Medical device package altitude testing evaluates the ability of medical device packaging to protect its contents during transportation and storage at high altitudes. This testing determines if medical devices remain safe and effective during use, particularly in environments such as aviation, mountainous areas, or space travel, where reduced atmospheric pressure can have significant implications for the integrity of the packaging.
During transportation and storage, medical devices are subjected to a variety of stresses. These stresses include changes in temperature, humidity, and air pressure. At high altitudes, the reduced air pressure can cause packaging materials to expand or contract. This may potentially compromise the device’s safety and efficacy.
Summary of Altitude Testing for Medical Device Packaging
Medical device package altitude testing evaluates the ability of packaging materials to withstand these stresses and protect the device during transit.
The testing process involves subjecting the packaged device to reduced air pressure to determine the packaging’s performance. This can happen either in a simulated environment or at high altitudes.
More specifically, altitude testing can identify any potential issues that could compromise the device’s safety, such as leaks or damage to the packaging materials.
Many medical devices are fragile and require careful handling to prevent damage or contamination. By subjecting packaging to altitude testing, manufacturers can find weaknesses in their packaging materials and address these issues before they become a problem.
In addition to protecting medical devices from damage, altitude package and compliance testing also determinines if packages will remain sterile and free from contamination. Medical devices are often used in environments where cleanliness is essential, such as operating rooms or other sterile environments
On the other hand, if a package fails to adequately protect the device inside, it could become contaminated, rendering it unusable and potentially causing harm to patients.
Many countries have regulations governing the packaging and transportation of medical devices. In the United States, the Food and Drug Administration (FDA) requires that medical device packaging be designed to protect the device during normal shipping and handling, including transportation at high altitudes.
By conducting package altitude testing, manufacturers can ensure that their packaging meets these regulatory requirements. This will end up reducing the risk of non-compliance and associated penalties or fines.
In addition, compliance with these regulations helps to build trust and confidence in medical device manufacturers and their products, which can be a significant competitive advantage in the marketplace.
Package altitude testing can help manufacturers identify opportunities to improve their packaging materials and design. By evaluating the results of package altitude testing, manufacturers can identify areas where their packaging is weak and make changes to improve its performance. This can lead to better protection for medical devices during transit and storage, reducing the risk of damage or contamination and ultimately improving patient outcomes.
Expert Medical Device Altitude Testing
Keystone Package Testing is an ISTA-certified packaging test lab with multiple altitude chambers. We provide short lead times on scheduling and competitive pricing. 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 altitude testing.