Capsule: SOP for Bottling Capsules in High-Speed Packaging Lines – V 2.0

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Capsule: SOP for Bottling Capsules in High-Speed Packaging Lines – V 2.0

Standard Operating Procedure for Bottling Capsules in High-Speed Packaging Lines

Department Capsule Packaging
SOP No. SOP/CP/202/2025
Supersedes SOP/CP/202/2022
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 outline the procedure for bottling capsules in high-speed packaging lines to ensure that capsules are packaged correctly, efficiently, and in compliance with GMP standards.

2. Scope

This SOP applies to all bottling activities for capsules within the high-speed packaging lines. It covers the preparation, operation, and inspection procedures for the bottling process, including handling, verifying, and storing bottled capsules.

3. Responsibilities

  • Packaging Operator: Responsible for operating the high-speed bottling machines, ensuring capsules are bottled correctly, and performing initial checks for defects.
  • Quality Control (QC) Team: Responsible for conducting quality checks on bottled capsules, ensuring correct labeling, and verifying that packaging meets specifications.
  • Production Supervisor: Ensures that all bottling activities are carried out in accordance with the SOP and monitors performance on the production line.

4. Accountability

The Production Manager is accountable for ensuring the proper operation of the high-speed bottling machines and that the packaging process meets GMP and regulatory requirements. The QC Manager ensures the quality of the final product.

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5. Procedure

5.1 Pre-Packaging Preparation

Before starting the bottling process, ensure the following:

  1. Verify Bottling Materials

    1. Ensure that the appropriate bottles, caps, labels, and any other necessary packaging materials are available and in good condition.
  2. Check the Bottling Machine Setup

    1. Ensure the high-speed bottling machine is correctly set up, calibrated, and ready for use. Check the settings for filling volume, bottle size, and speed.
  3. Ensure Correct Product Lot

    1. Confirm that the correct batch of capsules is prepared for bottling. Verify batch number and quantity as per the batch production record (BPR).

5.2 Bottling Process

Follow these steps for the bottling procedure:

  1. Load Capsules into Bottling Machine

    1. Place the capsules into the machine’s hopper, ensuring that capsules are fed evenly into the machine.
  2. Set Machine Parameters

    1. Adjust the filling volume and machine speed according to the specifications provided in the BPR. Ensure that the correct number of capsules is dispensed into each bottle.
  3. Start the Bottling Machine

    1. Start the machine and monitor the process to ensure proper operation. Ensure that bottles are filled, capped, and sealed correctly.
  4. Monitor for Defects

    1. Regularly check bottles for defects such as underfilling, overfilling, or damaged caps. Reject any defective bottles for rework or disposal.
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5.3 Post-Bottling Activities

After the bottling process is complete, ensure the following:

  1. Inspect Bottles

    1. Perform a visual inspection of all bottles to ensure they are correctly filled, sealed, and labeled. Verify that no capsules are missing or damaged.
  2. Labeling and Final Packaging

    1. Ensure that each bottle is labeled with the correct product information, including the batch number, manufacturing date, and expiry date.
  3. Store Bottled Capsules

    1. Store the bottled capsules in the appropriate storage area, ensuring that they are kept under suitable environmental conditions until they are ready for distribution.
  4. Record Bottling Data

    1. Document all relevant bottling details, including the number of bottles filled, any deviations, and the results of the final inspection. Store records in compliance with GMP standards.

6. Abbreviations

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

7. Documents

  1. Annexure 1: Bottling 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: Bottling Log

Batch ID Bottling Date Number of Bottles Operator Comments
Batch 014 02/02/2025 50,000 John Doe No defects

Annexure 2: QC Inspection Report

Batch ID Inspection Date Defects Identified Corrective Actions Final
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Annexure 2: QC Inspection Report

Batch ID Inspection Date Defects Identified Corrective Actions Final Outcome
Batch 014 02/02/2025 None None Approved

Annexure 3: Equipment Calibration Log

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Bottling Line 502 01/02/2025 Jane Smith Calibration for fill volume and speed 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 bottling process QA Head
01/02/2025 2.0 Updated machine settings and inspection processes Process improvement QA Head
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