residues are left on the equipment and that the equipment is safe for the next production run.

Quality Assurance (QA) Team: Ensures compliance with GMP regulations and reviews all cleaning documentation for completeness and accuracy.

Maintenance Team: Inspects the machines after cleaning to ensure that all components are functioning correctly and that no damage occurred during the cleaning process.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that all capsule shell manufacturing machines are cleaned according to this SOP. The QA Manager is responsible for ensuring compliance with GMP and reviewing the cleaning documentation.

5. Procedure

5.1 Preparation for Cleaning Capsule Shell Manufacturing Machines

Before starting the cleaning process, ensure that the following preparations are made:

1. Turn Off and Isolate Equipment
   1. Ensure that the capsule shell manufacturing machine is turned off and safely isolated from any power, air, or liquid supplies.
   2. Disconnect any hoses or attachments to prevent contamination during cleaning.
2. Gather Cleaning Materials
   1. Collect the necessary cleaning materials, including detergents, cleaning brushes, microfiber cloths, non-abrasive sponges, and disinfectants.
   2. Ensure that all cleaning agents are compatible with the machine components and will not damage them.
3. Inspect the Machine
   1. Inspect the capsule shell manufacturing machine for any visible contamination, product residues, or damage that needs special attention during cleaning.
   2. Document any issues that may require maintenance or additional cleaning in the Equipment Maintenance Log (Annexure-1).

5.2 Cleaning Process for Capsule Shell Manufacturing Machines

Follow these steps to clean the capsule shell manufacturing machine:

1. Remove Dust and Debris
   1. Using a vacuum cleaner or soft brush, remove any dust, particles, or debris from all external and internal parts of the machine, including molds, trays, and mixing chambers.
   2. Ensure that no debris is left in areas that could obstruct airflow or contaminate future production batches.
2. Apply Cleaning Solution
   1. Apply an appropriate cleaning solution to all machine surfaces that require cleaning, such as the gelatin preparation area, molds, and conveyor systems.
   2. Use a non-abrasive cloth or sponge to scrub surfaces and remove product residues, paying special attention to hard-to-reach areas.
3. Rinse and Remove Residues
   1. Rinse all cleaned areas thoroughly with clean water to remove any remaining cleaning agents or residues.
   2. Ensure that no cleaning solution remains on the machine components to avoid contamination during the next production cycle.
4. Disinfect Machine Parts
   1. If required, disinfect the machine parts using an approved disinfectant. Allow the disinfectant to sit for the recommended duration.
   2. After disinfecting, rinse all components again with clean water to remove any disinfectant residues.
5. Dry Machine Components
   1. Use a clean, lint-free cloth to wipe down all parts of the machine, ensuring that no moisture remains on any component.
   2. Alternatively, use compressed air or a drying unit to dry all parts of the machine.

5.3 Post-Cleaning Inspection

After the cleaning process, inspect the machine to ensure it is properly cleaned and ready for use:

1. Visual Inspection
   1. Perform a visual inspection of the capsule shell manufacturing machine, ensuring that all surfaces are clean and free of residues, cleaning agents, or moisture.
   2. Check that all parts, including molds, trays, and conveyors, are properly cleaned and free from contamination.
2. Functional Check
   1. Test the machine’s functionality to ensure that all components are working as expected, and that there is no clogging, leakage, or malfunctioning parts.
3. Document Cleaning Results
   1. Record the cleaning process in the Cleaning Log (Annexure-2), documenting the date, operator name, cleaning actions performed, and any observations or issues encountered during the cleaning process.

5.4 Documentation

All cleaning activities should be documented thoroughly for compliance and traceability:

1. Complete Cleaning Log
   1. Document the cleaning actions in the Cleaning Log (Annexure-2), ensuring that all fields are completed and signed by the operator.
2. Post-Cleaning Inspection Report
   1. Complete the Post-Cleaning Inspection Report (Annexure-3), documenting the results of the inspection, any issues found, and corrective actions taken.

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-2)
2. Post-Cleaning Inspection Report (Annexure-3)
3. Equipment Maintenance Log (Annexure-1)

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-2: Cleaning Log

Batch ID	Cleaning Date	Operator	Cleaning Action	Comments
Batch 001	02/02/2025	John Doe	Completed cleaning of capsule shell manufacturing machine	No issues found

Annexure-3: Post-Cleaning Inspection Report

Machine ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Machine 001	02/02/2025	Clean and ready for use	Jane Smith	02/02/2026

Annexure-1: Equipment Maintenance Log

Machine ID	Maintenance Date	Maintenance Details	Operator	Next Inspection Date
Machine 001	02/02/2025	Routine maintenance and cleaning	Jane Smith	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 process steps	Improved cleaning methodology	QA Head