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Preventing Damage and Maintaining a Sterile Barrier: Why Medical Device Distribution Testing is Necessary

Medical devices must be reliably shipped across the country and around the world to arrive intact at their destinations for a positive impact on human health. Yet improper packaging preparation can mean the sometimes life-saving medical devices arrive in less-than-optimal condition. Medical device manufacturers must take all mandated and recommended packaging steps to ensure such a dismal outcome does not come to pass. That includes medical package testing.

Transit testing is the distribution simulation testing aspect of the medical package testing process and is important for verifying the medical device will not be damaged and the sterile barrier integrity can be preserved to meet compliance requirements. If the packaging is not robust enough or was designed for something other than what is packed inside, it may not arrive to the end user in one piece.

Aspects to distribution testing

Medical device distribution testing aspects range wide to include environmental conditioning, distribution testing itself and package testing.

Environmental conditioning

Environmental conditioning simulates what could be typical or extreme environments that the medical device packaging will encounter. There are many unforeseen environments packaging may be subjected to during transit, which necessitates testing to a wide range of temperature and humidity ranges. These include testing to a cold environment, and hot and humid environment and an extreme heat and dry environment. An important consideration for this type of testing: there is no “fast” way to achieve it. Each test requires a full 72 hours to truly measure the packaging resiliency.

Distribution simulation testing

Distribution testing is often called “shake, rattle and roll” testing and it’s fairly obvious why. It includes vibration testing, drop testing and compression testing. Ultimately the goal is to simulate any possible circumstance packaging may have to endure, from being tossed into a truck, driven over bumpy roads, or stacked beneath other boxes of varying weights.

Medical package testing

Package testing performs the necessary test challenges to ensure a medical device’s sterile barrier will remain intact and in place. It also tests for any damage done to the device: are the parts secure and undamaged? Are things rattling around in the package? These are noted in the testing to ensure changes can be made and support future transit success.

Timeline for testing

Distribution testing requires a specific amount of time to meet industry standards and requirements, and ultimately guarantee successful packaging. There should also be a written protocol for distribution testing. Questions your service provider may ask include:

Have you gone through this process before with this product?

Is this the first time you’re using this type of packaging?

Are your familiar with what to expect from the testing?

Speak with your service provider to get their recommendations based on your specific medical device, how you’ve tested it in the past and potential improvements that can be made.

Sample sizes

Many medical device manufacturers wonder what the required sample size will be for distribution testing, and there is no standard, average answer. However, a sample size of 30 would be common, and perhaps 60 if there is higher risk. Basically, it all leads back to the internal risk analysis that should be performed on the device itself. Sample sizes will vary. Your service provider can guide you to make the best decisions.

The best outsourced service provider

Life Science Outsourcing specializes in medical device distribution testing. Our 25+ years of industry experience offers the knowledge and insight you can count on to make your next distribution testing a success – and give you peace of mind that your valued medical device will arrive in one piece to its destination with the sterile barrier still intact. Contact us today at info@lso-inc.com or (714) 672-1090 for your next successful medical package testing and distribution testing needs.

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