Storage Conditions of 5-40 Celsius - Accelerated and real time aging - Dilemma

shimonv

Trusted Information Resource
#1
Hi fellows,
We got an odd finding:
The label on our device indicates storage conditions of 5-40 Celsius.
The accelerated and real time aging was done at 22 Celsius (ambient), which is the common practice. The common storage is done at room temperature; the the upper and lower limits (5, 40 Celsius) accounts for possible temperature conditions during transport.
Now we are challenged to amend the storage conditions or repeat the shelf life study to cover the entire temperature range.

Any advise on how to respond?

Thanks,
Shimion
 
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s27bax

Starting to get Involved
#3
It could easily go below 10 or above 30 in standard warehouse conditions. We are investigating a similar situation and are monitoring warehouse temperature fluctuations from 5 points and ground and top rack height, to gather data.

Id be interested to hear how you get on Shimion
 

planB

Super Moderator
#4
Shimion,

from what you reported, the finding is actually justified: if you performed real-time aging at 22°C and acc. aging for this reference temperature, then 22°C (or "room temperature") is the maximum substantiated storage temperature.

If you want to allow storage up to 40°C you have to actually test at this temperature in real time, and maybe not under accelerated conditions, since your acceleration factor will significantly drop at such high reference temperatures.

Transport: 5°C as lower boundary and 40°C as upper boundary for distribution is rather special: do you have a documented rationale why you cannot exceed these limits during distribution? If yes - fine; if no, have a look at temperature ranges recommended in e.g. ISTA 2A, a typical guidance document used for transport simulations.

HTH,

Gerhard
 
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