Capsule: SOP for Cleaning Capsule Polishing Equipment – V 2.0

Auditor

2 days ago

Standard Operating Procedure for Cleaning Capsule Polishing Equipment

Department	Capsule Manufacturing
SOP No.	SOP/CM/113/2025
Supersedes	SOP/CM/113/2022
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 define the procedures for cleaning capsule polishing equipment after each production run. The cleaning process ensures that no residue remains, preventing contamination, and ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all capsule polishing equipment used in the manufacturing of hard gelatin capsules. It covers the cleaning procedure after each batch to maintain equipment cleanliness and prevent contamination during the polishing process.

3. Responsibilities

Production Operators: Responsible for performing the cleaning procedure as per this SOP, including disassembling parts if needed, cleaning, and reassembling the polishing equipment.
Quality Control (QC) Team: Responsible for verifying that the cleaning has been carried out effectively and ensuring no residual contamination is present in the equipment.
Quality Assurance (QA) Team: Ensures the compliance of the cleaning process with GMP standards, verifies the documentation, and reviews any deviations from the process.
Maintenance Team: Ensures that any mechanical components that require cleaning or maintenance are in good condition and functional.
Production Supervisor: Oversees the cleaning process, ensures all procedures are followed, and ensures the polishing equipment is reassembled properly before the next production run.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule polishing equipment is cleaned according to this SOP and that the procedure is documented. The Maintenance Team is responsible for performing any necessary maintenance during cleaning. The QA Manager is responsible for reviewing the cleaning documentation and verifying compliance with GMP standards.

5. Procedure

5.1 Preparation for Cleaning

Before beginning the cleaning process, ensure the following preparations are made:

Turn Off the Equipment
1. Ensure that the polishing machine is turned off and that the power is disconnected to avoid accidents during cleaning.
Gather Cleaning Materials
1. Collect the required cleaning materials, such as warm water, approved cleaning agents, brushes, sponges, lint-free cloths, and PPE (Personal Protective Equipment) for safety.
2. Ensure that all cleaning agents used are non-corrosive and suitable for the materials the polishing equipment is made from.
Prepare Cleaning Log
1. Prepare the Cleaning Log (Annexure-1) to record all cleaning actions, including any deviations or observations made during the cleaning process.

5.2 Disassembling the Polishing Equipment

If necessary, disassemble parts of the polishing equipment that need cleaning:

Remove Polishing Brushes and Parts
1. Remove any polishing brushes, nozzles, and other parts that are in direct contact with the capsules and polishing agents. Take care not to damage any parts during disassembly.
Label Disassembled Parts
1. Label each part that is disassembled to ensure proper reassembly after cleaning.
Place Components in Cleaning Stations
1. Place all disassembled parts in the designated cleaning stations to ensure each part is cleaned thoroughly.

5.3 Cleaning Process

Follow these steps to clean the capsule polishing equipment:

Initial Rinse
1. Rinse the polishing machine and all components with warm water to remove any excess polishing powder, gelatin, or other residues. Ensure that all surfaces, including internal parts, are rinsed properly.
Apply Cleaning Agents
1. Apply an approved cleaning agent to the surfaces of the polishing machine and components. Use brushes to scrub the components, ensuring that all residue is removed.
Rinse with Water
1. Rinse all parts thoroughly with warm water to remove any cleaning solution and debris. Ensure there are no residues left on any components.
Disinfect (If Required)
1. If necessary, apply a disinfectant to all surfaces to prevent microbial contamination. Follow the manufacturer’s instructions for proper use.
Final Rinse
1. Perform a final rinse with warm water to ensure that all disinfectant is removed and no residues remain on the equipment.

5.4 Drying and Reassembly

Once the cleaning is complete, proceed with drying and reassembly:

Dry the Equipment
1. Dry all cleaned components with a clean, dry, lint-free cloth. Allow components to air dry if needed.
Reassemble the Equipment
1. Once components are completely dry, carefully reassemble the polishing equipment according to the labels placed during disassembly.

5.5 Post-Cleaning Inspection

After cleaning and reassembly, perform the following checks:

Inspect for Residual Contamination
1. Visually inspect all parts of the polishing machine to ensure no residual powder, cleaning agent, or gelatin remains. If any residues are found, repeat the cleaning process.
Check Reassembly
1. Ensure that all parts are properly reassembled and secure before starting the machine.
Run 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

Document the cleaning process for traceability and compliance purposes:

Complete Cleaning Log
1. Record all details of the cleaning process in the Cleaning Log (Annexure-1), including cleaning actions, date, time, and any issues or observations.
Record 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

Cleaning Log (Annexure-1)
Equipment Inspection Log (Annexure-2)
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 capsule polishing equipment	No residue found

Annexure-2: Equipment Inspection Log

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Polishing Machine You said: Continue ChatGPT said: Continuing from Annexure-2: Equipment Inspection Log: html Copy	Polishing 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
Polishing Machine 001	02/02/2025	Recalibrated polishing speed, 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 cleaning process accuracy	QA Head