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Medical Device Package Testing

Medical device package testing evaluates the safety and efficacy of medical devices. The packaging of medical devices must be designed to protect the product from damage and contamination during shipping, handling, and storage. Furthermore, it must also ensure the sterility and integrity of the device until it reaches the end-user. Therefore, the medical device package must undergo thorough testing to ensure that it meets regulatory requirements and industry standards.

Medical device packaging testing is a complex process. Generally, it involves a series of tests to evaluate the packaging’s performance under various conditions. The testing protocol varies depending on the type of device and packaging, but it generally includes the following tests:

Integrity testing: This test evaluates the package’s ability to maintain its seal and protect the device from contamination. Package integrity testing can be performed using various methods, including visual inspection, dye penetration, and vacuum decay.

Strength testing: This test evaluates the package’s ability to withstand external forces. This includes compression and vibration, during shipping and handling. Strength testing is performed using various methods, including drop testing, compression testing, and vibration testing.

Sterility testing: This test evaluates the package’s ability to maintain the sterility of the device until it reaches the end-user. This test can be performed using various methods, including microbial challenge testing and sterility testing.

Environmental testing: This test evaluates the package’s ability to withstand exposure to various environmental conditions, such as temperature, humidity, and light. This test can be performed using various methods, including accelerated aging testing and thermal cycling testing.

Transport simulation testing: This test evaluates the package’s ability to protect the device during shipping and handling. This test can be performed using various methods, including the ASTM D4169 test method, which simulates different transportation environments.

Medical device transit testing is essential to ensure that the device and its packaging meet regulatory requirements and industry standards. Generally, medical device manufacturers have to provide evidence of the packaging’s safety and efficacy as part of the device’s pre-market approval process.

In addition to regulatory requirements, medical device manufacturers must also comply with industry standards, such as ISO 11607. The ISO 11607 standard test method evaluates the design and validation of medical device packaging. ISO 11607 requires manufacturers to perform various tests to ensure the packaging’s safety and efficacy.

Medical device transportation testing helps ensure the safety and efficacy of medical devices. The testing process requires the use of various test methods to evaluate the packaging’s performance under various conditions. Test results demonstrate that the packaging can protect the device from damage and contamination during shipping, handling, and storage, maintain its sterility until it reaches the end-user.

Companies partner with Keystone Package Testing because we take pride in being a full-service testing laboratory that delivers accurate testing and reports in a timely fashion. Our customers appreciate the transparency and experience that we bring to every test.

Please contact us or request a quote if you are ready to start your regulatory compliance testing. We look forward to working with you.