Capsule: SOP for Daily and Weekly Cleaning of Capsule Manufacturing Tools – V 2.0

Auditor

2 weeks ago

Standard Operating Procedure for Daily and Weekly Cleaning of Capsule Manufacturing Tools

Department	Capsule Manufacturing
SOP No.	SOP/CM/133/2025
Supersedes	SOP/CM/133/2022
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 provide clear guidelines for the daily and weekly cleaning of capsule manufacturing tools. This process ensures that all tools are cleaned adequately after use to prevent contamination, cross-contamination, and maintain product integrity. It also ensures compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all tools used in the capsule manufacturing process, including but not limited to mixing equipment, capsule filling machines, granulation tools, sieves, hoppers, and other auxiliary tools. It covers daily cleaning procedures for tools used in a single batch and weekly cleaning for tools used over multiple batches.

3. Responsibilities

Production Operators: Responsible for performing daily cleaning of tools after each use and ensuring that weekly cleaning is done as scheduled.
Cleaning Staff: Responsible for thoroughly cleaning tools according to the defined SOP and ensuring that the tools are free of residues and contamination.
Quality Control (QC) Team: Responsible for verifying the effectiveness of cleaning methods, ensuring that no residues remain on the tools, and performing random sampling if required.
Quality Assurance (QA) Team: Ensures compliance with GMP and reviews the cleaning records and validation results to confirm that cleaning procedures are followed correctly.
Production Supervisor: Ensures that cleaning of tools is performed according to the established schedule and resolves any cleaning-related issues promptly.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that daily and weekly cleaning of tools is conducted as per this SOP. The QA Manager is accountable for ensuring compliance with GMP and reviewing the cleaning logs for accuracy and completeness.

5. Procedure

5.1 Daily Cleaning of Capsule Manufacturing Tools

Daily cleaning must be carried out after each production batch to ensure tools are free of residues and contaminants:

Turn Off Equipment
1. Ensure that all tools and equipment are turned off and disconnected from the power supply before starting the cleaning process.
2. Remove any remaining materials or capsules from the equipment.
Gather Cleaning Materials
1. Collect all necessary cleaning agents (such as detergents and disinfectants), PPE (Personal Protective Equipment), and tools (brushes, sponges, cloths, etc.) for cleaning the tools.
2. Ensure that cleaning agents are compatible with the materials of the tools and effective in removing residues.
Disassemble Tools (if necessary)
1. If required, disassemble the tools to ensure that all components can be thoroughly cleaned. Pay attention to areas that are typically prone to material buildup.
Perform Initial Rinse
1. Rinse the tools with warm water to remove any loose dust, powders, or product residues.
2. Ensure that water flows through all surfaces, including the internal components of the tools.
Apply Cleaning Solution
1. Apply a suitable cleaning agent to all tool surfaces, paying attention to crevices and areas where residues may have accumulated.
2. Use soft brushes to scrub areas with visible residues.
Rinse with Clean Water
1. Rinse the tools with clean water to remove any cleaning agents and residues.
2. Ensure that all surfaces are thoroughly rinsed and no cleaning agents remain on the tools.
Dry the Tools
1. Wipe down the cleaned tools with clean, lint-free cloths to remove excess moisture.
2. If necessary, use air drying or fans to speed up the drying process.
Post-Cleaning Inspection
1. Inspect the tools to ensure that all residues have been removed and that no cleaning agents remain.
2. If any contamination is found, repeat the cleaning process and document the discrepancy in the Cleaning Log (Annexure-1).
Reassemble Tools
1. Reassemble the tools if necessary and verify that they are in good working condition.

5.2 Weekly Cleaning of Capsule Manufacturing Tools

In addition to daily cleaning, weekly cleaning must be performed to ensure thorough cleanliness of tools:

Disassemble and Inspect Tools
1. Disassemble all tools that require weekly cleaning. Inspect each part for signs of wear, contamination, or accumulated residues.
Perform Deep Cleaning
1. Perform a more thorough cleaning using stronger cleaning agents, if required, and scrub all parts of the tools more thoroughly than during daily cleaning.
2. Pay close attention to areas that are difficult to reach, such as internal cavities or areas with grease or sticky residues.
Inspect for Residues
1. Inspect the tools after cleaning to ensure no residues or cleaning agents remain.
2. If needed, perform a residue test using a swab sample and verify results through QC testing.
Reassemble and Test Tools
1. Reassemble the tools and ensure they are in proper working condition. Perform a test run to ensure that the tools operate smoothly without issues.

5.3 Documentation

Ensure that all cleaning actions are documented for traceability and compliance:

Complete Cleaning Log
1. Document all cleaning actions, including the date, tools cleaned, operator details, and any issues encountered, in the Cleaning Log (Annexure-1).
Inspection Records
1. Document the results of the post-cleaning inspection, including any deviations or discrepancies found during cleaning.
Validation Records
1. Keep records of weekly cleaning validation and any testing performed to ensure cleaning effectiveness.

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-1)
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 daily cleaning of capsule filling machine	No residue found

Annexure-2: Post-Cleaning Inspection Report

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Filling 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 steps and added inspection checks	Improved process clarity	QA Head