and verifies that the systems are free from contamination before they are put into operation.

Quality Assurance (QA) Team: Reviews cleaning documentation for accuracy and completeness and verifies that the cleaning process is compliant with regulatory and GMP requirements.

Maintenance Team: Inspects heating systems 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 heating systems in gelatin preparation tanks are cleaned according to this SOP. The QA Manager is responsible for reviewing the cleaning documentation and ensuring compliance with GMP standards.

5. Procedure

5.1 Preparation for Cleaning Heating Systems

Before cleaning begins, ensure that the following preparations are made:

1. Turn Off and Isolate Equipment
   1. Ensure that the heating system is turned off and disconnected from any power supply. Isolate it from the gelatin preparation tank and other connected systems.
   2. Ensure that the system is not pressurized, and that there is no steam or hot liquid present in the system.
2. Gather Cleaning Materials
   1. Collect all necessary cleaning materials, including cleaning agents, brushes, cloths, and disinfectants suitable for the heating system components.
   2. Ensure that all cleaning agents used are safe for the heating system materials and will not cause corrosion or damage.
3. Inspect Heating System
   1. Perform an initial inspection of the heating system to check for any visible contamination, leaks, or wear and tear that may require special attention during cleaning.
   2. Document any issues or necessary maintenance in the Equipment Maintenance Log (Annexure-1).

5.2 Cleaning Process for Heating Systems

Follow these steps to clean the heating systems connected to the gelatin preparation tanks:

1. Remove Dust and Debris
   1. Use a vacuum cleaner or soft brush to remove any dust, powder, or other debris from the heating system, including external pipes, temperature control units, and heating elements.
   2. Ensure that all areas, especially those that come into contact with gelatin, are cleared of debris to prevent contamination.
2. Apply Cleaning Solution
   1. Apply a cleaning solution to the machine parts. Make sure the solution is suitable for use on the heating elements, pipes, and any other components of the heating system.
   2. Gently scrub the surfaces using a non-abrasive brush or cloth to remove any gelatin residues or dirt buildup.
3. Flush with Water
   1. After cleaning, flush the system with clean water to remove any remaining cleaning agents and residues. Ensure that all components are thoroughly rinsed.
   2. Check the system for any visible residue or cleaning solution left behind after flushing.
4. Disinfect the Heating System
   1. If required, apply a disinfectant solution to the heating system components and allow it to sit for the recommended duration.
   2. Rinse the system again to remove any disinfectant residues before allowing the system to dry.
5. Dry Heating System Components
   1. Dry all parts of the heating system using clean, lint-free cloths or by using air drying methods.
   2. Ensure that no moisture remains on any components before the system is reassembled and put back into service.

5.3 Post-Cleaning Inspection

After cleaning, perform a thorough inspection to verify that the heating system is clean and ready for use:

1. Visual Inspection
   1. Inspect all components of the heating system to ensure that there is no visible contamination, residue, or moisture left on any parts.
   2. Check for any damage or wear that may have occurred during the cleaning process and require maintenance.
2. Functional Check
   1. Test the heating system to ensure that all components are functioning properly and that there are no leaks, blockages, or malfunctioning parts.
3. Document Cleaning Results
   1. Record the results of the post-cleaning inspection, including the date, operator name, and any corrective actions taken, in the Equipment Inspection Log (Annexure-2).

5.4 Documentation

Ensure proper documentation of the cleaning process for traceability and compliance:

1. Complete Cleaning Log
   1. Record all cleaning actions, including the date, operator name, and cleaning actions performed, in the Cleaning Log (Annexure-2).
2. Post-Cleaning Inspection Report
   1. Complete the Post-Cleaning Inspection Report (Annexure-3) documenting the inspection results and confirming that the heating system is ready for use.

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 heating system	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