Capsule: SOP for Packaging of Capsules with Desiccants – V 2.0

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Capsule: SOP for Packaging of Capsules with Desiccants – V 2.0

Standard Operating Procedure for Packaging of Capsules with Desiccants

Department Capsule Packaging
SOP No. SOP/CP/205/2025
Supersedes SOP/CP/205/2022
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 describe the procedure for packaging capsules with desiccants to ensure that moisture-sensitive capsules are protected during storage and distribution.

2. Scope

This SOP applies to the packaging process of all moisture-sensitive capsules, specifically when desiccants are used. It includes steps for inserting desiccants into packaging materials, ensuring capsule protection, and confirming packaging integrity.

3. Responsibilities

  • Packaging Operator: Responsible for inserting desiccants into packaging materials and ensuring correct placement of desiccants in the bottles or blister packs.
  • Quality Control (QC): Responsible for inspecting packaged capsules to verify the correct amount and placement of desiccants, as well as ensuring the overall packaging meets specifications.
  • Production Supervisor: Ensures that packaging operations are carried out as per the SOP, monitors the quality of packaging, and handles any deviations.

4. Accountability

The Production Manager is responsible for ensuring proper packaging procedures are followed, including the inclusion of desiccants. The QC

Manager ensures the quality of the packaging and product.

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5. Procedure

5.1 Pre-Packaging Preparation

Before starting the packaging process, ensure the following:

  1. Prepare Packaging Materials

    1. Ensure that the necessary packaging materials (bottles, blister packs, caps, and desiccants) are available, intact, and meet the required standards.
    2. Ensure that the desiccants are sealed and labeled correctly to prevent exposure to moisture before use.
  2. Verify Capsule Batch

    1. Ensure that the correct batch of capsules is ready for packaging, confirming the batch number, quantity, and product details as per the batch production record (BPR).
  3. Check Packaging Machine Settings

    1. Ensure that the packaging machine is calibrated for the correct bottle size and fill volume. Set up the machine to accommodate the inclusion of desiccants in the packaging process.

5.2 Packaging Process

Follow these steps during the packaging procedure:

  1. Load Capsules into Packaging Line

    1. Ensure capsules are properly loaded into the packaging machine for bottling or blister packing.
  2. Insert Desiccants

    1. For bottle packaging, ensure that each bottle is fitted with the correct number of desiccants as specified by the product requirements. For blister packs, place desiccants in the appropriate cavity or packet before sealing the blister pack.
    2. Ensure desiccants are inserted carefully to prevent damage to the capsules.
  3. Seal the Packaging

    1. Seal the bottles or blister packs according to the specified procedure to ensure that the desiccants are enclosed and the packaging is airtight.
  4. Ensure Proper Labeling

    1. Ensure that the packaging is correctly labeled with the product name, batch number, manufacturing date, and expiry date. The label should also mention the presence of desiccants if required by regulatory standards.
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5.3 Post-Packaging Activities

After completing the packaging process, ensure the following:

  1. Inspect Packaged Products

    1. Perform a visual inspection of the packaged products to ensure that all capsules are properly packed with desiccants, and the seals are intact.
  2. Monitor Desiccant Placement

    1. Ensure that the desiccants are placed in the correct position and have not been displaced or damaged during the packaging process.
  3. Store Packaged Capsules

    1. Store the packaged capsules in a suitable storage area, ensuring they are protected from moisture, light, and temperature variations.
  4. Record Packaging Data

    1. Document the packaging process, including the number of bottles or blister packs produced, the number of desiccants used, and any defects or deviations encountered during packaging.

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: Desiccant 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 Bottles Desiccants Used Operator Comments
Batch 017 04/02/2025 40,000 40,000 sachets John Doe No defects

Annexure 2: QC Inspection Report

Batch ID Inspection Date Defects Identified Corrective Actions Final Outcome
Batch 017 04/02/2025 None None Approved

Annexure 3: Desiccant Calibration Log

Desiccant Type Calibration Date Operator Calibration Details Next Calibration Due
Silica Gel 01/02/2025 Jane Smith Calibration of desiccant moisture absorption capacity 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 packaging with desiccants QA Head
01/02/2025 2.0 Updated desiccant calibration and packaging process Improved moisture protection for capsules QA Head
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