SOP Guide for Pharma

Capsule: SOP for Operating Capsule Inspection Machines – V 2.0

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Capsule: SOP for Operating Capsule Inspection Machines – V 2.0

Standard Operating Procedure for Operating Capsule Inspection Machines

Department Capsule Manufacturing
SOP No. SOP/CM/098/2025
Supersedes SOP/CM/098/2022
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 operating capsule inspection machines. These machines are used to ensure that capsules meet the required specifications for size, shape, integrity, and appearance. This SOP ensures that capsules are properly inspected and that any defective capsules are rejected before packaging.

2. Scope

This SOP applies to the operation of capsule inspection machines used in the manufacturing process. It covers machine setup, operation, inspection procedures, and the handling of rejected capsules.

3. Responsibilities

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that capsule inspection machines are operated correctly and that defective capsules are identified and rejected. The QA Manager is responsible for ensuring compliance with regulatory standards and reviewing any discrepancies in the inspection process.

5. Procedure

5.1 Setting Up Capsule Inspection Machines

Before starting the inspection process, follow these steps to set up the capsule inspection machine:

  1. Check Machine Calibration
    1. Ensure that the capsule inspection machine is calibrated according to the manufacturer’s instructions. Use calibration tools and reference capsules to verify accuracy.
    2. Recalibrate the machine if necessary and document the calibration results in the machine’s maintenance log (Annexure-1).
  2. Inspect the Machine for Cleanliness
    1. Verify that the capsule inspection machine is clean and free from debris or residue that may interfere with the inspection process.
    2. Ensure that all parts of the machine, including the inspection cameras and sensors, are free from obstruction and functional.
  3. Set Inspection Parameters
    1. Set the acceptable specifications for capsule size, shape, color, and integrity according to product requirements.
    2. Adjust machine settings to detect common defects such as cracks, discoloration, capsule filling inconsistencies, and foreign particles.
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5.2 Operating the Capsule Inspection Machine

Once the inspection machine is set up, begin the capsule inspection process:

  1. Start the Machine
    1. Power on the capsule inspection machine and allow it to warm up as per the manufacturer’s instructions.
    2. Run a test batch of capsules through the machine to ensure that it is properly detecting and rejecting defective capsules.
  2. Feed Capsules into the Machine
    1. Ensure that the capsules are loaded into the machine hopper evenly, without any clumping or blockages.
    2. Feed capsules continuously into the machine, ensuring a steady flow for inspection.
  3. Monitor the Inspection Process
    1. Monitor the machine’s performance during the inspection process, watching for alerts or notifications indicating defective capsules.
    2. Ensure that the machine is operating smoothly and making accurate rejections when defects are detected.

5.3 Rejecting Defective Capsules

Capsules that do not meet the defined specifications should be rejected and handled as follows:

  1. Identify Defective Capsules
    1. The inspection machine should automatically identify defective capsules, including those with cracks, foreign particles, or weight irregularities.
    2. Any capsules that do not meet the acceptable quality standards should be automatically rejected by the machine.
  2. Segregate Rejected Capsules
    1. Rejected capsules should be collected in a designated container labeled “Rejected Capsules” to prevent accidental inclusion in the packaging process.
    2. Rejected capsules should be logged and documented in the Reject Log (Annexure-2), including the reason for rejection and the quantity of capsules rejected.
  3. Investigate Rejection Causes
    1. If a large number of capsules are rejected or if the rejection is due to a consistent issue, investigate the cause (e.g., machine malfunction, raw material defect, or operator error).
    2. Implement corrective actions, such as machine recalibration, material adjustments, or operator retraining, as necessary.
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5.4 Quality Control Checks

After the inspection process, the following quality control checks should be performed:

  1. Verify Capsule Quality
    1. The QC team should randomly select a sample of capsules from the production batch and verify that they meet the established specifications for size, shape, and integrity.
    2. Ensure that no defective capsules are present in the final batch before moving on to packaging.
  2. Review Inspection Results
    1. The QC team should review the capsule inspection data, including the number of capsules inspected, the number rejected, and the reasons for rejection, and verify that the process is in compliance with the specified standards.

5.5 Documenting the Inspection Process

All capsule inspection activities should be documented as follows:

  1. Maintain Inspection Records
    1. Document all details related to the capsule inspection process, including machine settings, inspection results, and any deviations or corrective actions taken in the Capsule Inspection Log (Annexure-3).
  2. Record Rejected Capsules
    1. Ensure that all rejected capsules are logged in the Reject Log (Annexure-2), including batch numbers, reasons for rejection, and quantities rejected.
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5.6 Final Approval and Packaging

Once the capsule inspection process is complete, the following steps should be followed:

  1. QA Review
    1. The QA team should review the inspection results, including any corrective actions taken, to ensure that the batch is compliant with quality standards.
  2. Approval for Packaging
    1. If the inspection results are satisfactory, the batch is approved for packaging and labeling.

6. Abbreviations

7. Documents

  1. Capsule Inspection Log (Annexure-3)
  2. Reject Log (Annexure-2)
  3. Batch Production Record (BPR) (Annexure-1)

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: Batch Production Record (BPR)

Batch ID Capsule Inspection Settings Defective Capsules Corrective Actions
Batch 001 Capsule size: 10mm, Shape: Round, Fill weight: 500mg 5
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Copy 		5 defective capsules Recalibrated inspection machine, retrained operators on handling

Annexure-2: Reject Log

Batch ID Defect Description Number of Rejected Capsules Reason for Rejection Corrective Action
Batch 001 Cracked capsules 10 Capsule shell cracks during handling Adjusted machine speed, increased pressure during filling

Annexure-3: Capsule Inspection Log

Batch ID Inspection Result Defective Capsules Operator Name Inspection Outcome
Batch 001 Capsules passed all checks 0 John Doe Passed inspection

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 machine settings and corrective actions Standardization QA Head
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