Capsule: SOP for Layering Pellets for Capsule Fill Materials – V 2.0

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Capsule: SOP for Layering Pellets for Capsule Fill Materials – V 2.0

Standard Operating Procedure for Layering Pellets for Capsule Fill Materials

Department Capsule Manufacturing
SOP No. SOP/CM/079/2025
Supersedes SOP/CM/079/2022
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 standardized procedure for layering pellets with active pharmaceutical ingredients (APIs) and excipients for capsule fill materials. The goal is to ensure the accurate and uniform application of layers, thereby achieving the desired release profile and bioavailability of the drug.

2. Scope

This SOP applies to the layering process of pellets used in capsule fill formulations. It covers the equipment setup, preparation of layering materials, the actual layering process, and quality control checks to ensure that the pellets meet the required specifications for capsule filling.

3. Responsibilities

  • Manufacturing Team: Responsible for performing the layering of pellets according to this SOP, ensuring that the process is executed efficiently and that the pellets are produced with the required specifications.
  • Quality Control (QC) Team: Responsible for monitoring the quality of layered pellets, performing in-process tests to verify that the pellets meet the required specifications for uniformity and content.
  • Quality Assurance (QA) Team: Ensures that the layering process complies with GMP and regulatory guidelines. Reviews records and approves the final pellets for capsule filling.
  • Maintenance Team: Responsible for ensuring that the pellet layering equipment is maintained and calibrated to ensure smooth operation during the process.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the pellet layering process is performed according to this SOP. The QA Manager is responsible for ensuring that the process complies with regulatory standards and that the final pellets are acceptable for use in capsule formulations.

5. Procedure

5.1 Preparation of Layering Materials

Before starting the layering process, ensure the following preparations are completed:

  1. Verify Pellets

    1. Verify that the base pellets are suitable for layering. The pellets should be dry, free from defects, and uniform in size.
    2. Ensure that the pellets are clean and free from any contaminants that could affect the layering process.
  2. Prepare Layering Solution

    1. Prepare the layering solution, which typically consists of the API, excipients, and a solvent or binder. Ensure the solution is homogeneous and that the correct proportions of API and excipients are used according to the formulation specifications.
    2. Filter the solution, if necessary, to remove any particulate matter that could interfere with the layering process.
  3. Set Up Layering Equipment

    1. Set up the pellet layering machine according to the manufacturer’s guidelines. Ensure that the equipment is clean and calibrated for the specific batch being processed.
    2. Ensure that the pellet bed, spray nozzles, and drying systems are correctly set up to ensure even application of the layering material.
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5.2 Layering Process

Follow these steps to layer the pellets:

  1. Load Pellets into Layering Machine

    1. Load the base pellets into the pellet layering machine. Ensure that the pellets are spread evenly to allow for uniform layering.
  2. Spray Layering Solution

    1. Start the spraying system and apply the layering solution to the pellets in a controlled manner. Ensure that the spray nozzle is correctly positioned and that the solution is applied evenly to the surface of the pellets.
    2. Adjust the spraying parameters such as pressure, flow rate, and nozzle position to achieve a uniform coating on the pellets.
  3. Monitor Layering Process

    1. Monitor the pellets during the layering process to ensure that the coating is applied uniformly and that the pellets do not clump or stick together.
    2. Check the appearance of the pellets for even coverage and ensure that no excess liquid accumulates on the pellets.
  4. Dry the Pellets

    1. Once the initial layer has been applied, transfer the pellets to the drying section of the machine to ensure that the layering material is properly dried before applying the next layer.
    2. Adjust the drying temperature and airflow to ensure that the pellets are dried efficiently without overheating or cracking.
  5. Apply Additional Layers

    1. Repeat the spraying and drying steps as necessary to build the desired number of layers on the pellets. Ensure that each layer is thin and uniform, and that the pellets are dried between applications to prevent clumping.
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5.3 Quality Control of Layered Pellets

Once the layering process is complete, perform the following quality control checks:

  1. Pellet Size and Shape

    1. Inspect the pellets for uniform size and shape. Ensure that the pellets are spherical and that no pellets are deformed or crushed during the layering process.
  2. Layer Uniformity

    1. Perform an inspection to verify that the layers are applied evenly. Use a microscope or other appropriate tools to check the uniformity of the coating on the pellets.
  3. Content Uniformity

    1. Perform a content uniformity test to ensure that the API is evenly distributed within the layered pellets. Test a sample of pellets for API content to verify that it matches the required specifications.
  4. Moisture Content

    1. Test the moisture content of the pellets to ensure it is within the acceptable range. Excess moisture can affect the stability of the pellets, while insufficient moisture can lead to cracking during storage or encapsulation.

5.4 Post-Layering Actions

After completing the layering process, perform the following actions:

  1. Segregate Defective Pellets

    1. Inspect the pellets for any defects, such as uneven layers, clumping, or incorrect size. Segregate any defective pellets for rework or disposal.
  2. Transfer to Capsule Filling

    1. Once the pellets pass the quality control checks, transfer them to the capsule filling area. Ensure that the pellets are stored in appropriate conditions to maintain their integrity before encapsulation.
  3. Documentation

    1. Document the entire layering process in the batch production record (BPR), including details such as pellet type, layering parameters, and quality control results. Include any deviations or corrective actions taken during the process.
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5.5 Equipment Cleaning and Maintenance

After completing the layering process, ensure the following maintenance steps:

  1. Clean Equipment

    1. Clean all equipment used in the layering process, including the pellet layering machine, spray nozzles, and drying system, to remove any residual materials that could affect future batches.
  2. Inspect for Wear and Tear

    1. Inspect the pellet layering machine for any signs of wear and tear, particularly on parts such as the spray nozzles, pumps, and drying system. Replace any worn-out components to prevent malfunction during future operations.
  3. Lubricate Moving Parts

    1. Lubricate any moving parts of the equipment to ensure smooth operation and minimize the risk of mechanical failure during subsequent use.

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. Pellet Quality Control Log (Annexure-2)
  3. Equipment Maintenance Log (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 Layering Date Pellet Type Layering Parameters Operator Name
Batch 001 01/02/2025 Base Pellets Speed: 25 rpm, Layering Solution: API + Excipient John Doe

Annexure-2: Pellet Quality Control Log

Sample ID Pellet Size Layer Uniformity Moisture Content Operator Name
Sample 001 Standard Uniform 5.5% John Doe

Annexure-3: Equipment Maintenance Log

Machine ID Maintenance Date Tasks Performed Technician Name
Layering Machine 1 01/02/2025 Calibrated and cleaned 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 layering parameters Standardization QA Head
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