Capsule: SOP for Drying Hard Gelatin Capsules Post-Filling – V 2.0

Auditor

2 weeks ago

Standard Operating Procedure for Drying Hard Gelatin Capsules Post-Filling

Department	Capsule Manufacturing
SOP No.	SOP/CM/058/2025
Supersedes	SOP/CM/058/2022
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 define the procedure for drying hard gelatin capsules after the filling process. This ensures that capsules achieve the proper moisture content, which is crucial for maintaining their integrity, stability, and ease of handling.

2. Scope

This SOP applies to the drying process of hard gelatin capsules post-filling, including the use of drying equipment, monitoring parameters, and ensuring the capsules meet required moisture specifications.

3. Responsibilities

Manufacturing Team: Responsible for operating drying equipment, ensuring capsules are properly dried according to the SOP, and monitoring moisture content during the process.
Quality Control (QC) Team: Responsible for testing the moisture content of capsules at various stages and ensuring they meet the required specifications.
Quality Assurance (QA) Team: Ensures compliance with GMP and regulatory standards, reviews documentation, and verifies the proper drying procedure is followed.
Maintenance Team: Responsible for maintaining the drying equipment, ensuring it is in good working condition and meets the necessary specifications for proper capsule drying.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the drying process is carried out in compliance with this SOP. The QA Manager is responsible for verifying the process and reviewing documentation to ensure regulatory compliance.

5. Procedure

5.1 Pre-Drying Setup

Before starting the drying process, ensure the following steps are completed:

Drying Equipment Inspection
1. Inspect the drying equipment for cleanliness, functionality, and proper calibration. Ensure that the dryer is free of contaminants from previous batches.
2. Check the temperature and humidity settings to ensure they are within the required specifications for drying hard gelatin capsules.
Capsule Preparation
1. Ensure that the filled capsules are properly sealed before starting the drying process. This will prevent any leakage or contamination during drying.
2. Ensure that capsules are placed evenly in the drying trays or conveyor system to allow uniform airflow and drying.
Documentation
1. Document all relevant batch information, including capsule details, drying equipment settings, and initial moisture content.

5.2 Drying Process

Once the setup is complete, follow these steps to dry the capsules:

Start the Drying Process
1. Start the dryer according to the machine manufacturer’s instructions. Monitor the drying process to ensure that the equipment is functioning correctly.
Control Drying Parameters
1. Set and maintain the drying temperature and humidity within the required range (typically 20°C-25°C and 30%-40% humidity) to ensure proper drying without damaging the gelatin shell.
2. Ensure that air circulation within the dryer is uniform to promote even drying of all capsules.
Monitor Drying Time
1. Monitor the drying time according to the specifications. Typical drying time for hard gelatin capsules ranges from 4 to 6 hours, depending on the batch size and moisture content.
Check Moisture Content
1. Check the moisture content of capsules periodically throughout the drying process. The target moisture content should be between 10% and 15%.

5.3 Post-Drying Inspection

After the drying process is complete, perform the following checks:

Capsule Inspection
1. Inspect the capsules for any signs of damage, such as cracks, warping, or softening. Reject any capsules that do not meet quality standards.
2. Ensure that the capsules have maintained their structural integrity during the drying process and are ready for further processing.
Moisture Content Testing
1. Perform a final moisture content test to ensure that the capsules meet the required specification (typically 10%-15%). Document the results.
Temperature and Humidity Logs
1. Ensure that temperature and humidity logs are reviewed for compliance with the specified drying parameters.

5.4 Equipment Cleaning and Maintenance

After completing the drying process, follow these cleaning and maintenance steps:

Cleaning of Drying Equipment
1. Turn off the dryer and clean all components that came into contact with the capsules. Use approved cleaning agents and ensure that all residues are removed.
2. Ensure that the dryer is properly dried before storage to prevent the growth of mold or bacteria.
Routine Maintenance
1. Perform any necessary routine maintenance on the drying equipment, including checking for wear and tear and lubricating moving parts according to the manufacturer’s guidelines.

5.5 Documentation and Record-Keeping

Proper documentation is essential for tracking the drying process:

Drying Batch Records
1. Document all details of the drying process, including machine settings, batch information, initial and final moisture content, and drying times.
Moisture Content Records
1. Maintain records of moisture content testing results, including sample size and test conditions.
Deviation Reports
1. If any deviations from the specified drying parameters occur, document them in a deviation report and outline the corrective actions taken.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance

7. Documents

Drying Batch Record (Annexure-1)
Moisture Content Testing Record (Annexure-2)
Deviation Report (Annexure-3)

8. References

USP <2040> – Soft Gelatin 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: Drying Batch Record

Batch ID	Machine ID	Drying Time	Initial Moisture Content	Final Moisture Content	Operator Name	Production Date
Batch 001	Dryer 1	5 hours	15%	10%	John Doe	01/02/2025

Annexure-2: Moisture Content Testing Record

Test Type	Result	Specification	Remarks
Moisture Content	10%	10%-15%	Pass

Annexure-3: Deviation Report

Deviation ID	Description	Corrective Action	Action Taken By
DR-001	Excessive drying time	Reduced drying time and re-calibrated dryer	Manufacturing Supervisor

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 times and procedures	Standardization	QA Head