ensures that it is carried out according to the SOP, and ensures that the equipment is fit for the next batch.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule filling machines are properly cleaned according to this SOP and that the cleaning process is documented and reviewed. The Maintenance Team is responsible for ensuring that any necessary repairs or maintenance are completed during cleaning. The QA Manager is responsible for confirming that the cleaning procedure meets all GMP standards.

5. Procedure

5.1 Preparation for Cleaning

Before beginning the cleaning process, the following preparations should be made:

1. Ensure the Machine is Stopped
   1. Ensure that the machine is turned off and that the power is disconnected to avoid any accidents during cleaning.
2. Gather Cleaning Materials
   1. Collect all necessary cleaning materials, including water, approved cleaning agents, brushes, lint-free cloths, and any required PPE (Personal Protective Equipment).
   2. Ensure that cleaning agents are non-corrosive and safe for the capsule filling machine components.
3. Prepare Cleaning Log
   1. Prepare the Cleaning Log (Annexure-1) where all cleaning actions and observations will be recorded.

5.2 Disassembly of Capsule Filling Machine

If required, the following steps should be followed to disassemble the parts of the capsule filling machine that need cleaning:

1. Remove All Product Contact Parts
   1. Remove all parts that come into direct contact with the capsule fill, such as the dosing discs, fill plates, hopper, and any tools or feeders.
2. Ensure Proper Labeling of Removed Parts
   1. Label all disassembled parts clearly to ensure that they are reassembled in the correct order after cleaning.
3. Place Parts in Appropriate Cleaning Stations
   1. Place all disassembled parts in designated cleaning stations to ensure that the cleaning process is carried out effectively.

5.3 Cleaning Process

Follow these steps to clean the capsule filling machine and its components:

1. Clean All Components
   1. Use a non-abrasive brush to remove any residual powder or product from the components. Pay special attention to areas that are difficult to reach, such as the hopper and dosing mechanism.
   2. Wipe all parts with a lint-free cloth to remove any remaining dust, powder, or cleaning solution.
2. Rinse with Water
   1. Rinse all components with warm water to remove any cleaning solution residues.
   2. Ensure that all parts are thoroughly rinsed and there are no traces of cleaning chemicals left on any surfaces.
3. Use Approved Cleaning Agents
   1. Apply approved cleaning agents to remove any sticky or residual substances that cannot be removed with water alone. Follow the manufacturer’s instructions on the use of cleaning agents.
   2. Ensure that the cleaning agents used are compatible with the machine parts and do not cause damage or degradation of the material.
4. Disinfect All Components
   1. If required, disinfect the components after cleaning to prevent microbial contamination.

5.4 Drying and Reassembly

After cleaning, the components must be dried and reassembled:

1. Dry All Components
   1. Ensure that all components are dried thoroughly using a clean, dry, lint-free cloth. Allow components to air dry if necessary.
2. Reassemble the Machine
   1. Once all components are dry, carefully reassemble the capsule filling machine, following the labels placed during disassembly.

5.5 Post-Cleaning Inspection

After the cleaning process, the following checks should be performed:

1. Inspect for Any Residues
   1. Visually inspect the machine for any residues of product or cleaning solution. If any residues are found, repeat the cleaning process as necessary.
2. Check the Machine for Proper Assembly
   1. Ensure that all parts are correctly reassembled and secured before starting the machine.
3. Run a Test Batch
   1. Run a small test batch to verify that the machine is functioning properly and that no contamination remains from the previous batch.

5.6 Documentation

Ensure all actions related to cleaning are documented properly:

1. Record Cleaning Details
   1. Document the details of the cleaning process, including date, time, operator, and any issues or deviations in the Cleaning Log (Annexure-1).
2. Record Inspection Results
   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

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Continuing from SOP 111: SOP for Cleaning Capsule Filling Machines After Batch Completion:

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	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 filling machine components	No residue found

Annexure-2: Equipment Inspection Log

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Filling 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
Filling Machine 001	02/02/2025	Recalibrated filling system and cleaned internal components	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 details	Improved accuracy and compliance	QA Head