Packaging validation for non-sterile Medical Equipment

Yaara

Registered
#1
Hello,

We developed an opto-elcto-mechanical device that is non-sterile, rather large (30 Kg in weight), and pretty expansive.
We are about to ship our first and only device, and looking at the ASTM D4169 standrad, I am horrified! I expect many of the test sound destructive to the gentle optics. Can we waive the various vibration and drop tests according to ASTM D4169, and instead attach a drop-and-tip indicators along with a post-intallation acceptance tests?
Thank you
 
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craiglab

Involved In Discussions
#2
You want to consider the transit environment early in the design, especially if you may need to add support/locking mechanisms for the optics or require field replacement/alignment. Adding drop and tip indicators and box labeling will not guarantee better handling. For that you may want to consider a white glove service, which can be expensive. But then you can test to DC-2 in D4169 per the conditions of the white glove service. You really want to pilot test shock and vibration and characterize how the product will be affected long before D4169. I would not want to use post-installation testing to catch shipping problems. That carries a lot of business risk.
 
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