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Accelerated shelf life testing


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#1 michela78

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Posted 12 May 2016 - 09:28 AM

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



#2 redfox

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Posted 12 May 2016 - 09:46 AM

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



#3 Mesha

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Posted 26 May 2016 - 05:37 AM

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


Regards,

 


#4 Charles.C

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Posted 26 May 2016 - 06:15 AM

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.


Kind Regards,

 

Charles.C


#5 Mesha

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Posted 26 May 2016 - 06:31 AM

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


Regards,

 


#6 Charles.C

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Posted 26 May 2016 - 06:45 AM

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.


Kind Regards,

 

Charles.C


#7 redfox

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Posted 26 May 2016 - 07:22 AM

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






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