Sealing integrity of medical device packaging: the first line of defense for sterile barriers

Visible seal characteristics and defects provide essential evidence regarding the integrity of sterile packaging and production sealing issues. These visual clues not only offer preliminary indications of variations in the heat-sealing process but can also reveal whether packaging integrity has been compromised after physical performance testing. Particularly for packaging configurations such as rigid blister trays with Tyvek lid materials, the transparent seal area makes visual inspection especially intuitive and effective.

According to the YY/T 0681.11-2014 standard, the following guidelines outline how to perform seal integrity inspection through visual examination supplemented with a magnifying glass:

Observation Conditions:
1. Maintain a visual distance of 30 cm to 45 cm.
2. Use white light with an illuminance of 540 LX or adequate daylight.
3. Utilize a magnifying glass as an analytical tool for defect identification.

Key Inspection Points:
Inspect the entire seal area to identify the following issues:
1. Uniformity and consistency of the seal
2. Signs of over-sealing
3. Insufficient seal width
4. Defects such as wrinkles or cracks
5. Fiber shedding or evidence of package opening

Record the number and specific locations of channel defects identified on each package in detail. This data provides essential support for process improvement.

Seal integrity inspection for medical device packaging is not only a critical aspect of quality control but also a fundamental safeguard for ensuring the sterility and safety of medical devices. Through systematic visual inspection, potential issues can be detected early, preventing more significant quality risks.