Standard Operating Procedure for Monitoring Packaging Line Speeds for Capsules

Department	Capsule Packaging
SOP No.	SOP/CP/208/2025
Supersedes	SOP/CP/208/2022
Page No.	Page 1 of 5
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 standard procedure for monitoring the packaging line speeds during capsule packaging. Ensuring that the line speed is properly set and maintained is crucial for ensuring product quality, avoiding defects, and optimizing production efficiency.

2. Scope

This SOP applies to all packaging lines used in the capsule packaging process. It covers the monitoring and adjustment of packaging line speeds, ensuring compliance with operational standards, and maintaining optimal packaging performance.

3. Responsibilities

• Packaging Operator: Responsible for monitoring and adjusting the packaging line speed as per the required specifications and ensuring the smooth operation of the packaging process.
• Production Supervisor: Oversees the packaging line speed settings, ensures the operators follow the SOP, and addresses any speed-related issues that may arise during production.
• Quality Control (QC) Team: Responsible for ensuring that the monitoring of the packaging line speeds is done accurately and that all production is in compliance with quality standards.

4. Accountability

The Production Manager is accountable for ensuring that packaging line speeds are properly monitored and maintained during the packaging process. The QC Manager ensures that the packaging meets the required standards and verifies that line speeds do not negatively affect capsule quality.

5. Procedure

5.1 Pre-Operation Setup

Before starting the packaging process, ensure the following:

1. Verify Packaging Line Setup
   1. Ensure that the packaging line is set up correctly for the batch of capsules being processed, including the necessary settings for speed, fill count, and packaging type (e.g., bottle or blister).
   2. Confirm that all packaging materials, such as capsules, bottles, blister packs, and labels, are ready for use.
2. Check Line Speed Parameters
   1. Ensure that the packaging line speed is set according to the product specifications, as defined in the batch production record (BPR).
   2. Verify that the line speed aligns with the required production rate for the batch and is consistent with the capacity of the machine.
3. Ensure Equipment Calibration
   1. Check that the packaging equipment is calibrated and functioning correctly. This includes the speedometer and other speed monitoring tools on the line.

5.2 Monitoring Packaging Line Speed

Follow these steps to monitor the packaging line speed during capsule packaging:

1. Start the Packaging Line
   1. Start the packaging machine, ensuring that capsules are properly loaded onto the line, and the primary and secondary packaging materials are being dispensed correctly.
2. Monitor Line Speed
   1. Regularly monitor the line speed using the speedometer and other monitoring devices integrated into the packaging equipment.
   2. Ensure that the line speed remains constant throughout the packaging process and is maintained within the specified range as per the product’s BPR.
3. Adjust Line Speed if Necessary
   1. If the packaging line speed exceeds or falls below the required specification, adjust the speed to bring it back into the acceptable range.
   2. Communicate any significant deviations or issues to the production supervisor for further action if necessary.
4. Record Speed Monitoring Data
   1. Document the packaging line speed and any adjustments made in the packaging log, including the reasons for any changes in speed.

5.3 Post-Packaging Activities

After completing the packaging process, ensure the following:

1. Final Inspection
   1. Perform a final inspection of the packaged capsules to ensure that the packaging is intact, correctly sealed, and labeled. Check that the capsules meet quality standards and are properly sealed in the packaging.
2. Store Packaged Capsules
   1. Store the finished packaged capsules in a suitable storage area, ensuring they are protected from environmental factors such as light, humidity, and temperature fluctuations.
3. Review Production Data
   1. Review the production data, including the line speed records, to ensure that the packaging process was completed efficiently and in compliance with SOPs.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• BPR: Batch Production Record
• USP: United States Pharmacopeia

7. Documents

1. Annexure 1: Packaging Log
2. Annexure 2: QC Inspection Report
3. Annexure 3: Equipment Calibration Log

8. References

• USP <701> – Disintegration of Tablets and Capsules
• European Pharmacopoeia 2.9.1 – Dissolution Testing
• 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: Packaging Log

Batch ID	Packaging Date	Number of Capsules Packaged	Line Speed	Operator	Comments
Batch 020	06/02/2025	75,000	120 capsules/min	Jane Smith	No issues

Annexure 2: QC Inspection Report

Batch ID	Inspection Date	Defects Identified	Corrective Actions	Final Outcome
Batch 020	06/02/2025	None	None	Approved

Annexure 3: Equipment Calibration Log

Equipment ID	Calibration Date	Operator	Calibration Details	Next Calibration Due
Packaging Line 503	01/02/2025	John Doe	Calibration of speed monitoring system	01/02/2026

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for monitoring packaging line speeds	QA Head
01/02/2025	2.0	Updated line speed monitoring process	Improvement in packaging line monitoring	QA Head