Capsule: SOP for Using Capsule Printing Machines – V 2.0

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Standard Operating Procedure for Using Capsule Printing Machines

Department	Capsule Manufacturing
SOP No.	SOP/CM/078/2025
Supersedes	SOP/CM/078/2022
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 establish a standardized procedure for operating capsule printing machines. This includes guidelines for the preparation, setup, operation, and maintenance of the printing machine to ensure consistent, accurate, and high-quality printing on soft gelatin capsules.

2. Scope

This SOP applies to the use of capsule printing machines in the capsule manufacturing process. It includes instructions for machine setup, operation, quality control checks, and troubleshooting to ensure the printed capsules meet the required standards.

3. Responsibilities

Machine Operators: Responsible for operating the capsule printing machine according to this SOP, ensuring accurate printing and addressing any issues during the printing process.
Quality Control (QC) Team: Responsible for inspecting the printed capsules for quality, ensuring that the printed information is legible and properly aligned, and verifying that all print meets regulatory and company standards.
Quality Assurance (QA) Team: Ensures compliance with GMP and internal quality standards for printed capsules, reviews the batch records, and approves the final printed capsules for packaging.
Maintenance Team: Responsible for maintaining and calibrating the printing machine to ensure proper functioning and addressing any mechanical issues that arise during operation.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule printing machine is used correctly according to this SOP. The QA Manager is responsible for ensuring the printed capsules meet the required quality standards.

5. Procedure

5.1 Preparation for Capsule Printing

Before starting the capsule printing process, the following preparations should be made:

Verify Capsule Type and Printing Requirements
1. Verify the type of capsule being printed (e.g., size, color, and gelatin type) and confirm the printing requirements such as the logo, text, and color.
2. Ensure that the correct print design and font size are provided, and that the printing specifications meet the formulation and regulatory guidelines.
Machine Setup
1. Set up the capsule printing machine according to the machine’s operational manual. Ensure that the printing heads, ink reservoirs, and other components are installed correctly.
2. Load the correct ink cartridges or containers that match the required color and formulation for the print.
3. Calibrate the machine to ensure proper alignment of the printing heads with the capsules.
Verify Capsule Feed Mechanism
1. Ensure that the capsule feed mechanism is functioning correctly. The capsules should move smoothly into the printing area without jamming or misalignment.
2. Adjust the speed of the feed mechanism to ensure that the capsules are printed at the correct rate.

5.2 Printing Process

Follow these steps to print on capsules:

Start Printing Process
1. Start the capsule printing machine. Ensure that the capsules are properly aligned and moving through the print heads at the correct speed.
2. Monitor the machine to ensure that the printing process is consistent and the ink is applied properly on the capsules.
Adjust Print Settings
1. If any adjustments to the printing speed, ink flow, or alignment are needed during the process, pause the machine and make the necessary changes. Restart the machine once the adjustments are complete.
Monitor Print Quality
1. During the printing process, periodically inspect the printed capsules to ensure the print is clear, legible, and free from defects such as smudging, fading, or misalignment.
2. Ensure that the ink is evenly distributed and the print is uniform across the batch.

5.3 Quality Control of Printed Capsules

Once printing is complete, perform the following quality control checks:

Visual Inspection
1. Inspect a sample of printed capsules for clarity, consistency, and alignment of the print. The print should be legible and correctly positioned on the capsule shell.
2. Check for any defects such as smearing, ink spots, or incomplete prints.
Text Legibility Test
1. Verify that all printed text is legible and matches the specifications, including font size and clarity. If text is illegible, adjust the printing machine and reprint the affected capsules.
Print Integrity Test
1. Perform adhesion tests to ensure that the ink adheres properly to the capsule shell and does not rub off during handling or packaging.

5.4 Troubleshooting Common Printing Issues

If issues are identified during the printing process, follow these troubleshooting steps:

Smudging or Ink Blurring
1. If the print smudges or becomes blurry, check the printing speed and ink flow. Adjust the speed of the machine or the amount of ink being applied to the capsules.
2. Ensure the capsules are moving smoothly through the printing heads and that there is no excessive friction or pressure on the capsules.
Misalignment of Print
1. If the print is misaligned, check the alignment of the printing heads and ensure the capsule feed mechanism is properly calibrated. Adjust the position of the print heads or capsule alignment as necessary.
Uneven Ink Distribution
1. If the ink distribution is uneven, check the ink cartridge or reservoir for any blockages or clogs. Replace or clean the ink cartridge if necessary.
2. Ensure the printing heads are functioning properly and that the ink is being distributed evenly across the capsules.

5.5 Post-Printing Actions

After the printing process is complete, perform the following actions:

Capsule Inspection
1. Inspect the entire batch of printed capsules for any defects. Ensure the print is clear, consistent, and properly aligned.
2. Remove any defective capsules from the batch and ensure that they are documented and segregated for rework or disposal.
Documentation
1. Document the capsule printing process in the batch production record (BPR). Include details such as batch number, capsule type, print specifications, any deviations, and corrective actions taken during the printing process.
Transfer to Packaging
1. Once the capsules are inspected and approved, transfer them to the packaging area. Ensure that the capsules are handled carefully to prevent damage to the print.

5.6 Maintenance and Cleaning of Capsule Printing
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5.6 Maintenance and Cleaning of Capsule Printing Machines

After completing the printing process, proper maintenance and cleaning are essential to ensure the continued functionality of the machine:

Cleaning the Printing Machine
1. Clean the printing machine thoroughly after each production run to remove any ink residue or contaminants. Use appropriate cleaning agents that are compatible with the machine’s components and the ink used.
2. Clean the printing heads, ink reservoirs, and all feed systems to prevent clogging or ink buildup that could affect future printing quality.
Inspecting the Printing Components
1. Inspect the printing components, including print rollers, ink delivery systems, and feed mechanisms, for signs of wear or damage. Replace any components that are worn or not functioning correctly.
2. Ensure that the printing heads are properly aligned and that there is no misalignment that could cause print defects in future batches.
Lubrication of Moving Parts
1. Lubricate any moving parts as per the machine’s maintenance schedule to ensure smooth operation and prevent wear and tear that could lead to operational issues.
Record Maintenance Activities
1. Document all maintenance activities, including cleaning, inspections, and repairs, in the equipment maintenance log. Include the date, tasks performed, and any parts replaced or repaired.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
BPR: Batch Production Record

7. Documents

Batch Production Record (BPR) (Annexure-1)
Machine Maintenance Log (Annexure-2)
Inspection Report (Annexure-3)
Deviation Report (Annexure-4)

8. References

USP <1163> – Pharmaceutical Dosage Forms: Capsules
FDA Guidelines for Capsule Manufacturing
International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Production Record (BPR)

Batch ID	Printing Date	Capsule Type	Print Design	Operator Name
Batch 001	01/02/2025	Soft Gelatin, Size 00	Logo and Product Name	John Doe

Annexure-2: Machine Maintenance Log

Machine ID	Maintenance Date	Tasks Performed	Technician Name
Printer 1	01/02/2025	Cleaning and calibration of print heads	Jane Smith

Annexure-3: Inspection Report

Batch ID	Inspection Type	Result	Inspector Name
Batch 001	Print Quality	Pass	John Doe

Annexure-4: Deviation Report

Deviation ID	Description	Corrective Action Taken	Operator Name
DEV-001	Misalignment of print	Recalibrated machine and aligned print heads	John Doe

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 printing process details	Standardization	QA Head