Packaging helps in protecting medical devices from various environmental factors during transportation, storage, and handling. By subjecting medical device packages to rigorous testing in extreme conditions, manufacturers can identify any weaknesses in their packaging design or materials and make the necessary improvements to ensure that the device remains safe and effective in real-world conditions.
Medical devices are often shipped over long distances and may be subjected to various environmental factors. These factors include temperature changes, humidity, and pressure fluctuations.
Summary of Package Testing to Environmental Extremes
Testing the packaging in extreme environments allows manufacturers to evaluate the packaging’s ability to protect the device from these factors during transit and storage. This can help to identify any weaknesses in the packaging design and materials. Testing also helps make necessary improvements to ensure that the device arrives at its destination in good condition.
Packages used in extreme environments like high altitudes or low-pressure environments need to withstand the stresses of the conditions mentioned above.
Additionally, testing the packaging in these environments can help manufacturers identify any issues that may arise such as changes in pressure or temperature that could affect the device’s performance. This can help ensure that the device remains safe and effective for its intended use.
Many countries have strict regulations governing the safety and performance of medical devices, and these regulations often require that devices be tested to environmental extremes. For instance, the US FDA requires that medical device packages be tested to ensure they can withstand environmental factors like extreme temperatures and humidity. By testing their packaging to these extremes, manufacturers can ensure that they meet these regulatory requirements and avoid any potential penalties or fines.
By subjecting packages to extreme conditions, manufacturers can identify any weaknesses in their design or materials that may need to be addressed. This can lead to improvements in the packaging’s ability to protect the device from environmental factors, ultimately enhancing the device’s safety and performance.
Expert Medical Device Package Testing to Environmental Extremes
Keystone Package Testing is an ISTA-certified cold chain package testing lab that tests medical devices to environmental extremes. Our service is one of the drivers behind us being one of the fastest-growing package testing companies in the country.
Please request a quote or contact us at (724) 698-2994 to see firsthand why so many companies partner with Keystone Package testing for their environmental extremes package testing.