SOP Guide for Pharma

Capsule: SOP for Monitoring Hardness of Capsule Shells – V 2.0

Auditor

Capsule: SOP for Monitoring Hardness of Capsule Shells – V 2.0

Standard Operating Procedure for Monitoring Hardness of Capsule Shells

Department Capsule Manufacturing
SOP No. SOP/CM/197/2025
Supersedes SOP/CM/197/2022
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 defines the procedure for monitoring the hardness of capsule shells to ensure that they meet the required quality specifications for strength and durability during the manufacturing process.

2. Scope

This SOP applies to all capsule shells manufactured at this facility and provides a method to assess the hardness of the shells to ensure they meet the specifications before being filled with the active ingredient.

3. Responsibilities

4. Accountability

The QA Manager is responsible for ensuring that the hardness testing is conducted according to GMP and regulatory requirements. The QC Supervisor ensures proper execution of the testing procedure, and the Production Supervisor ensures the proper handling and quality control of the capsule shells during manufacturing.

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5. Procedure

5.1 Pre-Testing Setup

Before performing hardness testing on capsule shells, ensure the following:

  1. Review Hardness Specifications
    1. Review the hardness specifications for the capsule shells, which should meet the required minimum and maximum values for the specific capsule type being produced.
  2. Prepare Testing Equipment
    1. Ensure that the hardness testing equipment (e.g., tablet hardness testers or force gauges) is calibrated and ready for use. The equipment should be capable of measuring the force required to break or crush the capsule shell.
  3. Sample Collection
    1. Collect a representative sample of capsule shells from the batch. Typically, 6-10 capsules are selected for testing, depending on batch size and regulatory guidelines.

5.2 Hardness Testing Procedure

Follow these steps to test the hardness of the capsule shells:

  1. Place Capsule in Testing Device
    1. Place each capsule in the hardness tester, ensuring it is properly aligned in the device to prevent any mechanical errors during testing.
  2. Measure Hardness
    1. Apply force to the capsule using the tester and record the maximum force required to break or crush the capsule shell. This value should be in the specified range for the product type (e.g., 4-12 N for standard gelatin capsules).
  3. Repeat Testing
    1. Perform the hardness test on multiple capsules from the sample to ensure that the batch consistency meets the required standards. Record the results for each capsule tested.
  4. Calculate Average Hardness
    1. Calculate the average hardness of the tested capsules to assess the overall consistency of the batch. This should fall within the acceptable limits established by the product specifications.
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5.3 Post-Testing Activities

After completing the hardness test, ensure the following:

  1. Review Results
    1. The QA Manager reviews the hardness test results to ensure that the capsules meet the required hardness specifications. If any capsules fall outside the acceptable range, further investigation is required.
  2. Corrective Actions
    1. If any capsules fail to meet the required hardness specifications, the root cause should be investigated (e.g., improper capsule drying, incorrect formulation parameters) and corrective actions should be implemented.
  3. Report and Release
    1. Provide the test results to the regulatory authorities if required, especially in cases where deviations or failures have been observed.
    2. If the capsules meet the hardness specifications, release the batch for further processing, such as filling and packaging.
  4. Record Keeping
    1. Ensure that all test results, observations, and corrective actions are documented and stored in compliance with GMP and regulatory guidelines. These records should be readily accessible for future reference or audits.

6. Abbreviations

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7. Documents

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

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: Equipment Calibration Log

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Hardness Tester 408 01/02/2025 John Doe Calibration of force measurement system 01/02/2026

Annexure 2: Hardness Testing Log

Batch ID Test Date Capsule ID Hardness (N) Result
Batch 011 02/02/2025 Capsule A 8.5 Pass

Annexure 3: Corrective Action Report

Batch ID Deviation Corrective Action Responsible Person Completion Date
Batch 011 Hardness outside range Adjusted capsule drying time 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 hardness testing QA Head
01/02/2025 2.0 Updated testing procedure and log format Improvement of testing accuracy and compliance QA Head
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