Capsule: SOP for Visual Inspection of Capsule Sealing – V 2.0

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Capsule: SOP for Visual Inspection of Capsule Sealing – V 2.0

Standard Operating Procedure for Visual Inspection of Capsule Sealing

Department Capsule Manufacturing
SOP No. SOP/CM/103/2025
Supersedes SOP/CM/103/2022
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 establish the procedure for the visual inspection of capsule sealing to ensure that capsules are sealed correctly, without leaks or defects. Proper capsule sealing is essential for maintaining the quality, stability, and safety of the product.

2. Scope

This SOP applies to the visual inspection of capsules during the sealing process. It includes the inspection of capsules for sealing integrity, ensuring that no leaks or improper seals are present before further processing or packaging.

3. Responsibilities

  • Production Operators: Responsible for visually inspecting capsules for sealing integrity during and after the sealing process. Operators must identify defects such as incomplete seals, cracks, or leaks.
  • Quality Control (QC) Team: Responsible for overseeing the inspection process, performing random spot checks, and verifying that the capsules meet quality standards for sealing.
  • Quality Assurance (QA) Team: Ensures the SOP is followed, reviews inspection records, and approves batches that meet sealing specifications for release.
  • Production Supervisor: Oversees the visual inspection process, ensures operators are trained in identifying seal defects, and resolves issues that arise during inspections.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that visual inspections of capsules are conducted correctly. The QA Manager is responsible for reviewing the inspection results and ensuring that the batch meets the required sealing specifications before release.

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5. Procedure

5.1 Visual Inspection Setup

Before performing the visual inspection, ensure the following steps are completed:

  1. Prepare Inspection Area

    1. Ensure the inspection area is well-lit and clean. Proper lighting is essential for detecting seal defects, including incomplete or damaged seals.
    2. Set up the inspection station with clean tools and ensure that inspectors have access to necessary documentation (e.g., batch production record, inspection checklist).
  2. Verify Equipment Functionality

    1. Ensure that the sealing machine is properly calibrated and functioning according to the manufacturer’s specifications. This includes checking temperature settings, pressure, and sealing time.
    2. Verify that the capsule inspection equipment is in good working order, particularly if automated visual inspection systems are used.

5.2 Conducting the Visual Inspection

Follow these steps for visual inspection of capsule sealing:

  1. Inspect Seals for Completeness

    1. Check that each capsule has a complete and intact seal with no gaps, cracks, or visible openings.
    2. Inspect capsules for any incomplete seals that may cause leakage, contamination, or product loss during packaging.
  2. Check for Leaks

    1. Check the capsules for leaks by applying pressure or using appropriate equipment (e.g., vacuum or pressure test equipment) to identify compromised seals.
    2. Use visual inspection for leaks by looking for any product leakage from the capsule after it has been sealed.
  3. Inspect for Cracks or Damage

    1. Look for any cracks, chips, or deformation of the capsule shell that could impact product quality or lead to contamination during storage or transport.
    2. Inspect both the body and cap of the capsule to ensure that they are intact and there is no damage that could affect their functionality.
  4. Check for Proper Alignment

    1. Ensure that the capsule body and cap are aligned correctly, with no offset or misalignment that could result in an incomplete or defective seal.
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5.3 Documentation of Inspection Results

Record the results of the visual inspection as follows:

  1. Record Inspection Findings

    1. Document the number of capsules inspected, the number of defective capsules, and the type of defect found (e.g., incomplete seals, cracks, leaks) in the Capsule Sealing Inspection Log (Annexure-1).
    2. For automated inspection systems, ensure that the inspection data is logged and stored for review.
  2. Retest Defective Capsules

    1. If defects are found, re-inspect the defective capsules manually or by using other inspection equipment to verify the severity of the issue.
    2. Document any corrective actions taken to resolve the issues, such as recalibrating equipment or adjusting sealing parameters.

5.4 Handling Defective Capsules

If defective capsules are identified, handle them as follows:

  1. Segregate Defective Capsules

    1. Immediately separate defective capsules from the acceptable batch to prevent contamination during packaging.
    2. Label the containers with the rejected capsules clearly, indicating the reason for rejection (e.g., incomplete seal, cracked shell, leakage).
  2. Reject and Document

    1. Reject the defective capsules based on the severity of the defect, and document the rejection in the Reject Log (Annexure-2).
    2. Investigate the cause of the defect and take corrective actions to prevent recurrence, such as adjusting machine settings or changing raw materials.
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5.5 Final Approval for Packaging

Once the visual inspection is complete and all defective capsules have been addressed, proceed as follows:

  1. QA Review

    1. The QA team should review the inspection results, including any corrective actions taken, to ensure that the sealing process meets quality standards.
  2. Approval for Packaging

    1. If the capsules meet the required sealing specifications, the batch is approved for packaging and labeling.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • BPR: Batch Production Record

7. Documents

  1. Capsule Sealing Inspection Log (Annexure-1)
  2. Reject Log (Annexure-2)

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: Capsule Sealing Inspection Log

Sample ID Capsule Seal Integrity Defects Found Operator
Sample 001 Pass None John Doe
Sample 002 You said:
Continue
ChatGPT said:
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Fail Cracked capsule Jane Smith

Annexure-2: Reject Log

Batch ID Reason for Rejection Number of Rejected Capsules Corrective Action
Batch 001 Incomplete seal 20 Recalibrated sealing machine

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 inspection criteria and corrective actions Standardization QA Head
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