Capsule: SOP for Encapsulation of Modified-Release Fill Materials – V 2.0

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Capsule: SOP for Encapsulation of Modified-Release Fill Materials – V 2.0

Standard Operating Procedure for Encapsulation of Modified-Release Fill Materials

Department Capsule Manufacturing
SOP No. SOP/CM/072/2025
Supersedes SOP/CM/072/2022
Page No. Page 1 of 7
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 procedures for the encapsulation of modified-release (MR) fill materials into capsules. The objective is to ensure that the MR capsules are manufactured with consistent release profiles and meet the required quality and regulatory specifications.

2. Scope

This SOP applies to the encapsulation of modified-release fill materials used in the production of hard gelatin capsules. It covers the preparation of the fill material, the encapsulation process, and the associated quality control measures to ensure that the modified-release formulation is produced accurately.

3. Responsibilities

  • Manufacturing Team: Responsible for performing the encapsulation of the modified-release fill materials according to this SOP and ensuring that all procedures are followed accurately during production.
  • Quality Control (QC) Team: Responsible for testing and verifying the quality of the modified-release capsules, including the release profile, weight uniformity, and integrity of the capsule.
  • Quality Assurance (QA) Team: Ensures compliance with the SOP and reviews all batch production records and test results to confirm that the encapsulation process meets all regulatory and quality standards.
  • Formulation Team: Provides the final modified-release formulation, ensuring that the release profile of the product is defined and consistent with the intended design.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the encapsulation process of modified-release materials is carried out according to this SOP. The QA Manager is responsible for reviewing all processes to ensure compliance with GMP and regulatory guidelines.

5. Procedure

5.1 Preparation of Modified-Release Fill Material

Ensure the following steps are completed before beginning the encapsulation process:

  1. Verify Raw Materials

    1. Ensure that all raw materials used in the modified-release formulation are approved by the QC department and meet the required specifications. This includes excipients, active pharmaceutical ingredients (APIs), and modified-release agents (e.g., polymers, coating materials).
  2. Weighing of Materials

    1. Weigh the appropriate amounts of excipients and APIs according to the formulation. Use calibrated weighing equipment and ensure that all materials are weighed accurately to maintain the proper ratio for the desired release profile.
  3. Mixing the Fill Material

    1. Mix the raw materials uniformly in a high-shear granulator or other appropriate mixing equipment. Ensure that the modified-release agents are thoroughly incorporated into the blend to maintain consistent release characteristics.
  4. Screening

    1. Screen the blended materials to remove any large agglomerates or particles that may affect the encapsulation process and capsule quality. The granules should be within the specified size range for smooth capsule filling.
  5. Moisture Content Check

    1. Verify that the moisture content of the fill material is within the acceptable range to ensure proper capsule filling and product stability. Excess moisture may cause sticking or degradation, while insufficient moisture may result in poor tablet formation.
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5.2 Encapsulation Process

Follow these steps to encapsulate the modified-release fill material into capsules:

  1. Loading of Fill Material

    1. Load the prepared fill material into the capsule filling machine. Ensure that the machine hopper is clean and free from any residual material from previous batches.
    2. Ensure that the capsule size and type match the formulation requirements. Select the appropriate size for both the body and cap of the capsule.
  2. Machine Settings

    1. Set the capsule filling machine parameters, including speed, dosing volume, and tamping pressure, based on the modified-release material characteristics and the batch requirements.
    2. Adjust the fill material dispensing settings to ensure that the capsules are filled accurately and consistently. Verify that the fill volume is within the required specifications.
  3. Filling Process

    1. Begin the filling process, ensuring that the modified-release fill material is dispensed evenly into the capsules. Continuously monitor the machine to ensure that the capsules are filled properly, with no overfill or underfill.
  4. Sealing and Closing

