R
raghuramas
Hello Friends,
Wishes.
I wish to have forum friends great advice before getting in to the process.
My product is medical device (MDD,class III). Due to various commercial reasons my management asked me to extend the shelf life of my product to 5 years. I am planning to do acceletated stability testing at 40 °C for 555 days using Arrehenius theory with Room Temperature 22 °C ( my products are stored at this temperature ). To avoid the time gap is it acceptable to take 2006 - 04 (mfg date) product for this study and age it for 333 days.
Regards,
Raghu
Wishes.
I wish to have forum friends great advice before getting in to the process.
My product is medical device (MDD,class III). Due to various commercial reasons my management asked me to extend the shelf life of my product to 5 years. I am planning to do acceletated stability testing at 40 °C for 555 days using Arrehenius theory with Room Temperature 22 °C ( my products are stored at this temperature ). To avoid the time gap is it acceptable to take 2006 - 04 (mfg date) product for this study and age it for 333 days.
Regards,
Raghu