SOP Guide for Pharma

Capsule: SOP for Monitoring Capsule Fill Volume Consistency – V 2.0

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Capsule: SOP for Monitoring Capsule Fill Volume Consistency – V 2.0

Standard Operating Procedure for Monitoring Capsule Fill Volume Consistency

Department Capsule Manufacturing
SOP No. SOP/CM/198/2025
Supersedes SOP/CM/198/2022
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 outlines the procedure for monitoring the consistency of capsule fill volume to ensure that each capsule contains the appropriate amount of active pharmaceutical ingredient (API) and excipient, as per regulatory and quality standards.

2. Scope

This SOP applies to all capsules produced at this facility and describes the procedure for sampling and testing capsule fill volume to ensure uniformity and consistency during the production process.

3. Responsibilities

4. Accountability

The QA Manager is responsible for ensuring that the SOP is followed and that the fill volume testing is performed according to GMP and regulatory standards. The QC Supervisor ensures that the testing process is correctly executed, and the Production Supervisor ensures that the filling process is properly maintained.

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5. Procedure

5.1 Pre-Testing Setup

Before conducting fill volume testing, ensure the following:

  1. Review Fill Volume Specifications
    1. Review the fill volume specifications for the capsule batch, including the acceptable range for both the weight and volume of the capsule content.
  2. Prepare Testing Equipment
    1. Ensure that all equipment used to measure fill volume, such as precision balances, volumetric cylinders, or capsule filling machines with integrated volume control, is calibrated and in good working order.
  3. Prepare Sample Collection
    1. Collect a representative sample of capsules from the batch. Typically, 10-20 capsules are selected for testing. Ensure that the sample is taken randomly from different parts of the batch to represent the whole production run.

5.2 Fill Volume Testing Procedure

Follow these steps to monitor the fill volume consistency:

  1. Weigh Each Capsule
    1. Individually weigh each capsule in the sample group using a calibrated balance. Record the weight of each capsule.
    2. The weight should include both the shell and the fill material, and it should fall within the specified weight range for the product.
  2. Measure Fill Material Volume
    1. If the capsule is not transparent or the fill material cannot be directly measured, extract the fill material from the capsule and measure the volume using a volumetric method, such as a displacement method using a graduated cylinder or liquid measuring system.
    2. Ensure that the volume measurement is done with care to prevent spillage or inaccurate measurement.
  3. Calculate Average Fill Volume
    1. Calculate the average fill volume for the sample group. This should be compared to the target fill volume specified in the product specifications.
    2. Ensure that the individual fill volumes fall within the acceptable tolerance limits specified by the product guidelines.
  4. Perform Statistical Analysis
    1. Analyze the fill volume data statistically (e.g., standard deviation, mean) to ensure consistency across the sample. If any capsules fall outside the acceptable range, further investigation and corrective actions are required.
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5.3 Post-Testing Activities

After completing the fill volume test, ensure the following:

  1. Review Results
    1. The QA Manager reviews the fill volume test results to ensure they meet the required specifications. If any capsules deviate from the acceptable fill volume range, the batch must be investigated for root cause and corrective action.
  2. Corrective Actions
    1. If the capsule fill volume fails to meet the required specifications, investigate the cause (e.g., incorrect machine settings, inconsistent filling material properties) and take corrective actions such as adjusting the machine settings or modifying the fill material.
  3. Reporting
    1. Provide the fill volume test results and any corrective actions taken to regulatory authorities if necessary. Ensure that all deviations are documented and addressed.
  4. Record Keeping
    1. Ensure that all records related to fill volume testing, including raw data, test results, and corrective actions, are properly documented and stored in accordance with GMP and regulatory requirements.
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6. Abbreviations

7. Documents

  1. Annexure 1: Equipment Calibration Log
  2. Annexure 2: Capsule Fill Volume 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
Fill Volume Tester 502 01/02/2025 John Doe Calibration of volume measurement system 01/02/2026

Annexure 2: Capsule Fill Volume Testing Log

Batch ID Test Date Capsule ID Fill Volume (mL) Result
Batch 012 02/02/2025 Capsule A 0.45 Pass

Annexure 3: Corrective Action Report

Batch ID Deviation Corrective Action Responsible Person Completion Date
Batch 012 Inconsistent fill volume Adjusted capsule filling machine settings 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 fill volume 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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