    1. After filling, the capsules should be sealed properly. Ensure that the capsule caps are firmly closed to prevent leakage or contamination. Use an appropriate capsule sealing method based on the formulation (e.g., banding or thermal sealing).
  5. Capsule Inspection

    1. Perform an initial inspection of the filled capsules to check for any defects such as improperly sealed capsules, broken capsules, or contamination. Segregate any defective capsules for further action (e.g., rework or disposal).
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5.3 Quality Control Testing

After encapsulation, conduct the following quality control tests:

  1. Weight Uniformity

    1. Weigh a sample of capsules to ensure that they meet the required weight uniformity criteria. The weight should be consistent with the specified fill weight for the batch.
  2. Content Uniformity

    1. Test the content uniformity of the capsules to ensure that each capsule contains the correct dose of the active ingredient. This test ensures that the active ingredient is evenly distributed within the capsule.
  3. Release Profile Testing

    1. Perform dissolution testing on a sample of capsules to verify that the modified-release profile is achieved as per the specifications. Ensure that the release rate and timing meet the designed profile for the formulation.
  4. Visual Inspection

    1. Perform a visual inspection to check for any physical defects such as cracks, discoloration, or improper sealing. Any defective capsules should be segregated for rework or disposal.

5.4 Post-Encapsulation Actions

After the encapsulation and quality control testing, follow these steps:

  1. Segregation of Defective Capsules

    1. Immediately segregate any defective capsules identified during the quality control checks. Record the defects and determine whether the capsules can be reworked or should be discarded.
  2. Documentation

    1. Document all encapsulation activities, including the batch number, machine settings, weight and content uniformity results, release profile results, and any deviations or corrective actions taken during the process. Maintain accurate records of all tests and inspections performed.
  3. Transfer to Packaging

    1. Once all quality control tests have been completed and capsules have passed inspection, transfer the capsules to the packaging area. Ensure that the capsules are stored in appropriate conditions to prevent damage or contamination before packaging.

5.5 Documentation and Record-Keeping

All activities related to the encapsulation of modified-release fill materials should be documented as follows:

  1. Batch Production Record (BPR)

    1. Document all encapsulation activities in the BPR, including raw material verification, granulation process, machine settings, and quality control test results. This ensures traceability for future audits and inspections.
  2. Deviation Report

    1. If any deviations from the standard process occur, document the issue and corrective actions taken in a deviation report. This should include details of the issue, the reason for the deviation, and the resolution.
  3. Inspection and Testing Logs

    1. Maintain logs for all inspections and tests performed on the encapsulated capsules, including weight and content uniformity, release profile, and any defects identified. These logs must be accessible for review by the QA team.
  4. Equipment Maintenance Log

    1. Record any maintenance or calibration performed on the encapsulation equipment in the maintenance log. This includes checks for proper functioning of the capsule filling machines and sealing equipment.

6. Abbreviations

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

7. Documents

  1. Batch Production Record (BPR) (Annexure-1)
  2. Deviation Report (Annexure-2)
  3. Inspection and Testing Logs (Annexure-3)
  4. Equipment Maintenance Log (Annexure-4)

8. References

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

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 Encapsulation Date Modified-Release Formulation Encapsulation Parameters Operator Name
Batch 001 01/02/2025 Modified-Release API Blend Speed: 100 rpm, Fill Volume: 0.5 mL John Doe

Annexure-2: Deviation Report

Deviation ID Description Corrective Action Taken Operator Name
DEV-001 Inconsistent capsule fill volume Adjusted machine settings and recalibrated the dosing system John Doe

Annexure-3: Inspection and Testing Logs

Batch ID Test Type Result Operator Name
Batch 001 Weight Uniformity Pass John Doe
Batch 001 Content Uniformity Pass Jane Smith

Annexure-4: Equipment Maintenance Log

Equipment ID Maintenance Date Tasks Performed Technician Name
Filling Machine 1 01/02/2025 Calibrated machine Jane Smith

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 encapsulation process Standardization QA Head
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