Video of the ASTM F2096 Bubble Emission Test

Methods for the mechanical testing of medical packaging

  • The ASTM D5276 standard (“Standard Test Method for Drop Test of Loaded Containers by Free Fall”) describes a standardized test procedure for determining the impact resistance of filled shipping containers. Its objective is to evaluate the ability of packaging (such as boxes, crates, drums, or sacks) to withstand drop-induced stresses during transport and handling, as well as its protective performance for the contents.

    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.

  • The ASTM D6344 standard (“Standard Test Method for Concentrated Impacts to Transport Packages”) describes a test method for determining the resistance of transport packaging to concentrated or point impacts. Its objective is to simulate localized impacts that occur during transport and handling—such as bumping against sharp loading edges, impact from falling cargo, or knocks from forklift forks.

    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.

  • ASTM D642 KompressionsprüfungPackaging is tested under compression according to ASTM D642 in order to simulate transportation or storage conditions. The packaging sample is placed between two horizontal plates and subjected to static loading. The test is terminated when a specified deformation is reached or when a drop in reaction force occurs. The maximum applied test force and the corresponding deformation of the packaging are recorded.

  • Packaging burst testing is a destructive quality control method used to measure the maximum pressure a package or its seals can withstand before rupturing. It ensures that products remain safely contained during transit, storage, and handling. This test is critical across multiple industries, including medical devices, pharmaceuticals, food, and consumer goods.

    First, the package is securely connected to a test nozzle. Next, air is pumped inside at a controlled, constant rate. The internal pressure rises until the package ruptures. The system records the peak pressure in units like psi, kPa, bar, or kg/cm².

    The test identifies if heat seals or adhesive bonds are strong enough to prevent leaks. It ensures the packaging can handle high-altitude air transit or physical compression.

    There are two different methods to choose from:

    1. Open/Free Burst Test: The package expands freely like a balloon until it pops. This measures the overall weakest point.
    2. Restrained Burst Test: Two rigid plates limit the expansion of the package body. This isolates and tests only the perimeter seals.

  • The seal is visually inspected in the seam area for sealing defects, uniformity, and completeness.

  • ASTM F1929 Dichtheitsprüfung mittels Dye Penetration TestTo evaluate the seal seam, dye is applied to one side of the seal. It is then visually examined whether the dye penetrates through the seal. Each side of the sample seal is observed for 5 seconds. The package must not contain liquids or condensation, as this could distort the test results. The dye used must provide strong contrast with the opaque packaging material. One of three methods is selected for seal testing.

    Method A: Injection method
    The dye solution is injected into the package. The seal is observed to detect possible seal defects indicated by dye leaking from the inside to the outside.

    Method B: Edge immersion method
    An outer edge of the seal is immersed in the dye solution. If dye penetrates from the outside to the inside, leakage points are present in the seal.

    Method C: Pipette method
    For this method, one outer edge of the package must remain unsealed. Using a pipette, drops of dye solution are applied to the inner side of the intact seal seam. The seal is then inspected for dye penetration.

  • ASTM F1980 accelerated agingThe ASTM F1980 standard (“Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices”) provides guidelines for conducting accelerated aging tests on sterile packaging and medical devices. Its objective is to rapidly demonstrate expiration dates (shelf life) and the long-term integrity of sterile barrier systems (e.g., pouches, blister packs) without having to wait for years of real-time aging.

    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.

  • ASTM F2096 Bubble Emission Test* In the bubble emission test according to ASTM F2096, the integrity of packaging or sterile barrier systems is evaluated by applying internal pressure. For this purpose, the packaging film is punctured on one side using a needle, internal air pressure is applied, and the package is submerged in water. In our setup, a second needle and a digital manometer are used to directly measure the internal pressure.

    To validate the procedure and to set the required internal pressure, a hole is intentionally introduced into the packaging using a 250 µm needle. The internal pressure is then adjusted until a continuous stream of air bubbles is produced.

    We are pleased to perform leak testing of your packaging using the bubble emission test.

  • The dimensions of the packaging are determined using a ruler.

  • ASTM F88 SiegelnahtprüfungThe seal strength of the packaging seam is tested in a tensile test. The packaging is cut into samples of defined size. Both ends of the seal are clamped, with one of three clamping configurations selected depending on the type of seal. The specimen is statically loaded at 200 to 300 mm/min until seal failure occurs. Only results obtained using the same clamping configuration may be compared.

  • The peel test according to DIN EN 868-5 (Annex D) is a standardized test method for determining the opening behavior (peelability) of sealable pouches and reels for the sterilization of medical devices.

    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).