Temperature Profile for Transport Simulation (Sterile Eye Drops)

[Riskophil]

Hi folks,

we are developing and producing sterile eye drops and would like to learn more about transport simulation.

As far as I know ISO 11607 is a good starting point. Various ASTM standards are listed to test several properties like mechanical shock, vibration and so on.
However, the most critical part for our products defenitely is temperature and humidity (according to our stability studies).

Now we are looking for the worst case scenarios that would simulate a transport by sea, land and air worldwide.

I thought that ASTM D 4332 might be helpful but after buying it, I can say it is not helping at all.

So do you maybe have a good rationale and/or simulation scenario or maybe a standard that could help us?

Thank you in advance.

Phil

 

[Ronen E]

Hi Phil,

Not sure what exactly you're looking for - the temperature profile for simulating worst case transport scenario? That would be driven by the actual supply routes, so you'd have to analyse them first. Otherwise your simulation might be an overkill.

Perhaps have a look at the ISTA website. It's not necessarily focused on sterile or even medical products, but it provides a systematic way of evaluating packaging.

Cheers,
Ronen.