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Medical device package inspection is the process of evaluating the quality and integrity of the packaging of medical devices to ensure that they are safe for use. The packaging of medical devices is critical, as it protects the device from damage during shipping and handling, prevents contamination from external sources, and maintains the sterility of the device until it is used.

The package inspection process involves examining the packaging for any defects or damage that could compromise the integrity of the device. This includes checking for punctures, tears, or holes in the packaging material, as well as inspecting the seals and closures to ensure that they are secure and intact.

Medical device manufacturers are required to adhere to strict regulations and standards to certify that their packaging meets the necessary quality and safety requirements. Package integrity testing is an essential part of this process, as it helps identify any potential defects or issues with the packaging before the device reaches the end user.

Destructive package integrity testing involves damaging the package in some way to evaluate its integrity. This type of testing is typically more invasive and may not be suitable for products that need to be sold intact. An example of destructive package integrity testing is burst testing, where the package is subjected to internal pressure until it ruptures.

Non-destructive package integrity testing, on the other hand, involves evaluating the package's integrity without damaging it. This type of testing is typically less invasive and is more suitable for products that need to be sold intact. An example of non-destructive package integrity testing includes pressure decay testing, where a package is subjected to a pressure change and any leaks are detected by measuring the change in pressure.

Vacuum Decay is a non-destructive Container Closure Integrity Test (CCIT) that provides a definite pass/fail quantitative data along with dependable, reproducible, repeatable, and accurate results. The basic idea underlying Vacuum Decay technology is to question the integrity of containers based on their basic physical characteristics. Sample packages are first put into an evacuation test chamber that is tightly fitted and has an external vacuum source. A predetermined vacuum level is selected for the test based on the test sample and required level of sensitivity. The next step is to evacuate the test chamber and test system dead space for a certain amount of time. Differential pressure transducers are used to track changes in vacuum level over time. A pressure increase above the specified pass/fail limit indicates that the container is leaking.

• Non-destructive, non-subjective, no sample preparation.
• Accurate, reliable, repeatable results.
• Definite pass/fail result based on quantitative test data.
• Accommodates multiple packaging formats.
• Eliminates destructive, subjective testing methods.
• Effective in detecting even minute leaks.