Sealing Integrity Check Procedures for Capsules

1) Purpose

The purpose of this SOP is to outline the procedure for ensuring that capsules are properly sealed to prevent leakage and maintain product integrity.

2) Scope

This SOP applies to all filled capsules produced within the pharmaceutical manufacturing facility.

3) Responsibilities

– QC personnel are responsible for conducting sealing integrity checks on filled capsules.
– Production personnel must provide samples of filled capsules for testing.
– QA personnel are responsible for reviewing and approving the test results.

4) Procedure

1. Sample Collection
1.1. Collect a representative sample of filled capsules from each batch.
1.2. Ensure samples are collected at regular intervals during the filling process.
1.3. Label each sample with batch number, date, and time of collection.
2. Visual Inspection
2.1. Visually inspect each capsule for signs of improper sealing, such as gaps, cracks, or leakage.
2.2. Use a magnifying glass if necessary to detect small defects.
3. Physical Integrity Test
3.1. Perform a physical integrity test, such as a dye penetration test, to check for leaks.
3.2. Submerge the capsules in a dye solution for a specified period.
3.3. Remove and rinse the capsules, then visually inspect for any dye penetration indicating a leak.
4. Documentation
4.1. Record all sealing integrity check results on the sealing integrity check form.
4.2. Include details such as batch number, date of testing, and any observations or anomalies.
4.3. Sign and date the integrity check form.
5. Acceptance Criteria
5.1. Capsules must show no signs of leakage or improper sealing.
5.2. Any capsules failing the sealing integrity test must be rejected.
6. Review and Approval
6.1. Submit the completed integrity check forms to the QA department for review.
6.2. QA will review and approve the results based on the criteria outlined in this SOP.
7. Corrective Actions
7.1. If capsules fail the sealing integrity test, initiate a corrective action report.
7.2. Document all actions taken to address issues identified during the sealing checks, including potential adjustments to the sealing process.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance

6) Documents, if any

– Sealing Integrity Check Form
– Corrective Action Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– USP <1207> Package Integrity Evaluation – Sterile Products

8) SOP Version

Version 1.0