SOP Guide for Pharma

Capsule: SOP for Encapsulation Trials Using New Fill Materials – V 2.0

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Capsule: SOP for Encapsulation Trials Using New Fill Materials – V 2.0

Standard Operating Procedure for Encapsulation Trials Using New Fill Materials

Department Capsule Manufacturing
SOP No. SOP/CM/040/2025
Supersedes SOP/CM/040/2022
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 conducting encapsulation trials using new fill materials. Encapsulation trials are essential for ensuring the compatibility of new fill materials with the capsule manufacturing process, as well as verifying that the material can be encapsulated effectively while maintaining the quality of the final product.

2. Scope

This SOP applies to all new fill materials being introduced into capsule manufacturing processes. It includes the preparation, testing, and evaluation of the fill material’s compatibility with the encapsulation process.

3. Responsibilities

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the encapsulation trials are conducted properly and that any issues are addressed during the process. The QA Manager is responsible for reviewing and approving the final report of the trials to ensure compliance with regulatory standards and company policies.

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5. Procedure

5.1 Preparation for Encapsulation Trials

Before beginning encapsulation trials, the following preparatory steps must be completed:

  1. Define Material Characteristics
    1. Obtain detailed information about the new fill material, including its density, flowability, moisture content, and particle size distribution.
    2. Ensure that the new fill material meets the minimum quality standards for pharmaceutical use.
  2. Formulation Review
    1. Review the formulation to confirm that the fill material is compatible with other excipients, including any binding agents or lubricants, that will be used in the capsule formulation.
  3. Prepare the Equipment
    1. Ensure that the capsule filling equipment is calibrated and set up according to the specifications for the new fill material.
    2. Check that the filling machine settings (e.g., fill weight, capsule size) are appropriate for the new material.
  4. Prepare the Trial Batches
    1. Prepare small-scale trial batches of the new fill material for testing. These batches should be representative of the formulation to be scaled up for commercial production.

5.2 Conducting the Encapsulation Trial

Perform the encapsulation trial according to the following steps:

  1. Fill Material Loading
    1. Load the new fill material into the capsule filling machine hopper, ensuring that the material is evenly distributed and does not form clumps or blockages.
  2. Trial Encapsulation
    1. Begin the encapsulation process by operating the capsule filling machine according to the pre-established parameters (e.g., speed, fill volume, compression force).
    2. Monitor the fill weight and uniformity of the capsules during the trial to ensure the capsules are filled correctly and evenly.
  3. Monitor for Issues
    1. Observe the capsule manufacturing process for any issues such as material clumping, powder leakage, or capsule misalignment.
    2. Adjust machine settings as necessary to accommodate the new fill material, and address any issues identified during the trial.
  4. Collect Samples
    1. Collect a representative sample of the encapsulated capsules for testing and evaluation (e.g., 10-20 capsules per batch).
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5.3 Evaluation of Encapsulated Capsules

Evaluate the performance of the capsules after the encapsulation trial:

  1. Capsule Weight Uniformity
    1. Test the uniformity of the capsule weights using a calibrated balance. All capsules should meet the specified fill weight within the acceptable tolerance range.
  2. Fill Weight
    1. Ensure that the fill material in each capsule is within the target weight range. Perform statistical analysis to confirm the consistency of the fill weight across the trial sample.
  3. Capsule Integrity
    1. Inspect the capsules for signs of physical damage, such as cracks, improper sealing, or irregular shape.
    2. Ensure that the capsules can be easily opened or dissolved as required, and that the fill material does not leak or cause the capsule to break during handling.
  4. Dissolution Testing
    1. Perform dissolution testing to ensure that the fill material performs as expected under physiological conditions. Compare the results with established dissolution profiles.

5.4 Documentation and Record-Keeping

Document all aspects of the encapsulation trial process:

  1. Trial Batch Records
    1. Document the batch details, including the formulation, equipment settings, and any adjustments made during the trial process.
  2. Testing Results
    1. Record all testing results, including capsule weight uniformity, fill weight, integrity tests, and dissolution profiles. Ensure that all data is accurate and traceable.
  3. Trial Report
    1. Prepare a trial report summarizing the results of the encapsulation trial. Include any observations, challenges, and recommended changes to the formulation or process.
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5.5 Adjustments Based on Trial Results

If the encapsulation trial reveals any issues or suboptimal results, take the following steps:

  1. Formulation Adjustments
    1. Modify the formulation if necessary to improve encapsulation, such as adjusting the particle size, density, or moisture content of the fill material.
  2. Machine Settings Adjustment
    1. Adjust the capsule filling machine settings, such as the filling speed, compression force, or capsule size, to optimize the encapsulation process.
  3. Repeat Trials
    1. If necessary, conduct additional trials with modified parameters to ensure that the process is fully optimized for the new fill material.

6. Abbreviations

7. Documents

  1. Encapsulation Trial Batch Record (Annexure-1)
  2. Encapsulation Trial Report Template (Annexure-2)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Encapsulation Trial Batch Record

Batch ID Fill Material Trial Date Machine Settings Capsule Size
Batch 001 Granules A 01/02/2025 Speed: 100 rpm, Force: 15 N Size 0

Annexure-2: Encapsulation Trial Report Template

Test Type Test Result Specification Remarks
Capsule Weight Pass ±5% of target weight No deviation

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 trial procedure Standardization QA Head
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