Capsule: SOP for Capsule Friability Testing – V 2.0

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Capsule: SOP for Capsule Friability Testing – V 2.0

Standard Operating Procedure for Capsule Friability Testing

Department Capsule Manufacturing
SOP No. SOP/CM/190/2025
Supersedes SOP/CM/190/2022
Page No. Page 1 of 8
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This SOP describes the procedure for conducting friability testing on capsules to ensure that they meet the required mechanical strength and durability criteria during handling and transportation.

2. Scope

This SOP applies to all soft and hard gelatin capsules to verify that their friability (resistance to mechanical stress) meets the specified standards, ensuring the quality and integrity of capsules during manufacturing and packaging.

3. Responsibilities

  • Quality Control (QC) Team: Responsible for performing friability testing on capsule samples, documenting the results, and ensuring compliance with specifications.
  • Quality Assurance (QA) Team: Reviews the friability test results and ensures that capsules meet the specified durability and mechanical strength requirements.
  • Production Team: Provides the necessary capsule samples for friability testing and ensures proper handling during the testing process.

4. Accountability

The QA Manager is responsible for ensuring that the friability testing process complies with GMP and regulatory standards. The QC Supervisor ensures the proper execution of the friability testing process

and result documentation. The Production Supervisor ensures timely provision of the necessary capsule samples for testing.

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5. Procedure

5.1 Pre-Testing Setup

Before beginning friability testing, ensure the following:

  1. Review Testing Criteria

    1. Review the friability specifications for capsules based on the regulatory guidelines (e.g., USP, EP). These limits must be approved by the QA department before testing.
  2. Prepare Testing Equipment

    1. Ensure that the friability testing apparatus (e.g., a friabilator) is calibrated and in proper working condition. Verify that the drum rotation speed is set to 25 rpm.
  3. Prepare Sample Collection

    1. Collect a representative sample of capsules, typically 10-20 capsules, from the batch for testing.

5.2 Friability Testing Procedure

Follow these steps to perform the friability test:

  1. Place Capsules in Friability Drum

    1. Place the selected sample of capsules into the friability drum. Ensure that the drum is clean and free of any previous residues.
  2. Initiate Testing

    1. Start the friability test and allow the drum to rotate for 100 revolutions (or as specified in the standard). During this process, capsules will collide and rub against each other to simulate handling stress.
  3. Weigh Capsules Before and After Testing

    1. Weigh the capsules before and after the friability test using an analytical balance. Record the weight loss after 100 revolutions.
  4. Record Results

    1. Calculate the percentage weight loss after the test. The weight loss should not exceed the allowable limit as per regulatory standards (typically 1% for most capsules).
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5.3 Post-Testing Activities

After the friability test is completed, ensure the following:

  1. Review Results

    1. The QA Manager reviews the friability test results to ensure that the capsules meet the specified criteria. If any capsule fails the test, an investigation will be conducted to identify the cause of the failure.
  2. Corrective Actions

    1. If any capsules fail the friability test, the root cause must be identified (e.g., formulation issues, capsule quality). Corrective actions, such as adjusting the formulation or process, should be implemented.
  3. Training and Feedback

    1. If discrepancies or failures are identified, provide feedback to the testing team and operators. Additional training may be required to prevent recurrence.
  4. Record Keeping

    1. Ensure that all records related to the friability test, including test logs, results, and corrective actions, are filed and archived as per regulatory requirements.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • USP: United States Pharmacopeia
  • EP: European Pharmacopeia

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7. Documents

  1. Annexure 1: Equipment Calibration Log
  2. Annexure 2: Friability Testing Log
  3. Annexure 3: Corrective Action Report

8. References

  • USP <701> – Friability Test
  • European Pharmacopoeia 2.9.7 – Friability Test for Capsules
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Equipment Calibration Log

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Friability Apparatus 102 01/02/2025 John Doe Calibration of drum speed and rotation time 01/02/2026

Annexure 2: Friability Testing Log

Capsule ID Test Date Weight Before Test (g) Weight After Test (g) Loss in Weight (%) Result
Batch 004 02/02/2025 0.75 0.74 1.33% Pass

Annexure 3: Corrective Action Report

Batch ID Deviation Corrective Action Responsible Person Completion Date
Batch 004 Excessive capsule weight loss Adjusted capsule formulation and process Production Supervisor 03/02/2025

12. Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version of SOP Creation of SOP for friability testing QA Head
01/02/2025 2.0 Updated testing procedure and log format Improvement of testing and documentation QA Head
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