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Accelerated Shelf Life Justification

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aescroggins

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Posted 25 January 2016 - 06:20 PM

Hello Everyone!  

At my company we have been trying to find justification for some accelerated shelf life testing we have been working on.  We do not have a controlled temperature/humidity box.  We do have a hot environment in our facility where we have been putting products to see an acceleration of changes that may occur over time.  I currently am monitoring the temperature and humidity and the temp appears to fluctuate be between 85 and 95 degrees F.  I am wondering if there is any way I can turn this into reliable results or if we just need to purchase a controlled temp box that will keep the temp the same at all times?  Does anyone know where I might be able to find research on this topic or information from a legitimate source showing 1 week at 90 degrees F= 1 month of accelerated shelf life?

Thanks!



MWidra

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Posted 25 January 2016 - 09:45 PM

Any statement that higher temps is equivalent to a longer storage time at lower temps will need to be validated.  You will need to measure the important changes in your product that you see at standard storage temps (what ever those are).  You will then need to measure those same parameters in product stored at the higher temps at several time points.  That way, you can show when the higher temp is equivalent to your standard shelf life at the standard temp.  You will also need to show that the higher temp does not cause changes that are NOT seen in the standard storage conditions.

 

As for how to maintain the higher temp, if you put up a data logger and average the temp in your production area, at least you have a measurement of the average difference between your standard condition and your test condition.  But, if you can't control the test condition, or if it is very variable, then you may need to throw out some of your future testing if the average is different than your validation model.  Better to get a temperature controlled box, it will make your validation and subsequent verifications much more reliable.

 

Martha


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Charles.C

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Posted 26 January 2016 - 12:06 AM

Hi aescroggins,

 

The attachments in post below and its  indicated sub-link illustrate the use of ASLT in some detail. But, as noted in previous post, the lack of an accurately controlled temperature may be  limiting.

 

http://www.ifsqn.com...ant/#entry96746

 

PS Welcome to the Forum !  :welcome:


Kind Regards,

 

Charles.C


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aescroggins

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Posted 26 January 2016 - 02:58 PM

Hello Martha and Charles,

 

I really appreciate you both taking the time to comment.  Right now I am monitoring the temperature variation where I would like to do accelerated testing.  I am afraid that the temperature is going to go too high and induce changes that would not occur over the shelf life at ambient conditions.  It seems that the easiest and most reliable method would be to purchase a controlled testing box.  Thank you for the link to the other thread- it looks like there is some very helpful information there.

Thanks,

Anna 





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