Capsule: SOP for Monitoring Capsule Shell Formation – V 2.0

Posted on By

Capsule: SOP for Monitoring Capsule Shell Formation – V 2.0

Standard Operating Procedure for Monitoring Capsule Shell Formation

Department Capsule Manufacturing
SOP No. SOP/CM/055/2025
Supersedes SOP/CM/055/2022
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 monitoring the formation of capsule shells during the encapsulation process. This includes ensuring that the capsule shells are formed with the correct integrity, thickness, and uniformity to meet product specifications.

2. Scope

This SOP applies to the monitoring of capsule shell formation for both soft and hard gelatin capsules. It covers the process from initial shell formation to final capsule quality checks.

3. Responsibilities

  • Formulation Development Team: Responsible for providing the formulation specifications for the capsule shell, including the gelatin concentration and plasticizer levels.
  • Capsule Manufacturing Team: Responsible for operating the equipment and monitoring capsule shell formation to ensure consistency and quality.
  • Quality Control (QC) Team: Responsible for performing periodic checks during the capsule shell formation process, including thickness, integrity, and uniformity tests.
  • Quality Assurance (QA) Team: Ensures that the process follows GMP and regulatory guidelines, and reviews all documentation to ensure compliance.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule shell formation process is carried out in compliance with this SOP. The QA Manager is responsible for reviewing all documentation and ensuring compliance with regulatory requirements.

See also  Capsule: SOP for Weighing Excipients for Capsule Formulations - V 2.0

5. Procedure

5.1 Pre-Operation Setup

Before starting the capsule shell formation process, ensure the following steps are completed:

  1. Machine Inspection

    1. Inspect the capsule shell forming equipment for cleanliness, alignment, and proper calibration. Ensure that all parts of the machine are free from contamination or damage.
    2. Ensure that the machine is properly set up according to the required capsule size and specifications.
  2. Preparation of Gelatin Solution

    1. Prepare the gelatin solution according to the formulation requirements. This includes selecting the correct gelatin type, concentration, and the addition of plasticizers for flexibility.
    2. Ensure the solution is at the correct temperature and viscosity for efficient capsule shell formation.
  3. Setting Machine Parameters

    1. Set the machine parameters such as temperature, pressure, and speed according to the capsule shell requirements. Adjust the settings based on the specifications provided in the formulation record.

5.2 Capsule Shell Formation

Once the machine is set up, begin the shell formation process:

  1. Gelatin Shell Formation

    1. Begin the shell formation process by pouring the prepared gelatin solution into the mold. Ensure that the solution fills the mold evenly to create uniform shell thickness.
    2. Monitor the temperature and pressure during the shell formation process to maintain optimal conditions for uniform capsule shell formation.
  2. Shell Thickness Monitoring

    1. Continuously monitor the thickness of the gelatin shell. Use a micrometer or other suitable measuring devices to measure the shell thickness at different points to ensure uniformity.
    2. If any variation in thickness is detected, adjust the gelatin concentration or machine settings to correct the issue.
  3. Gelatin Drying

    1. After the shell is formed, allow the gelatin capsules to undergo a controlled drying process. Ensure that the drying temperature and humidity are controlled to prevent the capsules from becoming too brittle or too soft.
    2. Monitor the drying time to ensure the capsules reach the correct moisture content as per the specifications.
See also  Capsule: SOP for Stability Studies During Formulation Development - V 2.0

5.3 Quality Control Checks

During the shell formation process, perform the following quality control checks:

  1. Shell Integrity Test

    1. Inspect the formed capsule shells for defects such as cracks, tears, or incomplete formation. Any defective capsules should be rejected and removed from the production line.
  2. Capsule Uniformity

    1. Check for uniformity in the size, shape, and color of the capsule shells. Ensure that each capsule is consistent with the required specifications for appearance.
  3. Moisture Content Test

    1. Test the moisture content of the dried capsule shells to ensure they meet the required range (typically 10-15%). Capsules with improper moisture content should not be filled.
  4. Shell Thickness Consistency

    1. Measure the thickness of the capsule shells at multiple points to ensure that they meet the required specifications for wall thickness.

5.4 Post-Operation Cleaning and Maintenance

After the capsule shell formation process, perform the following steps:

  1. Cleaning the Equipment

    1. Turn off the machine and clean all components that came into contact with the gelatin solution or capsules. Use approved cleaning agents and ensure that all residues are removed.
    2. Ensure the machine is properly dried before the next use to prevent contamination and build-up.
  2. Machine Maintenance

    1. Perform a maintenance check on the machine, lubricating components as needed and replacing any parts that show signs of wear and tear.

5.5 Documentation and Record-Keeping

Ensure proper documentation for the capsule shell formation process:

  1. Batch Records

    1. Document all parameters of the capsule shell formation process, including gelatin solution details, machine settings, shell thickness measurements, and any deviations.
  2. Quality Control Records

    1. Maintain records of all quality control tests, including shell integrity, uniformity, moisture content, and thickness checks.
  3. Deviation Reports

    1. Document any deviations or issues encountered during shell formation, along with the corrective actions taken to resolve them.
See also  Capsule: SOP for Selecting Plasticizers for Soft Gelatin Capsule Shells - V 2.0

6. Abbreviations

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

7. Documents

  1. Capsule Shell Formation Batch Record (Annexure-1)
  2. Quality Control Test Report (Annexure-2)
  3. Deviation Report (Annexure-3)

8. References

  • USP <601> – 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: Capsule Shell Formation Batch Record

Batch ID Gelatin Type Machine ID Shell Thickness Operator Name Production Date
Batch 001 Gelatin 150 Bloom Machine 1 0.3 mm John Doe 01/02/2025

Annexure-2: Quality Control Test Report

Test Type Result Specification Remarks
Shell Thickness 0.3 mm 0.28 – 0.32 mm Pass

Annexure-3: Deviation Report

Deviation ID Description Corrective Action Action Taken By
DR-001 Overfilled Capsules Adjusted machine parameters 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 monitoring steps Standardization QA Head
Capsules V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , , , , , ,