Determining the seal strength is crucial to ensure the quality and integrity of packaging in the medical device sector. Without proper sealing, packaging is not able to protect the product from external influences and maintain sterility.

Determination of the seal seam strength

The packaging of medical devices plays a central role, as it must not only protect the contents, but also ensure patient safety by complying with strict legal requirements.

We have specialized in the packaging inspection of medical products. Packaging inspection is an essential step in ensuring the quality and safety of medical devices in accordance with the guidelines.

The seal seam is a critical component of the packaging, and medical products in particular are subject to stringent requirements. Insufficient seal seam strength can lead to contamination risks and quality restrictions. It is therefore essential to evaluate the seal seam strength before and after the sterilization process, as well as after ageing processes.

The standards DIN EN 868 Part 5 and ASTM F88/F88M describe the requirements for testing the seal seam strength of packaging materials. This defines the test sample preparation and the tensile speed to be used during the test. The criteria for assessing the seal seam strength are also defined. These depend on the sterilization process used (steam sterilization or other sterilization processes).

The test procedure according to these standards first describes the cutting of samples from the packaging (15 mm wide), the performance of the tensile test on the seal seam using a tensile testing machine to determine the seal seam strength, and the evaluation based on defined limit values.

The seal seam strength test in accordance with DIN EN 868 Part 5 and ASTM F88/F88M is an indispensable step in quality control for manufacturers of packaging materials. It helps to ensure that the packaging meets the required standards and that the medical devices it contains are safe and protected.

The seal strength of packaging is crucial for maintaining the sterility of medical devices.


  • according to DIN EN 868-5, Annex D
  • according to ASTM F88/F88M

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