Capsule: SOP for Cleaning Manual Capsule Filling Tools – V 2.0

Auditor

1 week ago

Standard Operating Procedure for Cleaning Manual Capsule Filling Tools

Department	Capsule Manufacturing
SOP No.	SOP/CM/145/2025
Supersedes	SOP/CM/145/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedure for cleaning manual capsule filling tools. These tools, such as manual capsule fillers, tampers, and capsule trays, are integral to the capsule manufacturing process. Proper cleaning is essential to prevent contamination, maintain GMP standards, and ensure that tools are free from product residues, ensuring the safety and quality of the capsules produced.

2. Scope

This SOP applies to all manual capsule filling tools used in capsule production, including but not limited to manual capsule filling machines, trays, tampers, and other related components. The cleaning process described herein ensures that all tools are cleaned after each production run, before reuse, and after maintenance.

3. Responsibilities

Production Operators: Responsible for cleaning manual capsule filling tools according to this SOP and ensuring all equipment is free from contamination before and after use.
Cleaning Staff: Assists in the cleaning of tools, ensuring all steps are followed properly, and reports any issues during cleaning to the production supervisor.
Quality Control (QC) Team: Verifies that cleaning procedures have been properly followed and that tools are free from residues and contamination.
Quality Assurance (QA) Team: Ensures compliance with this SOP, reviews cleaning documentation, and ensures that all cleaning actions meet GMP and regulatory standards.
Production Supervisor: Oversees cleaning activities, ensures that the SOP is followed, and ensures that cleaning records are accurately maintained.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that manual capsule filling tools are cleaned according to this SOP. The QA Manager is responsible for ensuring that all cleaning documentation is properly reviewed and that the cleaning process complies with GMP standards.

5. Procedure

5.1 Preparation for Cleaning Manual Capsule Filling Tools

Before cleaning begins, the following steps must be performed:

Turn Off and Isolate Equipment
1. Ensure that all manual capsule filling equipment is turned off and properly isolated from any power or air supply.
2. Disconnect all tools and equipment that are to be cleaned, ensuring no operational risks while cleaning.
Gather Cleaning Materials
1. Collect the appropriate cleaning agents, such as detergents, non-abrasive cleaning cloths, brushes, and disinfectants suitable for the tools to be cleaned.
2. Ensure that the cleaning agents are safe for the materials the tools are made of and will not cause any damage or degradation.
Inspect Tools for Visible Contamination
1. Before cleaning, visually inspect the tools for any visible residues, dust, or particles that need to be removed.
2. Document any unusual issues or tool damage that may require additional attention during the cleaning process in the Equipment Maintenance Log (Annexure-1).

5.2 Cleaning Process for Manual Capsule Filling Tools

Follow these steps to clean manual capsule filling tools properly:

Remove Residues and Dust
1. Use a soft brush or vacuum cleaner to remove any loose dust or powder from the tools.
2. Ensure that all areas of the tools, especially those that come into direct contact with capsules or powders, are free from any loose particles.
Apply Cleaning Solution
1. Apply the appropriate cleaning solution to the tools, ensuring that it is suitable for removing residues without damaging the equipment.
2. Use a non-abrasive sponge or cloth to scrub the tools, focusing on areas where residues may have accumulated, such as tray compartments or tool edges.
Rinse with Clean Water
1. Rinse the tools with clean water to remove any cleaning solution residues, ensuring all surfaces are thoroughly rinsed.
2. Ensure that no cleaning solution remains on the tools as it may affect the next batch of capsules or contaminate the equipment.
Disinfect Tools (If Required)
1. If necessary, apply a disinfectant to all surfaces of the tools and allow it to remain for the recommended contact time.
2. After disinfecting, rinse the tools again to remove any disinfectant residue.
Dry the Tools
1. After cleaning, dry all parts of the tools using a clean, lint-free cloth or air-dry them using a drying unit to ensure they are free from moisture.
2. Ensure that the tools are completely dry before reassembling or returning them to use to avoid product contamination.

5.3 Post-Cleaning Inspection

After cleaning, inspect the manual capsule filling tools to ensure they are properly cleaned and ready for use:

Visual Inspection
1. Inspect all tools for cleanliness, ensuring there are no residues, cleaning agents, or moisture left on the surfaces.
2. Check that all components are intact and in good condition, and that no cleaning residues remain in hard-to-reach areas.
Functional Check
1. Test the operation of the tools to ensure that they function correctly, particularly any moving parts or components.
Document the Results
1. Document the results of the post-cleaning inspection, including the date, operator, and any corrective actions taken, in the Equipment Inspection Log (Annexure-2).

5.4 Documentation

Ensure that all cleaning activities are properly documented for traceability and compliance:

Cleaning Log
1. Record all cleaning actions, including the date, operator name, and cleaning steps, in the Cleaning Log (Annexure-2).
Post-Cleaning Inspection Report
1. Complete the Post-Cleaning Inspection Report (Annexure-3), documenting the inspection results and confirming that the tools are 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

Cleaning Log (Annexure-2)
Post-Cleaning Inspection Report (Annexure-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 manual capsule filling tools	No issues found

Annexure-3: Post-Cleaning Inspection Report

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

Annexure-1: Equipment Maintenance Log

Tool ID	Maintenance Date	Maintenance Details	Operator	Next Inspection Date
Tool 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 steps and documentation process	Improved cleaning and documentation process	QA Head