Shelf Life of Non-Sterile Disposable Drug Inhaler

Y

Y-Spi

Hello everyone,

We are developing a drug inhaler, which is supplied with a disposable mouthpiece. The mouthpiece is not sterile and the device is intended for single patient use.
The user is instructed to replace the mouthpiece whenever they replace the drug container (about once a month) - the reason for this is mostly commercial / aesthetic.

We don't know of any possible deterioration of the mouthpiece, if properly stored, so there is no "real" shelf life.

Is it a must to indicate the shelf life on the mouthpiece's package? on the mouthpiece itself?

thank you
 
N

NikkiQSM

Quite Involved in Discussions
I do not know if a shelf-life is required. Why not look into the shelf life of the material used to make the mouth piece? I assume it is a type of polymer?

You can then base your shelf-life on the documented shelf-life of the polymer itself. if you find that the shelf-life of the polymer is indefinite, then you have documentation to support your statement that the mouth piece has no shelf-life.
 
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