appropriate cleaning agents, ensuring no residue is left on the machine.

Quality Control (QC) Team: Responsible for inspecting the cleaned sorting machine to ensure that no residues remain and that the machine is ready for the next production run.

Quality Assurance (QA) Team: Ensures compliance with GMP standards and reviews cleaning logs to confirm that cleaning was carried out according to the SOP.

Production Supervisor: Oversees the cleaning process and ensures that it is carried out properly and in accordance with the cleaning schedule.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring the cleaning of the size sorting machines is completed as per the established SOP. The QA Manager ensures that the cleaning process adheres to GMP standards and that all cleaning and inspection records are accurately maintained.

5. Procedure

5.1 Preparation for Cleaning Capsule Size Sorting Machines

Before beginning the cleaning process, ensure the following steps are completed:

1. Turn Off and Disconnect Equipment
   1. Turn off the capsule size sorting machine and disconnect it from the power supply to prevent electrical hazards during cleaning.
   2. Remove any remaining capsules or material from the machine and surrounding areas.
2. Gather Cleaning Materials
   1. Collect all necessary cleaning agents such as detergents, disinfectants, and non-abrasive cleaning tools like brushes, cloths, and sponges.
   2. Ensure that the cleaning agents are safe for use on the machine and effective in removing any residues without damaging the machine components.
3. Inspect the Sorting Machine
   1. Inspect the machine for visible contamination, powder build-up, or other residues that need special attention during cleaning.
   2. Note any areas that require additional cleaning effort, especially if the machine is used for handling multiple capsule sizes.

5.2 Cleaning Process for Capsule Size Sorting Machines

Follow these steps to clean the size sorting machine effectively:

1. Initial Rinse
   1. Rinse the external surfaces of the machine with warm water to remove any loose particles or debris.
   2. If necessary, rinse internal components of the machine using a gentle flow of warm water to remove powder or residue that may have been left behind.
2. Apply Cleaning Solution
   1. Apply an appropriate cleaning solution to the external and internal surfaces of the machine.
   2. Use soft brushes or sponges to scrub surfaces that are prone to material build-up or contamination.
   3. Ensure that all surfaces of the machine, including rollers, sorting components, and conveyors, are thoroughly cleaned.
3. Rinse with Clean Water
   1. Rinse all components of the machine thoroughly with clean water to remove any detergent and cleaning solution residues.
   2. Ensure that all cleaning agents are completely rinsed away to avoid any interference with the next batch.
4. Disinfect (if required)
   1. If necessary, apply a disinfectant to the cleaned machine surfaces to eliminate any potential microbial contamination.
   2. Allow the disinfectant to sit for the recommended duration and then rinse thoroughly with clean water.
5. Dry the Equipment
   1. Wipe down the cleaned parts of the machine using clean, lint-free cloths to remove excess moisture.
   2. If necessary, use compressed air or drying equipment to ensure the machine is completely dry before reassembly.

5.3 Post-Cleaning Inspection

After cleaning, inspect the machine to ensure it is properly cleaned and free from residues:

1. Visual Inspection
   1. Visually inspect all parts of the machine for cleanliness. Ensure that no powder, residues, or cleaning agents are left on the surfaces.
   2. If any contamination is detected, repeat the cleaning process and document the discrepancy in the Cleaning Log (Annexure-1).
2. Check for Proper Reassembly
   1. Ensure that all parts of the sorting machine are reassembled properly and are functioning correctly.
   2. Perform a functional check of the machine to ensure all components are working as intended.
3. Document Cleaning Results
   1. Document the results of the cleaning process, including the date, operator details, and any issues encountered, in the Cleaning Log (Annexure-1).

5.4 Documentation

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

1. Complete Cleaning Log
   1. Document all cleaning actions, including the date, equipment cleaned, operator, and any discrepancies found in the Cleaning Log (Annexure-1).
2. Inspection Report
   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. Post-Cleaning Inspection Report (Annexure-2)

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	Completed cleaning of capsule size sorting machine	No residue found

Annexure-2: Post-Cleaning Inspection Report

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Size Sorting Machine 001	02/02/2025	Clean and ready for use	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 procedures	QA Head