Regulations covering Sterile product shipments

D

DrLee

Registered
#1
#1
I manufacture a Class 1 Medical Device overseas. I also manufacture Clean/Non-Sterile Product. Is anyone aware of a regulation that would prevent me from shipping these products in the same Container (trailer) from Asia to the US? Sterile product is contained on a pallet with each carton protected and the entire pallet protected. Clean/Non-Sterile product is also contained. Current policy is that any damage to any sterile packaging negates the sterility and the product cannot be used as sterile product.
 
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E

ECHO

Involved In Discussions
#2
#2
I think as along as the product is being shipped in the configuration that was used during transit testing (with sterilization testing at the end), I think you should be okay.
 
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