Capsule: SOP for Packing Capsules in Aluminum Foil – V 2.0

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Capsule: SOP for Packing Capsules in Aluminum Foil – V 2.0

Standard Operating Procedure for Packing Capsules in Aluminum Foil

Department Capsule Packaging
SOP No. SOP/CP/207/2025
Supersedes SOP/CP/207/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This SOP defines the procedure for packing capsules into aluminum foil to ensure product integrity, compliance with regulatory standards, and protection from moisture, light, and contaminants during storage and distribution.

2. Scope

This SOP applies to the process of packing capsules into aluminum foil packaging. It includes machine setup, foil application, sealing, and inspection to ensure that the capsules are packed securely and in compliance with GMP guidelines.

3. Responsibilities

  • Packaging Operator: Responsible for operating the machine to pack capsules into aluminum foil, ensuring correct foil placement, sealing, and labeling.
  • Quality Control (QC) Team: Responsible for inspecting the aluminum foil packaging process, ensuring that the capsules are properly packed, and performing final checks for packaging integrity.
  • Production Supervisor: Oversees the packaging process to ensure compliance with the SOP, monitors operator performance, and resolves any issues encountered during the packaging operation.

4. Accountability

The Production Manager is responsible for ensuring that all capsules are packed into aluminum foil in accordance with this SOP. The QC Manager is responsible for overseeing the quality of the packaging and ensuring compliance with regulatory standards.

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5. Procedure

5.1 Pre-Packaging Preparation

Before starting the packing process, ensure the following:

  1. Verify Packaging Materials

    1. Ensure that all aluminum foil, capsules, and other necessary packaging materials are available, intact, and meet the required specifications.
    2. Check that the aluminum foil is of the correct grade and quality, ensuring it provides adequate protection against light, moisture, and contamination.
  2. Check Capsule Batch

    1. Confirm that the correct batch of capsules is prepared for packaging and verify that the batch number, quantity, and product details match the Batch Production Record (BPR).
  3. Set Up Packaging Machine

    1. Ensure that the packaging machine is set up to accommodate the correct foil size, capsule count, and sealing parameters. Verify that the machine is clean and functioning properly before use.

5.2 Packing Process

Follow these steps during the packing process:

  1. Load Capsules onto Packaging Line

    1. Load the capsules into the packaging machine. Ensure that the capsules are placed in the correct orientation for easy dispensing into the aluminum foil packets.
  2. Place Aluminum Foil on Packaging Line

    1. Ensure that the aluminum foil is properly loaded onto the machine, and ensure it is aligned correctly for the pouch or blister formation.
  3. Form Packaging Pouches or Blisters

    1. Start the machine and ensure that the capsules are filled into the aluminum foil pockets or pouches. The foil should be securely wrapped around the capsules to prevent any exposure to external elements.
  4. Seal Packaging

    1. Ensure that the aluminum foil is properly sealed to protect the capsules from contamination. The seal should be airtight and free of defects.
  5. Apply Labels

    1. Apply the appropriate labels to the aluminum foil packaging, ensuring that the labels include product information such as batch number, expiry date, product name, and dosage.
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5.3 Post-Packaging Activities

After completing the packaging process, ensure the following:

  1. Final Inspection

    1. Inspect a sample of the aluminum foil packaging for defects such as improper sealing, incorrect labeling, or damaged foil. Ensure that the capsules are correctly sealed in the packaging material.
  2. Store Packaged Capsules

    1. Store the packaged capsules in the appropriate storage area, ensuring they are protected from temperature fluctuations, humidity, and light. Ensure that the storage area is clean and secure.
  3. Record Packaging Data

    1. Document the packaging process, including the number of capsules packed, any defects found, and the results of the final inspection. Ensure that records are stored in compliance with GMP standards.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • BPR: Batch Production Record
  • USP: United States Pharmacopeia
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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 Operator Comments
Batch 019 06/02/2025 50,000 John Doe No issues

Annexure 2: QC Inspection Report

Batch ID Inspection Date Defects Identified Corrective Actions Final Outcome
Batch 019 06/02/2025 None None Approved

Annexure 3: Equipment Calibration Log

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Packaging Machine 702 02/02/2025 Jane Smith Calibration of filling volume and sealing pressure 02/02/2026

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 capsule packaging in aluminum foil QA Head
01/02/2025 2.0 Updated packaging procedure and machine setup Improvement of packaging quality and efficiency QA Head
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