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MEDICAL PACKAGE TEST

ASTM D 4169 and ISO 11607 are the guidepost test standards for medical packaging. These tests provide a reliable indicator that medical devices remain in a sterile environment during the distribution stages. To avoid the risk of a costly product recall, the sterile barrier system must protect the packaged product and maintain the sterility of the product from the moment it leaves your manufacturing facility until the end-user opens it.

To rapidly determine the effects of time on integrity of the sterile barrier system and the physical properties of their component packaging materials.

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To provide special atmospheric conditioning that may be used to simulate field conditions that package may encounter during its life or testing.

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This test method is intended for use in evaluating the capability of a container to withstand the sudden shock resulting from a free fall, or to evaluate the capability of a container.

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This test method is intended to determine the ability of the shipping unit to withstand the compressive loads that occur during warehouse storage or vehicle transport.

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Exposure to vibration can affect the shipping container, its interior packaging, means of closure, and contents. These tests allow analysis of the interaction of these components.

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This test method determines the effects of pressure differential when packaged products are transported via certain modes of transport, such as aircraft or by ground over mountain passes.

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This test method may be used to assess the performance of a container with its interior packing in terms of its ruggedness and the protection that it provides when subjected to random vibration.

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This test method is for testing complete filled transport packages for resistance against concentrated low-level impacts typical of those encountered in the distribution environment.

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This test method will visually detect channel defects and/or potential compromise to medical package integrity after the course of testing.

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This test method will detect and locate a leak in package edge seals formed between a transparent film and a porous sheet material.

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This test method covers the detection of gross leaks in medical packaging. It may be used for tray and pouch packages of medical devices.

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This test method will determine the ability of medical device packages to withstand pressure differentials that may occur during sterilization or transportation.

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This test method measures the force required to separate a test strip of material containing the seal. It also identifies the mode of specimen failure.

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