Capsule: SOP for Cleaning Capsule Printing Machines – V 2.0

Auditor

19 hours ago

Standard Operating Procedure for Cleaning Capsule Printing Machines

Department	Capsule Manufacturing
SOP No.	SOP/CM/117/2025
Supersedes	SOP/CM/117/2022
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 procedure for cleaning capsule printing machines used in the production process. Cleaning the printing machines ensures that no printing ink, powder, or other residues remain, preventing contamination and ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all capsule printing machines used in the production of hard gelatin capsules. It covers the cleaning procedure after each production batch to ensure that the printing machine is free of contamination and complies with GMP standards.

3. Responsibilities

Production Operators: Responsible for disassembling the printing machine, cleaning the parts, and reassembling it after cleaning as per this SOP.
Quality Control (QC) Team: Ensures that the cleaning process has been completed properly and verifies that there are no residues or contaminants left on the machine.
Quality Assurance (QA) Team: Ensures that the cleaning process is compliant with GMP standards and reviews the cleaning documentation for completeness and accuracy.
Maintenance Team: Ensures that any necessary mechanical repairs are performed during cleaning and reassembles the equipment properly.
Production Supervisor: Oversees the cleaning process, ensures that the machine is reassembled correctly, and ensures that the printing machine is ready for the next production run.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule printing machines are properly cleaned according to this SOP. The QA Manager is responsible for ensuring that the cleaning process complies with GMP and verifying the cleanliness of the machine.

5. Procedure

5.1 Preparation for Cleaning

Before starting the cleaning process, ensure the following steps are completed:

Turn Off the Machine
1. Ensure that the printing machine is turned off, and the power supply is disconnected to avoid electrical hazards during cleaning.
Gather Cleaning Materials
1. Collect the necessary cleaning materials, including warm water, approved cleaning agents, brushes, lint-free cloths, sponges, and appropriate Personal Protective Equipment (PPE) for safety.
2. Ensure that the cleaning agents used are non-corrosive and safe for the materials of the printing machine.
Prepare Cleaning Log
1. Ensure the Cleaning Log (Annexure-1) is available to record the cleaning actions, operator name, time, and any deviations during the cleaning process.

5.2 Disassembling the Capsule Printing Machine

If necessary, disassemble the machine parts to ensure proper cleaning:

Remove Components for Cleaning
1. Carefully remove parts such as ink rollers, printing heads, belts, and trays. These components should be handled carefully to avoid damage.
Label Disassembled Parts
1. Label each disassembled part to ensure proper reassembly after cleaning.
Place Parts in Cleaning Stations
1. Place all removed components in the designated cleaning stations for proper washing and cleaning.

5.3 Cleaning Process

Follow these steps to clean the capsule printing machine:

Initial Rinse
1. Rinse the capsule printing machine and its components with warm water to remove any printing ink, dust, and debris.
2. Ensure all surfaces, including internal parts, are rinsed thoroughly.
Apply Cleaning Agents
1. Apply an approved, mild, non-abrasive cleaning agent to the surfaces of the machine and its components. Use brushes to scrub surfaces and remove any residual ink or debris.
Rinse with Warm Water
1. Rinse all machine parts thoroughly with warm water to remove all cleaning agents and residues.
2. Ensure that no cleaning chemicals remain on any part of the machine.
Disinfect (If Required)
1. If required, apply an appropriate disinfectant to all machine components to prevent microbial contamination. Follow the disinfectant’s instructions for proper use and dilution.
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 cleaning, proceed with drying and reassembling the equipment:

Dry the Components
1. Dry all cleaned components with a clean, dry, lint-free cloth. Allow parts to air dry if necessary.
Reassemble the Equipment
1. After drying, carefully reassemble the printing machine, ensuring all parts are correctly reinstalled following the labels placed during disassembly.

5.5 Post-Cleaning Inspection

Once the cleaning and reassembly are complete, perform the following checks:

Inspect for Residual Contamination
1. Visually inspect the machine for any remaining cleaning agents, ink, or other contaminants. If contamination is found, repeat the cleaning process.
Check for Proper Reassembly
1. Ensure that all components are properly reassembled and secure.
Run Test Batch
1. Run a small test batch of capsules to ensure that the printing machine is working correctly and that no contamination remains from the previous batch.

5.6 Documentation

Document the entire cleaning process for compliance and traceability:

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

Annexure-2: Equipment Inspection Log

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Printing 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
Printing Machine 001	02/02/2025	Recalibrated ink dispensing system 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 procedure and added post-cleaning inspection steps	Improved cleaning process accuracy	QA Head