cleaning process complies with GMP standards and that the necessary documentation is properly filled out and maintained.

Maintenance Team: Ensures that any mechanical issues with the hopper bins are addressed during the cleaning process and that the bins are reassembled correctly after cleaning.

Production Supervisor: Oversees the cleaning process, verifies that the hopper bins are reassembled correctly, and ensures that the bins are ready for the next production run.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the hopper bins are cleaned following this SOP. The QA Manager is responsible for ensuring compliance with GMP and confirming that the cleaning documentation is completed and accurate.

5. Procedure

5.1 Preparation for Cleaning

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

1. Turn Off the Equipment
   1. Ensure that the hopper bin is disconnected from the capsule filling machine, and the power supply is turned off to avoid electrical hazards during cleaning.
2. Gather Cleaning Materials
   1. Collect the necessary cleaning materials, including warm water, approved cleaning agents, soft brushes, lint-free cloths, and Personal Protective Equipment (PPE) as needed for safety.
   2. Ensure that all cleaning agents are non-corrosive and compatible with the materials of the hopper bins.
3. Prepare Cleaning Log
   1. Prepare the Cleaning Log (Annexure-1) to record cleaning actions, operator details, time, and any deviations encountered during the cleaning process.

5.2 Disassembling the Hopper Bin

If necessary, disassemble the hopper bin components for thorough cleaning:

1. Remove Hopper Bin Components
   1. Carefully disassemble the hopper bin and remove any removable components such as the lids, nozzles, and funnel attachments. Take care to avoid damaging any sensitive parts.
2. Label Disassembled Parts
   1. Label each disassembled part to ensure proper reassembly after cleaning.
3. Place Components in Cleaning Stations
   1. Place all disassembled components in the designated cleaning stations to facilitate proper cleaning and ensure they are cleaned thoroughly.

5.3 Cleaning Process

Follow these steps to clean the hopper bin:

1. Initial Rinse
   1. Rinse the hopper bin and its components with warm water to remove any powder, dust, or residues from the previous batch.
   2. Ensure that all areas, including internal parts, are rinsed thoroughly.
2. Apply Cleaning Agents
   1. Apply a mild, non-abrasive cleaning agent to the hopper bin surfaces and components. Use soft brushes to scrub the surfaces and remove any remaining powder or contaminants.
3. Rinse with Warm Water
   1. Rinse all parts thoroughly with warm water to remove any cleaning agents and residues.
   2. Ensure that no cleaning chemicals remain on any part of the hopper bin.
4. Disinfect (If Required)
   1. If required, apply an appropriate disinfectant to all surfaces of the hopper bin components to prevent microbial contamination.
   2. Follow the manufacturer’s guidelines for proper dilution and application of the disinfectant.
5. Final Rinse
   1. Perform a final rinse with clean warm water to ensure that all disinfectant or cleaning agents are removed.

5.4 Drying and Reassembly

After cleaning, proceed with drying and reassembly:

1. Dry the Components
   1. Dry all cleaned components with a clean, dry, lint-free cloth. If necessary, allow parts to air dry completely.
2. Reassemble the Equipment
   1. After the components are dry, carefully reassemble the hopper bin, ensuring that all parts are correctly installed and secured following the labeling placed during disassembly.

5.5 Post-Cleaning Inspection

Once cleaning and reassembly are complete, perform the following checks:

1. Inspect for Residual Contamination
   1. Visually inspect the hopper bin and its components for any remaining cleaning agents, dust, or contaminants. If contamination is detected, repeat the cleaning process.
2. Check for Proper Reassembly
   1. Ensure that all components are correctly reassembled and securely fastened.
3. Run Test Batch
   1. Run a test batch of capsules to ensure the hopper bin is working correctly and that there are no residues or contamination left from the previous batch.

5.6 Documentation

Document the entire cleaning process for compliance and traceability:

1. Complete Cleaning Log
   1. Record all cleaning actions, including date, time, operator, actions taken, and any observations or deviations encountered during the cleaning process in the Cleaning Log (Annexure-1).
2. Post-Cleaning Inspection
   1. Document 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 hopper bin components	No residue found

Annexure-2: Equipment Inspection Log

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Hopper Bin 001	02/02/2025	No defects found, equipment fully operational	Jane Smith	02/02/2026

Annexure-3: Maintenance Log

Equipment ID	Maintenance Date	Maintenance Activity	Performed By	Next Maintenance Due
Hopper Bin 001	02/02/2025	Cleaned and calibrated material flow 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	Updated cleaning procedure and added inspection steps	Improved cleaning process and inspection accuracy	QA Head