Ensures that any necessary mechanical repairs are performed during the cleaning process and that the inspection machine is reassembled correctly.

Production Supervisor: Oversees the cleaning process, ensures proper reassembly, and confirms that the inspection machine is ready for the next batch of capsules.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule inspection machines are cleaned in accordance with this SOP. The Maintenance Team is responsible for performing any necessary repairs. The QA Manager ensures that the cleaning process meets GMP standards and that all documentation is complete.

5. Procedure

5.1 Preparation for Cleaning

Before beginning the cleaning process, ensure the following preparations are made:

1. Turn Off the Machine
   1. Ensure that the capsule inspection machine is turned off and that the power supply is disconnected to avoid any electrical hazards during cleaning.
2. Gather Cleaning Materials
   1. Collect necessary cleaning materials such as warm water, approved cleaning agents, lint-free cloths, soft brushes, and any required Personal Protective Equipment (PPE) for safety.
   2. Ensure that the cleaning agents used are non-corrosive and compatible with the machine’s materials.
3. Prepare Cleaning Log
   1. Ensure that the Cleaning Log (Annexure-1) is ready to record all actions taken, time, operator, and any issues observed during cleaning.

5.2 Disassembling the Capsule Inspection Machine

If necessary, disassemble parts of the inspection machine to facilitate thorough cleaning:

1. Remove Components for Cleaning
   1. Carefully remove parts such as the inspection cameras, conveyors, sensors, and any other components that may come into direct contact with the capsules or dust during the inspection process.
2. Label Disassembled Parts
   1. Label all disassembled parts to ensure that they are reassembled correctly after cleaning.
3. Place Parts in Cleaning Stations
   1. Place all disassembled parts in the designated cleaning stations where they will be cleaned properly.

5.3 Cleaning Process

Follow these steps to clean the capsule inspection machine:

1. Initial Rinse
   1. Rinse the capsule inspection machine and all components with warm water to remove any residual capsule debris, dust, or other contaminants.
   2. Ensure that all areas, including hard-to-reach sections, are thoroughly rinsed.
2. Apply Cleaning Agents
   1. Apply a mild, non-abrasive cleaning agent to all surfaces of the machine. Use brushes to scrub the surfaces and remove any remaining residue.
3. Rinse with Warm Water
   1. Rinse all parts thoroughly with warm water to remove any cleaning agent and residues from the machine.
   2. Ensure that no cleaning chemicals are left on any components.
4. Disinfect (If Required)
   1. If required, apply an appropriate disinfectant to all surfaces to prevent microbial contamination.
   2. Follow the manufacturer’s guidelines for disinfectant use.
5. Final Rinse
   1. Perform a final rinse with clean warm water to ensure that no disinfectant or cleaning agent remains on the equipment.

5.4 Drying and Reassembly

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

1. Dry the Components
   1. Dry all cleaned components using a clean, dry, lint-free cloth. If necessary, allow parts to air dry.
2. Reassemble the Equipment
   1. Once all parts are completely dry, carefully reassemble the capsule inspection machine following the labeling placed during disassembly.

5.5 Post-Cleaning Inspection

After cleaning and reassembly, perform the following checks:

1. Inspect for Residual Contamination
   1. Visually inspect all parts for any remaining cleaning agents, dust, or capsule residue. If contamination is found, repeat the cleaning process.
2. Check Reassembly
   1. Ensure that all parts are properly reassembled and securely fastened before starting the machine.
3. Run Test Batch
   1. Run a small test batch to ensure that the inspection machine is functioning correctly and that no contamination remains.

5.6 Documentation

Document the cleaning process for compliance and traceability:

1. Complete Cleaning Log
   1. Record all cleaning actions, including date, time, operator, cleaning actions, and any observations, 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 inspection machine components	No residue found

Annexure-2: Equipment Inspection Log

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Inspection 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
Inspection Machine 001	02/02/2025	Recalibrated sensors and cleaned inspection 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	Added inspection and reassembly details	Improved cleaning process accuracy	QA Head