to ensure that the sealing machine is functioning properly and no contamination remains from the previous batch.

5.6 Documentation

Document the cleaning process for compliance and traceability:

1. Record Cleaning Details
   1. Document all cleaning actions, including the cleaning date, operator, actions taken, and any deviations observed in the Cleaning Log (Annexure-1).
2. Record Post-Cleaning Inspection
   1. Record 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 capsule sealing machine components	No residue found

Annexure-2: Equipment Inspection Log

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Sealing Machine 001	02/02/2025	No defects found, machine fully operational	Jane Smith	02/02/2026

Annexure-3: Maintenance Log

Equipment ID	Maintenance Date	Maintenance Activity	Performed By	Next Maintenance Due
Sealing Machine 001	02/02/2025	Recalibrated sealing pressure and cleaned internal components	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	Added inspection and reassembly details	Improved cleaning process accuracy	QA Head