Accelerated Stability Studies - In vitro Diagnostic Devices

[Vincnet]

Hello all,
we are manufacturing In vitro Diagnostic Devices, one of the requirements put on us is to determine our products shelf life or stability. One way to do so, is real time studies (this takes quite a long time as one might understand).
I heard about accelerated stability studies, but could find anything on the subject.
Could someone suggest me some path where to dig info from ?

Thanks per advance

V

[Aaron Lupo]

Originally Posted by Vincnet

Hello all,
we are manufacturing In vitro Diagnostic Devices, one of the requirements put on us is to determine our products shelf life or stability. One way to do so, is real time studies (this takes quite a long time as one might understand).
I heard about accelerated stability studies, but could find anything on the subject.
Could someone suggest me some path where to dig info from ?

Thanks per advance

V

Vincnet- Funny you should ask. the company I work for does shelf life studies for many medical device companies.We do shelf life/accelerated aging. Drop me a line at alupo@stsduotek.com

Hello Vincnet, Well being a person from Pharmaceutical background we normally deal with this accelerated studies in terms of detyermining the shelf life of our formulations. Normaly we follow these guidelines :
if storage temp. is 25 degrees or 30 degree,an accelerated study of 6 months at 40 degrees and 75 % RH is sufficient to claim shelf life of two years.
if the storage condition is 2-8 , then accelearted conditions are 25 degrees and 60 % RH.
We have many a guidelines giving the justification for the same. Here is a link to one :
ich guidelines
hope this helps,
cheers abhishek