Good Practices for ASTM 4332-22

Dears,

I am seeking opinions and good practices for applications of ASTM 4332 into the test scenarios of trasport testing of medical devices packaging.

Best to my knowledge, the aim of implementing this norm, is to sumbit the samples to field conditions that are more or less likely to be observed in our distribution routes and may have impact on packaging/device. I found in various sources, that most common practice is to precondition the specimen in 3 conditions (subzero, e.g -18/tropical/dessert).

I would like to understand if I should e.g.:

- use fixed sequence : from coldest to hottest?
- add conditioning in ambient conditions inbetween extremes (subzero-ambient-tropical-ambient-desert)?
- how to establish if e.g. 24h extreme conditions is sufficient?

Looking forward to hear your comments.

HermanKruger said:

conditions that are more or less likely to be observed in our distribution routes and may have impact on packaging/device

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This. We don't know anything about your product, so you won't find an answer here. You need to determine what the packaging will ensure during during transport and test accordingly. I'm guessing that you won't be doing package testing yourself, so the best resource would be for you to discuss this with your package testing service provider.

indubioush said:

This. We don't know anything about your product, so you won't find an answer here. You need to determine what the packaging will ensure during during transport and test accordingly. I'm guessing that you won't be doing package testing yourself, so the best resource would be for you to discuss this with your package testing service provider.

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I am not seeking advice on how to test certain product, rather general opinions on aspects reated to ASTM D4332: for example - how deep into climate details you'd investigate (e.g. sterilized, IIa class product)? Is there a consensus worst case scenario for world wide shippments.