SOP Guide for Pharma

Capsule: SOP for Monitoring Packaging Line Speeds for Capsules – V 2.0

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Capsule: SOP for Monitoring Packaging Line Speeds for Capsules – V 2.0

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

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.

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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.
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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.

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6. Abbreviations

7. Documents

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

8. References

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
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