Accelerated shelf life testing
Dear all,
I'm approaching for the first time the accelerated shelf life test. I haven't found any ISO guideline or something similar. We have a calibrated oven where we can store the product (we produce grain, grain flakes...all the products are dried and need cooking before eating) at 40 °C. I would like to know the formula (if exist) that converts the normal time in the accelerated one. I mean a week in an oven corresponds to 1 month at an ambient temperature of about 25 degree? In the event of audits, which is the bibliographic sources I can quote as reference?
thanks a lot
Michela
Hello Michaela,
There are lots of factors to consider in conducting ASLS. Temp., %RH, packaging and the nature of your product. Let the TPL conduct the ASLS for you and you have to undergone training about ASLS.
Regards,
redfox
AOAC and ICH guidelines can provide you good insights on conducting ASLT. You can design your shelf-life study considering your products chemistry.
Accordingly the accelerated conditions can be defined.
ICH guidlines mentions to claim 3 months for 1 months ASLT.
Regards,
Meena
AOAC and ICH guidelines can provide you good insights on conducting ASLT. You can design your shelf-life study considering your products chemistry.
Accordingly the accelerated conditions can be defined.
ICH guidlines mentions to claim 3 months for 1 months ASLT.
Regards,
Meena
Hi Meena,
Can you suggest a specific link to the above guidelines for ALST ?. I don't recall ever seeing such discussions.
www.ich.org
Otherwise also there are references which mention Arrhenius equation as the basis for 1 month (accelerated) to 3 months (Ambient). Need little googling :smile:
Regards,
Meena
www.ich.org
Otherwise also there are references which mention Arrhenius equation as the basis for 1 month (accelerated) to 3 months (Ambient). Need little googling :smile:
Regards,
Meena
Based on my googling, "nada".
But thanks anyway.
PS - except of course for the various ASLT posts i have previously made here.
Dear Michaela,
IMO, i would suggest you undergo training from govt or any private entity (ex; SGS, like we did) that could provide you how to conduct ASLS. CB would ask a training certificate from the person who conduct ASLS on your company.
regards,
redfox