Capsule: SOP for Post-Encapsulation Drying for Soft Capsules – V 2.0

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Capsule: SOP for Post-Encapsulation Drying for Soft Capsules – V 2.0

Standard Operating Procedure for Post-Encapsulation Drying for Soft Capsules

Department Capsule Manufacturing
SOP No. SOP/CM/076/2025
Supersedes SOP/CM/076/2022
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 the post-encapsulation drying process of soft gelatin capsules. The objective is to remove excess moisture from the freshly encapsulated soft gelatin capsules to ensure they achieve the correct moisture content, improving their stability and shelf life.

2. Scope

This SOP applies to the post-encapsulation drying process of soft gelatin capsules in capsule manufacturing. It covers the drying techniques, parameters, and monitoring required to ensure capsules are sufficiently dried and meet the moisture content specifications before packaging.

3. Responsibilities

  • Manufacturing Team: Responsible for performing the post-encapsulation drying process according to this SOP. They must ensure the drying process is carried out accurately and safely.
  • Quality Control (QC) Team: Responsible for monitoring and verifying the moisture content of the capsules, ensuring the capsules meet the required specifications.
  • Quality Assurance (QA) Team: Ensures compliance with GMP guidelines and this SOP during the post-encapsulation drying process. Reviews records to ensure the drying process is properly documented and executed.
  • Maintenance Team: Responsible for ensuring that all drying equipment is properly maintained and calibrated to function effectively during the drying process.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the post-encapsulation drying process is performed correctly and in compliance with this SOP. The QA Manager is responsible for overseeing compliance with regulatory guidelines and quality standards.

5. Procedure

5.1 Pre-Drying Preparation

Before starting the drying process, the following steps should be completed:

  1. Verify Soft Capsules

    1. Ensure that all soft capsules have passed the encapsulation process and are properly sealed. Inspect capsules for defects, leaks, or other visible issues that may affect the drying process.
  2. Ensure Proper Equipment Setup

    1. Check the drying equipment to ensure it is clean, calibrated, and functioning properly. Verify that temperature and humidity control systems are in place and operational.
    2. Ensure that drying trays or baskets are clean and appropriately configured for soft capsules. Verify that there are no obstructions that may impede airflow during the drying process.
  3. Document Setup

    1. Ensure that the necessary documentation is ready, including the batch production record (BPR) and drying process parameters. Confirm that the batch number, operator name, and date are documented before starting the drying process.
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5.2 Drying Process

Follow these steps to properly dry soft gelatin capsules after encapsulation:

  1. Loading Capsules into the Dryer

    1. Place the freshly encapsulated soft gelatin capsules into the drying equipment. Ensure the capsules are arranged in a single layer on the drying trays or baskets to allow uniform airflow and drying.
    2. Ensure that the dryer is not overloaded, as this may hinder effective drying and cause uneven moisture content.
  2. Setting the Drying Parameters

    1. Set the dryer to the specified temperature and humidity levels as per the formulation requirements. Typically, soft capsules are dried at a temperature range of 40°C to 50°C with controlled humidity.
    2. Ensure that the drying temperature does not exceed the recommended level to prevent degradation of the soft gelatin shell or the encapsulated material.
  3. Drying Time

    1. Start the drying process and monitor the capsules regularly. The drying process may take anywhere from 4 to 12 hours, depending on the size of the batch, capsule type, and environmental conditions.
    2. During the drying process, ensure that the airflow is consistent and that the capsules are not exposed to excessive heat or moisture.

5.3 Monitoring During Drying

Regular monitoring during the drying process is essential to ensure consistency and quality:

  1. Moisture Content Testing

    1. At regular intervals, sample the soft capsules and check the moisture content using a moisture analyzer or other approved testing methods. The moisture content should typically fall within 4-8% for soft gelatin capsules.
    2. If the moisture content exceeds the acceptable range, adjust the drying parameters and extend the drying time as needed to reach the desired moisture level.
  2. Temperature and Humidity Control

    1. Monitor the temperature and humidity within the drying chamber to ensure that they remain within the specified range. Use temperature and humidity sensors to record data during the drying process.
    2. Ensure that the drying environment is stable and does not fluctuate significantly, as this could affect the final product quality.
  3. Capsule Inspection

    1. Inspect the capsules visually for signs of over-drying or under-drying. Ensure that the capsules do not become brittle or sticky, which can result from incorrect drying conditions.
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5.4 Post-Drying Actions

Once the drying process is complete, perform the following steps:

  1. Final Inspection

    1. Perform a final visual inspection of the capsules to ensure they meet the required appearance standards. Check for any signs of cracks, deformation, or moisture retention.
    2. Inspect the surface of the capsules to ensure they are smooth and free from any stickiness or excessive moisture.
  2. Moisture Content Verification

    1. Take a final sample of capsules and measure the moisture content. Ensure that the moisture content is within the required range as per the formulation requirements.
    2. If the moisture content is within specification, the capsules are ready for packaging. If not, continue drying and monitor until the desired moisture level is achieved.
  3. Transfer to Packaging

    1. Once the capsules have passed the final inspection and moisture content check, transfer them to the packaging area. Ensure the capsules are stored in a controlled environment to maintain their integrity before packaging.

5.5 Documentation and Record-Keeping

Ensure that all drying process activities are properly documented:

  1. Batch Production Record (BPR)

    1. Document all details of the drying process, including the batch number, drying parameters (temperature, humidity, time), moisture content testing results, and inspection findings.
    2. Record any deviations or corrective actions taken during the process, along with the date, operator name, and the outcome of corrective actions.
  2. Moisture Content Log

    1. Maintain a log of moisture content readings taken during the drying process. Ensure that each log entry includes the sample number, moisture content result, and any actions taken if the results were outside the acceptable range.
  3. Deviations and Corrective Actions

    1. If any deviations occur during the drying process (e.g., excessive moisture content or temperature fluctuations), document the issue in a deviation report. Record the corrective actions taken and verify that the issue is resolved.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • BPR: Batch Production Record

7. Documents

  1. Batch Production Record (BPR) (Annexure-1)
  2. Moisture Content Log (Annexure-2)
  3. Deviation Report (Annexure-3)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Production Record (BPR)

Batch ID Drying Date Drying Parameters Moisture Content Operator Name
Batch 001 01/02/2025 Temperature: 45°C, Humidity: 60%, Time: 8 hours 5.2% John Doe

Annexure-2: Moisture Content Log

Sample ID Moisture Content Time of Sample Operator Name
Sample 001 5.2% 10:00 AM John Doe

Annexure-3: Deviation Report

Deviation ID Description Corrective Action Taken Operator Name
DEV-001 Excessive moisture content Extended drying time and adjusted temperature John Doe

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated drying process details Standardization QA Head
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