Capsule: SOP for Moisture Content Testing of Capsules During Manufacturing – V 2.0

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Capsule: SOP for Moisture Content Testing of Capsules During Manufacturing – V 2.0

Standard Operating Procedure for Moisture Content Testing of Capsules During Manufacturing

Department Capsule Manufacturing
SOP No. SOP/CM/101/2025
Supersedes SOP/CM/101/2022
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 testing the moisture content of capsules during the manufacturing process. Accurate moisture content is essential for ensuring the stability, integrity, and quality of the capsules.

2. Scope

This SOP applies to the process of testing moisture content in capsules during manufacturing. It covers the steps for sampling, testing, and evaluating the moisture content to ensure that it meets the established specifications.

3. Responsibilities

  • Production Operators: Responsible for collecting capsule samples and conducting initial moisture content testing during production runs.
  • Quality Control (QC) Team: Responsible for overseeing the moisture content testing process, ensuring that tests are performed according to the SOP, and reviewing test results.
  • Quality Assurance (QA) Team: Ensures the SOP is followed and approves the final test results and batch release based on moisture content specifications.
  • Production Supervisor: Oversees the moisture content testing procedure, ensures all equipment is calibrated and functioning, and ensures compliance with SOP.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that moisture content testing is performed correctly and that capsules meet the required specifications. The QA Manager is responsible for reviewing and approving the results of moisture content testing.

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5. Procedure

5.1 Sample Collection for Moisture Content Testing

Before conducting the moisture content test, ensure the following steps are followed:

  1. Determine Sample Size

    1. Determine the number of capsules to be sampled for testing, ensuring that the sample size is statistically representative of the entire batch.
    2. Ensure that the sample size is adequate to obtain reliable moisture content results, typically 10-20 capsules depending on batch size.
  2. Random Sampling

    1. Randomly select the sample capsules from different parts of the batch to ensure an accurate representation of the entire production run.
    2. Label the capsules clearly to avoid mix-ups and maintain traceability.

5.2 Moisture Content Testing Procedure

Once the sample has been collected, follow these steps to test the moisture content of the capsules:

  1. Prepare the Moisture Content Testing Equipment

    1. Ensure the moisture analyzer is calibrated according to the manufacturer’s instructions. Verify the equipment’s accuracy using a standard moisture content reference sample.
    2. Clean the moisture analyzer and ensure it is free from contaminants that may affect the test results.
  2. Test the Capsules

    1. Place the selected capsules on the moisture analyzer. If the capsules are filled with an active ingredient, ensure that the fill material does not interfere with the testing process.
    2. Activate the moisture analyzer and begin the test, ensuring that the correct testing parameters are set based on the capsule material (e.g., gelatin, HPMC) and formulation.
  3. Record the Results

    1. Record the moisture content percentage for each capsule sample tested. Ensure that the results are noted in the Moisture Content Test Log (Annexure-1).
    2. Compare the test results with the established moisture content specifications to determine if they fall within the acceptable range.
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5.3 Handling Deviations

If the moisture content is outside the acceptable range, follow these steps:

  1. Identify the Cause

    1. Investigate the root cause of the deviation. Possible causes may include improper drying, excessive humidity during manufacturing, or formulation inconsistencies.
    2. Evaluate whether the deviation is related to environmental conditions, equipment malfunction, or process variation.
  2. Take Corrective Action

    1. Adjust the environmental conditions, such as humidity or temperature, to bring the moisture content back within the acceptable range.
    2. If the issue is equipment-related, perform the necessary adjustments, calibration, or maintenance to restore proper operation.
  3. Retest the Capsules

    1. After corrective actions are implemented, retest the capsules to confirm that the moisture content is within specification.
    2. Continue testing at regular intervals throughout the manufacturing process to ensure that the moisture content remains stable.

5.4 Quality Control and Documentation

Ensure proper documentation and follow-up actions as part of the moisture content testing process:

  1. Maintain Test Records

    1. Document all moisture content test results in the Moisture Content Test Log (Annexure-1), including the sample IDs, test results, and any deviations observed.
    2. Ensure that all documentation is signed and dated by the responsible operator and reviewed by the QA team.
  2. Submit Reports for Review

    1. Submit the test results, along with any corrective actions taken, to the QA department for review and final approval.
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5.5 Final Approval

Once the moisture content has been successfully tested and meets specifications, proceed as follows:

  1. QA Review

    1. The QA team will review the moisture content test results to ensure they meet the defined standards and are compliant with GMP guidelines.
  2. Approval for Further Processing

    1. If the moisture content meets the requirements, the batch can proceed to the next manufacturing step or packaging.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance

7. Documents

  1. Moisture Content Test Log (Annexure-1)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • 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: Moisture Content Test Log

Sample ID Moisture Content (%) Deviation Corrective Action Taken Operator
Sample 001 5.2% No None John Doe

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 sampling and testing process Standardization QA Head
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