Capsule: SOP for Cleaning Sieves and Screens in Capsule Production – V 2.0

Auditor

6 days ago

Standard Operating Procedure for Cleaning Sieves and Screens in Capsule Production

Department	Capsule Manufacturing
SOP No.	SOP/CM/148/2025
Supersedes	SOP/CM/148/2022
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 describe the procedure for cleaning sieves and screens used in capsule production. Sieves and screens are critical to ensuring the quality and consistency of the materials used in capsule manufacturing. Proper cleaning of these components is essential to avoid contamination, maintain their efficiency, and meet GMP requirements.

2. Scope

This SOP applies to all sieves and screens used in the manufacturing process for capsules, including those used for powder sieving, granulation processes, and other material handling functions in capsule production. It includes cleaning steps that ensure all sieves and screens are free from residues before use in subsequent batches.

3. Responsibilities

Production Operators: Responsible for cleaning the sieves and screens according to this SOP and ensuring all parts are free from contamination before use.
Cleaning Staff: Assists with cleaning activities, ensuring that sieves and screens are thoroughly cleaned and free from material residues.
Quality Control (QC) Team: Ensures that cleaning procedures are followed properly and verifies that sieves and screens are clean and free of contamination before re-use.
Quality Assurance (QA) Team: Reviews the cleaning documentation to ensure compliance with GMP and regulatory standards and oversees the cleanliness verification process.
Maintenance Team: Inspects sieves and screens after cleaning to ensure that there is no damage and that the equipment is functioning properly.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that sieves and screens are cleaned according to this SOP. The QA Manager is responsible for reviewing the cleaning logs and ensuring that all cleaning activities comply with GMP standards.

5. Procedure

5.1 Preparation for Cleaning Sieves and Screens

Before beginning the cleaning process, ensure that the following steps are completed:

Turn Off and Isolate Equipment
1. Ensure that all sieves and screens are disconnected from any active equipment, power, or air supplies.
2. Ensure the area around the equipment is clear to prevent contamination and allow for proper cleaning.
Gather Cleaning Materials
1. Collect all necessary cleaning materials, including non-abrasive brushes, cleaning agents, disinfectants, and microfiber cloths suitable for the sieves and screens.
2. Ensure that cleaning solutions do not damage the materials of the sieves or screens.
Inspect Sieves and Screens
1. Inspect the sieves and screens for visible contamination, product residues, or damage that may require special attention during cleaning.
2. Document any damage or maintenance needs in the Equipment Maintenance Log (Annexure-1).

5.2 Cleaning Process for Sieves and Screens

Follow these steps to properly clean sieves and screens:

Remove Powder and Residues
1. Use a soft brush, compressed air, or vacuum to remove any powder, granules, or residues from the sieves and screens.
2. Ensure all surfaces, including mesh areas, are free of any remaining product particles.
Apply Cleaning Solution
1. Apply an appropriate cleaning solution to all surfaces of the sieves and screens. Use a non-abrasive sponge or cloth to scrub and remove any remaining material residues.
2. Pay special attention to the mesh areas of the screens to ensure they are free from blockages.
Rinse with Clean Water
1. Rinse the sieves and screens thoroughly with clean water to remove all cleaning solutions and residues.
2. Ensure that the rinse water does not contain any impurities that could cause contamination.
Disinfect Sieves and Screens
1. If required, apply a disinfectant solution to the sieves and screens, ensuring that the disinfectant is compatible with the equipment material.
2. Allow the disinfectant to sit for the recommended contact time and then rinse thoroughly to remove any disinfectant residues.
Dry Sieves and Screens
1. Dry the sieves and screens completely using clean, lint-free cloths or by allowing them to air dry. Ensure there is no residual moisture.
2. If necessary, use compressed air or a drying unit to speed up the drying process.

5.3 Post-Cleaning Inspection

After the cleaning process, inspect the sieves and screens to ensure they are clean and ready for use:

Visual Inspection
1. Visually inspect the sieves and screens for cleanliness, ensuring there are no residues, cleaning agents, or moisture left on any surfaces.
2. Check the mesh for any blockages or damage that could affect functionality during production.
Functional Check
1. Ensure that the sieves and screens are properly functioning, and there are no obstructions or damage that could affect their use in production.
Document Cleaning Results
1. Record the cleaning actions, inspection results, and any issues found during the inspection in the Cleaning Log (Annexure-2).

5.4 Documentation

Document all cleaning actions and inspections for traceability:

Cleaning Log
1. Document the date, operator name, and cleaning actions performed in the Cleaning Log (Annexure-2).
Post-Cleaning Inspection Report
1. Complete the Post-Cleaning Inspection Report (Annexure-3) to document the inspection results and confirm the equipment 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

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 sieves and screens	No issues found

Annexure-3: Post-Cleaning Inspection Report

Machine ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Screen 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
Screen 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 procedure steps	Enhanced cleaning methodology	QA Head