Capsule: SOP for Disassembling and Cleaning Capsule Banding Equipment – V 2.0

Auditor

1 day ago

Standard Operating Procedure for Disassembling and Cleaning Capsule Banding Equipment

Department	Capsule Manufacturing
SOP No.	SOP/CM/116/2025
Supersedes	SOP/CM/116/2022
Page No.	Page 1 of 7
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 disassembling and cleaning capsule banding equipment to ensure that no residue or contamination is left behind after each batch. Proper cleaning helps to maintain equipment performance, ensures batch quality, and meets Good Manufacturing Practices (GMP) standards.

2. Scope

This SOP applies to all capsule banding equipment used in capsule production. It covers the disassembly and cleaning procedure after each production batch to prevent cross-contamination and ensure compliance with GMP.

3. Responsibilities

Production Operators: Responsible for disassembling the capsule banding equipment, cleaning it thoroughly, and reassembling it according to this SOP.
Quality Control (QC) Team: Verifies that the equipment has been cleaned properly and that no contaminants remain.
Quality Assurance (QA) Team: Ensures that the cleaning process is compliant with GMP and verifies that all required documentation is complete.
Maintenance Team: Responsible for ensuring the equipment is in good condition and that any mechanical issues are addressed during the cleaning process.
Production Supervisor: Oversees the cleaning process, ensures adherence to this SOP, and confirms that the banding equipment is reassembled and ready for the next production run.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule banding equipment is properly disassembled, cleaned, and reassembled as per this SOP. The QA Manager is responsible for ensuring compliance with GMP standards and the proper documentation of the cleaning process.

5. Procedure

5.1 Preparation for Cleaning

Before starting the cleaning process, the following steps must be taken:

Turn Off the Equipment
1. Ensure that the capsule banding equipment is turned off and disconnected from the power source to avoid electrical hazards during cleaning.
Gather Cleaning Materials
1. Collect the necessary cleaning materials, such as warm water, approved cleaning agents, sponges, brushes, lint-free cloths, and any required PPE (Personal Protective Equipment) for safety.
2. Ensure that the cleaning agents used are safe for the equipment and non-corrosive.
Prepare Cleaning Log
1. Ensure that the Cleaning Log (Annexure-1) is ready to record all cleaning actions, the operator’s name, time, and any observations during the process.

5.2 Disassembling the Capsule Banding Equipment

If necessary, disassemble the equipment for thorough cleaning:

Remove Parts to Be Cleaned
1. Disassemble the parts that come into direct contact with the banding material, such as rollers, banding nozzles, brushes, and trays.
2. Take care to remove all parts carefully to avoid damage to sensitive components.
Label Disassembled Parts
1. Label all disassembled parts to ensure proper reassembly after cleaning.
Place Components in Cleaning Stations
1. Place all removed components in the designated cleaning stations to facilitate effective cleaning.

5.3 Cleaning Process

Follow these steps to clean the capsule banding equipment:

Initial Rinse
1. Rinse all parts of the capsule banding machine with warm water to remove any banding material, dust, or debris.
2. Ensure that all surfaces are properly rinsed, including internal parts.
Apply Cleaning Agents
1. Apply a mild, non-abrasive cleaning agent to the machine and components. Use brushes or sponges to scrub surfaces and remove any residual banding material.
Rinse with Warm Water
1. Rinse all parts thoroughly with warm water to remove any cleaning agents and contaminants.
2. Ensure that no cleaning chemicals are left on the components.
Disinfect (If Required)
1. If required, apply a disinfectant to all cleaned surfaces to prevent microbial contamination.
2. Follow the manufacturer’s guidelines for proper use and dilution of disinfectants.
Final Rinse
1. Perform a final rinse with warm water to ensure that all disinfectant and cleaning agents are removed.

5.4 Drying and Reassembly

After the cleaning process is completed, proceed with drying and reassembly:

Dry the Components
1. Use a clean, dry, lint-free cloth to dry all cleaned components. Allow parts to air dry if necessary.
Reassemble the Equipment
1. After the components are dry, reassemble the capsule banding machine following the labels placed during disassembly.

5.5 Post-Cleaning Inspection

After cleaning and reassembly, the following checks should be performed:

Inspect for Residual Contamination
1. Visually inspect the equipment for any remaining cleaning agents, dust, or banding material residue. If contamination is found, repeat the cleaning process.
Check for Proper Reassembly
1. Ensure that all components are correctly reassembled and securely fastened.
Run Test Batch
1. Run a test batch of capsules to ensure that the banding machine is working properly and there is no contamination from the previous batch.

5.6 Documentation

Ensure that the cleaning process is properly documented:

Complete Cleaning Log
1. Record all cleaning actions, including date, time, operator, cleaning activities, and any deviations or issues, in the Cleaning Log (Annexure-1).
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 banding machine components	No residue found

Annexure-2: Equipment Inspection Log

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Banding 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
Banding Machine 001	02/02/2025	Recalibrated sealing pressure 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 procedures and inspection protocols	Improved cleaning accuracy and equipment validation	QA Head