Atmospheric Conditioning of Medical Devices

Altitude Conditioning Testing for Medical Devices

Atmospheric conditioning of medical device packages evaluates the performance and safety of packaging materials. It involves subjecting packaged medical devices to different atmospheric conditions, such as temperature and humidity, to evaluate the packaging’s ability to protect its contents during transportation and storage.¬†

This testing is essential in ensuring that medical devices remain safe and effective; particularly in environments where atmospheric conditions can have significant implications for the integrity of the packaging.

Summary of Medical Device Atmospheric Conditioning Testing

Medical devices are often sensitive to environmental factors, and changes in temperature or humidity can cause damage or degradation. During transportation and storage, medical devices are subjected to various environmental stresses, including temperature and humidity fluctuations. Atmospheric conditioning tests evaluate the ability of packaging materials to withstand these stresses and protect the device during transit.

Atmospheric conditioning testing also helps identify if medical devices 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. If a package fails to adequately protect the device inside, it could become contaminated, rendering it unusable and potentially causing harm to patients. By subjecting packaging to temperature and humidity conditioning tests, manufacturers can identify weaknesses in their packaging materials and address these issues before they become a problem.

Many countries have strict regulations governing the packaging and transportation of medical devices. In the United States, for example, the Food and Drug Administration (FDA) requires that medical device packaging be designed to protect the device from damage during normal transportation and handling, including exposure to temperature and humidity changes. By conducting atmospheric conditioning tests, manufacturers can ensure that their packaging meets these regulatory requirements, reducing the risk of non-compliance and associated penalties or fines.

By evaluating the results of atmospheric conditioning 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 Altitude Conditioning Testing

Keystone Package Testing is an ISTA-certified cold chain package test lab with dozens of thermal chambers. Our chambers range from small reach-ins to large walk-ins and we can test individual samples to oversized pallets. 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 atmospheric conditioning needs.