Environmental conditions for real time samples - Shelf life study

[Balachander]

Hi,

Storage condition for our product is 5-25C. We are currently planning on performing shelf life extension studies. For AA calculation, we used TRT = 25C.

To avoid expenses for storing real time and accelerated samples in an external lab, we decided to keep it in our warehouse which can monitor Temp/RH but not controlled.

Per ASTMF1980 - Section 7.4.9 says, Actual real time aging temp may differ from the temp used for accelerated AA duration but there is no clear
directive as to how much can the temp differ.

our options at the moment ?

1. Store in a uncontrolled space with RH/Temp monitored ? No temp ranges defined.
2. Store in a controlled space with defined ranges (15-35C) and target mean temp is 25C. our product is labelled with storage condition 5-25C
3. Store in a controlled space at external lab - 25C +- 2C

Can you tell me what's the current requirement per FDA for real time conditions and any applicable standards that can guide us.

Thanks,
Bala

 

[planB]

Balachander,

two questions ahead:

- (Increased) Temperature is a typical driver for aging/degradation: what is the reason that you restrict your permissible temperature range also to the lower end?
- from your risk management and/or verification/validation experience: is increased/decreased humidity also a driver for aging for your product?