The goal is to ensure that the seal strength is sufficient to keep the product hermetically sealed during transport and sterilization, while also allowing it to be peeled open cleanly without residue (without fiber shedding or tearing of the film).

The separation process is evaluated visually:

• Fiber-free opening: No loose fibers must form when separating paper or nonwoven layers, as these could fall onto the sterile product and cause contamination.
• No delamination/tearing: The film must not tear or split into multiple layers.
• Uniformity: The seal must open continuously without jerky force spikes (stick-slip effect).

Der Beitrag DIN EN 868-5:2019 Peel Test of Flexible Packaging erschien zuerst auf INNOPROOF GmbH.

The packaged products are stored at elevated temperatures (commonly between 50 °C and 60 °C) and controlled humidity levels to thermally accelerate physical degradation processes. The mathematical basis of accelerated aging is the Arrhenius equation. This is grounded in the model that a 10 °C temperature increase approximately doubles the rate of aging reactions. As a result, 12 months of real-time aging can often be simulated in just a few weeks within an environmental chamber.

Following the calculated test duration, the packaging is tested for parameters such as seal strength, integrity (sterile barrier protection), and material embrittlement, while the medical device itself is evaluated for functionality.

Der Beitrag ASTM F1980: Accelerated aging of sterile barrier systems and medical devices erschien zuerst auf INNOPROOF GmbH.

A test object in the form of a cylindrical steel rod with a hemispherical tip impacts specific weak points or surfaces of the packaging with a defined kinetic energy. In our custom-built test rig, this is carried out via a guided drop from a specified height.

In contrast to the free-fall drop test (ASTM D5276), where the total weight of the packaging acts upon a surface, edge, or corner, the D6344 method tests the outer packaging’s resistance to penetration and denting against external, concentrated forces. The evaluation assesses whether the outer shell (e.g., corrugated cardboard, plastic, or wood) is punctured or severely indented and whether the contents were damaged as a result.

Der Beitrag ASTM D6344: Concentrated Impacts to Transport Packages erschien zuerst auf INNOPROOF GmbH.

The loaded and sealed container is dropped from a defined height in free fall onto a rigid, non-yielding impact surface. For this purpose, INNOPROOF engineers developed a proprietary drop tower. The test enables targeted drops onto different areas of the container:

• Flat drop: Impact flat on one of the side walls.
• Edge drop: Targeted impact on an edge.
• Corner drop: Direct impact on a corner (often the most critical stress).

Following the drop, the container is inspected for external damage (cracks, buckling, opening of closures), and the contents are examined for damage or leakage.

Der Beitrag ASTM D5276: Drop Test of Loaded Containers by Free Fall erschien zuerst auf INNOPROOF GmbH.

For testing, specimens are fixed in the testing machine parallel to the implant axis. A vertical load is first applied from inferior to superior, and the loosening rate is recorded. The test is stopped when one of the following occurs:

• The insert separates from the backing
• The applied load reaches its maximum and begins to decrease
• Gross deformation of the insert occurs without loosening

After this, a new insert is placed in the test fixture, and the test is repeated under the same conditions but applied from anterior to posterior. The test is stopped again as soon as one of the above cases occurs. The backing is visually inspected for damage after each test.

At least five equivalent samples should be tested, and the test can be conducted either in air at room temperature or under defined physiological conditions.

Der Beitrag ASTM F1829 – Glenoid shear test erschien zuerst auf INNOPROOF GmbH.

Der Beitrag DIN EN 455-4 shelf life of gloves* erschien zuerst auf INNOPROOF GmbH.

Depending on the intended use of the gloves, different dimensional requirements apply. For determination of tensile strength, dumbbell-shaped specimens are punched from the palm area of the gloves. The single wall thickness of the glove and the thickness of the dumbbell specimen are measured. The statically determined tensile force is multiplied by the ratio of single wall thickness to specimen thickness. The resulting tensile force value is then compared with the values specified in the standard.

Der Beitrag DIN EN 455-2 physical properties of gloves* erschien zuerst auf INNOPROOF GmbH.

Der Beitrag DIN EN 455-1 glove watertightness* erschien zuerst auf INNOPROOF GmbH.

The glenoid component is fixed in a bone substitute material using bone cement, and the humeral head component is placed into the glenoid component. An axial load is applied through the glenoid component while the humeral head is moved in opposite directions to determine the maximum displacement before dislocation. Then, the humeral head is cyclically moved at a speed of up to 50 mm/min for 100,000 cycles in both directions until 90% of the displacement at dislocation is reached. During the test, axial displacement (rocking) of the glenoid edges is recorded. The test can be conducted dry or in water at 37°C.

Der Beitrag ASTM F2028 – Glenoid loosening test* erschien zuerst auf INNOPROOF GmbH.

Der Beitrag ASTM F2203 linear dimensions* erschien zuerst auf INNOPROOF GmbH.