Standard Operating Procedure for Sealing Integrity Check

Purpose

The purpose of this SOP is to establish procedures for the systematic and thorough checking of sealing integrity in pharmaceutical packaging, ensuring compliance with regulatory standards and maintaining product quality.

Scope

This SOP applies to all personnel involved in the manufacturing and quality control of pharmaceutical products, specifically those responsible for sealing operations and integrity verification.

Responsibilities

• Operators: Responsible for executing procedures related to the sealing of pharmaceutical products.
• Quality Control Personnel: Responsible for monitoring and verifying sealing integrity for compliance.

Procedure

1. Inspect sealing equipment for any visible damage or defects before each use.
2. Ensure that the equipment is clean, calibrated, and set up according to the approved process parameters for sealing.
3. Verify the quality and specifications of sealing materials used in the packaging process.
4. During sealing operations, monitor and document key process parameters, including but not limited to sealing temperature, sealing time, and pressure.
5. Collect samples at specified intervals during the packaging process for subsequent sealing integrity checks.
6. Use appropriate testing methods, such as visual inspection, dye penetration, or seal strength testing, to perform sealing integrity checks.
7. Record the results of sealing integrity checks, including any deviations from the predefined specifications, in the designated logbook or electronic system.
8. If sealing integrity is compromised, segregate and document affected units, and initiate an investigation to determine the root cause.
9. Implement corrective actions based on the findings of the investigation to prevent the recurrence of sealing integrity issues.
10. For finished batches, ensure that the required sampling plan for sealing integrity checks is followed, and document the results accordingly.
11. Document any out-of-specification (OOS) results, initiate an investigation, and implement corrective actions as needed.
12. Archive sealing integrity check records in accordance with established retention policies.
13. Regularly review and update sealing integrity check procedures based on industry standards or process changes.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Sealing Integrity Check Logbook
• Calibration Records
• Validation Reports
• Deviation and Corrective Action Logs

Reference

ISO 11607 – Packaging for Terminally Sterilized Medical Devices

SOP Version

Version 1.0